Buckeye (OH)Commercial Clinical Policy

Ohio Department of Medicaid 30 Day Change Notice Form

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Ohio Department of Medicaid 30 Day Change Notice

Indications

(10001) Is there documentation of chronic heart failure for Entresto (SACUBITRIL/VALSARTAN)? 
(10002) Is the chronic heart failure classified as NYHA Class II-IV? 
(10003) Is the chronic heart failure classified as ACC/AHA Stage B-D? 
(20001) Is there documentation of medical necessity beyond convenience for why the patient cannot be changed to a preferred drug? 
(20002) Is the reason for not changing to a preferred drug due to allergies? 

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Effective Date

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Last Reviewed

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Original Document

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Ohio Department of Medicaid 30 Day Change Notice Effective Date: July 1, 2024

NEW PREFERRED DRUGS

THERAPEUTIC CLASS NO PA REQUIRED PREFERRED
Cardiovascular Agents: Angina, Hypertension and Heart Failure Entresto
Dermatologic Agents: Topical Acne Products Adapalene Gel 0.3%<br>Altreno<br>Clindamycin Swabs<br>Onexton Gel
Infectious Disease Agents: Antivirals – HIV* Cabenuva
Ophthalmic Agents: Dry Eye Treatments Restasis

NEW CLINICAL PA REQUIRED PREFERRED DRUGS

THERAPEUTIC CLASS CLINICAL CRITERIA REQUIRED PREFERRED
Central Nervous System (CNS) Agents: Anticonvulsants* Epidiolex
Endocrine Agents: Growth Hormone Skytrofa

NEW STEP THERAPY REQUIRED PREFERRED DRUGS

THERAPEUTIC CLASS CLINICAL CRITERIA REQUIRED PREFERRED
Central Nervous System (CNS) Agents: Antidepressants* Vraylar
Endocrine Agents: Growth Hormone Skytrofa
Genitourinary Agents: Electrolyte Depleter Agents Velphoro

NEW NON-PREFERRED DRUGS

THERAPEUTIC CLASS PA REQUIRED NON-PREFERRED
Central Nervous System (CNS) Agents: Anticonvulsants* Motpoly XR
Central Nervous System (CNS) Agents: Atypical Antipsychotics* Rykindo
Dermatologic Agents: Topical Acne Products Cabtreo Gel<br>Clindamycin/Benz Perox 1.2-3.75%<br>Lintera Wash
Endocrine Agents: Diabetes – Non-Insulin Zituvio
Gastrointestinal Agents: Ulcerative Colitis Velsipity
Genitourinary Agents: Electrolyte Depleter Agents Xphozah
Immunomodulator Agents: Systemic Inflammatory Disease Abrilada<br>Bimzelx

Ohio Department of Medicaid 30 Day Change Notice Effective Date: July 1, 2024

| Ophthalmic Agents: Dry Eye Treatments | Entyvio<br>Omvoh<br>Vevye |

THERAPEUTIC CATEGORIES WITH CHANGES IN CRITERIA

  • Cardiovascular Agents: Angina, Hypertension & Heart Failure
  • Central Nervous System (CNS) Agents: Antidepressants*
  • Central Nervous System (CNS) Agents: Attention Deficit Hyperactivity Disorder Agents
  • Central Nervous System (CNS) Agents: Atypical Antipsychotics*
  • Dermatologic Agents: Topical Acne Products
  • Endocrine Agents: Diabetes – Non-Insulin
  • Endocrine Agents: Growth Hormone
  • Gastrointestinal Agents: Ulcerative Colitis
  • Genitourinary Agents: Electrolyte Depleter Agents
  • Immunomodulator Agents: Systemic Inflammatory Disease
  • Infectious Disease Agents: Antivirals – HIV*
  • Ophthalmic Agents: Dry Eye Treatments

REVISED THERAPEUTIC CATEGORY CRITERIA

THERAPEUTIC CLASS SUMMARY OF CHANGE
Cardiovascular Agents: Angina, Hypertension & Heart Failure SACUBITRIL/VALSARTAN (ENTRESTO) CRITERIA:<br>• Must provide documentation of chronic heart failure classified as either NYHA Class II-IV or ACC/AHA Stage B-D<br><br>NON-PREFERRED CRITERIA:<br>• 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<br> ◦ For any nonsolid oral dosage formulation: must provide documentation of medical necessity for why patient cannot be changed to a solid oral dosage formulation<br>• Must have had an inadequate clinical response of at least 30 days of at least two preferred drugs within the same class mechanism of action if available and indicated for the same diagnosis<br><br>STEP THERAPY CRITERIA:<br>• Must have had an inadequate clinical response of at least 30 days with at least two preferred drugs
Central Nervous System (CNS) Agents: Antidepressants* STEP THERAPY CRITERIA:<br>• Must have had an inadequate clinical response of at least 30 days with at least two preferred drugs<br><br>NON-PREFERRED CRITERIA:<br>• 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<br> ◦ For any nonsolid oral dosage formulation: must provide documentation of medical necessity for why patient cannot be changed to a solid oral dosage formulation<br>• Must have had an inadequate clinical response of at least 30 days with at least three two preferred drugs
Central Nervous System (CNS) Agents: Atypical Antipsychotics* ADDITIONAL RISPERIDONE (RYKINDO) CRITERIA:<br>• Must have had a trial of at least 30 days with one preferred risperidone or paliperidone product OR must provide documentation of medical necessity for patient’s inability to use preferred risperidone or paliperidone product
Dermatologic Agents: Topical Acne Products ADDITIONAL CLINDAMYCIN/ADAPALENE/BENZOYL PEROXIDE (CABTREO) CRITERIA:<br>• Must provide documentation for patient’s inability to use the individual drugs
Endocrine Agents: Diabetes – Non-Insulin ADDITIONAL SITAGLIPTIN (ZITUVIO) CRITERIA:<br>• Must have had a trial of at least 120 days with Januvia OR must provide documentation of medical necessity for patient’s inability to use Januvia
Endocrine Agents: Growth Hormone STEP THERAPY CRITERIA:<br>• Must have had an inadequate clinical response of at least 90 days with at least one preferred daily-dosed growth hormone formulation<br><br>NON-PREFERRED CRITERIA:<br>• 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<br> ◦ For any nonsolid oral dosage formulation: must provide documentation of medical necessity for why patient cannot be changed to a solid oral dosage formulation<br>• Must have had an inadequate clinical response of at least 90 days with at least one preferred drug and of similar duration of action
Gastrointestinal Agents: Ulcerative Colitis ADDITIONAL OZANIMOD (ZEPOSIA) AND ETRASIMOD (VELSIPITY) CRITERIA:<br>• Must have had a documented side effect, allergy, or treatment failure of at least 90 days with at least one preferred Systemic Immunomodulator indicated for Ulcerative Colitis (refer to Immunomodulator Agents: Systemic Inflammatory Disease class for complete list)
Genitourinary Agents: Electrolyte Depleter Agents STEP THERAPY CRITERIA:<br>• Must have had an inadequate clinical response of at least 7 days with at least one preferred drug
Immunomodulator Agents: Systemic Inflammatory Disease NON-PREFERRED CRITERIA:<br>• 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<br> ◦ For any nonsolid oral dosage formulation: must provide documentation of medical necessity for why patient cannot be changed to a solid oral dosage formulation<br>• Must have had an inadequate clinical response of at least 90 days with at least two preferred drugs that are not biosimilars of the same reference product, if indicated for diagnosis<br> ◦ For non-preferred extended-release formulations: must provide documentation of an inadequate clinical response with its immediate release formulation (if available)<br> ◦ For non-preferred biosimilars: must provide documentation of inadequate clinical response to its preferred reference product<br> ◦ 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)<br><br>ADDITIONAL CROHN’S DISEASE CRITERIA:<br>• Must provide documentation of Crohn’s Disease Activity Index (CDAI) score of 220 or higher to be considered moderate to severe disease<br><br>ADDITIONAL ULCERATIVE COLITIS CRITERIA:<br>• If an inadequate clinical response after 90 days with one TNF inhibitor, further TNF inhibitors will not be authorized
Infectious Disease Agents: Antivirals – HIV* ABACAVIR/DOLUTEGRAVIR/LAMIVUDINE (TRIUMEQ PD) CRITERIA:<br>• Must provide documentation of patient’s weight (only authorized for those 10 6 – 25 kg)<br><br>FOSTEMSAVIR (RUKOBIA) CRITERIA:<br>• Must provide documentation of a multidrug-resistant HIV-1 infection<br><br>STEP THERAPY CRITERIA:<br>• Must have had an inadequate clinical response of at least 14 days with at least one artificial tear or OTC dry eye drop in the previous 120 days preferred drug in this category in the previous 120 days<br><br>NON-PREFERRED CRITERIA:<br>• Must provide documentation of medical necessity beyond convenience for why the patient cannot be changed to a preferred drug (i.e., allergies) OR<br> ◦ For any nonsolid oral dosage formulation: must provide documentation of medical necessity for why patient cannot be changed to a solid oral dosage formulation<br>• Must have had an inadequate clinical response of at least 14 days with at least one two preferred drugs
Ophthalmic Agents: Dry Eye Treatments

Date of Notice: 06/1/2024

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