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Kentucky Medicaid drug review and coverage options (P&T agenda)

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Summarizes drug-specific coverage criteria, prior authorization and PDL (preferred drug list) status recommendations to be reviewed by MedImpact for the Kentucky Department for Medicaid Services; affects prescribers and pharmacy benefit administrators managing Kentucky Medicaid drug benefits.

Policy Summary

Payermedimpact

PolicyKentucky Medicaid drug review and coverage options (P&T agenda)

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionProviders must submit required clinical documentation including diagnosis, prior medication trials, and objective baseline and follow-up assessments for prior authorization and renewal.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Sep 21, 2023meeting date

Multiplereviews

1 yearauth duration

Specifiedage limits

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Coverage Criteria and Drug-specific Rules

Initial Therapy

Covered when ALL of the following are met

Abilify Asimtufii initial: Pt has a diagnosis of bipolar disorder OR schizophrenia; AND Pt has had at least a 2-week trial of ONE preferred Antipsychotic (oral or parenteral) at an appropriate dose; AND Patient is established on oral aripiprazole with adequate response and tolerability; AND Age > 18 years

Quantity limit: 1 syringe every 2 months; Length of Authorization: 1 year

Initial and Renewal Therapy

Covered when ALL of the following are met

Daybue initial: Patient has a diagnosis of classical/typical OR variant/atypical Rett syndrome established by BOTH molecular genetic testing with heterozygous MECP2 pathogenic variant AND diagnosis based on clinical presentation; AND Other causes for symptoms have been ruled out; AND Therapy will NOT be used for other genetically related (allelic) disorders; AND Physician has assessed baseline disease severity using an objective measure (e.g., CGI-I, MBA, Interval History Form, Clinical Severity Scale, Rett Syndrome Gross Motor Scale); AND Patient does NOT have progressive weight loss prior to initiation; AND Patient does NOT have moderate or severe renal impairment (eGFR < 45 mL/min/1.73m2)

Age ≥ 2 years; Quantity limit: 8 bottles every 30 days; Length of Authorization: 1 year

Daybue renewal: Patient has response from pre-treatment baseline with disease stability or improvement in core symptoms evidenced by objective measure or tool (e.g., RSBQ, CGI-I, MBA, Interval History Form, Clinical Severity Scale); AND Patient has NOT experienced treatment-restricting adverse effects (e.g., severe diarrhea, dehydration, significant weight loss)

Length of Authorization: 1 year

Initial Therapy

Covered when ALL of the following are met

Inpefa indications: Diagnosis of Type 2 Diabetes Mellitus AND diagnosis of chronic kidney disease (ICD-10 Group N18) AND patient has other cardiovascular risk factors; OR diagnosis of heart failure; AND Patient has had ≥ 3 month trial and therapeutic failure, allergy, contraindication or intolerance of 1 preferred agent

Quantity limit: 30 tablets per 30 days; Length of Authorization: 1 year

Initial Therapy

Covered when ALL of the following are met

Sogroya initial: Patient will be at least 2.5 years old at the start of treatment; AND Diagnosis of growth hormone deficiency; AND Patient does NOT have hypersensitivity to the product or any excipients; AND Pediatric patient must NOT have closed epiphyses if used for longitudinal growth; AND Patient does NOT have active malignancy; AND Patient does NOT have active proliferative or severe non-proliferative diabetic retinopathy; AND Patient does NOT have, or previously had, intracranial tumor growth as confirmed by sellar MRI with contrast; AND Patient does NOT have Prader-Willi syndrome with severe obesity, history of upper airway obstruction/sleep apnea, severe respiratory impairment, or unidentified respiratory infection; AND Trial and therapeutic failure, allergy, contraindication or intolerance of 2 preferred agents

Quantity limit: 4 pens per 28 days; Length of Authorization: 1 year

Initial Therapy

Covered when ALL of the following are met

Uzedy initial: Pt has a diagnosis of schizophrenia; AND Pt has had at least a 2-week trial of ONE preferred Antipsychotic (oral or parenteral) at an appropriate dose; AND Patient is established on oral risperidone with adequate response and tolerability; AND Age > 18 years

Quantity limit: 1 syringe per 30 days; Initial length of authorization: 3 months; Renewal length: 1 year

Initial and Renewal Therapy

Covered when ALL of the following are met

Veozah initial: Patient has a diagnosis of menopause with moderate to severe vasomotor symptoms; AND Patient does not have cirrhosis; AND Patient does not have severe renal impairment or end-stage renal disease; AND Patient will avoid concomitant therapy with weak, moderate, or strong CYP1A2 inhibitors (e.g., fluvoxamine, mexiletine, cimetidine); AND Prescriber attests baseline liver function tests (total bilirubin, ALT, AST) are not ≥ 2× ULN; AND Prescriber attests to planned liver function follow-up as outlined in prescribing information; AND Patient has trialed and failed or is not a candidate for hormone therapy

Age > 18 years; Initial length: 3 months; Renewal length: 1 year

Veozah renewal: Patient must continue to meet criteria and must have symptom improvement

Patient must not have treatment-restricting adverse effects (e.g., ALT or AST > 3× ULN)

Initial and Renewal Therapy

Covered when ALL of the following are met

Zavzpret initial: Patient has a diagnosis of migraine with or without aura; AND Prescriber attestation that product will NOT be used for preventive treatment or chronic migraine; AND Patient must NOT have hypersensitivity to any component of the product; AND Patient must have tried and failed or have a contraindication or intolerance to 2 triptans

Age ≥ 18 years; Quantity limit: 8 nasal spray devices every 30 days; Length of Authorization: 1 year

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

For Daybue™ (trofinetide), coverage is limited to patients with a confirmed diagnosis of classical/typical or variant/atypical Rett syndrome established by both molecular genetic testing showing a heterozygous MECP2 pathogenic variant and clinical presentation. The policy specifies that therapy will NOT be used for other genetically related (allelic) disorders, and baseline disease severity must be documented using an objective measure (examples include CGI-I, MBA, Interval History Form, Clinical Severity Scale, or Rett Syndrome Gross Motor Scale). Additionally, patients must not have progressive weight loss prior to initiation and must not have moderate or severe renal impairment (e.g., eGFR < 45 mL/min/1.73m2).

Zavzpret™ (zavegepant) is indicated only for the acute treatment of migraine with or without aura in adults and is not indicated for preventive treatment of migraine or for chronic migraine. The coverage criteria require the prescriber to attest that the product will NOT be used for preventive or chronic migraine; use for prevention would therefore be outside the covered indication.

Initial Therapy Rules

Initial therapy rules

Initial therapy approval requires diagnosis confirmation plus specified prior trials, age limits, and baseline testing where indicated

General initial requirements: Diagnosis confirmed; AND Required prior trials or documented intolerance/contraindication to preferred agents as specified per product (examples: ≥2-week trial of one preferred antipsychotic prior to injectable antipsychotic; ≥3 month trial and failure of 1 preferred agent for Inpefa; trial and failure of 2 triptans for Zavzpret); AND Baseline objective assessment or laboratory testing where indicated (examples: baseline disease severity assessment for Daybue; baseline LFTs for Veozah); AND Age and renal/hepatic function eligibility criteria as specified per product

Drug-specific details provided in individual criteria sets and quantity/length limits

Renewal and Continuation Requirements

Renewal/Continuation requirements

Renewal requires continued benefit and absence of significant toxicity

General renewal: Patient continues to meet initial criteria; AND Patient demonstrates symptom improvement or stability compared to baseline as assessed by objective measures or prescriber assessment; AND No treatment-restricting adverse effects (examples provided per drug such as severe diarrhea or dehydration and significant weight loss for Daybue; ALT or AST > 3× ULN for Veozah)

Length of Authorization typically 1 year for renewal

Provider Prior Authorization, Documentation, and Denial Risks

Prior Authorization

Prior authorization for non-preferred agents and new chemical entities

Agents not selected as preferred within a class are considered non-preferred and require prior authorization. Any new chemical entity in a class also requires prior authorization until it has been reviewed by the P&T Advisory Committee.

Prior Authorization

Drug-specific prior authorization requirements

Specific products have defined prior authorization criteria that must be met for initial approval and renewal, including diagnosis, age limits, required prior trials of preferred agents, baseline assessments or laboratory testing, and documentation of clinical response or absence of treatment‑restricting adverse effects.

Abilify Asimtufii® (aripiprazole): diagnosis of bipolar disorder or schizophrenia; ≥2-week trial of ONE preferred antipsychotic; established on oral aripiprazole; age >18 (Qty limit: 1 syringe every 2 months).
Daybue™ (trofinetide): molecular genetic testing (MECP2) and clinical diagnosis of Rett syndrome; baseline objective assessment; no progressive weight loss; no eGFR <45 mL/min/1.73m2; age ≥2 (Qty limit: 8 bottles/30 days).

Diagnosis and Clinical Limits (Coding)

Referenced diagnosis codesICD-10

ICD-10 Group N18

Chronic kidney disease (as referenced for sotagliflozin/Inpefa)

eGFR clinical threshold

eGFR thresholdeGFR < 45 mL/min/1.73m2

ContextApplied as a renal eligibility cutoff for trofinetide (Daybue) initiation

Source guidancePatients with moderate or severe renal impairment (eGFR < 45 mL/min/1.73m2) are excluded from initiation

Step Therapy Requirements

Step	Requirement	Notes
1	Trial of ONE preferred antipsychotic (oral or parenteral) at an appropriate dose for at least 2 weeks	Required prior to approval of injectable antipsychotics (example: aripiprazole/Abilify Asimtufii®)

Step	Requirement	Notes
1	Patient has had ≥ 3 month trial and therapeutic failure, allergy, contraindication or intolerance of 1 preferred agent	Requirement applies for sotagliflozin (Inpefa™) initial approval

Quantity Limits by Product

Abilify Asimtufii® — quantity limit

DrugAbilify Asimtufii® (aripiprazole)

Quantity limit1 syringe every 2 months

Authorization length noteLength of Authorization: 1 year

Daybue™ — quantity limit

DrugDaybue™ (trofinetide)

Quantity limit8 bottles every 30 days

Age requirementAge ≥ 2 years

Background and Scope

This document summarizes the clinical criteria, prior authorization conditions, and renewal requirements presented to the Kentucky Medicaid Pharmacy & Therapeutics Advisory Committee. It lists drug-specific initial approval rules (diagnosis confirmation, required prior trials, age limits, and baseline testing where indicated), quantity limits, contraindications, and the objective assessment tools expected for baseline and renewal reviews across multiple specialty products.

Definitions and Assessment Tools

Examples of assessment tools

CGI-IClinical Global Impression-Improvement — used for baseline and follow-up assessments

MBAMotor-Behavior Assessment — objective measure for Rett syndrome severity and response

RSBQRett Syndrome Behavior Questionnaire — used to document core symptom change at renewal

Interval History FormStructured interval history to assess symptom change from baseline

Additional toolsClinical Severity Scale; Rett Syndrome Gross Motor Scale — supplemental objective measures