Ohio Department of Medicaid 30 Day Change Notice Form

Effective Date

Last Reviewed

Original Document

Ohio Department of Medicaid 30 Day Change Notice Effective Date: October 1, 2025

NEW PREFERRED DRUGS

THERAPEUTIC CLASS	NO PA REQUIRED PREFERRED
Analgesic Agents: Opioids	hydrocodone/APAP 2.5, 5, 7.5, 10-325mg
Cardiovascular Agents: Angina, Hypertension and Heart Failure	bumetanide<br>chlorthalidone<br>furosemide<br>hydrochlorothiazide<br>INZIRQO<br>torsemide<br>triamterene<br>triamterene/HCTZ
Endocrine Agents: Diabetes – Non-Insulin	exenatide<br>saxagliptin<br>saxagliptin/metformin

NEW CLINICAL PA REQUIRED PREFERRED DRUGS

THERAPEUTIC CLASS	CLINICAL CRITERIA REQUIRED PREFERRED
Duchenne Muscular Dystrophy Agents: Corticosteroids	EMFLAZA
Immunomodulator Agents: Systemic Inflammatory Disease	infliximab (gen of REMICADE)<br>PYZCHIVA (Bio of STELARA)<br>SKYRIZI SUBQ INJ
Sickle Cell Gene Therapy Agents	CASGEVY<br>LYFGENIA

NEW NON PREFERRED DRUGS

THERAPEUTIC CLASS	PA REQUIRED NON PREFERRED
Blood Formation, Coagulation, and Thrombosis Agents: Hemophilia A, von Willebrand Disease, and Factor XIII Deficiency* LEGACY CATEGORY	ALHEMO<br>QFITLIA
Blood Formation, Coagulation, and Thrombosis Agents: Hemophilia B* LEGACY CATEGORY	ALHEMO<br>QFITLIA
Central Nervous System (CNS) Agents: Anticonvulsants* LEGACY CATEGORY	eslicarbazepine<br>perampanel<br>topiramate soln
Central Nervous System (CNS) Agents: Antidepressants* LEGACY CATEGORY	RALDESY
Central Nervous System (CNS) Agents: Parkinson's Agents	ONAPGO
Duchenne Muscular Dystrophy Agents: Corticosteroids	AGAMREE<br>deflazacort
Gastrointestinal Agents: Bowel Preparations	peg/NaSul/C/ sol NaCL/Pot soln
Immunomodulator Agents: Systemic	INFLECTRA (Bio of REMICADE)

Date of Notice: 9/1/2025

Ohio Department of Medicaid 30 Day Change Notice Effective Date: October 1, 2025

Inflammatory Disease	OTULFI (Bio of STELARA)<br>STEQEYMA<br>ustekinumab (gen of STELARA)<br>ustekinumab-aekn (gen of SELARSDI)<br>ustekinumab-ttwe (gen of PYZCHIVA)<br>YESINTEK (Bio of STELARA)
Infectious Disease Agents: Antivirals – HIV* LEGACY CATEGORY	emtricitabine/tilpivirine/tenofovir
Respiratory Agents: Inhaled Agents	fluticasone furoate

THERAPEUTIC CATEGORIES WITH CHANGES IN CRITERIA

Blood Formation, Coagulation, and Thrombosis Agents: Hemophilia A, von Willebrand Disease, and Factor XIII Deficiency* LEGACY CATEGORY
Blood Formation, Coagulation, and Thrombosis Agents: Hemophilia B* LEGACY CATEGORY
Cardiovascular Agents: Angina, Hypertension and Heart Failure
Central Nervous System (CNS) Agents: Parkinson's Agents
Immunomodulator Agents: Systemic Inflammatory Disease
Infectious Disease Agents: Antibiotics – Cephalosporins
Respiratory Agents: Monoclonal Antibodies-Anti-IL/Anti-IgE

REVISED THERAPEUTIC CATEGORY CRITERIA

THERAPEUTIC CLASS	SUMMARY OF CHANGE
Blood Formation, Coagulation, and Thrombosis Agents: Hemophilia A, von Willebrand Disease, and Factor XIII Deficiency* LEGACY CATEGORY	NON-PREFERRED CRITERIA:<br>• Must have had an inadequate clinical response such as increased in bleeding episodes, OR require a need for more factor replacement therapy, OR demonstrate worsening joint health, of at least 14 days with at least one preferred drug in this UPDL category and indicated for diagnosis<br><br>ADDITIONAL HYMPAVZI (MARSTACIMAB-HNCQ) CRITERIA<br>• Must have had an inadequate clinical response such as an increased in bleeding episodes, OR require a need for more factor replacement therapy, OR demonstrate worsening joint health, of at least 30 days with HELMIBRA<br>• Must have Hemophilia A without factor VIII inhibitors<br>• Must be prescribed by or in consultation with a hematologist<br><br>ADDITIONAL ALHEMO (CONCIZUMAB-MTCI) CRITERIA<br>• Must have had an inadequate clinical response such as an increased in bleeding episodes, OR require a need for more factor replacement therapy, OR demonstrate worsening joint health, of at least 30 days with HELMIBRA<br>• Must have Hemophilia A with factor VIII inhibitors<br>• Must be prescribed by or in consultation with a hematologist

THERAPEUTIC CLASS

SUMMARY OF CHANGE

Blood Formation, Coagulation, and Thrombosis Agents: Hemophilia A, von Willebrand Disease, and Factor XIII Deficiency* LEGACY CATEGORY

NON-PREFERRED CRITERIA: • Must have had an inadequate clinical response such as increased in bleeding episodes, OR require a need for more factor replacement therapy, OR demonstrate worsening joint health, of at least 14 days with at least one preferred drug in this UPDL category and indicated for diagnosis ADDITIONAL HYMPAVZI (MARSTACIMAB-HNCQ) CRITERIA • Must have had an inadequate clinical response such as an increased in bleeding episodes, OR require a need for more factor replacement therapy, OR demonstrate worsening joint health, of at least 30 days with HELMIBRA • Must have Hemophilia A without factor VIII inhibitors • Must be prescribed by or in consultation with a hematologist ADDITIONAL ALHEMO (CONCIZUMAB-MTCI) CRITERIA • Must have had an inadequate clinical response such as an increased in bleeding episodes, OR require a need for more factor replacement therapy, OR demonstrate worsening joint health, of at least 30 days with HELMIBRA • Must have Hemophilia A with factor VIII inhibitors • Must be prescribed by or in consultation with a hematologist

Date of Notice: 9/1/2025

Ohio Department of Medicaid 30 Day Change Notice Effective Date: October 1, 2025

Blood Formation, Coagulation, and Thrombosis Agents: Hemophilia B* LEGACY CATEGORY	ADDITIONAL QFITLIA (FITUSIRAN) CRITERIA<br>• Must have had an inadequate clinical response such as an increased in bleeding episodes, OR require a need for more factor replacement therapy, OR demonstrate worsening joint health, of at least 30 days with HELMIBRA<br>• Must have Hemophilia A with or without factor VIII inhibitors<br>• Must be prescribed by or in consultation with a hematologist<br><br>NON-PREFERRED CRITERIA:<br>• Must have had an inadequate clinical response such as an increase in bleeding episodes, OR require a need for more factor replacement therapy, OR demonstrate worsening joint health, of at least 14 days with at least one preferred drug in this UPDL category and indicated for diagnosis
Cardiovascular Agents: Angina, Hypertension and Heart Failure	ADDITIONAL FINERENONE (KERENDIA) CRITERIA:<br>• Must be on a maximally tolerated dose of an angiotensin-converting enzyme inhibitor or angiotensin receptor blocker AND<br>• 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)<br><br>AR – INZIRQO SOLN: a PA is required for patients 12 years and older
Central Nervous System (CNS) Agents: Parkinson's Agents	ADDITIONAL APOMORPHINE (ONAPGO) CRITERIA:<br>• Must have had an inadequate clinical response of at least 30 days with at least two preferred drugs in this UPDL category, one of which must be carbidopa/levodopa
Immunomodulator Agents: Systemic Inflammatory Disease	CLINICAL PA CRITERIA:<br>• Authorization of dosing regimens (loading/maintenance) will be based upon diagnosis. Document the requested loading and maintenance dosing on PA form, if applicable<br>• Must not have a current, active infection<br>• Must provide evidencede of negative TB test within the past 365 days prior to initiation of biologic therapy, if required by labeling<br><br>ADDITIONAL CHRONIC SPONTANEOUS URTICARIA CRITERIA:<br>• Must be prescribed by or in consultation with a specialist (i.e., allergist/ immunologist, dermatologist, rheumatologist)<br>• Must have had an inadequate clinical response of at least 14 days with at least two different second-generation antihistamines at 4 times standard dose
Infectious Disease Agents: Antibiotics – Cephalosporins	AR – cephalexin susp: a PA is required for patients 12 years and older
Respiratory Agents: Monoclonal	CLINICAL PA CRITERIA:

Date of Notice: 9/1/2025

Ohio Department of Medicaid 30 Day Change Notice Effective Date: October 1, 2025

| Antibodies-Anti-IL/Anti-IgE | • Must be prescribed by or in consultation with an applicable specialist (i.e., allergist/ immunologist, pulmonologist, otolaryngologist) • For Asthma – Must have had uncontrolled asthma symptoms and/or exacerbations despite at least 30 days with: ○ 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 Spontaneous Urticaria – Must have had an inadequate clinical response of at least 14 days with at least two different second-generation antihistamines at 4 times standard dose |

NEW THERAPEUTIC CATEGORIES

Duchenne Muscular Dystrophy Agents: Corticosteroids
Sickle Cell Gene Therapy Agents

NEW THERAPEUTIC CATEGORY CRITERIA

THERAPEUTIC CLASS	SUMMARY OF CHANGE
Duchenne Muscular Dystrophy Agents: Corticosteroids	LENGTH OF AUTHORIZATIONS: 365 Days<br><br>CLINICAL PA CRITERIA:<br>• Must be prescribed by or in consultation with a neurologist or specialist in Duchenne Muscular Dystrophy<br>• Must have documented DMD diagnosis confirmed by genetic testing or muscle biopsy with dystrophin absent results<br>• Must have had an inadequate clinical response of at least 180 days or contraindication to prednisone<br>• Must provide documentation of patient’s weight<br><br>NON-PREFERRED CRITERIA:<br>Must have had unmanageable side effects, such as significant weight gain/obesity, persistent psychiatric/behavioral conditions, diabetes, growth delay, cataracts, hypertension, or cushingoid appearance OR intolerance of at least 30 days with at least one preferred drug in this UPDL category and indicated for diagnosis
Sickle Cell Gene Therapy Agents	LENGTH OF AUTHORIZATIONS: 365 Days<br><br>CLINICAL PA CRITERIA:<br>• Please see the Prior Authorization Form for criteria

THERAPEUTIC CLASS

SUMMARY OF CHANGE

Duchenne Muscular Dystrophy Agents: Corticosteroids

LENGTH OF AUTHORIZATIONS: 365 Days CLINICAL PA CRITERIA: • Must be prescribed by or in consultation with a neurologist or specialist in Duchenne Muscular Dystrophy • Must have documented DMD diagnosis confirmed by genetic testing or muscle biopsy with dystrophin absent results • Must have had an inadequate clinical response of at least 180 days or contraindication to prednisone • Must provide documentation of patient’s weight NON-PREFERRED CRITERIA: Must have had unmanageable side effects, such as significant weight gain/obesity, persistent psychiatric/behavioral conditions, diabetes, growth delay, cataracts, hypertension, or cushingoid appearance OR intolerance of at least 30 days with at least one preferred drug in this UPDL category and indicated for diagnosis

Sickle Cell Gene Therapy Agents

LENGTH OF AUTHORIZATIONS: 365 Days CLINICAL PA CRITERIA: • Please see the Prior Authorization Form for criteria

Date of Notice: 9/1/2025

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Ohio Department of Medicaid 30 Day Change Notice Form

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