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Commissioner selections for preferred prescription products (Kentucky) — PDL coverage criteria summary

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Summarizes the Commissioner for the Department for Medicaid Services' final Preferred Drug List (PDL) selections and associated coverage criteria for selected drugs/classes in Kentucky; intended for providers and pharmacy staff managing Medicaid prescription coverage.

Policy Summary

Payermedimpact

PolicyCommissioner selections for preferred prescription products (Kentucky) — PDL coverage criteria summary

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization with required documentation demonstrating diagnosis, trials of preferred agents, and necessary baseline tests as specified for each product.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

multipleNon-preferred agents

1 yearAuth length

specifiedAge limits

presentQuantity limits

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CurrentmedimpactPolicy N/A

Commissioner selections for preferred prescription products (Kentucky) — PDL coverage criteria summary

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Policy Summary

Payermedimpact

PolicyCommissioner selections for preferred prescription products (Kentucky) — PDL coverage criteria summary

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization with required documentation demonstrating diagnosis, trials of preferred agents, and necessary baseline tests as specified for each product.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

multipleNon-preferred agents

1 yearAuth length

specifiedAge limits

presentQuantity limits

≥18Age floor (yrs)

Coverage Criteria (Initial & Renewal)

Abilify Asimtufii (aripiprazole) - Initial Approval

Covered when ALL of the following are met:

Diagnosis: Pt has a diagnosis of bipolar disorder or schizophrenia

Preferred antipsychotic trial: Pt has had at least a 2-week trial of ONE preferred Antipsychotic (oral or parenteral) at an appropriate dose>=2 weeks

Oral aripiprazole established: Patient is established on oral aripiprazole with adequate response and tolerability

Veozah (fezolinetant) - Initial Approval

Covered when ALL of the following are met:

Indication: Patient has a diagnosis of menopause with moderate to severe vasomotor symptoms

No cirrhosis: Patient does not have cirrhosis

Renal function: Patient does not have severe renal impairment or end-stage renal disease

CYP1A2 avoidance: Patient will avoid concomitant therapy with weak, moderate, or strong CYP1A2 inhibitors

Examples: fluvoxamine, mexiletine, cimetidine

Baseline LFTs: Prescriber attests baseline total bilirubin, ALT, and AST levels are not elevated >= 2x ULN and follow-up LFT testing will be conducted per PIALT/AST < 2x ULN

Daybue (trofinetide) - Initial and Renewal

Initial covered when ALL of the following are met:

Diagnosis confirmation: Diagnosis of classical/typical or variant/atypical Rett syndrome established by molecular genetic testing with heterozygous MECP2 pathogenic variant OR by previous clinical diagnosis with other causes ruled out

Not for allelic disorders: Therapy will NOT be used for other genetically related (allelic) disorders

Baseline assessment: Physician has assessed baseline disease severity of behavior and/or functionality using an objective measure or tool (e.g., CGI-I, MBA, Interval History Form, Clinical Severity Scale, Rett Syndrome Gross Motor Scale)

Weight stability: Patient does NOT have progressive weight loss prior to initiation

Inpefa (sotagliflozin) - Initial Approval

Covered when ONE of the following diagnosis pathways is met and additional requirements satisfied:

T2DM pathway: Diagnosis of Type 2 Diabetes Mellitus AND diagnosis of chronic kidney disease AND patient has other cardiovascular risk factors

Heart failure pathway: Diagnosis of heart failure

If using HF pathway, patient must have had >= 3 month trial and therapeutic failure, allergy, contraindication or intolerance of 1 preferred agent

Sogroya (somapacitan) - Initial Approval

Covered when ALL of the following are met:

Age: Patient will be at least 2.5 years old at the start of treatment>=2.5 years

Diagnosis of growth hormone deficiency

Hypersensitivity exclusion: Patient does NOT have a hypersensitivity to any somapacitan product or any of the excipients

Open epiphyses for pediatrics: Pediatric patient must NOT have closed epiphyses if used for longitudinal growth promotion

No active malignancy: Patient does NOT have active malignancy

Zavzpret (zavegepant) - Initial Approval

Covered when ALL of the following are met:

Indication: Patient has a diagnosis of migraine with or without aura

Not for prevention: Prescriber attestation will NOT be used for preventive treatment of migraine or for chronic migraine

Hypersensitivity exclusion: Patient must NOT have hypersensitivity to any component of the product

Triptan failures: Patient must have tried and failed or have a contraindication or intolerance to 2 triptans2 triptans

Uzedy (risperidone) injectable - Initial Approval

Covered when ALL of the following are met:

Diagnosis: Pt has a diagnosis of schizophrenia

Preferred antipsychotic trial: Pt has had at least a 2-week trial of ONE preferred Antipsychotic (oral or parenteral) at an appropriate dose>=2 weeks

Oral risperidone established: Patient is established on oral risperidone with adequate response and tolerability

Daybue (trofinetide) coverage requires confirmation that the drug will NOT be used for other genetically related (allelic) disorders. The initial approval criteria specify that the patient must have a diagnosis of classical/typical or variant/atypical Rett syndrome established by molecular genetic testing demonstrating a heterozygous MECP2 pathogenic variant or by a prior clinical diagnosis with other causes ruled out, and the policy explicitly states therapy will NOT be used for other genetically related (allelic) disorders as a condition of coverage.

Veozah (fezolinetant) is excluded from coverage for patients with cirrhosis. The initial approval criteria require that the patient has menopause-related moderate to severe vasomotor symptoms and specifically state the patient does not have cirrhosis as a prerequisite for coverage.

Veozah (fezolinetant) coverage also excludes patients with severe renal impairment or end-stage renal disease and requires avoidance of CYP1A2 inhibitors. The policy explicitly notes the patient does not have severe renal impairment or end-stage renal disease and that the patient will avoid concomitant therapy with weak, moderate, or strong CYP1A2 inhibitors (e.g., fluvoxamine, mexiletine, cimetidine) as conditions for approval.

For Zavzpret (zavegepant), the prescriber attestation cannot be used to satisfy criteria for preventive therapy or chronic migraine. The initial approval requirements state that prescriber attestation will NOT be used for preventive treatment of migraine or for chronic migraine, and therefore attestation alone does not qualify the request when the intended use is preventive or for chronic migraine.

Use of Zavzpret (zavegepant) for preventive treatment of migraine or for chronic migraine is considered outside the stated coverage intent. The document clarifies that the product is approved only for acute treatment of migraine with or without aura and that use for prevention or chronic migraine is not indicated and would be outside the stated coverage intent.

Initial Therapy Requirements

Antipsychotics: Injectable

Initial Approval Criteria — CGRP inhibitors for migraine

Initial Approval Requirements: Patient has a diagnosis of migraine with or without aura; prescriber attestation will NOT be used for preventive treatment of migraine or for chronic migraine; patient must NOT have hypersensitivity to any component of the product; patient must have tried and failed or have a contraindication or intolerance to 2 triptans; patient must have tried and failed or have a contraindication or intolerance to 1 preferred CGRP antagonist.

Initial Therapy — CGRP inhibitors

Initial Approval Criteria — CGRP inhibitors for migraine

Quantity limit: 8 nasal spray devices per 30 days; Age >= 18 years.

Renewal / Continuation Requirements

Daybue renewal

Renewal criteria summarized where provided

Daybue renewal: Patient must have response to therapy from pre-treatment baseline with disease stability or improvement in core symptoms as evidenced by objective measure; AND patient has not experienced treatment-restricting adverse effects

Sogroya renewal

Renewal criteria summarized where provided

Sogroya renewal: Patient continues to meet initial criteria; has not had unacceptable toxicity; and has a positive response compared to pre-treatment baseline

Zavzpret renewal

Renewal criteria summarized where provided

Prior Authorization, Documentation & Step Requirements

Prior Authorization

Prior authorization required for Abilify Asimtufii

Abilify Asimtufii (injectable aripiprazole) is non-preferred and requires prior authorization documenting the diagnosis (bipolar disorder or schizophrenia), evidence of at least a 2‑week trial of one preferred antipsychotic (oral or parenteral) at an appropriate dose, and that the patient is established on oral aripiprazole with adequate response and tolerability.

Quantity limit: 1 syringe every 2 months
Age limit: ≥ 18 years

Prior Authorization

PA: Daybue — diagnostic confirmation and baseline assessment required

Daybue (trofinetide) requires prior authorization with documentation of Rett syndrome by molecular genetic testing demonstrating a heterozygous MECP2 pathogenic variant or by prior clinical diagnosis with other causes ruled out, an objective baseline disease severity assessment, absence of progressive weight loss, and exclusion of moderate or severe renal impairment.

Baseline objective measure (e.g., CGI-I, MBA, Interval History Form, Clinical Severity Scale, Rett Syndrome Gross Motor Scale)

Age & Quantity Limits / Coding Notes

Quantity limit — Zavzpret

Quantity limit8 nasal spray devices per 30 days

Applies toZavzpret (zavegepant) — acute migraine nasal spray formulation

Reporting periodPer 30 days

Age limit

Age eligibility>= 18 years

Applies toAdults for Zavzpret (zavegepant) acute migraine indication

DocumentationAge must be verified in prior authorization and at dispensing

Step Therapy Tables & Requirements

Drug / Class	Required prior step(s)
Abilify Asimtufii (aripiprazole) — injectable non-preferred antipsychotic
Prior trial of at least ONE preferred antipsychotic (oral or parenteral) for ≥2 weeks at an appropriate dose; patient established on oral aripiprazole with adequate response and tolerability

Drug	Required prior step(s)
Zavzpret (zavegepant) — acute migraine, non-preferred
Failure, intolerance, or contraindication to 2 triptans AND trial/failure, intolerance, or contraindication to 1 preferred CGRP antagonist; prescriber attestation may NOT be used for preventive or chronic migraine

Drug	Required prior step(s)
Sogroya (somapacitan) — growth hormone (non-preferred)
Trial and therapeutic failure, allergy, contraindication, or intolerance of 2 preferred growth hormone agents prior to approval

Policy statement	Operational step requirement
Trial of preferred agents required prior to approval of non-preferred agents
DMS selects preferred agents (at least 2 distinct/unique chemical entities per class); agents not selected are non-preferred and require prior authorization, which implies a required trial of preferred agents before coverage of non-preferred products
New chemical entities in a class require prior authorization until reviewed by the P&T Advisory Committee
For CGRP inhibitors (acute migraine), prior failure/intolerance/contraindication to 2 triptans and 1 preferred CGRP antagonist is required before approval; prescriber attestation cannot be used for preventive or chronic migraine

Per-product Quantity Limits

Abilify Asimtufii — Quantity

Abilify Asimtufii quantity limit1 syringe

Frequency noteQuantity limit documented as part of injectable antipsychotics class limits

Applies toAbilify Asimtufii (aripiprazole) injectable

Uzedy — Quantity

Uzedy quantity limit1 syringe

Applies toUzedy (risperidone) injectable

Class contextNon-preferred injectable antipsychotic per PDL listing

Background & Scope

This document lists the clinical indications for selected products and the safety prerequisites that inform PDL placement and coverage decisions. It ties specific inclusion and exclusion criteria (for example, diagnosis confirmation for Rett syndrome, liver and renal exclusions for Veozah, hypersensitivity and prior therapy requirements for Zavzpret), age and quantity limits, and required documentation or prescriber attestation to the prior authorization and renewal processes used by the Medicaid program.

Definitions & Terminology

Rett syndrome definition

DefinitionRett syndrome: neurodevelopmental disorder confirmed by molecular genetic testing showing a heterozygous MECP2 pathogenic variant OR by prior clinical diagnosis with other causes ruled out

Diagnostic methodsMolecular genetic testing (MECP2) or established clinical diagnosis with exclusion of other causes

Relevant productIndication for trofinetide (Daybue)

Acute migraine treatment — note re: zavegepant

Acute vs preventive noteZavegepant (Zavzpret) is indicated for acute treatment of migraine and is NOT indicated for preventive treatment or chronic migraine; prescriber attestation cannot be used for prevention/chronic migraine

Implication for PARequests for preventive/chronic use are outside stated coverage intent and may be denied

Policy Summary

Payermedimpact

PolicyCommissioner selections for preferred prescription products (Kentucky) — PDL coverage criteria summary

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization with required documentation demonstrating diagnosis, trials of preferred agents, and necessary baseline tests as specified for each product.

SourceLink

On This Page

Hormone therapy trial: Patient has trialed and failed, or is not a candidate for, hormone therapy

Renal function exclusion: Patient does NOT have moderate or severe renal impairment (eGFR < 45 mL/min/1.73m2)eGFR >= 45

No proliferative diabetic retinopathy: Patient does NOT have active proliferative or severe non-proliferative diabetic retinopathy

No intracranial tumor growth: Patient does NOT have, or previously had, an intracranial tumor growth as confirmed by a sellar MRI scan with contrast

Prader-Willi exclusions: Patient does NOT have Prader-Willi syndrome with >1 of listed risk features (severe obesity, history of upper airway obstruction or sleep apnea, severe respiratory impairment, unidentified respiratory infection)

Preferred agent trials: Trial and therapeutic failure, allergy, contraindication, or intolerance of 2 preferred agents2 agents

CGRP antagonist trial:

Patient must have tried and failed or have a contraindication or intolerance to 1 preferred CGRP antagonist

Initial Therapy — CGRP inhibitors for migraine (detailed initial criteria)

Renewal Criteria — CGRP inhibitors for migraine

Renewal Requirements: Patient must continue to meet the initial approval criteria; patient must demonstrate symptom improvement (e.g., resolution in headache pain or reduction in headache severity) as assessed by the prescriber.

Quantity limit: 8 nasal spray devices per 30 days; Age >= 18 years.

Zavzpret renewal: Patient must continue to meet initial criteria and demonstrate symptom improvement (e.g., resolution in headache pain or reduction in headache severity) as assessed by the prescriber

Quantity limit: 8 nasal spray devices per 30 days; Age >= 18 years.

Veozah renewal

Renewal criteria summarized where provided

Veozah renewal: Patient must continue to meet initial criteria, have symptom improvement, and not have experienced treatment-restricting adverse effects (e.g., ALT or AST >3x ULN)ALT/AST <=3x ULN

Renewal — CGRP inhibitors

Renewal for migraine CGRP inhibitors

Renewal Criteria: Patient must continue to meet initial approval criteria and must demonstrate symptom improvement as assessed by the prescriber.

Quantity limit: 8 nasal spray devices per 30 days; Age >= 18 years.

Renewal requires objective evidence of response/stability and no treatment‑restricting adverse effects

Prior Authorization

PA required for Inpefa with diagnosis and prior trial documentation

Inpefa (sotagliflozin) is non‑preferred and requires prior authorization documenting the applicable diagnosis pathway (T2DM with CKD and other CV risk factors OR heart failure) and, when using the heart failure pathway, documentation of a ≥3‑month trial and therapeutic failure, allergy, contraindication, or intolerance of one preferred agent.

Quantity limit: 8 bottles every 30 days
Age limit: ≥ 2 years

Prior Authorization

PA: Veozah — VMS diagnosis, LFTs, and CYP1A2 avoidance required

Veozah (fezolinetant) requires prior authorization documenting menopause with moderate to severe vasomotor symptoms, that the patient does not have cirrhosis or severe renal impairment/ESRD, prescriber attestation of baseline LFTs and planned follow‑up per the PI, and avoidance of concomitant CYP1A2 inhibitors.

Prescriber must attest baseline total bilirubin, ALT, and AST are not ≥ 2× ULN and that follow‑up LFT testing will be conducted per prescribing information
Patient must have trialed and failed, or be not a candidate for, hormone therapy

Prior Authorization

PA: Zavzpret — confirm acute migraine and prior therapy failures

Zavzpret (zavegepant) requires prior authorization confirming an acute migraine diagnosis (with or without aura), that it will not be used for preventive or chronic migraine, and documentation of prior failure/intolerance/contraindication to 2 triptans and 1 preferred CGRP antagonist.

Prescriber attestation will NOT be used to support preventive or chronic migraine use
Quantity limit on renewal: 8 nasal spray devices per 30 days; Age ≥ 18 years

Prior Authorization

PA: Uzedy — schizophrenia diagnosis and preferred agent trial required

Uzedy (injectable risperidone) is non‑preferred and requires prior authorization documenting a diagnosis of schizophrenia, evidence of at least a 2‑week trial of one preferred antipsychotic (oral or parenteral) at an appropriate dose, and that the patient is established on oral risperidone with adequate response and tolerability.

Quantity limit: 1 syringe per 30 days
Length of authorization: 1 year

Prior Authorization

PA required for non‑preferred agents and new chemical entities

Prior authorization is required for non‑preferred agents and for any new chemical entity in a class until reviewed by the P&T Advisory Committee; DMS selected preferred agents and non‑preferred agents require PA with the specific initial criteria applicable to each product.

Applies across listed classes (agents not selected as preferred require PA)
New chemical entities require PA until P&T review

Prior Authorization

CGRP inhibitors — initial PA requirements for acute migraine

Initial prior authorization for CGRP inhibitors for acute migraine requires a diagnosis of migraine (with or without aura) and documentation of prior failure/intolerance/contraindication to 2 triptans and 1 preferred CGRP antagonist; prescriber attestation cannot be used to support preventive or chronic migraine treatment.

Patient must NOT have hypersensitivity to product components
Renewal requires documentation of symptom improvement as assessed by the prescriber

Step Therapy

Step therapy: injectable antipsychotics require prior preferred agent trial

Injectable non‑preferred antipsychotics (Abilify Asimtufii, Uzedy) require a prior trial of at least one preferred antipsychotic (oral or parenteral) for ≥2 weeks prior to approval.

Preferred injectable antipsychotics list provided in policy; documentation of trial duration and dose required

Step Therapy

Step requirement for Zavzpret — triptan and CGRP trials required

Zavzpret requires documented prior failure, intolerance, or contraindication to two triptans and one preferred CGRP antagonist before approval will be granted.

Prescriber attestation cannot be used to justify preventive or chronic migraine use

Step Therapy

Step therapy: Sogroya and Inpefa prior trial requirements

Growth hormone therapy (Sogroya) requires trial and therapeutic failure, allergy, contraindication, or intolerance of two preferred growth hormone agents prior to initiation; Inpefa requires trial/failure of one preferred SGLT2 when indicated (e.g., heart failure pathway).

Sogroya: trial/failure of 2 preferred agents required
Inpefa: ≥3 months trial and therapeutic failure of 1 preferred agent required for HF pathway

Note

Class selection and step approach — preferred agents required

DMS selects preferred agents (at least two distinct chemical entities per class); agents not selected as preferred are non‑preferred and require prior authorization, implying step therapy toward preferred agents.

At least 2 preferred agents expected per class
Non‑preferred status triggers PA and step requirements

Documentation Required

Veozah LFT attestation required

For Veozah prior authorization, the prescriber must attest that baseline total bilirubin, ALT, and AST are not elevated ≥ 2× ULN and that follow‑up liver function testing will be performed per the prescribing information.

Attestation is required as part of PA for Veozah

Documentation Required

Daybue diagnostic and baseline assessment documentation

For Daybue, document diagnosis via molecular genetic testing showing a heterozygous MECP2 pathogenic variant or a prior clinical diagnosis with other causes ruled out, and include an objective baseline assessment of disease severity (e.g., CGI‑I, MBA, Interval History Form).

Exclude use for other genetically related (allelic) disorders
Include baseline objective measures to support PA and renewal

Documentation Required

Sogroya documentation and prior preferred agent trials required

For Sogroya, provide documentation of growth hormone deficiency, that the patient is ≥ 2.5 years old at treatment start, and evidence of trial and therapeutic failure, allergy, contraindication, or intolerance of two preferred growth hormone agents; renewal requires continued benefit and absence of unacceptable toxicity.

Confirm open epiphyses in pediatric patients when used for longitudinal growth promotion
Exclude active malignancy and certain retinal or intracranial tumor conditions per criteria

Documentation Required

Renewal requires prescriber‑documented symptom improvement

On renewal for CGRP inhibitor therapies (including Zavzpret), the prescriber must document symptom improvement (for example, resolution in headache pain or reduction in headache severity) as assessed by the prescriber.

Patient must continue to meet initial approval criteria for renewal

Denial Risk

Denial risk: injectable antipsychotics — missing preferred agent trial

Failure to document a ≥2‑week trial of one preferred antipsychotic (oral or parenteral) and failure to show establishment on oral aripiprazole or risperidone may lead to denial for injectable non‑preferred antipsychotics such as Abilify Asimtufii and Uzedy.

Ensure documentation includes agent, dose, and trial duration

Denial Risk

Denial risk: Inpefa — missing diagnosis or prior trial documentation

For Inpefa (sotagliflozin), lack of documentation of the required diagnosis pathway (T2DM with CKD and CV risk factors OR heart failure) or absence of documented trial/failure of a preferred agent when applicable may result in denial.

When using the heart failure pathway, document ≥3 months trial and therapeutic failure, allergy, contraindication, or intolerance of 1 preferred agent

Denial Risk

Denial risk: Veozah — missing liver/renal safety documentation or contraindicated therapy

Veozah coverage may be precluded if baseline liver function tests are not documented, if the patient has cirrhosis or severe renal impairment/ESRD, or if the patient will use concomitant CYP1A2 inhibitors.

Examples of CYP1A2 inhibitors: fluvoxamine, mexiletine, cimetidine

Denial Risk

Denial risk: Zavzpret — insufficient prior therapy trials

For Zavzpret, lack of prior trials of two triptans and one preferred CGRP antagonist (or lack of documented contraindication/intolerance) may result in non‑coverage for the acute migraine indication.

Prescriber attestation cannot be used to support preventive or chronic migraine use

Denial Risk

Denial triggers for CGRP inhibitors — missing triptan/CGRP trials or improper attestation

Requests for CGRP inhibitor therapy may be denied if the patient has not tried and failed (or has no documented contraindication/intolerance to) two triptans and one preferred CGRP antagonist, or if prescriber attestation is submitted to support preventive or chronic migraine use.

Ensure documentation shows triptans and the specific preferred CGRP antagonist tried, with dates and reasons for failure/intolerance/contraindication

Veozah / Zavzpret quantity summary

Veozah quantity limit30 tablets per 30 days

Zavzpret quantity limit8 nasal spray devices per 30 days

Reporting periodPer 30 days for both products

Renewal documentation requirement (cross-reference)

Renewal requirementPrescriber must document symptom improvement on renewal (e.g., resolution in headache pain or reduction in headache severity)

Assessment sourceAs assessed and documented by the prescriber

Applies toCGRP inhibitors including Zavzpret

Inpefa — Quantity

Inpefa quantity limit8 bottles per 30 days

Applies toInpefa (sotagliflozin) — SGLT2 inhibitor

Reporting periodPer 30 days

Sogroya — Quantity

Sogroya quantity limit4 pens

Reporting periodPer 28 days (as noted in renewal/quantity limits)

Applies toSogroya (somapacitan) growth hormone therapy

Veozah / Zavzpret — Quantity summary

Veozah quantity limit30 tablets per 30 days

Zavzpret quantity limit8 nasal spray devices per 30 days

Reporting periodPer 30 days

Nasal spray devices (CGRP antagonist formulation implied)

Nasal spray devices limit8 devices per 30 days

ContextLimit applies to CGRP antagonist nasal spray formulation (Zavzpret)

VerificationQuantity enforced at dispensing and in PA criteria

Applies toZavzpret (zavegepant) — CGRP receptor antagonist

Symptom improvement — renewal assessment

Symptom improvement definitionClinical response as assessed by the prescriber, e.g., resolution in headache pain or reduction in headache severity, documented at renewal

Use at renewalRequired evidence for continuation of CGRP inhibitor therapy including Zavzpret

DocumentationPrescriber assessment must be recorded in renewal request