Ohio
Medicaid
Pharmacy Benefit Management Program
Unified Preferred Drug
List
Medicaid Fee-for-Service
and Managed Care
Plans
Effective July 1, 2023
Ohio Medicaid Unified PDL effective July 1, 2023 2
Helpful Links
Prior Authorization (PA)
Prior Authorization (PA) Information |
pharmacy.medicaid.ohio.gov
• General Prior Authorization Requirements
• PA and Step Therapy Frequently Asked Questions
(FAQ)
Unified Preferred Drug List (UPDL)
Ohio Unified Preferred Drug List | pharmacy.medicaid.ohio.gov
• Unified Preferred Drug List (UPDL)
Terminology/Abbreviations:
AR (Age Restriction) – An edit allowing claims for members within a defined age range to be covered without PA
BvG (Brand Preferred Over the Generic) – The brand name drug is preferred over the generic equivalent
PA (Clinical Prior Authorization) – A prior authorization (PA) is required before the drug will be covered
QL (Quantity Limit) – A limit on the quantity that will be covered within a given time frame
ST (Step Therapy) – Drug requires a trial with one or more preferred drugs before being covered
General Information
- The Statewide UPDL is not an all-inclusive list of drugs covered by Ohio Department of Medicaid.
- Medications that are new to market will be non-preferred, PA required until reviewed by the Ohio Department of
Medicaid Pharmacy and Therapeutics (P&T) Committee.
- The document is listed in sections defined by therapeutic class. Drugs are listed by generic name if a generic is
available unless the brand name of the drug is preferred. In most cases, when a generic for a brand-name drug is
available, the generic drug will be preferred, and the brand name will be non‐preferred. Some drugs may also require
a specific manufacturer or the brand to be dispensed.
- Ohio Department of Medicaid will only cover drugs that are part of the Medicaid Drug Rebate Program, with limited
exceptions. This document may not reflect the most current rebate status of a drug (i.e., a drug may be listed on the
document but is non-rebateable and therefore non-payable).
- Some therapeutic categories are grandfathered. These categories will be denoted with an “*” next to their title on the
table on contents and their place within the criteria document.
- Some therapeutic categories may have quantity limits on specific drugs detailed in the criteria document, however
this is not an all-inclusive list. For a list of the quantity limits on specific drugs, please reference the Quantity Limit
Document found here: Quantity Limits Document | pharmacy.medicaid.ohio.gov
Ohio Medicaid Unified PDL effective July 1, 2023 3
New UPDL Criteria Format
- With a few minor exceptions, all therapeutic categories have the same standardized outline format. The design of this
new format is intended to have a cumulative approach bottom-to-top.
Example Category
LENGTH OF AUTHORIZATIONS: X days or Initial: X days; Subsequent: X days (if different)
GRANDFATHERING*:
Patients who have a claim for a non-preferred drug in the previous 120 days will be automatically approved to continue the
drug. Patients who have taken the drug previously, but do not have claims history (e.g. new to Medicaid), will need to submit
a prior authorization in order to continue coverage.
ALL AUTHORIZATIONS: Must be
prescribed in accordance with FDA approved labeling
CLINICAL PA CRITERIA (if applicable):
“DRUG” CRITERIA (if applicable):
STEP THERAPY CRITERIA:
•
Must have had an inadequate clinical response of at least X days with at least X preferred drugs
NON-PREFERRED CRITERIA:
• Must provide documentation of medical necessity beyond convenience for why the patient cannot be changed to a
preferred drug (i.e., allergies, drug-drug interactions, contraindications, or intolerances) OR
o For any nonsolid oral dosage formulation: must provide documentation of medical necessity for why patient
cannot be changed to a solid oral dosage formulation
•
Must have had an inadequate clinical response of at least X days with X preferred drugs
o For non-preferred extended-release formulations: must provide documentation of an inadequate clinical
response
with its immediate release formulation (if available)
o For non-preferred brand names that have preferred generics: must provide documentation of an inadequate
clinical response or allergy to two or more generic labelers (if available)
ADDITIONAL “DRUG” CRITERIA (if applicable):
ADDITIONAL INFORMATION (if applicable):
SUBSEQUENT AUTHORIZATION CRITERIA:
• Must provide documentation of patient’s response to treatment from baseline and/or attestation of clinical
stabilization
QL – Drug: X doses per X days
AR – a PA is required for patients X years and older OR younger than X years
Ohio Medicaid Unified PDL effective July 1, 2023 4
Interpretation of New UPDL Criteria Format
- Beginning January 2023 and with a few minor exceptions, all therapeutic categories have the same standardized outline
format. The design of this new format is intended to have a cumulative approach bottom-to-top. The following
scenarios will aid in illustrating this point:
Scenario 1: Clinical PA drug
- All Authorizations
- Clinical PA Criteria
Scenario 2: Clinical PA drug with drug-specific criteria
- All Authorizations
- Drug-Specific Criteria
Scenario 3: Step-Therapy drug
- All Authorizations
- Clinical PA Criteria (if applicable)
- Step Therapy Criteria
Scenario 4: Non-Preferred drug
- All Authorizations
- Clinical PA Criteria (if applicable)
- Step Therapy Criteria (if applicable)
- Non-Preferred Criteria
Scenario 5: Non-Preferred drug with drug-specific criteria
- All Authorizations
- Clinical PA Criteria (if applicable)
- Step Therapy Criteria (if applicable)
- Non-Preferred Criteria
- Additional Drug-Specific Criteria
Ohio Medicaid Unified PDL effective July 1, 2023 5
Table of Contents
Analgesic Agents: Gout ....................................................................................................................... 8
Analgesic Agents: NSAIDs ................................................................................................................... 9
Analgesic Agents: Opioids ................................................................................................................. 10
Blood Formation, Coagulation, and Thrombosis Agents: Colony Stimulating Factors ........................... 13
Blood Formation, Coagulation, and Thrombosis Agents: Hematopoietic Agents .................................. 14
Blood Formation, Coagulation, and Thrombosis Agents: Hemophilia Factors* ..................................... 15
Blood Formation, Coagulation, and Thrombosis Agents: Heparin-Related Preparations....................... 16
Blood Formation, Coagulation, and Thrombosis Agents:
Or
al Anticoagulants ...................................... 17
Blood Formation, Coagulation, and Thrombosis Agents:
Or
al Antiplatelet .......................................... 18
Cardiovascular Agents: Angina, Hypertension & Heart Failure............................................................. 19
Cardiovascular Agents: Antiarrhythmics ........................................................................................... 21
Cardiovascular Agents: Lipotropics ................................................................................................... 22
Cardiovascular Agents: Pulmonary Arterial Hypertension* ................................................................ 24
Central Nervous System (CNS) Agents: Alzheimer’s Agents* ............................................................. 25
Central Nervous System (CNS) Agents: Anti-Migraine Agents, Acute................................................... 26
Central Nervous System (CNS) Agents: Anti-Migraine Agents, Cluster Headache ................................. 27
Central Nervous System (CNS) Agents: Anti-Migraine Agents, Prophylaxis .......................................... 28
Central Nervous System (CNS) Agents: Anticonvulsants* .................................................................. 30
Central Nervous System (CNS) Agents: Anticonvulsants Rescue ......................................................... 32
Central Nervous System (CNS) Agents: Antidepressants* .................................................................. 33
Central Nervous System (CNS) Agents: Attention Defic
it
Hyperactivity Disorder Age
nts
...................... 35
Central Nervous System (CNS) Agents: Atypical Antipsychotics* ......................................................... 35
Central Nervous System (CNS) Agents: Fibromyalgia Agents .............................................................. 38
Central Nervous System (CNS) Agents: Medication
Assisted
Treatment of Opioid
Addiction
............... 39
Central Nervous System (CNS) Agents: Movement Disorders .............................................................. 41
Central Nervous System (CNS) Agents: Multiple Sclerosis* ................................................................ 42
Central Nervous System (CNS) Agents: Narcolepsy ........................................................................... 43
Central Nervous System (CNS) Agents: Neuropathic Pain .................................................................. 44
Central Nervous System (CNS) Agents: Parkinson's Agents ................................................................ 45
Central Nervous System (CNS) Agents: Restless
L
egs
Synd
rome .......................................................... 46
Central Nervous System (CNS) Agents: Sedative-Hypnotics, Non-Barbiturate ...................................... 47
Central Nervous System (CNS) Agents: Skeletal
Mus
cle Relaxants,
Non
-
Ben
z
odia
zep
ine
..................... 48
Central Nervous System (CNS) Agents: Smoking Deterrents .............................................................. 49
Dermatologic Agents: Oral Acne Products ........................................................................................ 50
Dermatologic Agents: Topical Acne Products ..................................................................................... 51
Ohio Medicaid Unified PDL effective July 1, 2023 6
Endocrine Agents: Androgens ........................................................................................................... 52
Endocrine Agents: Diabetes – Hypoglycemia Treatments .................................................................. 53
Endocrine Agents: Diabetes – Insulin ............................................................................................... 54
Endocrine Agents: Diabetes –
Non
-
Insulin
........................................................................................ 56
Endocrine Agents: Endometriosis ...................................................................................................... 57
Endocrine Agents: Estrogenic
A
gen
ts
............................................................................................... 58
Endocrine Agents: Growth Hormone ................................................................................................ 59
Endocrine Agents: Osteoporosis – Bone
Ossi
fic
ation
Enh
ancers ......................................................... 61
Endocrine Agents: Progestin Agents................................................................................................. 62
Endocrine Agents: Uterine Fibroids .................................................................................................. 63
Gastrointestinal Agents: Anti-Emetics .............................................................................................. 64
Gastrointestinal Agents: Crohn’s Disease.......................................................................................... 65
Gastrointestinal Agents: Hepatic Encephalopathy ............................................................................. 66
Gastrointestinal Agents: Irritable Bowel Syndrome (IBS) with Diarrhea ............................................. 67
Gastrointestinal Agents: Pancreatic Enzymes .................................................................................... 68
Gastrointestinal Agents: Proton Pump
Inhibitors
.............................................................................. 69
Gastrointestinal Agents: Ulcerative Colitis ........................................................................................ 70
Gastrointestinal Agents: Unspecified GI ........................................................................................... 71
Genitourinary Agents: Benign Prostatic Hyperplasia ......................................................................... 72
Genitourinary Agents: Electrolyte Depleter Agents ........................................................................... 73
Genitourinary Agents: Urinary Antispasmodics ................................................................................. 74
Immunomodulator Agents: Systemic Inflammatory Disease ............................................................... 75
Infectious Disease Agents: Antibiotics – Cephalosporins ................................................................... 77
Infectious Disease Agents: Antibiotics – Inhaled ................................................................................. 78
Infectious Disease Agents: Antibiotics – Macrolides .......................................................................... 79
Infectious Disease Agents: Antibiotics – Quinolones ......................................................................... 80
Infectious Disease Agents: Antibiotics – Tetracyclines ........................................................................ 81
Infectious Disease Agents: Antifungals ............................................................................................. 82
Infectious Disease Agents: Antivirals – Hepatitis C Agents ................................................................. 83
Infectious Disease Agents: Antivirals – Herpes .................................................................................. 84
Infectious Disease Agents: Antivirals – HIV* ..................................................................................... 85
Ophthalmic Agents: Antibiotic and
Antibiotic
-
St
e
roid
Combination Drops and
Ointm
e
nts
.................. 86
Ophthalmic Agents: Antihistamines & Mast Cell Stabilizers ............................................................... 87
Ophthalmic Agents: Dry Eye Treatments .......................................................................................... 88
Ophthalmic Agents: Glaucoma Age
nts
............................................................................................. 89
Ophthalmic Agents: NSAIDs ............................................................................................................. 90
Ohio Medicaid Unified PDL effective July 1, 2023 7
Ophthalmic Agents: Ophthalmic Steroids ......................................................................................... 91
Otic Agents: Antibacterial and
Antibact
e
rial/Steroid Combinations
................................................... 92
Respiratory Agents: Antihistamines – Second Generation ................................................................. 93
Respiratory Agents: Cystic Fibrosis .................................................................................................... 94
Respiratory Agents: Epinephrine Auto-Injectors ................................................................................ 95
Respiratory Agents: Hereditary Angioedema ..................................................................................... 96
Respiratory Agents: Inhaled Agents................................................................................................... 97
Respiratory Agents: Leukotriene Receptor Modifiers & Inhibitors ...................................................... 98
Respiratory Agents: Monoclonal Antibodies-Anti-IL/Anti-IgE ............................................................. 99
Respiratory Agents: Nasal Preparations .......................................................................................... 100
Respiratory Agents: Other Agents .................................................................................................. 101
Topical Agents: Antifungals ........................................................................................................... 102
Topical Agents: Antiparasitics ........................................................................................................ 103
Topical Agents: Corticosteroids ...................................................................................................... 104
Topical Agents: Immunomodulators .............................................................................................. 105
Ohio Medicaid Unified PDL effective July 1, 2023 8
Analgesic Agents: Gout
LENGTH OF AUTHORIZATIONS: 365 days except 180 days for Familial Mediterranean Fever
ALL AUTHORIZATIONS: Must be
prescribed in accordance with FDA approved labeling
CLINICAL PA CRITERIA:
• Must have had an inadequate clinical response with an NSAID and oral corticosteroid
within the last 30 days for acute gout diagnosis OR
• Must have had an inadequate clinical response of at least 30 days with the maximally
tolerated xanthine oxidase inhibitor dose for chronic gout diagnosis
NON-PREFERRED CRITERIA:
• Must provide documentation of medical necessity beyond convenience for why the
patient cannot be changed to a preferred drug (i.e., allergies, drug-drug interactions,
contraindications, or intolerances) OR
o For any nonsolid oral dosage formulation: must provide documentation of
medical necessity for why patient cannot be changed to a solid oral dosage
formulation
•
Must have had an inadequate clinical response of at least 30 days with at least one
preferred drug
o For non-preferred extended-release formulations: must provide documentation
of an inadequate clinical response
with its immediate release formulation (if
available)
o For non-preferred brand names that have preferred generics: must provide
documentation of an inadequate clinical response or allergy to two or more
generic labelers (if available)
ADDITIONAL COLCHICINE CAPSULE (MITIGARE) CRITERIA:
• Must have had an inadequate clinical response of 30 days with colchicine tablets
ADDITIONAL COLCHICINE SOLUTION (GLOPERBA) CRITERIA:
• Must be unable to swallow tablets or capsules for authorization of colchicine solution
SUBSEQUENT AUTHORIZATION CRITERIA:
• Must provide documentation of patient’s clinical response to treatment and ongoing
safety monitoring
QL – All colchicine products: 6 doses per claim for acute gout; 2 doses per day for 30 days for
chronic gout; 4 doses per day per 30 days for Familial Mediterranean Fever
Ohio Medicaid Unified PDL effective July 1, 2023 9
Analgesic Agents: NSAIDs
LENGTH OF AUTHORIZATIONS: Dependent upon the table below
Authorization Length
H. Pylori Treatment
30 days
Transdermal/Topical
90 days
All Other Treatments
365 days
ALL AUTHORIZATIONS: Must be
prescribed in accordance with FDA approved labeling
NON-PREFERRED CRITERIA:
• Must provide documentation of medical necessity beyond convenience for why the
patient cannot be changed to a preferred drug (i.e., allergies, drug-drug interactions,
contraindications, or intolerances) OR
o For any nonsolid oral dosage formulation: must provide documentation of
medical necessity for why patient cannot be changed to a solid oral dosage
formulation
•
Must have had an inadequate clinical response of at least 30 days with at least two
preferred drugs
o For non-preferred extended-release formulations: must provide documentation
of an inadequate clinical response
with its immediate release formulation (if
available)
o For non-preferred brand names that have preferred generics: must provide
documentation of an inadequate clinical response or allergy to two or more
generic labelers (if available)
SUBSEQUENT AUTHORIZATION CRITERIA:
• Must provide documentation of patient’s clinical response to treatment and ongoing
safety monitoring
AR – Naproxen Suspension: a PA is required for patients 12 years old and older
Ohio Medicaid Unified PDL effective July 1, 2023 10
Analgesic Agents: Opioids
**Ohio law requires prescribers to request and review an OARRS report before initially prescribing or personally
furnishing any controlled substance, such as an opioid analgesic or a benzodiazepine, and gabapentin**
LENGTH OF AUTHORIZATIONS: For the course of therapy, up to 180 days
ALL AUTHORIZATIONS: Must be
prescribed in accordance with FDA approved labeling
BUPRENORPHINE TOPICAL (BUTRANS) CRITERIA:
• Must provide documentation of an inadequate clinical response of at least 60
consecutive days
with at least one immediate release opioid formulation
• Must provide documentation of medical necessity for why patient cannot be changed to
a solid oral dosage formulation
MORPHINE SULFATE ER (KADIAN, MS CONTIN) & TAPENTADOL ER (NUCYNTA) CRITERIA:
• Must provide documentation of an inadequate clinical response of at least 60
consecutive days
with at least one immediate release opioid formulation
NON-PREFERRED CRITERIA:
• Must provide documentation of medical necessity beyond convenience for why the
patient cannot be changed to a preferred drug (i.e., allergies, drug-drug interactions,
contraindications, or intolerances) OR
o For any nonsolid oral dosage formulation: must provide documentation of
medical necessity for why patient cannot be changed to a solid oral dosage
formulation
•
Must have had
an inadequate clinical response of at least 7 days of at least two unrelated
preferred drugs
o For non-preferred extended-release formulations: must provide documentation
of an inadequate clinical response
with its immediate release formulation (if
available)
o For non-preferred brand names that have preferred generics: must provide
documentation of an inadequate clinical response or allergy to two or more
generic labelers (if available)
ADDITIONAL SHORT-ACTING OPIOIDS CRITERIA:
• The system defines an “initial request” as having no opioid claims in the previous 90 days
• Initial short-acting requests can be authorized up to 90 days
o Length of authorization is dependent on indication, previous patient utilization, and
requested length of therapy (could be more restrictive)
o To exceed acute opioid limits, documentation of the following must be provided:
▪ Diagnosis code which must be for somatic type pain
▪ Prescriber attestation that the benefits and risks of opioid therapy has been
discussed with patient
Ohio Medicaid Unified PDL effective July 1, 2023 11
o Exemptions to the additional criteria:
▪ Patients receiving short-acting opioids for active cancer treatment, palliative
care, and end-of-life/hospice care, sickle cell, severe burn, traumatic
crushing of tissue, amputation, major orthopedic surgery
▪ Prescriber attestation that patient is not opioid naïve (i.e., new to Medicaid
or was on higher dose in hospital)
• Subsequent short-acting requests can be authorized up to 180 days
o Documentation of the following must be provided:
▪ Current treatment plan
▪ Demonstrated adherence to treatment plan through progress notes,
including pain and function scores, random urine screenings results
reviewed, concerns addressed, and no serious adverse outcomes observed
• Dose escalation requests can be authorized up to 180 days
o Documentation of the following must be provided:
▪ Prescriber attestation that dose escalation is likely to result in improved
function and pain control
▪ Requests for a cumulative daily dose >100 MED must be prescribed by or in
consultation with a pain specialist or anesthesiologist consultation
Effective July 1, 2018, patients with short acting opioid therapy will be limited to 30 MED per
day and a
maximum of 7 days per prescription. Prior authorization will be required to exceed these limits.
ADDITIONAL LONG-ACTING OPIOIDS CRITERIA:
• The system defines an “initial request” as having no opioid claims in the previous 90 days
• Initial long-acting requests can be authorized up to 90 days
o Documentation of the following must be provided:
▪ Request is a daily dose equivalent of ≤ 80 MED
▪ Inadequate clinical response to both non-opioid pharmacologic and non-
pharmacologic treatments
▪ Current use of short-acting opioids for ≥ 60 consecutive days
▪
Treatment plan including risk assessment, substance abuse history,
concurrent therapies, and requirements for random urine screenings
(baseline urine drug tests must be submitted)
▪ Pain and function scores at each visit
▪ Opioid contract required to be in place and submitted with PA form
o Exemptions to the additional criteria:
▪ Patients receiving long-acting opioids for catastrophic injury or cancer pain
• Subsequent long-acting requests can be authorized up to 180 days
o Documentation of the following must be provided:
▪ Current treatment plan
▪ Demonstrated adherence to treatment plan through progress notes,
including pain and function scores, random urine screenings results
reviewed, concerns addressed, and no serious adverse outcomes observed
• Dose escalation requests can be authorized up to 180 days
o Documentation of the following must be provided:
Ohio Medicaid Unified PDL effective July 1, 2023 12
▪ Prescriber attestation that dose escalation is likely to result in improved
function and pain control
▪ Requests for a cumulative daily dose >100 MED must be prescribed by or in
consultation with a pain specialist or anesthesiologist consultation
ADDITIONAL TRANSMUCOSAL FENTANYL CRITERIA:
• Must be prescribed by an oncologist, pain specialist, or hospice/palliative prescriber
• Must be concurrently taking a long-acting opioid at a therapeutic dose of any of the
following for at least 7 days without adequate pain relief:
≥ 60 mg oral morphine/day
≥ 8 mg oral hydromorphone/day
≥ 25 mcg/hr transdermal fentanyl
≥ 25 mg oral oxymorphone/day
≥ 30 mg oral oxycodone/day
Equianalgesic dose of another opioid
QL – Transmucosal Fentanyl: 4 doses per day
Ohio Medicaid Unified PDL effective July 1, 2023 13
Blood Formation, Coagulation, and Thrombosis Agents: Colony
Stimulating Factors
LENGTH OF AUTHORIZATIONS: Dependent upon diagnosis below
Diagnosis
Authorization Length
Acute Myeloid Leukemia (AML)
14 days or duration of
chemotherapy regimen
Malignancy at risk for febrile neutropenia or undergoing
myeloablative chemotherapy prior to allogeneic or autologous
bone marrow transplantation
14 days or duration of
chemotherapy regimen
Myeloid Engraftment for bone marrow transplant (BMT)
30 days
Severe, chronic neutropenia with absolute neutrophil count
(ANC) of less than 500/mm
3
and have symptoms associated
with neutropenia (e.g., fever, infections, oropharyngeal ulcers).
30 days
Hematopoietic radiation injury syndrome
30 days
ALL AUTHORIZATIONS: Must be
prescribed in accordance with FDA approved labeling
CLINICAL PA CRITERIA:
• Must provide documentation of diagnosis, patient’s weight, and duration of treatment
NON-PREFERRED CRITERIA:
• Must provide documentation of medical necessity beyond convenience for why the
patient cannot be changed to a preferred drug (i.e., allergies, drug-drug interactions,
contraindications, or intolerances) OR
o For any nonsolid oral dosage formulation: must provide documentation of
medical necessity for why patient cannot be changed to a solid oral dosage
formulation
•
Must have had an inadequate clinical response of at least
14 days with
at least
one
preferred drug
o For non-preferred extended-release formulations: must provide documentation
of an inadequate clinical response
with its immediate release formulation (if
available)
o For non-preferred brand names that have preferred generics: must provide
documentation of an inadequate clinical response or allergy to two or more
generic labelers (if available)
SUBSEQUENT AUTHORIZATION CRITERIA:
• Must provide documentation of patient’s clinical response to treatment and ongoing
safety monitoring
Ohio Medicaid Unified PDL effective July 1, 2023 14
Blood Formation, Coagulation, and Thrombosis Agents:
Hematopoietic Agents
LENGTH OF AUTHORIZATIONS: Dependent upon diagnosis below
Authorization of epoetin alfa or darbepoetin:
Diagnosis
Hemoglobin
Level
Authorization Length
Anemia due to chronic renal failure, patient on dialysis
≤11
365 days
Anemia due to chronic renal failure, patient not on dialysis
≤10
365 days
Chemotherapy-induced anemia
≤10
90 days
Anemia in myelodysplastic syndrome
≤11
180 days
Authorization of epoetin alfa ONLY:
Diagnosis
Hemoglobin
Level
Authorization
Length
Autologous blood donation, patient will require blood
transfusions
>10 to ≤13
30 days
Anemia of prematurity, age ≤6 months
N/A
42 days
Anemia associated with chronic inflammatory disorders
(e.g., rheumatoid arthritis)
≤
11
180 days
Anemia associated with ribavirin combination therapy in
hepatitis C-infected patient
≤11
180 days
Anemia in zidovudine-treated HIV-infected patients
≤11
180 days
ALL AUTHORIZATIONS: Must be
prescribed in accordance with FDA approved labeling
NON-PREFERRED CRITERIA:
• Must provide documentation of medical necessity beyond convenience for why the
patient cannot be changed to a preferred drug (i.e., allergies, drug-drug interactions,
contraindications, or intolerances) OR
o For any nonsolid oral dosage formulation: must provide documentation of
medical necessity for why patient cannot be changed to a solid oral dosage
formulation
•
Must have had an inadequate clinical response of at least
14 days with
at least
one
preferred drug
o For non-preferred extended-release formulations: must provide documentation
of an inadequate clinical response
with its immediate release formulation (if
available)
o For non-preferred brand names that have preferred generics: must provide
documentation of an inadequate clinical response or allergy to two or more
generic labelers (if available)
SUBSEQUENT AUTHORIZATION CRITERIA:
• Must provide documentation of patient’s clinical response to treatment and ongoing
safety monitoring
Ohio Medicaid Unified PDL effective July 1, 2023 15
Blood Formation, Coagulation, and Thrombosis Agents:
Hemophilia Factors*
LENGTH OF AUTHORIZATIONS: 365 Days
GRANDFATHERING*:
Patients who have a claim for a non-preferred drug in the previous 120 days will be
automatically authorized to continue the drug. Patients who have taken the drug previously,
but do not have claims history (e.g., new to Medicaid), will need to submit a prior authorization
in order to continue coverage.
ALL AUTHORIZATIONS: Must be
prescribed in accordance with FDA approved labeling
CLINICAL PA CRITERIA:
• Must provide documentation of patient’s body weight
NON-PREFERRED CRITERIA:
• Must provide documentation of medical necessity beyond convenience for why the
patient cannot be changed to a preferred drug (i.e., allergies, drug-drug interactions,
contraindications, or intolerances) OR
o For any nonsolid oral dosage formulation: must provide documentation of
medical necessity for why patient cannot be changed to a solid oral dosage
formulation
•
Must have had an inadequate clinical response of at least
14 days with
at least
one
preferred drug
o For non-preferred extended-release formulations: must provide documentation
of an inadequate clinical response
with its immediate release formulation (if
available)
o For non-preferred brand names that have preferred generics: must provide
documentation of an inadequate clinical response or allergy to two or more
generic labelers (if available)
ADDITIONAL EXTENDED HALF-LIFE FACTOR CRITERIA
• Must provide attestation that the patient is not a suitable candidate for treatment with
a shorter-acting half-life drug
SUBSEQUENT AUTHORIZATION CRITERIA:
• Must provide documentation of patient’s clinical response to treatment and ongoing
safety monitoring
Ohio Medicaid Unified PDL effective July 1, 2023 16
Blood Formation, Coagulation, and Thrombosis Agents:
Heparin-Related Preparations
LENGTH OF AUTHORIZATIONS: Dependent upon criteria below
ALL AUTHORIZATIONS: Must be
prescribed in accordance with FDA approved labeling
NON-PREFERRED CRITERIA:
• Must provide documentation of medical necessity beyond convenience for why the
patient cannot be changed to a preferred drug (i.e., allergies, drug-drug interactions,
contraindications, or intolerances) OR
o For any nonsolid oral dosage formulation: must provide documentation of
medical necessity for why patient cannot be changed to a solid oral dosage
formulation
•
Must have had an inadequate clinical response of at least
14 days with
at least
one
preferred drug
o For non-preferred extended-release formulations: must provide documentation
of an inadequate clinical response
with its immediate release formulation (if
available)
o For non-preferred brand names that have preferred generics: must provide
documentation of an inadequate clinical response or allergy to two or more
generic labelers (if available)
ADDITIONAL INFORMATION:
• For most indications: Guidelines from the American College of Chest Physicians limit
duration of therapy in the outpatient setting for most indications to less than 35 days
and patients should be transitioned to oral warfarin as soon as possible
• For requests over 35 days and/or the patient cannot be transitioned to warfarin,
prescriber must submit additional documentation for reasoning:
o For patients with cancer – authorized up to 180 days
o For pregnant women – authorized up to 280 days
o For patients unable to take warfarin – authorized up to 180 days
SUBSEQUENT AUTHORIZATION CRITERIA:
• Must provide documentation of patient’s clinical response to treatment and ongoing
safety monitoring
Ohio Medicaid Unified PDL effective July 1, 2023 17
Blood Formation, Coagulation, and Thrombosis Agents:
Or
al
Anticoagulants
LENGTH OF AUTHORIZATION: 365 days
ALL AUTHORIZATIONS: Must be
prescribed in accordance with FDA approved labeling
NON-PREFERRED CRITERIA:
• Must provide documentation of medical necessity beyond convenience for why the
patient cannot be changed to a preferred drug (i.e., allergies, drug-drug interactions,
contraindications, or intolerances) OR
o For any nonsolid oral dosage formulation: must provide documentation of
medical necessity for why patient cannot be changed to a solid oral dosage
formulation
•
Must have had an inadequate clinical response of at least
14 days with
at least
two
preferred drugs
o For non-preferred extended-release formulations: must provide documentation
of an inadequate clinical response
with its immediate release formulation (if
available)
o For non-preferred brand names that have preferred generics: must provide
documentation of an inadequate clinical response or allergy to two or more
generic labelers (if available)
SUBSEQUENT AUTHORIZATION CRITERIA:
• Must provide documentation of patient’s clinical response to treatment and ongoing
safety monitoring
Ohio Medicaid Unified PDL effective July 1, 2023 18
Blood Formation, Coagulation, and Thrombosis Agents:
Or
al
Antiplatelet
LENGTH OF AUTHORIZATION: 365 days
ALL AUTHORIZATIONS: Must be
prescribed in accordance with FDA approved labeling
NON-PREFERRED CRITERIA:
• Must provide documentation of medical necessity beyond convenience for why the
patient cannot be changed to a preferred drug (i.e., allergies, drug-drug interactions,
contraindications, or intolerances) OR
o For any nonsolid oral dosage formulation: must provide documentation of
medical necessity for why patient cannot be changed to a solid oral dosage
formulation
•
Must have had an inadequate clinical response of at least
14 days with
at least
two
preferred drugs
o For non-preferred extended-release formulations: must provide documentation
of an inadequate clinical response
with its immediate release formulation (if
available)
o For non-preferred brand names that have preferred generics: must provide
documentation of an inadequate clinical response or allergy to two or more
generic labelers (if available)
SUBSEQUENT AUTHORIZATION CRITERIA:
• Must provide documentation of patient’s clinical response to treatment and ongoing
safety monitoring
Ohio Medicaid Unified PDL effective July 1, 2023 19
Cardiovascular Agents: Angina, Hypertension & Heart Failure
LENGTH OF AUTHORIZATIONS: 365 days except nimodipine: 21 days
ALL AUTHORIZATIONS: Must be
prescribed in accordance with FDA approved labeling
PROPRANOLOL ORAL SOLUTION (HEMANGEOL) CRITERIA:
• Must provide documentation of the patient’s weight
SACUBITRIL/VALSARTAN (ENTRESTO) CRITERIA:
• Must provide documentation of chronic heart failure classified as either NYHA Class II-IV
or ACC/AHA Stage B-D
NON-PREFERRED CRITERIA:
• Must provide documentation of medical necessity beyond convenience for why the
patient cannot be changed to a preferred drug (i.e., allergies, drug-drug interactions,
contraindications, or intolerances) OR
o For any nonsolid oral dosage formulation: must provide documentation of
medical necessity for why patient cannot be changed to a solid oral dosage
formulation
•
Must have had an inadequate clinical response of at least 30 days of at least two
preferred drugs within the same class, if indicated for diagnosis
o For non-preferred extended-release formulations: must provide documentation of
an inadequate clinical response with its immediate release formulation (if
available)
o For non-preferred brand names that have preferred generics: must provide
documentation of
an inadequate clinical response
or allergy to two or more
generic labelers (if available)
ADDITIONAL FINERENONE (KERENDIA) CRITERIA:
• Must be on a maximally tolerated dose of an angiotensin-converting enzyme inhibitor
or angiotensin receptor blocker
• Must provide documentation of an inadequate clinical response to a SGLT2 Inhibitor
OR provide documentation of medical necessity beyond convenience for why the
patient cannot try a SGLT2 inhibitor (i.e., chronic kidney disease diagnosis)
ADDITIONAL MAVACAMTEN (CAMZYOS) CRITERIA:
• Must be prescribed by or in consultation with a cardiologist
• Must provide documentation of NYHA Class II-III symptoms and left ventricular
ejection fraction ≥55%
Ohio Medicaid Unified PDL effective July 1, 2023 20
ADDITIONAL VERICIGUAT (VERQUVO) CRITERIA:
• Must provide documentation of ejection fraction
• Must have been hospitalized for the treatment of heart failure in the previous 180 days
or needs treatment with an outpatient intravenous diuretic in the previous 90 days
• Must be treated with an agent from ALL the following unless contraindicated:
o Angiotensin-converting enzyme inhibitor, angiotensin II receptor blocker, OR an
angiotensin receptor neprilysin inhibitor
o Beta-blocker
o Aldosterone antagonist and/or SGLT2 inhibitor as appropriate for renal function
SUBSEQUENT AUTHORIZATION CRITERIA:
• Must provide documentation of patient’s clinical response to treatment and ongoing
safety monitoring
AR – Sotylize Solution: a PA is required for patients 6 years and older
Ohio Medicaid Unified PDL effective July 1, 2023 21
Cardiovascular Agents: Antiarrhythmics
LENGTH OF AUTHORIZATIONS: 365 Days
ALL AUTHORIZATIONS: Must be
prescribed in accordance with FDA approved labeling
NON-PREFERRED CRITERIA:
• Must provide documentation of medical necessity beyond convenience for why the
patient cannot be changed to a preferred drug (i.e., allergies, drug-drug interactions,
contraindications, or intolerances) OR
o For any nonsolid oral dosage formulation: must provide documentation of
medical necessity for why patient cannot be changed to a solid oral dosage
formulation
•
Must have had an inadequate clinical response of at least 30 days with at least one
preferred drug
o For non-preferred extended-release formulations: must provide documentation of
an inadequate clinical response with its immediate release formulation (if
available)
o For non-preferred brand names that have preferred generics: must provide
documentation of
an inadequate clinical response
or allergy to two or more
generic labelers (if available)
SUBSEQUENT AUTHORIZATION CRITERIA:
• Must provide documentation of patient’s clinical response to treatment and ongoing
safety monitoring
Ohio Medicaid Unified PDL effective July 1, 2023 22
Cardiovascular Agents: Lipotropics
LENGTH OF AUTHORIZATIONS: See below
Juxtapid (Initial)
180 days
Vascepa, Lovaza, ACL inhibitors (Initial)
84 days
All others (Initial and Subsequent)
365 days
ALL AUTHORIZATIONS: Must be
prescribed in accordance with FDA approved labeling
CLINICAL PA CRITERIA:
• Must provide documentation of baseline labs AND have documented adherence to 90
days of prescribed lipid lowering medications
• Must have had an inadequate clinical response of at least 90 days AND unable to reach
goal LDL-C (see below) despite treatment with maximally tolerated dose of high-
potency statin and ezetimibe (or a clinical reason that these drugs cannot be utilized)
NON-PREFERRED CRITERIA:
• Must provide documentation of medical necessity beyond convenience for why the
patient cannot be changed to a preferred drug (i.e., allergies, drug-drug interactions,
contraindications, or intolerances) OR
o For any nonsolid oral dosage formulation: must provide documentation of
medical necessity for why patient cannot be changed to a solid oral dosage
formulation
•
Must have had an inadequate clinical response of at least 30 days (or 90 days for
fibrates) with at least one preferred drug in the same drug class
o For non-preferred extended-release formulations: must provide documentation of
an inadequate clinical response with its immediate release formulation (if
available)
o For non-preferred brand names that have preferred generics: must provide
documentation of
an inadequate clinical response
or allergy to two or more
generic labelers (if available)
ADDITIONAL LOVASTATIN ER (ALTOPREV), PITAVASTATIN (LIVALO), FLUVASTATIN (LESCOL)
CRITERIA
•
Must have had an inadequate clinical response of at least 30 days with two preferred
drugs in the same drug class
ADDITIONAL COLESEVELAM (WELCHOL) CRITERIA:
• Must provide documentation of a Type 2 Diabetes diagnosis
Ohio Medicaid Unified PDL effective July 1, 2023 23
ADDITIONAL ICOSAPENT ETHYL (VASCEPA) CRITERIA:
• Must provide documentation of baseline labs indicating triglyceride levels ≥500mg/dL
after an inadequate clinical response to fibrates, niacin, and diet/exercise
• Must provide documentation of discontinuation of drugs known to increase
triglyceride levels (i.e., beta blockers, thiazides, and estrogens), if clinically appropriate
ADDITIONAL LOMITAPIDE (JUXTAPID) & ATP CITRATE LYASE (ACL) INHIBITOR CRITERIA:
• Must provide documentation of baseline labs AND have documented adherence to 90
days of prescribed lipid lowering medications
• Must have had
inadequate clinical response of
at least 90 days AND unable to reach
goal LDL-C with high-potency statin, ezetimibe and PCSK9 inhibitor (or a clinical reason
that these drugs cannot be utilized)
ADDITIONAL INFORMATION:
• High potency statins: atorvastatin (Lipitor) 40-80mg & rosuvastatin (Crestor) 20-40mg
• LDL goals for Familial Hypercholesterolemia (includes Heterozygous & Homozygous
FH): LDL ≤ 100mg/dL for adults or LDL ≤ 110mg/dL for those < 18 years of age
• LDL goals for Clinical Atherosclerotic Cardiovascular Disease (ASCVD): LDL ≤ 70mg/dL
SUBSEQUENT AUTHORIZATION CRITERIA:
• Must provide documentation of patient’s clinical response to treatment and ongoing
safety monitoring
Ohio Medicaid Unified PDL effective July 1, 2023 24
Cardiovascular Agents: Pulmonary Arterial Hypertension*
LENGTH OF AUTHORIZATIONS: 365 Days
GRANDFATHERING*:
Patients who have a claim for a non-preferred drug in the previous 120 days will be
automatically approved to continue the drug. Patients who have taken the drug previously, but
do not have claims history (e.g., new to Medicaid), will need to submit a prior authorization in
order to continue coverage.
ALL AUTHORIZATIONS: Must be
prescribed in accordance with FDA approved labeling
CLINICAL PA CRITERIA:
• Must provide documentation of NYHA Functional Class for Pulmonary Hypertension and
symptoms experienced by patient
NON-PREFERRED CRITERIA:
• Must provide documentation of medical necessity beyond convenience for why the
patient cannot be changed to a preferred drug (i.e., allergies, drug-drug interactions,
contraindications, or intolerances) OR
o For any nonsolid oral dosage formulation: must provide documentation of
medical necessity for why patient cannot be changed to a solid oral dosage
formulation
•
Must have had an inadequate clinical response of at least 30 days with at least two
preferred drugs, one of which must be a phosphodiesterase-5 inhibitor
o For non-preferred extended-release formulations: must provide documentation of
an inadequate clinical response with its immediate release formulation (if
available)
o For non-preferred brand names that have preferred generics: must provide
documentation of
an inadequate clinical response
or allergy to two or more
generic labelers (if available)
ADDITIONAL INFORMATION:
• Patients who have class III or IV symptoms defined by the NYHA Functional Class
for Pulmonary Hypertension may be authorized for inhalation or intravenous
agents
SUBSEQUENT AUTHORIZATION CRITERIA:
• Must provide documentation of patient’s clinical response to treatment and ongoing
safety monitoring
AR - Sildenafil Susp and Tadliq: a PA is required for patients 6 years and older
Ohio Medicaid Unified PDL effective July 1, 2023 25
Central Nervous System (CNS) Agents: Alzheimer’s Agents*
LENGTH OF AUTHORIZATIONS: 365 Days
GRANDFATHERING*:
Patients who have a claim for a non-preferred drug in the previous 120 days will be
automatically approved to continue the drug. Patients who have taken the drug previously, but
do not have claims history (e.g., new to Medicaid), will need to submit a prior authorization in
order to continue coverage.
ALL AUTHORIZATIONS: Must be
prescribed in accordance with FDA approved labeling
NON-PREFERRED CRITERIA:
• Must provide documentation of medical necessity beyond convenience for why the
patient cannot be changed to a preferred drug (i.e., allergies, drug-drug interactions,
contraindications, or intolerances) OR
o For any nonsolid oral dosage formulation: must provide documentation of
medical necessity for why patient cannot be changed to a solid oral dosage
formulation
•
Must have had an inadequate clinical response of at least 30 days with at least two
preferred drugs
o For non-preferred extended-release formulations: must provide documentation of
an inadequate clinical response with its immediate release formulation (if
available)
o For non-preferred brand names that have preferred generics: must provide
documentation of
an inadequate clinical response
or allergy to two or more
generic labelers (if available)
SUBSEQUENT AUTHORIZATION CRITERIA:
• Must provide documentation of patient’s clinical response to treatment and ongoing
safety monitoring
AR – All drugs: a PA is required for patients younger than 40 years
Ohio Medicaid Unified PDL effective July 1, 2023 26
Central Nervous System (CNS) Agents: Anti-Migraine Agents,
Acute
LENGTH OF AUTHORIZATIONS: 180 Days
ALL AUTHORIZATIONS: Must be
prescribed in accordance with FDA approved labeling
STEP THERAPY CRITERIA:
•
Must have had an inadequate clinical response of at least 14 days with at least two
preferred drugs
NON-PREFERRED CRITERIA:
• Must provide documentation of medical necessity beyond convenience for why the
patient cannot be changed to a preferred drug (i.e., allergies, drug-drug interactions,
contraindications, or intolerances) OR
o For any nonsolid oral dosage formulation: must provide documentation of
medical necessity for why patient cannot be changed to a solid oral dosage
formulation
•
Must have had an inadequate clinical response of at least 14 days with at least two
preferred drugs
o For non-preferred extended-release formulations: must provide documentation of
an inadequate clinical response with its immediate release formulation (if
available)
o For non-preferred brand names that have preferred generics: must provide
documentation of
an inadequate clinical response
or allergy to two or more
generic labelers (if available)
ADDITIONAL UBROGEPANT (UBRELVY) CRITERIA
• Must have had
an inadequate clinical response of at least 14 days with at least one
preferred oral CGRP antagonist
SUBSEQUENT AUTHORIZATION CRITERIA:
• Must provide documentation of patient’s clinical response to treatment and ongoing
safety monitoring
QL - Nurtec ODT: 8 doses per 30 days for acute treatment
Ohio Medicaid Unified PDL effective July 1, 2023 27
Central Nervous System (CNS) Agents: Anti-Migraine Agents,
Cluster Headache
LENGTH OF AUTHORIZATIONS: 180 days
ALL AUTHORIZATIONS: Must be
prescribed in accordance with FDA approved labeling
NON-PREFERRED CRITERIA:
• Must provide documentation of medical necessity beyond convenience for why the
patient cannot be changed to a preferred drug (i.e., allergies, drug-drug interactions,
contraindications, or intolerances) OR
o For any nonsolid oral dosage formulation: must provide documentation of
medical necessity for why patient cannot be changed to a solid oral dosage
formulation
•
Must have had an inadequate clinical response of at least 60 days to at least one
preferred drug
o For non-preferred extended-release formulations: must provide documentation of
an inadequate clinical response with its immediate release formulation (if
available)
o For non-preferred brand names that have preferred generics: must provide
documentation of
an inadequate clinical response
or allergy to two or more
generic labelers (if available)
ADDITIONAL INFORMATION:
•
An inadequate clinical response to verapamil is defined as a titration to at least 480mg
daily
SUBSEQUENT AUTHORIZATION CRITERIA:
• Must provide documentation of patient’s clinical response to treatment and ongoing
safety monitoring
QL – Emgality: 3 doses per 30 days
Ohio Medicaid Unified PDL effective July 1, 2023 28
Central Nervous System (CNS) Agents: Anti-Migraine Agents,
Prophylaxis
LENGTH OF AUTHORIZATIONS: Initial: 180 days; Subsequent: 365 days
ALL AUTHORIZATIONS: Must be
prescribed in accordance with FDA approved labeling
STEP THERAPY CRITERIA:
•
Must have had an inadequate clinical response of at least 30 days with at least three
preferred controller migraine drugs
•
Must include
objective documentation of severity, frequency, type of migraine, and
number of headache days per month (preferably a headache diary)
ERENUMAB (AIMOVIG) CRITERIA:
• Must have had an inadequate clinical response of at least 60 days with the 70mg dose
to request a dose increase
FREMANEZUMAB (AJOVY) CRITERIA:
• Must have demonstrated efficacy for at least 90 days before quarterly administration
will be authorized
NON-PREFERRED CRITERIA:
• Must provide documentation of medical necessity beyond convenience for why the
patient cannot be changed to a preferred drug (i.e., allergies, drug-drug interactions,
contraindications, or intolerances) OR
o For any nonsolid oral dosage formulation: must provide documentation of
medical necessity for why patient cannot be changed to a solid oral dosage
formulation
•
Must have had an inadequate clinical response of at least 30 days with at least three
preferred controller migraine drugs
AND one step therapy drug
o For non-preferred extended-release formulations: must provide documentation of
an inadequate clinical response with its immediate release formulation (if
available)
o For non-preferred brand names that have preferred generics: must provide
documentation of
an inadequate clinical response
or allergy to two or more
generic labelers (if available)
ADDITIONAL INFORMATION:
• Controller migraine drug classes include beta-blockers, anticonvulsants, tricyclic
antidepressants, or serotonin-norepinephrine reuptake inhibitors
Ohio Medicaid Unified PDL effective July 1, 2023 29
SUBSEQUENT AUTHORIZATION CRITERIA:
• Must provide documentation of patient’s clinical response to treatment (preferably a
headache diary or other objective documentation of severity, frequency, and number
of headache days per month).
QL – Nurtec ODT: 18 doses per 30 days for prophylactic treatment
QL – Aimovig, Ajovy: 1 dose per 30 days
QL – Emgality: 2 doses per 30 days (for initial loading dose only), then 1 dose per 30 days
thereafter
Ohio Medicaid Unified PDL effective July 1, 2023 30
Central Nervous System (CNS) Agents: Anticonvulsants*
LENGTH OF AUTHORIZATIONS: 365 days except Epidiolex and Diacomit – Initial: 180 days
GRANDFATHERING* (except Diacomit):
Patients who have a claim for a non-preferred drug in the previous 120 days will be
automatically approved to continue the drug. Patients who have taken the drug previously, but
do not have claims history (e.g., new to Medicaid), will need to submit a prior authorization in
order to continue coverage.
ALL AUTHORIZATIONS: Must be
prescribed in accordance with FDA approved labeling
STEP THERAPY CRITERIA:
•
Must have had an inadequate clinical response of at least 30 days with at least one
preferred drug
CANNABIDIOL (EPIDIOLEX) CRITERIA
• Must have had an inadequate clinical response of at least 30 days with any two of the
following anticonvulsants: clobazam, levetiracetam, valproic acid, lamotrigine,
topiramate, rufinamide, or felbamate within the past 365 days (members who meet
this criteria will not require a PA)
STIRIPENTOL (DIACOMIT) CRITERIA
• Must be prescribed by or in consultation with a neurologist
• Must be concomitantly taking clobazam (Onfi)
• Must provide documentation of addressed comorbidities and baseline hematologic
testing (CBC)
o Patients with phenylketonuria (PKU) must provide evidence of total daily amount
of phenylalanine
o Prescribers must include management plans for patients with neutrophil counts
<1,500 cells/mm
3
or platelet count <150,000/µL
• Must provide documentation of patient’s weight
o Maximum daily dose does not exceed: 50 mg/kg/day or 3,000mg/day
• Must provide baseline average number of seizure days per month (measured monthly
or quarterly)
NON-PREFERRED CRITERIA:
• Must provide documentation of medical necessity beyond convenience for why the
patient cannot be changed to a preferred drug (i.e., allergies, drug-drug interactions,
contraindications, or intolerances) OR
o For any nonsolid oral dosage formulation: must provide documentation of
medical necessity for why patient cannot be changed to a solid oral dosage
formulation
Ohio Medicaid Unified PDL effective July 1, 2023 31
•
Must have had an inadequate clinical response of at least 30 days with at least two
preferred drugs
o For non-preferred extended-release formulations: must provide documentation of
an inadequate clinical response with its immediate release formulation (if
available)
o For non-preferred brand names that have preferred generics: must provide
documentation of
an inadequate clinical response
or allergy to two or more
generic labelers (if available)
• Prescriptions submitted from a prescriber who is credentialed as a neurology specialty
with Ohio Medicaid AND for drugs that are used only for seizures,
there must have
been an inadequate clinical response of at least 30 days
with one preferred drug. This
provision applies only to the standard tablet/capsule dosage form.
SUBSEQUENT AUTHORIZATION CRITERIA:
• Must provide documentation of patient’s clinical response to treatment and ongoing
safety monitoring (i.e., documented reduction in average number of seizure days per
month [measured monthly or quarterly])
AR – Vigabatrin Powder: a PA is required for patients 3 years and older
AR – Eprontia Solution: a PA is required for patients 12 years and older
Ohio Medicaid Unified PDL effective July 1, 2023 32
Central Nervous System (CNS) Agents: Anticonvulsants Rescue
LENGTH OF AUTHORIZATIONS: 365 Days
ALL AUTHORIZATIONS: Must be
prescribed in accordance with FDA approved labeling
NON-PREFERRED CRITERIA:
• Must provide documentation of medical necessity beyond convenience for why the
patient cannot be changed to a preferred drug (i.e., allergies, drug-drug interactions,
contraindications, or intolerances) OR
o For any nonsolid oral dosage formulation: must provide documentation of
medical necessity for why patient cannot be changed to a solid oral dosage
formulation
•
Must have had an inadequate clinical response with at least one preferred drug
o For non-preferred extended-release formulations: must provide documentation
of
an inadequate clinical response with its immediate release formulation (if
available)
o For non-preferred brand names that have preferred generics: must provide
documentation of
an inadequate clinical response
or allergy to two or more
generic labelers (if available)
SUBSEQUENT AUTHORIZATION CRITERIA:
• Must provide documentation of patient’s clinical response to treatment and ongoing
safety monitoring
AR – Valtoco: a PA is required for patients younger than 6 years old
AR – Nayzilam: a PA is required for patients younger than 12 years old
Ohio Medicaid Unified PDL effective July 1, 2023 33
Central Nervous System (CNS) Agents: Antidepressants*
LENGTH OF AUTHORIZATIONS: 365 Days
GRANDFATHERING*:
Patients who have a claim for a non-preferred drug in the previous 120 days will be
automatically approved to continue the drug. Patients who have taken the drug previously, but
do not have claims history (e.g., new to Medicaid), will need to submit a prior authorization in
order to continue coverage.
PSYCHIATRIST EXEMPTION:
Prescribers (as identified below) are exempt from prior authorization of any non-preferred
antidepressant, or step therapy of any preferred drug, in the standard tablet/capsule dosage
forms. Other dosage forms may still require prior authorization. The exemption will be
processed by the claims system when the pharmacy has submitted the prescriber on the claim
using the individual national provider identifier (NPI) for the prescriber.
Prescribers are defined as:
Physicians with a specialty in psychiatry, nurse practitioners certified in psychiatric mental health,
or clinical nurse specialists certified in psychiatric mental health, who are credentialed with the
Ohio Department of Medicaid.
ALL AUTHORIZATIONS: Must be
prescribed in accordance with FDA approved labeling
NON-PREFERRED CRITERIA:
• Must provide documentation of medical necessity beyond convenience for why the
patient cannot be changed to a preferred drug (i.e., allergies, drug-drug interactions,
contraindications, or intolerances) OR
o For any nonsolid oral dosage formulation: must provide documentation of
medical necessity for why patient cannot be changed to a solid oral dosage
formulation
•
Must have had an inadequate clinical response of at least 30 days with at least two
preferred drugs
o For non-preferred extended-release formulations: must provide documentation of
an inadequate clinical response with its immediate release formulation (if
available)
o For non-preferred brand names that have preferred generics: must provide
documentation of
an inadequate clinical response
or allergy to two or more
generic labelers (if available)
ADDITIONAL DEXTROMETHORPHAN/BUPROPION (AUVELITY) CRITERIA
• Must have an inadequate clinical response of at least 30 days with ALL of the following:
o ONE dopamine/norepinephrine reuptake inhibitor (DNRI)
o ONE selective norepinephrine reuptake inhibitor (SNRI)
Ohio Medicaid Unified PDL effective July 1, 2023 34
o TWO selective serotonin reuptake inhibitors (SSRIs) (ONE of which must be
either vilazodone (Viibryd) OR vortioxetine (Trintellix))
SUBSEQUENT AUTHORIZATION CRITERIA:
• Must provide documentation of patient’s clinical response to treatment and ongoing
safety monitoring
Ohio Medicaid Unified PDL effective July 1, 2023 35
Central Nervous System (CNS) Agents: Attention Defic
it
Hyperactivity Disorder Age
nts
LENGTH OF AUTHORIZATIONS: 365 days
ALL AUTHORIZATIONS: Must be
prescribed in accordance with FDA approved labeling
STEP THERAPY CRITERIA:
•
Must have had an inadequate clinical response of at least 30 days with atomoxetine OR
at least two preferred stimulants
NON-PREFERRED CRITERIA:
• Must provide documentation of medical necessity beyond convenience for why the
patient cannot be changed to a preferred drug (i.e., allergies, drug-drug interactions,
contraindications, or intolerances) OR
o For any nonsolid oral dosage formulation: must provide documentation of
medical necessity for why patient cannot be changed to a solid oral dosage
formulation
•
Must have had an inadequate clinical response of at least 30 days with at least three
preferred drugs
o For non-preferred extended-release formulations: must provide documentation of
an inadequate clinical response with its immediate release formulation (if
available)
o For non-preferred brand names that have preferred generics: must provide
documentation of
an inadequate clinical response
or allergy to two or more
generic labelers (if available)
ADDITIONAL INFORMATION
• Requests for non-preferred immediate-release formulations must have all required
trials with preferred immediate-release drugs, and requests for non-preferred
extended-release formulations must have all required trials with preferred extended-
release drugs
• For patients established on drugs that change from preferred to non-preferred on
January 1, a prior authorization is NOT required until after June 30
th
of that year.
SUBSEQUENT AUTHORIZATION CRITERIA:
• Must provide documentation of patient’s clinical response to treatment and ongoing
safety monitoring
AR – Adderall, Dexedrine, & Zenzedi IR: a PA is required for patients younger than 3 years
AR – Adderall XR, Atomoxetine, Cotempla XR-ODT, Daytrana, Dexedrine ER, Dexmethylphenidate,
Methylphenidate IR & ER, & Xelstrym: a PA is required for patients younger than 6 years
AR – Dextroamphetamine Solution & Dyanavel XR: a PA is required for patients 12 years and older
AR – Methylphenidate solution/suspension: a PA is required for patients younger than 6 years and
12 years and older
Ohio Medicaid Unified PDL effective July 1, 2023 36
Central Nervous System (CNS) Agents: Atypical
Antipsychotics*
LENGTH OF AUTHORIZATIONS: 365 Days
GRANDFATHERING*:
Patients who have a claim for a non-preferred drug in the previous 120 days will be
automatically approved to continue the drug. Patients who have taken the drug previously, but
do not have claims history (e.g., new to Medicaid), will need to submit a prior authorization in
order to continue coverage.
PSYCHIATRIST EXEMPTION:
Prescribers (as identified below) are exempt from prior authorization of any non-preferred
second-generation antipsychotic, or step therapy of any preferred drug, in the standard
tablet/capsule and long-acting injectable dosage forms. Other dosage forms may still require prior
authorization. The exemption will be processed by the claims system when the pharmacy has
submitted the prescriber on the claim using the individual national provider identifier (NPI) for the
prescriber.
Prescribers are defined as:
Physicians with a specialty in psychiatry, nurse practitioners certified in psychiatric mental health,
or clinical nurse specialists certified in psychiatric mental health, who are credentialed with the
Ohio Department of Medicaid.
ALL AUTHORIZATIONS: Must be
prescribed in accordance with FDA approved labeling
PALIPERIDONE PALMITATE (INVEGA HAFYERA) CRITERIA:
• Must have had 4 months of treatment with Invega Sustenna or 3 months with Invega
Trinza
STEP THERAPY CRITERIA:
•
Must have had an inadequate clinical response of at least 30 days with at least one
preferred drug
NON-PREFERRED CRITERIA:
• Must provide documentation of medical necessity beyond convenience for why the
patient cannot be changed to a preferred drug (i.e., allergies, drug-drug interactions,
contraindications, or intolerances) OR
o For any nonsolid oral dosage formulation: must provide documentation of
medical necessity for why patient cannot be changed to a solid oral dosage
formulation
•
Must have had an inadequate clinical response of at least 30 days with at least two
preferred drugs
o For non-preferred extended-release formulations: must provide documentation of
Ohio Medicaid Unified PDL effective July 1, 2023 37
an inadequate clinical response with its immediate release formulation (if
available)
o For non-preferred brand names that have preferred generics: must provide
documentation of
an inadequate clinical response
or allergy to two or more
generic labelers (if available)
ADDITIONAL ARIPIPRAZOLE (ABILIFY MYCITE) CRITERIA:
• Must be prescribed by or in consultation with a psychiatrist following an aripiprazole
serum blood level draw indicating need for further investigation of adherence
ADDITIONAL OLANZAPINE/SAMIDORPHAN (LYBALVI) CRITERIA:
• Must provide documentation that patient is not using opioids or undergoing acute
opioid withdrawal
ADDITIONAL PIMAVANSERIN (NUPLAZID) CRITERIA:
• For Parkinson-related Hallucinations & Delusions ALL of the following must be met:
o Psychotic symptoms are severe and frequent enough to warrant treatment with
an antipsychotic AND are not related to dementia or delirium
o The patient’s other Parkinson’s Disease drugs have been reduced or adjusted
and psychotic symptoms persist OR patient is unable to tolerate adjustment of
these other drugs
o Must have been inadequate clinical response or contraindication to at least 30
days of either quetiapine or clozapine
• An exemption to the criteria will be authorized for prescribers with a neurology
specialty to a patient with a history of the related condition
ADDITIONAL FLUOXETINE/OLANZAPINE (SYMBYAX) CRITERIA
• Must provide documentation for patient’s inability to use the individual drugs
ADDITIONAL INFORMATION
• Long-acting injectable antipsychotics may be billed by the pharmacy if they are not
dispensed directly to the patient. If not administered by the pharmacist, the drug must
be released only to the administering provider or administering provider’s staff,
following all regulations for a Prescription Pick-Up Station as described by the Ohio
Board of Pharmacy
SUBSEQUENT AUTHORIZATION CRITERIA:
• Must provide documentation of patient’s clinical response to treatment and ongoing
safety monitoring
Ohio Medicaid Unified PDL effective July 1, 2023 38
Central Nervous System (CNS) Agents: Fibromyalgia Agents
LENGTH OF AUTHORIZATIONS: 365 Days
ALL AUTHORIZATIONS: Must be
prescribed in accordance with FDA approved labeling
NON-PREFERRED CRITERIA:
• Must provide documentation of medical necessity beyond convenience for why the
patient cannot be changed to a preferred drug (i.e., allergies, drug-drug interactions,
contraindications, or intolerances) OR
o For any nonsolid oral dosage formulation: must provide documentation of
medical necessity for why patient cannot be changed to a solid oral dosage
formulation
•
Must have had an inadequate clinical response of at least 14 days with at least two
preferred drugs in different classes (see Additional Information section below)
o For non-preferred extended-release formulations: must provide documentation of
an inadequate clinical response with its immediate release formulation (if
available)
o For non-preferred brand names that have preferred generics: must provide
documentation of
an inadequate clinical response
or allergy to two or more
generic labelers (if available)
ADDITIONAL INFORMATION
• Drugs and drug classes include gabapentin, pregabalin, short- and/or long-acting
opioids, skeletal muscle relaxants, SNRIs, SSRIs, trazodone, and tricyclic
antidepressants
• The P&T Committee does not recommend the use of opioids for treatment of
fibromyalgia
SUBSEQUENT AUTHORIZATION CRITERIA:
• Must provide documentation of patient’s clinical response to treatment and ongoing
safety monitoring
Ohio Medicaid Unified PDL effective July 1, 2023 39
Central Nervous System (CNS) Agents: Medication
Assisted
Treatment of Opioid
Addiction
LENGTH OF AUTHORIZATIONS: 180 days except 14 days for Lucemyra
ALL AUTHORIZATIONS: Must be
prescribed in accordance with FDA approved labeling
NON-PREFERRED CRITERIA:
• Must provide documentation of medical necessity beyond convenience for why the
patient cannot be changed to a preferred drug (i.e., allergies, drug-drug interactions,
contraindications, or intolerances) OR
o For any nonsolid oral dosage formulation: must provide documentation of
medical necessity for why patient cannot be changed to a solid oral dosage
formulation
•
Must have had an inadequate clinical response of at least 30 days with at least two
preferred drugs
o For non-preferred extended-release formulations: must provide documentation
of
an inadequate clinical response with its immediate release formulation (if
available)
o For non-preferred brand names that have preferred generics: must provide
documentation of
an inadequate clinical response
or allergy to two or more
generic labelers (if available)
ADDITIONAL LOFEXIDINE (LUCEMYRA) CRITERIA
• May be authorized if ALL of the following criteria are met:
o Must provide medical justification supporting why an opioid taper (such as with
buprenorphine or methadone) cannot be used
o Must have had an inadequate clinical response or contraindication to clonidine
• Must provide documentation that the drug was initiated in an inpatient setting to be
exempt from the above criteria
BUPRENORPHINE SAFETY EDITS AND DRUG UTILIZATION REVIEW CRITERIA:
• Prescribing for buprenorphine products must follow the requirements of Ohio
Administrative Code rule 4731-33-03 Office based treatment for opioid addiction.
• In favor of eliminating prior authorization for all forms of oral short acting
buprenorphine- containing products, ODM and the Managed Care Plans will implement
safety edits and a retrospective drug utilization review process for all brand and generic
forms of oral short acting buprenorphine-containing products. Safety edits are in place
for dosages over 24mg of buprenorphine equivalents/day.
• Buprenorphine sublingual tablets (generic Subutex) will be restricted to pregnancy,
breastfeeding, or contraindication to preferred products
• Buprenorphine injection (Sublocade) dosing schedule will be limited to 300mg/30 days
Ohio Medicaid Unified PDL effective July 1, 2023 40
ADDITIONAL INFORMATION
•
Vivitrol and Sublocade may be billed by the pharmacy if it is not dispensed directly to the
patient. If not administered by the
pharmacist, the drug must be released only to the
administering provider or administering provider's staff, following all regulations for a
Prescription Pick-Up Station as described by the Ohio Board of Pharmacy.
SUBSEQUENT AUTHORIZATION CRITERIA:
• Must provide documentation of patient’s clinical response to treatment and ongoing
safety monitoring
Ohio Medicaid Unified PDL effective July 1, 2023 41
Central Nervous System (CNS) Agents: Movement Disorders
LENGTH OF AUTHORIZATIONS: 365 Days
ALL AUTHORIZATIONS: Must be
prescribed in accordance with FDA approved labeling
CLINICAL PA CRITERIA:
• Must be prescribed by or in consultation with a neurologist or psychiatrist
STEP THERAPY CRITERIA:
• Must have an inadequate clinical response of at least 90 days to a maximally
tolerated dose of tetrabenazine for Huntington’s Disease only
NON-PREFERRED CRITERIA:
• Must provide documentation of medical necessity beyond convenience for why the
patient cannot be changed to a preferred drug (i.e., allergies, drug-drug interactions,
contraindications, or intolerances) OR
o For any nonsolid oral dosage formulation: must provide documentation of
medical necessity for why patient cannot be changed to a solid oral dosage
formulation
•
Must have had an inadequate clinical response of at least 30 days with at least two
preferred drugs
o For non-preferred extended-release formulations: must provide documentation
of
an inadequate clinical response with its immediate release formulation (if
available)
o For non-preferred brand names that have preferred generics: must provide
documentation of
an inadequate clinical response
or allergy to two or more
generic labelers (if available)
SUBSEQUENT AUTHORIZATION CRITERIA:
• Must provide documentation of patient’s clinical response to treatment and ongoing
safety monitoring
Ohio Medicaid Unified PDL effective July 1, 2023 42
Central Nervous System (CNS) Agents: Multiple Sclerosis*
LENGTH OF AUTHORIZATIONS: 365 Days
GRANDFATHERING*:
Patients who have a claim for a non-preferred drug in the previous 120 days will be
automatically approved to continue the drug. Patients who have taken the drug previously, but
do not have claims history (e.g., new to Medicaid), will need to submit a prior authorization in
order to continue coverage.
ALL AUTHORIZATIONS: Must be
prescribed in accordance with FDA approved labeling
NON-PREFERRED CRITERIA:
• Must provide documentation of medical necessity beyond convenience for why the
patient cannot be changed to a preferred drug (i.e., allergies, drug-drug interactions,
contraindications, or intolerances) OR
o For any nonsolid oral dosage formulation: must provide documentation of
medical necessity for why patient cannot be changed to a solid oral dosage
formulation
•
Must have had an inadequate clinical response of at least 30 days with at least one
preferred drug
o For non-preferred extended-release formulations: must provide documentation
of
an inadequate clinical response with its immediate release formulation (if
available)
o For non-preferred brand names that have preferred generics: must provide
documentation of
an inadequate clinical response
or allergy to two or more
generic labelers (if available)
ADDITIONAL SIPONIMOD (MAYZENT) CRITERIA:
• Must provide documentation of genotype, liver function tests (LFTS) complete blood
count (CBC), ophthalmic examination, varicella zoster virus antibodies, and
electrocardiogram (ECG)
SUBSEQUENT AUTHORIZATION CRITERIA:
• Must provide documentation of patient’s clinical response to treatment and ongoing
safety monitoring
Ohio Medicaid Unified PDL effective July 1, 2023 43
Central Nervous System (CNS) Agents: Narcolepsy
LENGTH OF AUTHORIZATIONS: 365 days
ALL AUTHORIZATIONS: Must be
prescribed in accordance with FDA approved labeling
NON-PREFERRED CRITERIA:
• Must provide documentation of medical necessity beyond convenience for why the
patient cannot be changed to a preferred drug (i.e., allergies, drug-drug interactions,
contraindications, or intolerances) OR
o For any nonsolid oral dosage formulation: must provide documentation of
medical necessity for why patient cannot be changed to a solid oral dosage
formulation
•
Must have had an inadequate clinical response of at least 30 days with at least two
preferred drugs -
either (1) modafinil or armodafinil; or (2) preferred methylphenidate
or amphetamine drug
o For non-preferred extended-release formulations: must provide documentation of
an inadequate clinical response with its immediate release formulation (if
available)
o For non-preferred brand names that have preferred generics: must provide
documentation of
an inadequate clinical response
or allergy to two or more
generic labelers (if available)
ADDITIONAL OXYBATE SALTS (XYWAV) CRITERIA:
• Must have documented adherence to sodium restricted diet
SUBSEQUENT AUTHORIZATION CRITERIA:
• Must provide documentation of patient’s clinical response to treatment and ongoing
safety monitoring
AR – Adderall IR: a PA is required for patients younger than 3 years
AR – Adderall XR, Dexedrine ER: a PA is required for patients younger than 6 years
AR – Methylphenidate: a PA is required for patients younger than 6 years
Ohio Medicaid Unified PDL effective July 1, 2023 44
Central Nervous System (CNS) Agents: Neuropathic Pain
LENGTH OF AUTHORIZATIONS: 365 Days
ALL AUTHORIZATIONS: Must be
prescribed in accordance with FDA approved labeling
NON-PREFERRED CRITERIA:
• Must provide documentation of medical necessity beyond convenience for why the
patient cannot be changed to a preferred drug (i.e., allergies, drug-drug interactions,
contraindications, or intolerances) OR
o For any nonsolid oral dosage formulation: must provide documentation of
medical necessity for why patient cannot be changed to a solid oral dosage
formulation
•
Must have had an inadequate clinical response of at least 30 days with at least two
preferred drugs in different drug classes
o For non-preferred extended-release formulations: must provide documentation of
an inadequate clinical response with its immediate release formulation (if
available)
o For non-preferred brand names that have preferred generics: must provide
documentation of
an inadequate clinical response
or allergy to two or more
generic labelers (if available)
SUBSEQUENT AUTHORIZATION CRITERIA:
• Must provide documentation of patient’s clinical response to treatment and ongoing
safety monitoring
Ohio Medicaid Unified PDL effective July 1, 2023 45
Central Nervous System (CNS) Agents: Parkinson's Agents
LENGTH OF AUTHORIZATIONS: 365 Days
ALL AUTHORIZATIONS: Must be
prescribed in accordance with FDA approved labeling
NON-PREFERRED CRITERIA:
• Must provide documentation of medical necessity beyond convenience for why the
patient cannot be changed to a preferred drug (i.e., allergies, drug-drug interactions,
contraindications, or intolerances) OR
o For any nonsolid oral dosage formulation: must provide documentation of
medical necessity for why patient cannot be changed to a solid oral dosage
formulation
•
Must have had an inadequate clinical response of at least 30 days with at least one
preferred drug
o For non-preferred extended-release formulations: must provide documentation of
an inadequate clinical response with its immediate release formulation (if
available)
o For non-preferred brand names that have preferred generics: must provide
documentation of
an inadequate clinical response
or allergy to two or more
generic labelers (if available)
ADDITIONAL APOMORPHINE (APOKIN/KYNMOBI), LEVODOPA INHALATION (INBRIJA), &
ISTRADEFYLLINE (NOURIANZ) CRITERIA:
• Must have had inadequate clinical response to at least 30 days with one other drug for the
treatment of “off episodes” (dopamine agonist, COMT inhibitor, or MAO-B inhibitor)
SUBSEQUENT AUTHORIZATION CRITERIA:
• Must provide documentation of patient’s clinical response to treatment and ongoing
safety monitoring
Ohio Medicaid Unified PDL effective July 1, 2023 46
Central Nervous System (CNS) Agents: Restless
L
egs
Synd
rome
LENGTH OF AUTHORIZATIONS: 365 Days
ALL AUTHORIZATIONS: Must be
prescribed in accordance with FDA approved labeling
NON-PREFERRED CRITERIA:
• Must provide documentation of medical necessity beyond convenience for why the
patient cannot be changed to a preferred drug (i.e., allergies, drug-drug interactions,
contraindications, or intolerances) OR
o For any nonsolid oral dosage formulation: must provide documentation of
medical necessity for why patient cannot be changed to a solid oral dosage
formulation
•
Must have had an inadequate clinical response of at least 30 days with at least one
preferred drug
o For non-preferred extended-release formulations: must provide documentation of
an inadequate clinical response with its immediate release formulation (if
available)
o For non-preferred brand names that have preferred generics: must provide
documentation of
an inadequate clinical response
or allergy to two or more
generic labelers (if available)
SUBSEQUENT AUTHORIZATION CRITERIA:
• Must provide documentation of patient’s clinical response to treatment and ongoing
safety monitoring
Ohio Medicaid Unified PDL effective July 1, 2023 47
Central Nervous System (CNS) Agents: Sedative-Hypnotics,
Non-Barbiturate
LENGTH OF AUTHORIZATIONS: 180 Days
ALL AUTHORIZATIONS: Must be
prescribed in accordance with FDA approved labeling
NON-PREFERRED CRITERIA:
• Must provide documentation of medical necessity beyond convenience for why the
patient cannot be changed to a preferred drug (i.e., allergies, drug-drug interactions,
contraindications, or intolerances) OR
o For any nonsolid oral dosage formulation: must provide documentation of
medical necessity for why patient cannot be changed to a solid oral dosage
formulation
•
Must have had an inadequate clinical response of at least 10 days with at least two
preferred drugs
o For non-preferred extended-release formulations: must provide documentation of
an inadequate clinical response with its immediate release formulation (if
available)
o For non-preferred brand names that have preferred generics: must provide
documentation of
an inadequate clinical response
or allergy to two or more
generic labelers (if available)
ADDITIONAL INFORMATION
• Non-controlled medications may be authorized if the prescriber indicates the patient
has a history of addiction
•
The P&T Committee does not recommend the use of flurazepam (Dalmane) or
triazolam (Halcion)
SUBSEQUENT AUTHORIZATION CRITERIA:
• Must provide documentation of patient’s clinical response to treatment and ongoing
safety monitoring
Ohio Medicaid Unified PDL effective July 1, 2023 48
Central Nervous System (CNS) Agents: Skeletal
Mus
cle
Relaxants,
Non
-
Ben
z
odia
zep
ine
LENGTH OF AUTHORIZATIONS: 365 Days
ALL AUTHORIZATIONS: Must be
prescribed in accordance with FDA approved labeling
NON-PREFERRED CRITERIA:
• Must provide documentation of medical necessity beyond convenience for why the
patient cannot be changed to a preferred drug (i.e., allergies, drug-drug interactions,
contraindications, or intolerances) OR
o For any nonsolid oral dosage formulation: must provide documentation of
medical necessity for why patient cannot be changed to a solid oral dosage
formulation
•
Must have had an inadequate clinical response of at least 30 days with at least one
preferred drug
o For non-preferred extended-release formulations: must provide documentation of
an inadequate clinical response
with its immediate release formulation (if
available)
o For non-preferred brand names that have preferred generics, requests must
provide documentation of an inadequate clinical response or allergy to two or
more generic labelers (if available)
ADDITIONAL BACLOFEN SOLUTION CRITERIA:
• Must provide documentation of trial with baclofen tablets or justification why a non-
solid oral dosage form is indicated
ADDITIONAL CARISOPRODOL (SOMA) CRITERIA:
• Must provide medical justification that no other muscle relaxant or agent to treat
fibromyalgia, or any musculoskeletal condition would serve the clinical needs of the
patient
SUBSEQUENT AUTHORIZATION CRITERIA:
• Must provide documentation of patient’s clinical response to treatment and ongoing
safety monitoring
Ohio Medicaid Unified PDL effective July 1, 2023 49
Central Nervous System (CNS) Agents: Smoking Deterrents
All products are covered without a PA
Ohio Medicaid Unified PDL effective July 1, 2023 50
Dermatologic Agents: Oral Acne Products
LENGTH OF AUTHORIZATIONS: 150 days
ALL AUTHORIZATIONS: Must be
prescribed in accordance with FDA approved labeling
CLINICAL PA CRITERIA:
• Must have had an inadequate clinical response of at least 90 days with at least one
preferred topical AND one preferred oral antibiotic for acne
• Must be absent of oral tretinoin in the past 56 days
• Patient must be registered and meet all of the requirements of the iPLEDGE program
NON-PREFERRED CRITERIA:
• Must provide documentation of medical necessity beyond convenience for why the
patient cannot be changed to a preferred drug (i.e., allergies, drug-drug interactions,
contraindications, or intolerances) OR
o For any nonsolid oral dosage formulation: must provide documentation of
medical necessity for why patient cannot be changed to a solid oral dosage
formulation
•
Must have had an inadequate clinical response of at least 90 days with at least two
preferred drugs
o For non-preferred extended-release formulations: must provide documentation
of
an inadequate clinical response with its immediate release formulation (if
available)
o For non-preferred brand names that have preferred generics: must provide
documentation of
an inadequate clinical response
or allergy to two or more
generic labelers (if available)
ADDITIONAL INFORMATION
• Authorization length will be for no more than 150 days at a time then must take 56
days off
SUBSEQUENT AUTHORIZATION CRITERIA:
• Must provide documentation of patient’s clinical response to treatment and ongoing
safety monitoring
Ohio Medicaid Unified PDL effective July 1, 2023 51
Dermatologic Agents: Topical Acne Products
LENGTH OF AUTHORIZATIONS: 365 Days
ALL AUTHORIZATIONS: Must be
prescribed in accordance with FDA approved labeling
NON-PREFERRED CRITERIA:
• Must provide documentation of medical necessity beyond convenience for why the
patient cannot be changed to a preferred drug (i.e., allergies, drug-drug interactions,
contraindications, or intolerances) OR
o For any nonsolid oral dosage formulation: must provide documentation of
medical necessity for why patient cannot be changed to a solid oral dosage
formulation
•
Must have had an inadequate clinical response of at least 30 days or (90 days for
retinoids) of at least three preferred drugs
o For non-preferred extended-release formulations: must provide documentation
of
an inadequate clinical response with its immediate release formulation (if
available)
o For non-preferred brand names that have preferred generics: must provide
documentation of
an inadequate clinical response
or allergy to two or more
generic labelers (if available)
ADDITIONAL TRETINOIN/BENZOYL PEROXIDE (TWYNEO) CRITERIA
• Must provide documentation for patient’s inability to use the individual drugs
ADDITIONAL INFORMATION
• All retinoids - May be authorized with a diagnosis of skin cancer
• Tazarotene (Tazorac) - May be authorized with a diagnosis of psoriasis
SUBSEQUENT AUTHORIZATION CRITERIA:
• Must provide documentation of patient’s clinical response to treatment and ongoing
safety monitoring
AR - All topical retinoids: a PA is required for patients 24 years and older
Ohio Medicaid Unified PDL effective July 1, 2023 52
Endocrine Agents: Androgens
LENGTH OF AUTHORIZATIONS: 365 Days
ALL AUTHORIZATIONS: Must be
prescribed in accordance with FDA approved labeling
CLINICAL PA CRITERIA:
• Must provide documentation of lab work to support the need for testosterone
supplementation
NON-PREFERRED CRITERIA:
• Must provide documentation of medical necessity beyond convenience for why the
patient cannot be changed to a preferred drug (i.e., allergies, drug-drug interactions,
contraindications, or intolerances) OR
o For any nonsolid oral dosage formulation: must provide documentation of
medical necessity for why patient cannot be changed to a solid oral dosage
formulation
•
Must have had an inadequate clinical response of at least 90 days with ALL preferred
drugs
o For non-preferred extended-release formulations: must provide documentation
of
an inadequate clinical response with its immediate release formulation (if
available)
o For non-preferred brand names that have preferred generics: must provide
documentation of
an inadequate clinical response
or allergy to two or more
generic labelers (if available)
SUBSEQUENT AUTHORIZATION CRITERIA:
• Must provide documentation of patient’s clinical response to treatment and ongoing
safety monitoring (i.e., testosterone and hematocrit)
AR: All drugs: a PA is required for patients younger than 18 years
Ohio Medicaid Unified PDL effective July 1, 2023 53
Endocrine Agents: Diabetes – Hypoglycemia Treatments
LENGTH OF AUTHORIZATIONS: 365 Days
ALL AUTHORIZATIONS: Must be
prescribed in accordance with FDA approved labeling
NON-PREFERRED CRITERIA:
• Must provide documentation of medical necessity beyond convenience for why the
patient cannot be changed to a preferred drug (i.e., allergies, drug-drug interactions,
contraindications, or intolerances) OR
o For any nonsolid oral dosage formulation: must provide documentation of
medical necessity for why patient cannot be changed to a solid oral dosage
formulation
•
Must have had an inadequate clinical response of at least two preferred drugs OR the
inability of the member and/or caregiver to administer a preferred glucagon product in
a timely fashion
o For non-preferred extended-release formulations: must provide documentation
of
an inadequate clinical response with its immediate release formulation (if
available)
o For non-preferred brand names that have preferred generics: must provide
documentation of
an inadequate clinical response
or allergy to two or more
generic labelers (if available)
SUBSEQUENT AUTHORIZATION CRITERIA:
• Must provide documentation of patient’s clinical response to treatment and ongoing
safety monitoring
QL – All glucagon products: 2 doses per 34 days
Ohio Medicaid Unified PDL effective July 1, 2023 54
Endocrine Agents: Diabetes – Insulin
LENGTH OF AUTHORIZATIONS: 365 Days
ALL AUTHORIZATIONS: Must be
prescribed in accordance with FDA approved labeling
STEP THERAPY CRITERIA:
•
Must have had an inadequate clinical response of at least 120 days with at least one
preferred drug
having a similar duration of action
NON-PREFERRED CRITERIA:
• Must provide documentation of medical necessity beyond convenience for why the
patient cannot be changed to a preferred drug (i.e., allergies, drug-drug interactions,
contraindications, or intolerances) OR
o For any nonsolid oral dosage formulation: must provide documentation of
medical necessity for why patient cannot be changed to a solid oral dosage
formulation
•
Must have had an inadequate clinical response of at least 120 days with at least two
preferred drugs
having a similar duration of action
o For non-preferred extended-release formulations: must provide documentation
of an
inadequate clinical response with its immediate release formulation (if
available)
o For non-preferred brand names that have preferred generics: must provide
documentation of an
inadequate clinical response
or allergy to two or more
generic labelers (if available)
ADDITIONAL TEMPO PEN CRITERIA
• Must have had an inadequate clinical response or documentation of medical necessity
beyond convenience for why the patient cannot use the corresponding FlexPens or
Kwikpens
ADDITIONAL INHALED INSULIN (AFREZZA) CRITERIA:
• Must provide documentation of spirometry testing prior to initiation with a predicted
FEV1 ≥70% - Will not be authorized for patients with asthma or COPD
• Must provide documentation of being nicotine-free for at least 180 days
ADDITIONAL INFORMATION
• An
inadequate clinical response
is defined as the inability to reach A1C goal after at
least 120 days of current regimen with documented adherence and appropriate dose
escalation.
•
Requests may be authorized for patients with a condition that is difficult to
control
(i.e., prone to ketoacidosis, hypoglycemia)
Ohio Medicaid Unified PDL effective July 1, 2023 55
SUBSEQUENT AUTHORIZATION CRITERIA:
• Must provide documentation of patient’s clinical response to treatment and ongoing
safety monitoring
Ohio Medicaid Unified PDL effective July 1, 2023 56
Endocrine Agents: Diabetes –
Non
-
Insulin
LENGTH OF AUTHORIZATIONS: 365 Days
ALL AUTHORIZATIONS: Must be
prescribed in accordance with FDA approved labeling
NON-PREFERRED CRITERIA:
• Must provide documentation of medical necessity beyond convenience for why the
patient cannot be changed to a preferred drug (i.e., allergies, drug-drug interactions,
contraindications, or intolerances) OR
o For any nonsolid oral dosage formulation: must provide documentation of
medical necessity for why patient cannot be changed to a solid oral dosage
formulation
•
Must have had an inadequate clinical response of at least 120 days with at least three
preferred drugs
o For non-preferred extended-release formulations: must provide documentation
of
an inadequate clinical response with its immediate release formulation (if
available)
o For non-preferred brand names that have preferred generics: must provide
documentation of
an inadequate clinical response
or allergy to two or more
generic labelers (if available)
ADDITIONAL ORAL AND INJECTABLE COMBINATION DRUGS CRITERIA
•
Must have had a trial of at least 120 days with
the individual drugs OR must provide
documentation of medical necessity beyond convenience for patient’s inability to use
the individual drugs
ADDITIONAL INFORMATION
• An
inadequate clinical response
is defined as the inability to reach A1C goal after at
least 120 days of current regimen with documented adherence and appropriate dose
escalation.
•
Requests may be authorized for patients with a condition that is difficult to
control
(i.e., prone to ketoacidosis, hypoglycemia)
• For non-preferred drugs that have preferred drugs in the same drug class: must provide
documentation that there was at least one inadequate clinical response with a drug in
same drug class
SUBSEQUENT AUTHORIZATION CRITERIA:
• Must provide documentation of patient’s clinical response to treatment and ongoing
safety monitoring
Ohio Medicaid Unified PDL effective July 1, 2023 57
Endocrine Agents: Endometriosis
LENGTH OF AUTHORIZATIONS: 365 Days
ALL AUTHORIZATIONS: Must be
prescribed in accordance with FDA approved labeling
STEP THERAPY CRITERIA:
•
Must have had an inadequate clinical response of at least 84 days with at least one
preferred NSAID and one preferred oral contraceptive
NON-PREFERRED CRITERIA:
• Must provide documentation of medical necessity beyond convenience for why the
patient cannot be changed to a preferred drug (i.e., allergies, drug-drug interactions,
contraindications, or intolerances) OR
o For any nonsolid oral dosage formulation: must provide documentation of
medical necessity for why patient cannot be changed to a solid oral dosage
formulation
•
Must have had an inadequate clinical response of at least 84 days with at least one
preferred NSAID, one preferred oral contraceptive, AND one preferred step-therapy
drug
o For non-preferred extended-release formulations: must provide documentation
of
an inadequate clinical response with its immediate release formulation (if
available)
o For non-preferred brand names that have preferred generics: must provide
documentation of
an inadequate clinical response
or allergy to two or more
generic labelers (if available)
SUBSEQUENT AUTHORIZATION CRITERIA:
• Must provide documentation of patient’s clinical response to treatment and ongoing
safety monitoring
Ohio Medicaid Unified PDL effective July 1, 2023 58
Endocrine Agents: Estrogenic
A
gen
ts
LENGTH OF AUTHORIZATIONS: 365 Days
ALL AUTHORIZATIONS: Must be
prescribed in accordance with FDA approved labeling
NON-PREFERRED CRITERIA:
• Must provide documentation of medical necessity beyond convenience for why the
patient cannot be changed to a preferred drug (i.e., allergies, drug-drug interactions,
contraindications, or intolerances) OR
o For any nonsolid oral dosage formulation: must provide documentation of
medical necessity for why patient cannot be changed to a solid oral dosage
formulation
•
Must have had an inadequate clinical response of at least 30 days with at least two
preferred drugs
o For non-preferred extended-release formulations: must provide documentation
of
an inadequate clinical response with its immediate release formulation (if
available)
o For non-preferred brand names that have preferred generics: must provide
documentation of
an inadequate clinical response
or allergy to two or more
generic labelers (if available)
ADDITIONAL INFORMATION:
• Requests for non-preferred drugs must have
an inadequate clinical response
with
preferred drugs with the same delivery method
SUBSEQUENT AUTHORIZATION CRITERIA:
• Must provide documentation of patient’s clinical response to treatment and ongoing
safety monitoring
Ohio Medicaid Unified PDL effective July 1, 2023 59
Endocrine Agents: Growth Hormone
LENGTH OF AUTHORIZATIONS: Initial: 180 days; Subsequent: 365 days
ALL AUTHORIZATIONS: Must be
prescribed in accordance with FDA approved labeling
CLINICAL PA CRITERIA:
Pediatric Approvals (under 18 years of age):
• Must be treated and followed by a pediatric endocrinologist, nephrologist, clinical
geneticist, endocrinologist, or gastroenterologist (or as appropriate for diagnosis)
• Must provide documentation to justify criteria being met, including height, weight,
bone age (children), date and results of most current x-ray, stimulus test results,
IGF-1 levels, and a growth chart (children)
• Must not being used in combination with another somatropin agent
Adult Approvals (18 years of age or older):
• Must be treated and following by an endocrinologist
• Must provide documentation of growth hormone deficiency by means of a negative
response to an appropriate stimulation test (clonidine test is not acceptable for adults)
• Must provide documentation of baseline evaluation of the following clinical indicators:
(1) insulin-like growth factor (IGF-1); (2) fasting lipid profile; (3) BUN; (4) fasting glucose;
(5) electrolytic levels; (6) evaluation of any new osteoarthritis and joint pain; (7) bone
density test
• Must have had other hormonal deficiencies addressed with adequate replacement
therapy
NON-PREFERRED CRITERIA:
• Must provide documentation of medical necessity beyond convenience for why the
patient cannot be changed to a preferred drug (i.e., allergies, drug-drug interactions,
contraindications, or intolerances) OR
o For any nonsolid oral dosage formulation: must provide documentation of
medical necessity for why patient cannot be changed to a solid oral dosage
formulation
•
Must have had an inadequate clinical response of at least 90 days with at least one
preferred drug
o For non-preferred extended-release formulations: must provide documentation
of an inadequate clinical response
with its immediate release formulation (if
available)
o For non-preferred brand names that have preferred generics: must provide
documentation of an inadequate clinical response or allergy to two or more
generic labelers (if available)
Ohio Medicaid Unified PDL effective July 1, 2023 60
SUBSEQUENT AUTHORIZATION CRITERIA:
• Must provide documentation of patient’s clinical response to treatment and ongoing
safety monitoring (i.e., height, weight gain, improved body composition)
For adults:
must provide documentation by endocrinologist that discontinuing agent
would have a detrimental effect on body composition or other metabolic parameters
Ohio Medicaid Unified PDL effective July 1, 2023 61
Endocrine Agents: Osteoporosis – Bone
Ossi
fic
ation
Enh
ancers
LENGTH OF AUTHORIZATIONS: 365 Days
ALL AUTHORIZATIONS: Must be
prescribed in accordance with FDA approved labeling
TERIPARATIDE (FORTEO™) CRITERIA:
• Must have had an inadequate clinical response of at least 365 days with one
bisphosphonate
• A total lifetime duration of therapy of 730 days will be authorized between any
parathyroid analog
NON-PREFERRED CRITERIA:
• Must provide documentation of medical necessity beyond convenience for why the
patient cannot be changed to a preferred drug (i.e., allergies, drug-drug interactions,
contraindications, or intolerances) OR
o For any nonsolid oral dosage formulation: must provide documentation of
medical necessity for why patient cannot be changed to a solid oral dosage
formulation
•
Must have had an inadequate clinical response of at least 365 days with at least one
preferred drug within the same class
o For non-preferred extended-release formulations: must provide documentation
of an inadequate clinical response
with its immediate release formulation (if
available)
o For non-preferred brand names that have preferred generics: must provide
documentation of an inadequate clinical response or allergy to two or more
generic labelers (if available)
A
DDIT
I
O
NAL ABAL
OPAR
A
T
I
D
E
(T
YMLOS™) CRIT
ERIA
:
• Must have had an inadequate clinical response of at least 365 days with one
bisphosphonate
• A total lifetime duration of therapy of 730 days will be authorized between any
parathyroid analog
ADDITIONAL INFORMATION
• Patients should only be on ONE of the therapeutic classes (bisphosphonates,
calcitonin-salmon)
SUBSEQUENT AUTHORIZATION CRITERIA:
• Must provide documentation of patient’s clinical response to treatment and ongoing
safety monitoring
Ohio Medicaid Unified PDL effective July 1, 2023 62
Endocrine Agents: Progestin Agents
All products are covered without a PA
Ohio Medicaid Unified PDL effective July 1, 2023 63
Endocrine Agents: Uterine Fibroids
LENGTH OF AUTHORIZATIONS: Up to 180 Days
ALL AUTHORIZATIONS: Must be
prescribed in accordance with FDA approved labeling
CLINICAL PA CRITERIA:
• Must have had an inadequate
clinical response of at least 90 days with at least one
preferred oral contraceptive
NON-PREFERRED CRITERIA:
• Must provide documentation of medical necessity beyond convenience for why the
patient cannot be changed to a preferred drug (i.e., allergies, drug-drug interactions,
contraindications, or intolerances) OR
o For any nonsolid oral dosage formulation: must provide documentation of
medical necessity for why patient cannot be changed to a solid oral dosage
formulation
•
Must have had an inadequate clinical response of at least 90 days with at least one
preferred drug
o For non-preferred extended-release formulations: must provide documentation
of an inadequate clinical response
with its immediate release formulation (if
available)
o For non-preferred brand names that have preferred generics: must provide
documentation of an inadequate clinical response or allergy to two or more
generic labelers (if available)
ADDITIONAL INFORMATION:
• A total lifetime duration of therapy of 730 days between Oriahnn and Myfembree or
180 days for Lupron Depot will be authorized
SUBSEQUENT AUTHORIZATION CRITERIA:
• Must provide documentation of patient’s clinical response to treatment and ongoing
safety monitoring
Ohio Medicaid Unified PDL effective July 1, 2023 64
Gastrointestinal Agents: Anti-Emetics
LENGTH OF AUTHORIZATIONS: 365 Days
ALL AUTHORIZATIONS: Must be
prescribed in accordance with FDA approved labeling
NON-PREFERRED CRITERIA:
• Must provide documentation of medical necessity beyond convenience for why the
patient cannot be changed to a preferred drug (i.e., allergies, drug-drug interactions,
contraindications, or intolerances) OR
o For any nonsolid oral dosage formulation: must provide documentation of
medical necessity for why patient cannot be changed to a solid oral dosage
formulation
•
Must have had an inadequate clinical response of at least 7 days with at least one
preferred drug
o For non-preferred extended-release formulations: must provide documentation
of an inadequate clinical response
with its immediate release formulation (if
available)
o For non-preferred brand names that have preferred generics: must provide
documentation of an inadequate clinical response or allergy to two or more
generic labelers (if available)
SUBSEQUENT AUTHORIZATION CRITERIA:
• Must provide documentation of patient’s clinical response to treatment and ongoing
safety monitoring
Ohio Medicaid Unified PDL effective July 1, 2023 65
Gastrointestinal Agents: Crohn’s Disease
LENGTH OF AUTHORIZATIONS: 365 Days; Ortikos ER – based on indication
ALL AUTHORIZATIONS: Must be
prescribed in accordance with FDA approved labeling
NON-PREFERRED CRITERIA:
• Must provide documentation of medical necessity beyond convenience for why the
patient cannot be changed to a preferred drug (i.e., allergies, drug-drug interactions,
contraindications, or intolerances) OR
o For any nonsolid oral dosage formulation: must provide documentation of
medical necessity for why patient cannot be changed to a solid oral dosage
formulation
•
Must have had an inadequate clinical response of at least 30 days with at least two
preferred drugs
o For non-preferred extended-release formulations: must provide documentation
of an inadequate clinical response
with its immediate release formulation (if
available)
o For non-preferred brand names that have preferred generics: must provide
documentation of an inadequate clinical response or allergy to two or more
generic labelers (if available)
SUBSEQUENT AUTHORIZATION CRITERIA:
• Must provide documentation of patient’s clinical response to treatment and ongoing
safety monitoring
Ohio Medicaid Unified PDL effective July 1, 2023 66
Gastrointestinal Agents: Hepatic Encephalopathy
LENGTH OF AUTHORIZATIONS: 365 Days
ALL AUTHORIZATIONS: Must be
prescribed in accordance with FDA approved labeling
STEP THERAPY CRITERIA:
•
Must have had an inadequate clinical response of at least 14 days with at least one
preferred drug
RIFAXAMIN (XIFAXAN) CRITERIA:
• Must have had an inadequate clinical response of at least 14 days to lactulose to be
authorized for monotherapy or add on therapy
NON-PREFERRED CRITERIA:
• Must provide documentation of medical necessity beyond convenience for why the
patient cannot be changed to a preferred drug (i.e., allergies, drug-drug interactions,
contraindications, or intolerances) OR
o For any nonsolid oral dosage formulation: must provide documentation of
medical necessity for why patient cannot be changed to a solid oral dosage
formulation
•
Must have had an inadequate clinical response of at least 14 days with at least two
preferred drugs
o For non-preferred extended-release formulations: must provide documentation
of an inadequate clinical response
with its immediate release formulation (if
available)
o For non-preferred brand names that have preferred generics: must provide
documentation of an inadequate clinical response or allergy to two or more
generic labelers (if available)
SUBSEQUENT AUTHORIZATION CRITERIA:
• Must provide documentation of patient’s clinical response to treatment and ongoing
safety monitoring
Ohio Medicaid Unified PDL effective July 1, 2023 67
Gastrointestinal Agents: Irritable Bowel Syndrome (IBS) with
Diarrhea
LENGTH OF AUTHORIZATIONS: 365 Days
ALL AUTHORIZATIONS: Must be
prescribed in accordance with FDA approved labeling
STEP THERAPY CRITERIA:
•
Must have had an inadequate clinical response of at least 30 days with at least one
preferred drug
NON-PREFERRED CRITERIA:
• Must provide documentation of medical necessity beyond convenience for why the
patient cannot be changed to a preferred drug (i.e., allergies, drug-drug interactions,
contraindications, or intolerances) OR
o For any nonsolid oral dosage formulation: must provide documentation of
medical necessity for why patient cannot be changed to a solid oral dosage
formulation
•
Must have had an inadequate clinical response of at least 30 days with at least two
preferred drugs
o For non-preferred extended-release formulations: must provide documentation
of an inadequate clinical response
with its immediate release formulation (if
available)
o For non-preferred brand names that have preferred generics: must provide
documentation of an inadequate clinical response or allergy to two or more
generic labelers (if available)
SUBSEQUENT AUTHORIZATION CRITERIA:
• Must provide documentation of patient’s clinical response to treatment and ongoing
safety monitoring
Ohio Medicaid Unified PDL effective July 1, 2023 68
Gastrointestinal Agents: Pancreatic Enzymes
LENGTH OF AUTHORIZATIONS: 365 Days
ALL AUTHORIZATIONS: Must be
prescribed in accordance with FDA approved labeling
NON-PREFERRED CRITERIA:
• Must provide documentation of medical necessity beyond convenience for why the
patient cannot be changed to a preferred drug (i.e., allergies, drug-drug interactions,
contraindications, or intolerances) OR
o For any nonsolid oral dosage formulation: must provide documentation of
medical necessity for why patient cannot be changed to a solid oral dosage
formulation
•
Must have had an inadequate clinical response of at least 14 days with at least one
preferred drug
o For non-preferred extended-release formulations: must provide documentation
of an inadequate clinical response
with its immediate release formulation (if
available)
o For non-preferred brand names that have preferred generics: must provide
documentation of an inadequate clinical response or allergy to two or more
generic labelers (if available)
SUBSEQUENT AUTHORIZATION CRITERIA:
• Must provide documentation of patient’s clinical response to treatment and ongoing
safety monitoring
Ohio Medicaid Unified PDL effective July 1, 2023 69
Gastrointestinal Agents: Proton Pump
Inhibitors
LENGTH OF AUTHORIZATIONS: 180 days, except as listed under additional criteria
ALL AUTHORIZATIONS: Must be
prescribed in accordance with FDA approved labeling
NON-PREFERRED CRITERIA:
• Must provide documentation of medical necessity beyond convenience for why the
patient cannot be changed to a preferred drug (i.e., allergies, drug-drug interactions,
contraindications, or intolerances) OR
o For any nonsolid oral dosage formulation: must provide documentation of
tmedical necessity for why patient cannot be changed to a solid oral dosage
formulation
•
Must have had an inadequate clinical response of at least 30 days with at least two
preferred drugs
o For non-preferred extended-release formulations: must provide documentation
of an inadequate clinical response
with its immediate release formulation (if
available)
o For non-preferred brand names that have preferred generics: must provide
documentation of an inadequate clinical response or allergy to two or more
generic labelers (if available)
ADDITIONAL CRITERIA FOR PPI DOSES GREATER THAN ONCE DAILY
• For H. Pylori diagnosis: Must provide documentation of diagnosis
o Authorization length: 30 days
• For any of the following diagnoses: carcinoma of GI tract, COPD, Crest Syndrome,
dyspepsia, esophageal varices, gastritis, gastroparesis, scleroderma, symptomatic
uncomplicated Barret’s Esophagus, systemic mastocytosis, or Zollinger Ellison
Syndrome: Must provide documentation of diagnosis AND must have failed once-daily
dosing of the requested drug
o Authorization length: 365 days
ADDITIONAL INFORMATION
•
Request may be authorized If the drug was initiated in the hospital for the treatment of
a condition such as a GI bleed or the presence of a gastrostomy and/or jejunostomy
(G,
GJ, J-tube)
SUBSEQUENT AUTHORIZATION CRITERIA:
• Must provide documentation of patient’s clinical response to treatment and ongoing
safety monitoring
AR - Protonix Pak/Pantoprazole Packet: a PA is required for patients 6 years and older
AR – Omeprazole & Pantoprazole Tab/Cap/ODT: a PA is required for patient 22 years and
older requesting more than once daily dosing
Ohio Medicaid Unified PDL effective July 1, 2023 70
Gastrointestinal Agents: Ulcerative Colitis
LENGTH OF AUTHORIZATIONS: 365 Days; except Uceris foam – based on indication
ALL AUTHORIZATIONS: Must be
prescribed in accordance with FDA approved labeling
NON-PREFERRED CRITERIA:
• Must provide documentation of medical necessity beyond convenience for why the
patient cannot be changed to a preferred drug (i.e., allergies, drug-drug interactions,
contraindications, or intolerances) OR
o For any nonsolid oral dosage formulation: must provide documentation of
medical necessity for why patient cannot be changed to a solid oral dosage
formulation
•
Must have had an inadequate clinical response of at least 30 days with at least two
preferred drugs
o For non-preferred extended-release formulations: must provide documentation
of an inadequate clinical response
with its immediate release formulation (if
available)
o For non-preferred brand names that have preferred generics: must provide
documentation of an inadequate clinical response or allergy to two or more
generic labelers (if available)
SUBSEQUENT AUTHORIZATION CRITERIA:
• Must provide documentation of patient’s clinical response to treatment and ongoing
safety monitoring
QL – Budesonide ER 9mg tablets: 56 tablets per 90 days
Ohio Medicaid Unified PDL effective July 1, 2023 71
Gastrointestinal Agents: Unspecified GI
LENGTH OF AUTHORIZATIONS: 365 days except 3 days for Aemcolo
ALL AUTHORIZATIONS: Must be
prescribed in accordance with FDA approved labeling
STEP THERAPY CRITERIA:
•
Must have had an inadequate clinical response to at least 14 days with at least two
preferred drugs
NON-PREFERRED CRITERIA:
• Must provide documentation of medical necessity beyond convenience for why the
patient cannot be changed to a preferred drug (i.e., allergies, drug-drug interactions,
contraindications, or intolerances) OR
o For any nonsolid oral dosage formulation: must provide documentation of
medical necessity for why patient cannot be changed to a solid oral dosage
formulation
•
Must have had an inadequate clinical response of at least 14 days with at least three
preferred drugs, if indicated for diagnosis
o For non-preferred extended-release formulations: must provide documentation
of an inadequate clinical response
with its immediate release formulation (if
available)
o For non-preferred brand names that have preferred generics: must provide
documentation of an inadequate clinical response or allergy to two or more
generic labelers (if available)
ADDITIONAL METHYLNALTREXONE (RELISTOR) AND NALDEMEDINE (SYMPROIC) CRITERIA:
• Must have a history of chronic pain requiring continuous opioid therapy for ≥84 days
ADDITIONAL RIFAMYCIN DELAYED-RELEASE (AEMCOLO) CRITERIA:
• Must have the inability to take, or failure of ALL of the following: azithromycin,
ciprofloxacin, levofloxacin, ofloxacin, or rifaximin
ADDITIONAL SOMATROPIN INJECTION (ZORBTIVE) AND TEDLOGLUTIDE (GATTEX) CRITERIA:
• Must have evidence of specialized parenteral nutritional support
• Must have documentation of appropriate lab assessment (bilirubin, alkaline
phosphatase, lipase, and amylase) at least 180 days prior to initiation
SUBSEQUENT AUTHORIZATION CRITERIA:
• Must provide documentation of patient’s clinical response to treatment and ongoing
safety monitoring (i.e., decreased frequency of specialized nutrition support or
improvement in symptoms)
Ohio Medicaid Unified PDL effective July 1, 2023 72
Genitourinary Agents: Benign Prostatic Hyperplasia
LENGTH OF AUTHORIZATIONS: 365 Days
ALL AUTHORIZATIONS: Must be
prescribed in accordance with FDA approved labeling
TADALAFIL (CIALIS) CRITERIA:
• Must have had
an inadequate clinical response of
at least 30 days with at least one
alpha-1 adrenergic blocker and at least 90 days of finasteride
NON-PREFERRED CRITERIA:
• Must provide documentation of medical necessity beyond convenience for why the
patient cannot be changed to a preferred drug (i.e., allergies, drug-drug interactions,
contraindications, or intolerances) OR
o For any nonsolid oral dosage formulation: must provide documentation of
medical necessity for why patient cannot be changed to a solid oral dosage
formulation
•
Must have had an inadequate clinical response of at least 30 days with at least two
preferred drugs
o For non-preferred extended-release formulations: must provide documentation
of an inadequate clinical response
with its immediate release formulation (if
available)
o For non-preferred brand names that have preferred generics: must provide
documentation of an inadequate clinical response or allergy to two or more
generic labelers (if available)
ADDITIONAL DUTASTERIDE/TAMSULOSIN (JALYN) & FINASTERIDE/TADALAFIL (ENTADFI)
CRITERIA
• Must provide documentation for patient’s inability to use the individual drugs
SUBSEQUENT AUTHORIZATION CRITERIA:
• Must provide documentation of patient’s clinical response to treatment and ongoing
safety monitoring
Ohio Medicaid Unified PDL effective July 1, 2023 73
Genitourinary Agents: Electrolyte Depleter Agents
LENGTH OF AUTHORIZATIONS: 365 Days
ALL AUTHORIZATIONS: Must be
prescribed in accordance with FDA approved labeling
NON-PREFERRED CRITERIA:
• Must provide documentation of medical necessity beyond convenience for why the
patient cannot be changed to a preferred drug (i.e., allergies, drug-drug interactions,
contraindications, or intolerances) OR
o For any nonsolid oral dosage formulation: must provide documentation of
medical necessity for why patient cannot be changed to a solid oral dosage
formulation
•
Must have had an inadequate clinical response of at least 7 days with at least two
preferred drugs
o For non-preferred extended-release formulations: must provide documentation
of an inadequate clinical response
with its immediate release formulation (if
available)
o For non-preferred brand names that have preferred generics: must provide
documentation of an inadequate clinical response or allergy to two or more
generic labelers (if available)
SUBSEQUENT AUTHORIZATION CRITERIA:
• Must provide documentation of patient’s clinical response to treatment and ongoing
safety monitoring
Ohio Medicaid Unified PDL effective July 1, 2023 74
Genitourinary Agents: Urinary Antispasmodics
LENGTH OF AUTHORIZATIONS: 365 Days
ALL AUTHORIZATIONS: Must be
prescribed in accordance with FDA approved labeling
NON-PREFERRED CRITERIA:
• Must provide documentation of medical necessity beyond convenience for why the
patient cannot be changed to a preferred drug (i.e., allergies, drug-drug interactions,
contraindications, or intolerances) OR
o For any nonsolid oral dosage formulation: must provide documentation of
medical necessity for why patient cannot be changed to a solid oral dosage
formulation
•
Must have had an inadequate clinical response of at least 30 days with at least two
preferred drugs with different active ingredients
o For non-preferred extended-release formulations: must provide documentation
of an inadequate clinical response
with its immediate release formulation (if
available)
o For non-preferred brand names that have preferred generics: must provide
documentation of an inadequate clinical response or allergy to two or more
generic labelers (if available)
SUBSEQUENT AUTHORIZATION CRITERIA:
• Must provide documentation of patient’s clinical response to treatment and ongoing
safety monitoring
AR – Vesicare LS: a PA is required for patients younger than 2 years old AND 5 years and older
AR – Myrbetriq Granules: a PA is required for patients younger than 3 years old AND 5 years
and older
Ohio Medicaid Unified PDL effective July 1, 2023 75
Immunomodulator Agents: Systemic Inflammatory Disease
LENGTH OF AUTHORIZATIONS: Initial: 90 days; Subsequent: 365 days
ALL AUTHORIZATIONS: Must be
prescribed in accordance with FDA approved labeling
CLINICAL PA CRITERIA:
• Must have been an inadequate clinical response of at least 90 days with
at least
two
applicable first-line drugs indicated for diagnosis – provide documentation of the
trialed drugs, dosages, dates, and durations
• Authorization of dosing regimens (loading/maintenance) will be based upon diagnosis.
Document the requested loading and maintenance dosing on PA form, if applicable
• Must not have a current, active infection
• Must provide evidence of negative TB test prior to initiation of biologic therapy, if
required by labeling
STEP THERAPY CRITERIA:
•
Must had had an inadequate clinical response of at least 90 days with at least one
preferred TNF inhibitor indicated for diagnosis
NON-PREFERRED CRITERIA:
• Must provide documentation of medical necessity beyond convenience for why the
patient cannot be changed to a preferred drug (i.e., allergies, drug-drug interactions,
contraindications, or intolerances) OR
o For any nonsolid oral dosage formulation: must provide documentation of
medical necessity for why patient cannot be changed to a solid oral dosage
formulation
•
Must have had an inadequate clinical response of at least 90 days with at least two
preferred drugs, if indicated for diagnosis
o For non-preferred extended-release formulations: must provide documentation
of an inadequate clinical response
with its immediate release formulation (if
available)
o For non-preferred brand names that have preferred generics: must provide
documentation of an inadequate clinical response or allergy to two or more
generic labelers (if available)
ADDITIONAL ALOPECIA AREATA CRITERIA:
• Must be prescribed by or in consultation with a specialist (i.e., dermatologist,
rheumatologist)
• Must provide documentation of an inadequate clinical response of at least 90 days
with a topical steroid
Ohio Medicaid Unified PDL effective July 1, 2023 76
ADDITIONAL ATOPIC DERMATITIS CRITERIA:
• Must have at least 10% body surface area (BSA) involvement with
two of the
following: topical corticosteroids or topical calcineurin inhibitors [e.g., Elidel] unless
atopic dermatitis is severe and involves >
25% BSA
ADDITIONAL PLAQUE PSORIASIS CRITERIA:
• For patients currently receiving phototherapy, initial authorization for preferred drugs
requires an inadequate clinical response to at least 90 days of phototherapy
ADDITIONAL ULCERATIVE COLITIS CRITERIA:
• If an inadequate clinical response after 90 days with one TNF inhibitor, further TNF
inhibitors will not be authorized
SUBSEQUENT AUTHORIZATION CRITERIA:
• Must provide documentation of patient’s clinical response to treatment and ongoing
safety monitoring
Ohio Medicaid Unified PDL effective July 1, 2023 77
Infectious Disease Agents: Antibiotics – Cephalosporins
LENGTH OF AUTHORIZATIONS: Based on indication
ALL AUTHORIZATIONS: Must be
prescribed in accordance with FDA approved labeling
NON-PREFERRED CRITERIA:
• Must provide documentation of medical necessity beyond convenience for why the
patient cannot be changed to a preferred drug (i.e., allergies, drug-drug interactions,
contraindications, or intolerances) OR
o For any nonsolid oral dosage formulation: must provide documentation of
medical necessity for why patient cannot be changed to a solid oral dosage
formulation
•
Must have had an inadequate clinical response of at least 3 days with at least one
preferred antibiotic
o For non-preferred extended-release formulations: must provide documentation
of an inadequate clinical response
with its immediate release formulation (if
available)
o For non-preferred brand names that have preferred generics: must provide
documentation of an inadequate clinical response or allergy to two or more
generic labelers (if available)
ADDITIONAL INFORMATION
• Requests may be authorized if:
o The infection is caused by an organism resistant to ALL preferred
antibiotics
(must provide diagnosis and any culture/sensitivity results)
o The patient is completing a course of therapy that was started in the hospital or
other similar location or was started before Medicaid eligibility, only the
remaining course will be authorized
SUBSEQUENT AUTHORIZATION CRITERIA:
• Must provide documentation of patient’s clinical response to treatment, ongoing safety
monitoring, AND medical necessity for continued use
AR - Cefaclor Suspension: a PA is required for patients 12 years and older
AR - Cefixime Suspension: a PA is required for patients 12 years and older
AR - Cefprozil Suspension: a PA is required for patients 12 years and older
AR - Suprax Chewable Tablet: a PA is required for patients 12 years and older
Ohio Medicaid Unified PDL effective July 1, 2023 78
Infectious Disease Agents: Antibiotics – Inhaled
LENGTH OF AUTHORIZATIONS: Initial: 180 days; Subsequent: 365 days
ALL REQUESTS: Must be
prescribed in accordance with FDA approved labeling
CLINICAL PA CRITERIA:
• Must provide documentation of cultures demonstrating drug is prescribed in alignment
with approved indication
NON-PREFERRED CRITERIA:
• Must provide documentation of medical necessity beyond convenience for why the
patient cannot be changed to a preferred drug (i.e., allergies, drug-drug interactions,
contraindications, or intolerances) OR
o For any nonsolid oral dosage formulation: must provide documentation of
medical necessity for why patient cannot be changed to a solid oral dosage
formulation
•
Must have had an inadequate clinical response of at least 28 days with at least one
preferred drug
o For non-preferred extended-release formulations: must provide documentation
of an inadequate clinical response
with its immediate release formulation (if
available)
o For non-preferred brand names that have preferred generics: must provide
documentation of an inadequate clinical response or allergy to two or more
generic labelers (if available)
SUBSEQUENT AUTHORIZATION CRITERIA:
• Must provide documentation of patient’s clinical response to treatment and ongoing
safety monitoring (i.e., culture conversion, symptom improvement)
QL – Tobramycin drugs: 56 doses in 56 days
Ohio Medicaid Unified PDL effective July 1, 2023 79
Infectious Disease Agents: Antibiotics – Macrolides
LENGTH OF AUTHORIZATIONS: Based on indication
ALL AUTHORIZATIONS: Must be
prescribed in accordance with FDA approved labeling
NON-PREFERRED CRITERIA:
• Must provide documentation of medical necessity beyond convenience for why the
patient cannot be changed to a preferred drug (i.e., allergies, drug-drug interactions,
contraindications, or intolerances) OR
o For any nonsolid oral dosage formulation: must provide documentation of
medical necessity for why patient cannot be changed to a solid oral dosage
formulation
•
Must have had an inadequate clinical response of at least 3 days with at least one
preferred drug
o For non-preferred extended-release formulations: must provide documentation
of an inadequate clinical response
with its immediate release formulation (if
available)
o For non-preferred brand names that have preferred generics: must provide
documentation of an inadequate clinical response or allergy to two or more
generic labelers (if available)
ADDITIONAL INFORMATION
• Requests may be authorized if:
o The infection is caused by an organism resistant to ALL preferred
antibiotics
(must provide diagnosis and any culture/sensitivity results)
o The patient is completing a course of therapy that was started in the hospital or
other similar location or was started before Medicaid eligibility, only the
remaining course will be authorized
SUBSEQUENT AUTHORIZATION CRITERIA:
• Must provide documentation of patient’s clinical response to treatment, ongoing safety
monitoring, AND medical necessity for continued use
Ohio Medicaid Unified PDL effective July 1, 2023 80
Infectious Disease Agents: Antibiotics – Quinolones
LENGTH OF AUTHORIZATIONS: Based on indication
ALL AUTHORIZATIONS: Must be
prescribed in accordance with FDA approved labeling
NON-PREFERRED CRITERIA:
• Must provide documentation of medical necessity beyond convenience for why the
patient cannot be changed to a preferred drug (i.e., allergies, drug-drug interactions,
contraindications, or intolerances) OR
o For any nonsolid oral dosage formulation: must provide documentation of
medical necessity for why patient cannot be changed to a solid oral dosage
formulation
•
Must have had an inadequate clinical response of at least 3 days with at least one
preferred drug
o For non-preferred extended-release formulations: must provide documentation
of an inadequate clinical response
with its immediate release formulation (if
available)
o For non-preferred brand names that have preferred generics: must provide
documentation of an inadequate clinical response or allergy to two or more
generic labelers (if available)
ADDITIONAL INFORMATION
• Requests may be authorized if:
o The infection is caused by an organism resistant to ALL preferred
antibiotics
(must provide diagnosis and any culture/sensitivity results)
o The patient is completing a course of therapy that was started in the hospital or
other similar location or was started before Medicaid eligibility, only the
remaining course will be authorized
SUBSEQUENT AUTHORIZATION CRITERIA:
• Must provide documentation of patient’s clinical response to treatment, ongoing safety
monitoring, AND medical necessity for continued use
AR - Ciprofloxacin Suspension: a PA is required for patients 12 years and older
Ohio Medicaid Unified PDL effective July 1, 2023 81
Infectious Disease Agents: Antibiotics – Tetracyclines
LENGTH OF AUTHORIZATIONS: Based on indication for acute infections or 365 days for acne
ALL REQUESTS: Must be
prescribed in accordance with FDA approved labeling
NON-PREFERRED CRITERIA:
• Must provide documentation of medical necessity beyond convenience for why the
patient cannot be changed to a preferred drug (i.e., allergies, drug-drug interactions,
contraindications, or intolerances) OR
o For any nonsolid oral dosage formulation: must provide documentation of
medical necessity for why patient cannot be changed to a solid oral dosage
formulation
•
Must have had an inadequate clinical response of at least 3 days with at least one
preferred drug for acute infections OR at least 90 days with at least one preferred oral
drug for acne
o For non-preferred extended-release formulations: must provide documentation
of an inadequate clinical response
with its immediate release formulation (if
available)
o For non-preferred brand names that have preferred generics: must provide
documentation of an inadequate clinical response or allergy to two or more
generic labelers (if available)
ADDITIONAL INFORMATION
• Requests may be authorized if:
o The infection is caused by an organism resistant to ALL preferred
antibiotics
(must provide diagnosis and any culture/sensitivity results)
o The patient is completing a course of therapy that was started in the hospital or
other similar location or was started before Medicaid eligibility, only the
remaining course will be authorized
SUBSEQUENT AUTHORIZATION CRITERIA:
• Must provide documentation of patient’s clinical response to treatment, ongoing safety
monitoring, AND medical necessity for continued use
AR – Vibramycin Suspension: a PA is required for patients 12 years and older
AR – Doxycycline Syrup: a PA is required for patients 12 years and older
Ohio Medicaid Unified PDL effective July 1, 2023 82
Infectious Disease Agents: Antifungals
LENGTH OF AUTHORIZATIONS: Based on indication
ALL AUTHORIZATIONS: Must be
prescribed in accordance with FDA approved labeling
NON-PREFERRED CRITERIA:
• Must provide documentation of medical necessity beyond convenience for why the
patient cannot be changed to a preferred drug (i.e., allergies, drug-drug interactions,
contraindications, or intolerances) OR
o For any nonsolid oral dosage formulation: must provide documentation of
medical necessity for why patient cannot be changed to a solid oral dosage
formulation
•
Must have had an inadequate clinical response of at least 7 days with at least one
preferred drug
o For non-preferred extended-release formulations: must provide documentation
of an inadequate clinical response
with its immediate release formulation (if
available)
o For non-preferred brand names that have preferred generics: must provide
documentation of an inadequate clinical response or allergy to two or more
generic labelers (if available)
ADDITIONAL OTESECONAZOLE (VIVJOA) CRITERIA:
• Must provide documentation of at least three symptomatic episodes of vulvovaginal
candidiasis in the past 12 months
• Must provide documentation of non-reproductive potential (i.e., post-menopausal)
• Must have had an inadequate clinical response of at least 180 day maintenance course
with oral fluconazole shown by documentation of more than one breakthrough infection
ADDITIONAL INFORMATION:
• Requests may be authorized if:
o The infection is caused by an organism resistant to ALL preferred
antifungals
(must provide diagnosis and any culture/sensitivity results)
o The patient is completing a course of therapy that was started in the hospital or
other similar location or was started before Medicaid eligibility, only the
remaining course will be authorized
SUBSEQUENT AUTHORIZATION CRITERIA:
• Must provide documentation of patient’s clinical response to treatment, ongoing safety
monitoring, AND medical necessity for continued use
Ohio Medicaid Unified PDL effective July 1, 2023 83
Infectious Disease Agents: Antivirals – Hepatitis C Agents
LENGTH OF AUTHORIZATIONS: Dependent upon authorized course
ALL REQUESTS: Must be
prescribed in accordance with FDA approved labeling
CLINICAL PA CRITERIA:
• Only regimens recommended by the American Association for the Study of Liver
Diseases (AASLD) will be authorized
• Please see the Hepatitis C Direct Acting Antiviral Prior Authorization Form for criteria
NON-PREFERRED CRITERIA:
• Must provide documentation of medical necessity beyond convenience for why the
patient cannot be changed to a preferred drug (i.e., allergies, drug-drug interactions,
contraindications, or intolerances) OR
o For any nonsolid oral dosage formulation: must provide documentation of
medical necessity for why patient cannot be changed to a solid oral dosage
formulation
•
Must have had an inadequate clinical response defined as not achieving SVR with
guideline-recommended preferred drugs
o For non-preferred extended-release formulations: must provide documentation
of an inadequate clinical response
with its immediate release formulation (if
available)
o For non-preferred brand names that have preferred generics: must provide
documentation of an inadequate clinical response or allergy to two or more
generic labelers (if available)
ADDITIONAL INFORMATION:
• Requests for patients established on current therapy with prior payer (i.e.,
Commercial, Fee-for-Service, Managed Care Plan, etc) will be authorized with
documentation
• Requests for regimens including pegylated Interferons must include close
monitoring with periodic clinical and laboratory evaluations
• Requests for regimens including ribavirins must include documentation of at least
two reliable forms of contraception being used during therapy
Ohio Medicaid Unified PDL effective July 1, 2023 84
Infectious Disease Agents: Antivirals – Herpes
LENGTH OF AUTHORIZATIONS: For the duration of the prescription (up to 180 days)
ALL AUTHORIZATIONS: Must be
prescribed in accordance with FDA approved labeling
NON-PREFERRED CRITERIA:
• Must provide documentation of medical necessity beyond convenience for why the
patient cannot be changed to a preferred drug (i.e., allergies, drug-drug interactions,
contraindications, or intolerances) OR
o For any nonsolid oral dosage formulation: must provide documentation of
medical necessity for why patient cannot be changed to a solid oral dosage
formulation
•
Must have had an inadequate clinical response of at least 3 days with at least one
preferred drug
o For non-preferred extended-release formulations: must provide documentation
of an inadequate clinical response
with its immediate release formulation (if
available)
o For non-preferred brand names that have preferred generics: must provide
documentation of an inadequate clinical response or allergy to two or more
generic labelers (if available)
SUBSEQUENT AUTHORIZATION CRITERIA:
• Must provide documentation of patient’s clinical response to treatment and ongoing
safety monitoring
Ohio Medicaid Unified PDL effective July 1, 2023 85
Infectious Disease Agents: Antivirals – HIV*
LENGTH OF AUTHORIZATIONS: 365 Days
GRANDFATHERING*:
Patients who have a claim for a non-preferred drug in the previous 120 days will be
automatically approved to continue the drug. Patients who have taken the drug previously, but
do not have claims history (e.g., new to Medicaid), will need to submit a prior authorization in
order to continue coverage.
ALL AUTHORIZATIONS: Must be
prescribed in accordance with FDA approved labeling
ABACAVIR/DOLUTEGRAVIR/LAMIVUDINE (TRIUMEQ PD) CRITERIA:
• Must provide documentation of patient’s weight (only authorized for those 10 – 25 kg)
NON-PREFERRED CRITERIA:
• Must provide documentation of medical necessity beyond convenience for why the
patient cannot be changed to a preferred drug (i.e., allergies, drug-drug interactions,
contraindications, or intolerances) OR
o For any nonsolid oral dosage formulation: must provide documentation of
medical necessity for why patient cannot be changed to a solid oral dosage
formulation
•
Must have had an inadequate clinical response of at least 30 days with at least one
preferred drug.
If applicable, the request must address the inability to use the individual
components.
o For non-preferred extended-release formulations: must provide documentation
of an inadequate clinical response
with its immediate release formulation (if
available)
o For non-preferred brand names that have preferred generics: must provide
documentation of an inadequate clinical response or allergy to two or more
generic labelers (if available)
SUBSEQUENT AUTHORIZATION CRITERIA:
• Must provide documentation of patient’s clinical response to treatment and ongoing
safety monitoring
AR – Isentress chewable tablet: a PA is required for patients 12 years and older
AR – Lamivudine solution: a PA is required for patients 3 years and older
AR – Nevirapine solution: a PA is required for patients 3 years and older
Ohio Medicaid Unified PDL effective July 1, 2023 86
Ophthalmic Agents: Antibiotic and
Antibiotic
-
St
e
roid
Combination Drops and
Ointm
e
nts
LENGTH OF AUTHORIZATIONS: 30 days
ALL AUTHORIZATIONS: Must be
prescribed in accordance with FDA approved labeling
NON-PREFERRED CRITERIA:
• Must provide documentation of medical necessity beyond convenience for why the
patient cannot be changed to a preferred drug (i.e., allergies, drug-drug interactions,
contraindications, or intolerances) OR
o For any nonsolid oral dosage formulation: must provide documentation of
medical necessity for why patient cannot be changed to a solid oral dosage
formulation
•
Must have had an inadequate clinical response of at least 3 days with at least two
preferred drugs
o For non-preferred extended-release formulations: must provide documentation
of an inadequate clinical response
with its immediate release formulation (if
available)
o For non-preferred brand names that have preferred generics: must provide
documentation of an inadequate clinical response or allergy to two or more
generic labelers (if available)
ADDITIONAL INFORMATION
• Requests may be authorized if:
o The infection is caused by an organism resistant to ALL preferred
antibiotics
(must provide diagnosis and any culture/sensitivity results)
o The patient is completing a course of therapy that was started in the hospital or
other similar location or was started before Medicaid eligibility, only the
remaining course will be authorized
Ohio Medicaid Unified PDL effective July 1, 2023 87
Ophthalmic Agents: Antihistamines & Mast Cell Stabilizers
LENGTH OF AUTHORIZATIONS: 365 Days
ALL AUTHORIZATIONS: Must be
prescribed in accordance with FDA approved labeling
NON-PREFERRED CRITERIA:
• Must provide documentation of medical necessity beyond convenience for why the
patient cannot be changed to a preferred drug (i.e., allergies, drug-drug interactions,
contraindications, or intolerances) OR
o For any nonsolid oral dosage formulation: must provide documentation of
medical necessity for why patient cannot be changed to a solid oral dosage
formulation
•
Must have had an inadequate clinical response of at least 14 days with at least two
preferred drugs
o For non-preferred extended-release formulations: must provide documentation
of an inadequate clinical response
with its immediate release formulation (if
available)
o For non-preferred brand names that have preferred generics: must provide
documentation of an inadequate clinical response or allergy to two or more
generic labelers (if available)
SUBSEQUENT AUTHORIZATION CRITERIA:
• Must provide documentation of patient’s clinical response to treatment and ongoing
safety monitoring
Ohio Medicaid Unified PDL effective July 1, 2023 88
Ophthalmic Agents: Dry Eye Treatments
LENGTH OF AUTHORIZATIONS: 14 Days for Eysuvis; 365 Days for all other drugs
ALL AUTHORIZATIONS: Must be
prescribed in accordance with FDA approved labeling
STEP THERAPY CRITERIA:
•
Must have had an inadequate clinical response of at least 14 days with one artificial
tear or OTC dry eye drop in the previous 120 days
NON-PREFERRED CRITERIA:
• Must provide documentation of medical necessity beyond convenience for why the
patient cannot be changed to a preferred drug (i.e., allergies, drug-drug interactions,
contraindications, or intolerances) OR
o For any nonsolid oral dosage formulation: must provide documentation of
medical necessity for why patient cannot be changed to a solid oral dosage
formulation
•
Must have had an inadequate clinical response of at least 14 days with at least one
preferred drug
o For non-preferred extended-release formulations: must provide documentation
of an inadequate clinical response
with its immediate release formulation (if
available)
o For non-preferred brand names that have preferred generics: must provide
documentation of an inadequate clinical response or allergy to two or more
generic labelers (if available)
SUBSEQUENT AUTHORIZATION CRITERIA:
• Must provide documentation of patient’s clinical response to treatment and ongoing
safety monitoring
Ohio Medicaid Unified PDL effective July 1, 2023 89
Ophthalmic Agents: Glaucoma Age
nts
LENGTH OF AUTHORIZATIONS: 365 Days
ALL AUTHORIZATIONS: Must be
prescribed in accordance with FDA approved labeling
STEP THERAPY CRITERIA:
•
Must have had an inadequate clinical response of at least 30 days with at least one
preferred drug in the same class, if available
NON-PREFERRED CRITERIA:
• Must provide documentation of medical necessity beyond convenience for why the
patient cannot be changed to a preferred drug (i.e., allergies, drug-drug interactions,
contraindications, or intolerances) OR
o For any nonsolid oral dosage formulation: must provide documentation of
medical necessity for why patient cannot be changed to a solid oral dosage
formulation
•
Must have had an inadequate clinical response of at least 30 days with at least two
preferred drugs in the same class, if available
o For non-preferred extended-release formulations: must provide documentation
of an inadequate clinical response
with its immediate release formulation (if
available)
o For non-preferred brand names that have preferred generics: must provide
documentation of an inadequate clinical response or allergy to two or more
generic labelers (if available)
SUBSEQUENT AUTHORIZATION CRITERIA:
• Must provide documentation of patient’s clinical response to treatment and ongoing
safety monitoring
Ohio Medicaid Unified PDL effective July 1, 2023 90
Ophthalmic Agents: NSAIDs
LENGTH OF AUTHORIZATIONS: 30 days
ALL AUTHORIZATIONS: Must be
prescribed in accordance with FDA approved labeling
NON-PREFERRED CRITERIA:
• Must provide documentation of medical necessity beyond convenience for why the
patient cannot be changed to a preferred drug (i.e., allergies, drug-drug interactions,
contraindications, or intolerances) OR
o For any nonsolid oral dosage formulation: must provide documentation of
medical necessity for why patient cannot be changed to a solid oral dosage
formulation
•
Must have had an inadequate clinical response of at least 3 days with at least one
preferred drug
o For non-preferred extended-release formulations: must provide documentation
of an inadequate clinical response
with its immediate release formulation (if
available)
o For non-preferred brand names that have preferred generics: must provide
documentation of an inadequate clinical response or allergy to two or more
generic labelers (if available)
Ohio Medicaid Unified PDL effective July 1, 2023 91
Ophthalmic Agents: Ophthalmic Steroids
LENGTH OF AUTHORIZATIONS: 30 days
ALL AUTHORIZATIONS: Must be
prescribed in accordance with FDA approved labeling
NON-PREFERRED CRITERIA:
• Must provide documentation of medical necessity beyond convenience for why the
patient cannot be changed to a preferred drug (i.e., allergies, drug-drug interactions,
contraindications, or intolerances) OR
o For any nonsolid oral dosage formulation: must provide documentation of
medical necessity for why patient cannot be changed to a solid oral dosage
formulation
•
Must have had an inadequate clinical response of at least 14 days with at least two
preferred drugs
o For non-preferred extended-release formulations: must provide documentation
of an inadequate clinical response
with its immediate release formulation (if
available)
o For non-preferred brand names that have preferred generics: must provide
documentation of an inadequate clinical response or allergy to two or more
generic labelers (if available)
Ohio Medicaid Unified PDL effective July 1, 2023 92
Otic Agents: Antibacterial and
Antibact
e
rial/Steroid
Combinations
LENGTH OF AUTHORIZATIONS: 30 days
ALL AUTHORIZATIONS: Must be
prescribed in accordance with FDA approved labeling
NON-PREFERRED CRITERIA:
• Must provide documentation of medical necessity beyond convenience for why the
patient cannot be changed to a preferred drug (i.e., allergies, drug-drug interactions,
contraindications, or intolerances) OR
o For any nonsolid oral dosage formulation: must provide documentation of
medical necessity for why patient cannot be changed to a solid oral dosage
formulation
•
Must have had an inadequate clinical response of at least
7 days with
at least
one
preferred drug
o For non-preferred extended-release formulations: must provide documentation
of an inadequate clinical response
with its immediate release formulation (if
available)
o For non-preferred brand names that have preferred generics: must provide
documentation of an inadequate clinical response or allergy to two or more
generic labelers (if available)
Ohio Medicaid Unified PDL effective July 1, 2023 93
Respiratory Agents: Antihistamines – Second Generation
LENGTH OF AUTHORIZATIONS: 365 Days
ALL AUTHORIZATIONS: Must be
prescribed in accordance with FDA approved labeling
NON-PREFERRED CRITERIA:
• Must provide documentation of medical necessity beyond convenience for why the
patient cannot be changed to a preferred drug (i.e., allergies, drug-drug interactions,
contraindications, or intolerances) OR
o For any nonsolid oral dosage formulation: must provide documentation of
medical necessity for why patient cannot be changed to a solid oral dosage
formulation
•
Must have had an inadequate clinical response of at least 30 days with at least two
different preferred drugs
o For non-preferred extended-release formulations: must provide documentation
of an inadequate clinical response
with its immediate release formulation (if
available)
o For non-preferred brand names that have preferred generics: must provide
documentation of an inadequate clinical response or allergy to two or more
generic labelers (if available)
SUBSEQUENT AUTHORIZATION CRITERIA:
• Must provide documentation of patient’s clinical response to treatment and ongoing
safety monitoring
AR – Cetirizine Chewables: a PA is required for patients 6 years and older
Ohio Medicaid Unified PDL effective July 1, 2023 94
Respiratory Agents: Cystic Fibrosis
LENGTH OF AUTHORIZATIONS: Initial: 90 days; Subsequent: 365 days
ALL AUTHORIZATIONS: Must be
prescribed in accordance with FDA approved labeling
CLINICAL PA CRITERIA:
• Must be prescribed by or in consultation with a pulmonologist or infectious disease
specialist
• Must provide documentation of the genetic mutation
NON-PREFERRED CRITERIA:
• Must provide documentation of medical necessity beyond convenience for why the
patient cannot be changed to a preferred drug (i.e., allergies, drug-drug interactions,
contraindications, or intolerances) OR
o For any nonsolid oral dosage formulation: must provide documentation of
medical necessity for why patient cannot be changed to a solid oral dosage
formulation
•
Must have had an inadequate clinical response of at least 30 days with at least one
preferred drug
o For non-preferred extended-release formulations: must provide documentation
of an inadequate clinical response
with its immediate release formulation (if
available)
o For non-preferred brand names that have preferred generics: must provide
documentation of an inadequate clinical response or allergy to two or more
generic labelers (if available)
ADDITIONAL BRONCHITOL CRITERIA:
• Must be used as an add-on maintenance therapy
• Must provide documentation of a completed Bronchitol Tolerance Test
SUBSEQUENT AUTHORIZATION CRITERIA:
• Must provide documentation of patient’s clinical response to treatment (adherence to
treatment demonstrated by claims history AND one or more of the following: FEV1,
weight gain, sweat chloride, pulmonary exacerbations, etc.) and ongoing safety
monitoring
Ohio Medicaid Unified PDL effective July 1, 2023 95
Respiratory Agents: Epinephrine Auto-Injectors
LENGTH OF AUTHORIZATIONS: 365 Days
ALL AUTHORIZATIONS: Must be
prescribed in accordance with FDA approved labeling
NON-PREFERRED CRITERIA:
• Must provide documentation of medical necessity beyond convenience for why the
patient cannot be changed to a preferred drug (i.e., allergies, drug-drug interactions,
contraindications, or intolerances) OR
o For any nonsolid oral dosage formulation: must provide documentation of
medical necessity for why patient cannot be changed to a solid oral dosage
formulation
•
Must have had an inadequate clinical response to at least one preferred drug
o For non-preferred extended-release formulations: must provide documentation
of an inadequate clinical response
with its immediate release formulation (if
available)
o For non-preferred brand names that have preferred generics: must provide
documentation of an inadequate clinical response or allergy to two or more
generic labelers (if available)
SUBSEQUENT AUTHORIZATION CRITERIA:
• Must provide documentation of patient’s clinical response to treatment and ongoing
safety monitoring
Ohio Medicaid Unified PDL effective July 1, 2023 96
Respiratory Agents: Hereditary Angioedema
LENGTH OF AUTHORIZATIONS: Initial: 90 days; Subsequent: 180 Days
ALL AUTHORIZATIONS: Must be
prescribed in accordance with FDA approved labeling
CLINICAL PA CRITERIA:
• Must provide documentation of diagnosis (i.e., C1-INH deficiency or dysfunction (Type I or
II HAE)) and whether the drug will be used for prophylaxis or treatment
• Must provide documentation of at-home administration
NON-PREFERRED CRITERIA:
• Must provide documentation of medical necessity beyond convenience for why the
patient cannot be changed to a preferred drug (i.e., allergies, drug-drug interactions,
contraindications, or intolerances) OR
o For any nonsolid oral dosage formulation: must provide documentation of
medical necessity for why patient cannot be changed to a solid oral dosage
formulation
•
Must have had an inadequate clinical response of at least 60 days with at least one
preferred drug
o For non-preferred extended-release formulations: must provide documentation
of an inadequate clinical response
with its immediate release formulation (if
available)
o For non-preferred brand names that have preferred generics: must provide
documentation of an inadequate clinical response or allergy to two or more
generic labelers (if available)
SUBSEQUENT AUTHORIZATION CRITERIA:
• Must provide documentation of patient’s clinical response to treatment and ongoing
safety monitoring
Ohio Medicaid Unified PDL effective July 1, 2023 97
Respiratory Agents: Inhaled Agents
LENGTH OF AUTHORIZATIONS: 365 Days
ALL AUTHORIZATIONS: Must be
prescribed in accordance with FDA approved labeling
NON-PREFERRED CRITERIA:
• Must provide documentation of medical necessity beyond convenience for why the
patient cannot be changed to a preferred drug (i.e., allergies, drug-drug interactions,
contraindications, or intolerances) OR
o For any nonsolid oral dosage formulation: must provide documentation of
medical necessity for why patient cannot be changed to a solid oral dosage
formulation
•
Must have had an inadequate clinical response of at least 14 days with at least two
preferred drugs
within the same class and duration of action
o For non-preferred extended-release formulations: must provide documentation
of an inadequate clinical response
with its immediate release formulation (if
available)
o For non-preferred brand names that have preferred generics: must provide
documentation of an inadequate clinical response or allergy to two or more
generic labelers (if available)
ADDITIONAL STEROID-CONTAINING INHALER CRITERIA
• May be authorized if documentation of one of the following is provided:
o Patient is 12 years or younger OR is disabled and is unable to use a preferred
inhaler
o Patient has been non-compliant on a preferred inhaler due to taste, dry mouth,
or infection
o Patient is clinically unstable, as defined by current guidelines in terms of oral
steroid use or patient’s current symptomatology
SUBSEQUENT AUTHORIZATION CRITERIA:
• Must provide documentation of patient’s clinical response to treatment and ongoing
safety monitoring
AR - Albuterol Nebulizer Solution 0.021% (0.63mg/3mL), 0.042% (1.25mg/3mL): a PA is required
for patients 13 years and older
AR - Budesonide Nebulizer Solution: a PA is required for patients 7 years and older
Ohio Medicaid Unified PDL effective July 1, 2023 98
Respiratory Agents: Leukotriene Receptor Modifiers &
Inhibitors
LENGTH OF AUTHORIZATIONS: 365 Days
ALL AUTHORIZATIONS: Must be
prescribed in accordance with FDA approved labeling
STEP THERAPY CRITERIA:
•
Must have had an inadequate clinical response of at least 90 days with at least one
preferred drug
NON-PREFERRED CRITERIA:
• Must provide documentation of medical necessity beyond convenience for why the
patient cannot be changed to a preferred drug (i.e., allergies, drug-drug interactions,
contraindications, or intolerances) OR
o For any nonsolid oral dosage formulation: must provide documentation of
medical necessity for why patient cannot be changed to a solid oral dosage
formulation
•
Must have had an inadequate clinical response of at least 90 days with at least two
preferred drugs
o For non-preferred extended-release formulations: must provide documentation
of an inadequate clinical response
with its immediate release formulation (if
available)
o For non-preferred brand names that have preferred generics: must provide
documentation of an inadequate clinical response or allergy to two or more
generic labelers (if available)
SUBSEQUENT AUTHORIZATION CRITERIA:
• Must provide documentation of patient’s clinical response to treatment and ongoing
safety monitoring
Ohio Medicaid Unified PDL effective July 1, 2023 99
Respiratory Agents: Monoclonal Antibodies-Anti-IL/Anti-IgE
LENGTH OF AUTHORIZATIONS: Initial: 180 days; Subsequent: 365 days
ALL AUTHORIZATIONS: Must be
prescribed in accordance with FDA approved labeling
CLINICAL PA CRITERIA:
• Must be prescribed by or in consultation with an applicable specialist (i.e., allergist/
immunologist, pulmonologist, or otolaryngologist)
• For Asthma – Must have had uncontrolled asthma symptoms and/or exacerbations
despite at least 30 days with:
o Medium dose preferred ICS/LABA inhaler for 6 years and older OR medium dose
preferred ICS/LABA inhaler with tiotropium or high dose ICS/LABA inhaler if 12
years and older
• For Chronic Rhinosinusitis with Nasal Polyposis – Must have had an inadequate
clinical response of at least 30 days to
at least
one oral corticosteroid AND one nasal
corticosteroid spray
• For Chronic Urticaria – Must have had an inadequate clinical response to at least 14
days with
at least
two different antihistamines
NON-PREFERRED CRITERIA:
• Must provide documentation of medical necessity beyond convenience for why the
patient cannot be changed to a preferred drug (i.e., allergies, drug-drug interactions,
contraindications, or intolerances) OR
o For any nonsolid oral dosage formulation: must provide documentation of
medical necessity for why patient cannot be changed to a solid oral dosage
formulation
• Must have had an inadequate clinical response of at least 90 days with
at least
one
preferred drug
o For non-preferred extended-release formulations: must provide documentation of
an inadequate clinical response
with its immediate release formulation (if
available)
o For non-preferred brand names that have preferred generics, requests must
provide documentation of an inadequate clinical response or allergy to two or
more generic labelers (if available)
SUBSEQUENT AUTHORIZATION CRITERIA:
• Must provide documentation of patient’s clinical response to treatment and ongoing
safety monitoring (i.e., PFT improvement, reduced affected BSA)
Ohio Medicaid Unified PDL effective July 1, 2023 100
Respiratory Agents: Nasal Preparations
LENGTH OF AUTHORIZATIONS: 365 days
ALL AUTHORIZATIONS: Must be
prescribed in accordance with FDA approved labeling
NON-PREFERRED CRITERIA:
• Must provide documentation of medical necessity beyond convenience for why the
patient cannot be changed to a preferred drug (i.e., allergies, drug-drug interactions,
contraindications, or intolerances) OR
o For any nonsolid oral dosage formulation: must provide documentation of
medical necessity for why patient cannot be changed to a solid oral dosage
formulation
•
Must have had an inadequate clinical response of at least 30 days with at least two
preferred drugs in the same class, if available
o For non-preferred extended-release formulations: must provide documentation
of an inadequate clinical response
with its immediate release formulation (if
available)
o For non-preferred brand names that have preferred generics: must provide
documentation of an inadequate clinical response or allergy to two or more
generic labelers (if available)
SUBSEQUENT AUTHORIZATION CRITERIA:
• Must provide documentation of patient’s clinical response to treatment and ongoing
safety monitoring
Ohio Medicaid Unified PDL effective July 1, 2023 101
Respiratory Agents: Other Agents
LENGTH OF AUTHORIZATIONS: Initial: 90 days; Subsequent: 180 days
ALL AUTHORIZATIONS: Must be
prescribed in accordance with FDA approved labeling
NON-PREFERRED CRITERIA:
• Must provide documentation of medical necessity beyond convenience for why the
patient cannot be changed to a preferred drug (i.e., allergies, drug-drug interactions,
contraindications, or intolerances) OR
o For any nonsolid oral dosage formulation: must provide documentation of
medical necessity for why patient cannot be changed to a solid oral dosage
formulation
•
Must have had an inadequate clinical response of at least 90 days with at least one
preferred long
-acting beta agonist AND
one preferred
long-acting muscarinic
antagonist-containing inhalers
o For non-preferred extended-release formulations: must provide documentation
of an inadequate clinical response
with its immediate release formulation (if
available)
o For non-preferred brand names that have preferred generics: must provide
documentation of an inadequate clinical response or allergy to two or more
generic labelers (if available)
ADDITIONAL ROFLUMILAST (DALIRESP) CRITERIA:
• Must be used in addition to a long-acting beta agonist AND a long-acting muscarinic
antagonist-containing inhalers
SUBSEQUENT AUTHORIZATION CRITERIA:
• Must provide documentation of patient’s clinical response to treatment, adherence to
maintenance inhaler per pharmacy claims, and ongoing safety monitoring
Ohio Medicaid Unified PDL effective July 1, 2023 102
Topical Agents: Antifungals
LENGTH OF AUTHORIZATIONS: Up to 180 days for all agents except 365 days for Jublia
ALL AUTHORIZATIONS: Must be
prescribed in accordance with FDA approved labeling
NON-PREFERRED CRITERIA:
• Must provide documentation of medical necessity beyond convenience for why the
patient cannot be changed to a preferred drug (i.e., allergies, drug-drug interactions,
contraindications, or intolerances) OR
o For any nonsolid oral dosage formulation: must provide documentation of
medical necessity for why patient cannot be changed to a solid oral dosage
formulation
•
Must have had an inadequate clinical response of at least 14 days with at least two
preferred drugs, if indicated for diagnosis
o For non-preferred extended-release formulations: must provide documentation
of an inadequate clinical response
with its immediate release formulation (if
available)
o For non-preferred brand names that have preferred generics: must provide
documentation of an inadequate clinical response or allergy to two or more
generic labelers (if available)
ADDITIONAL EFINACONAZOLE (JUBLIA) CRITERIA:
•
Must have had an inadequate clinical response of at least 365 days with at least one
preferred topical drug AND at least 84 days with at least one preferred oral drug
indicated for diagnosis
ADDITIONAL INFORMATION
• Requests may be authorized if:
o The infection is caused by an organism resistant to preferred
antibiotics
drugs
(note diagnosis and any culture/sensitivity results)
SUBSEQUENT AUTHORIZATION CRITERIA:
• Must provide documentation of patient’s clinical response to treatment and ongoing
safety monitoring
Ohio Medicaid Unified PDL effective July 1, 2023 103
Topical Agents: Antiparasitics
LENGTH OF AUTHORIZATIONS: 14 Days
ALL AUTHORIZATIONS: Must be
prescribed in accordance with FDA approved labeling
NON-PREFERRED CRITERIA:
• Must provide documentation of medical necessity beyond convenience for why the
patient cannot be changed to a preferred drug (i.e., allergies, drug-drug interactions,
contraindications, or intolerances) OR
o For any nonsolid oral dosage formulation: must provide documentation of
medical necessity for why patient cannot be changed to a solid oral dosage
formulation
•
Must have had an inadequate clinical response of at least 14 days with at least one
preferred drug
o For non-preferred extended-release formulations: must provide documentation
of an inadequate clinical response
with its immediate release formulation (if
available)
o For non-preferred brand names that have preferred generics: must provide
documentation of an inadequate clinical response or allergy to two or more
generic labelers (if available)
SUBSEQUENT AUTHORIZATION CRITERIA:
• Must provide documentation of patient’s clinical response to treatment and ongoing
safety monitoring
Ohio Medicaid Unified PDL effective July 1, 2023 104
Topical Agents: Corticosteroids
LENGTH OF AUTHORIZATIONS: 365 days for low/med potency; 90 days for high/very high
potency
ALL AUTHORIZATIONS: Must be
prescribed in accordance with FDA approved labeling
NON-PREFERRED CRITERIA:
• Must provide documentation of medical necessity beyond convenience for why the
patient cannot be changed to a preferred drug (i.e., allergies, drug-drug interactions,
contraindications, or intolerances) OR
o For any nonsolid oral dosage formulation: must provide documentation of
medical necessity for why patient cannot be changed to a solid oral dosage
formulation
•
Must have had an inadequate clinical response of at least 14 days with at least two
preferred drugs
o For non-preferred extended-release formulations: must provide documentation
of an inadequate clinical response
with its immediate release formulation (if
available)
o For non-preferred brand names that have preferred generics: must provide
documentation of an inadequate clinical response or allergy to two or more
generic labelers (if available)
SUBSEQUENT AUTHORIZATION CRITERIA:
• Must provide documentation of patient’s clinical response to treatment and ongoing
safety monitoring
Ohio Medicaid Unified PDL effective July 1, 2023 105
Topical Agents: Immunomodulators
LENGTH OF AUTHORIZATIONS: 365 Days
ALL AUTHORIZATIONS: Must be
prescribed in accordance with FDA approved labeling
STEP THERAPY CRITERIA:
•
Must have had an inadequate clinical response of at least 30 days with at least two
topical corticosteroids
NON-PREFERRED CRITERIA:
• Must provide documentation of medical necessity beyond convenience for why the
patient cannot be changed to a preferred drug (i.e., allergies, drug-drug interactions,
contraindications, or intolerances) OR
o For any nonsolid oral dosage formulation: must provide documentation of
medical necessity for why patient cannot be changed to a solid oral dosage
formulation
•
Must have had an inadequate clinical response of at least 30 days with at least one
preferred drug
o For non-preferred extended-release formulations: must provide documentation
of an inadequate clinical response
with its immediate release formulation (if
available)
o For non-preferred brand names that have preferred generics: must provide
documentation of an inadequate clinical response or allergy to two or more
generic labelers (if available)
SUBSEQUENT AUTHORIZATION CRITERIA:
• Must provide documentation of patient’s clinical response to treatment and ongoing
safety monitoring
AR - pimecrolimus and tacrolimus: a PA is required for patients younger than 2 years old
