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Kentucky Medicaid Drug Review — P&T Agenda and Coverage Options

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Lists drugs, proposed coverage criteria, and options for consideration to be reviewed by the Kentucky Department for Medicaid Services Pharmacy & Therapeutics Advisory Committee; affects Kentucky Medicaid drug coverage and prior authorization practices for the listed agents and classes.

Policy Summary

Payermedimpact

PolicyKentucky Medicaid Drug Review — P&T Agenda and Coverage Options

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionFor prior authorization, document required diagnostic and baseline measures (e.g., biopsy and genetic testing for hATTR; baseline viral load ≥400 copies/mL for lenacapavir) and attest to prior trials or contraindications as specified for each agent.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Mar 16, 2023meeting date for review agenda

1 yeartypical length of authorization proposed

≥18adult age limit

Yesquantity limits present

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Coverage Criteria (Proposed)

inv-01: Vutrisiran (Amvuttra) - Initial Approval

Covered when ALL of the following are met

Vutrisiran initial: Patient will receive supplementation with vitamin A at the recommended daily allowance during therapy; Vutrisiran is not used in combination with other transthyretin (TTR) reducing agents (e.g., inotersen, tafamidis, patisiran); definitive diagnosis of hereditary transthyretin-mediated (hATTR) amyloidosis/FAP documented by amyloid deposition on tissue biopsy and identification of a pathogenic TTR variant on molecular genetic testing; polyneuropathy demonstrated by >= 2 of the following: subjective patient symptoms suggestive of neuropathy, abnormal nerve conduction studies consistent with polyneuropathy, abnormal neurological examination suggestive of neuropathy; peripheral neuropathy attributed to hATTR/FAP with other causes excluded; baseline strength/weakness documented using an objective clinical measuring tool (e.g., Medical Research Council [MRC] muscle strength); patient has NOT been the recipient of an orthotopic liver transplant (OLT).

All conditions required.

inv-02: Vutrisiran (Amvuttra) - Renewal

Covered when ALL of the following are met

Vutrisiran renewal: Patient continues to meet the initial approval criteria; patient is absent of unacceptable toxicity from the drug; patient has experienced disease response compared to pretreatment baseline as evidenced by stabilization or improvement in >= 1 of the following: signs and symptoms of neuropathy, MRC muscle strength.

All conditions required.

inv-03: Sodium phenylbutyrate/taurursodiol (Relyvrio) - Initial Approval

Covered when ALL of the following are met

Relyvrio initial: Patient has a diagnosis of amyotrophic lateral sclerosis (ALS) based on validated criteria (e.g., revised El Escorial, Awaji, Gold Coast); patient has no hypersensitivity to any component of the product; patient has had an adequate trial of riluzole for >= 8 weeks; baseline disease severity assessed with an objective tool (e.g., ALSFRS-R); patient does not require permanent assisted ventilation; prescribed by, or in consultation with, a neurologist; prescriber attests to reviewing medical history and evaluating potential drug and disease state interactions.

All conditions required.

inv-04: Relyvrio - Renewal

Covered when ALL of the following are met

Relyvrio renewal: Patient continues to meet the initial approval criteria; patient demonstrates disease stabilization or improvement in the slope of decline as demonstrated on an objective measure/tool (e.g., ALSFRS-R); patient has not experienced unacceptable toxicity from treatment (e.g., worsening hypertension or heart failure).

All conditions required.

inv-05: Eflapegrastim (Rolvedon) - Initial Approval

Covered when ALL of the following are met

Rolvedon initial: Medication is being used for chemotherapy-induced neutropenia prophylaxis to decrease the incidence of febrile neutropenia; patient has a nonmyeloid malignancy and is receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia; patient has had at least a 7-day trial and therapeutic failure, allergy, contraindication, or intolerance of 2 preferred agents.

All conditions required.

inv-06: Lenacapavir (Sunlenca) - Initial Approval

Covered when ALL of the following are met

Lenacapavir initial: Patient has a diagnosis of HIV-1 infection; prescribed by, or in consultation with, an infectious disease/HIV specialist; patient is heavily treatment-experienced with multidrug resistant HIV-1 (documented resistance to >= 2 ARVs from each of >= 3 of the 4 main classes); patient has <= 2 fully active ARVs remaining that can be effectively combined; documentation of baseline viral load >= 400 copies/mL on current antiretroviral regimen; no history of treatment failure or known/suspected resistance to lenacapavir; will be taken with other antiretrovirals as an optimized background regimen; not used in combination with strong CYP3A inducers.>= 400 copies/mL

All conditions required.

inv-07: Lenacapavir - Renewal

Covered when ALL of the following are met

Lenacapavir renewal: Patient has been adherent to their ARV treatment regimen; patient has NOT experienced virologic failure of lenacapavir and has documented clinical improvement and/or stabilization (e.g., decreased viral load from pretreatment baseline; increased or stabilized CD4+ counts); patient has NOT experienced any treatment-restricting adverse effects.

All conditions required.

Vutrisiran must NOT be used in combination with other transthyretin (TTR)‑reducing agents (for example: inotersen [Tegsedi®], tafamidis [Vyndamax®, Vyndaqel®], patisiran [Onpattro®]). This combination prohibition is a required exclusion for approval of vutrisiran and conflicts with the initial and renewal criteria for therapy.

Agents within a drug class that are not selected as preferred by the state will be designated non‑preferred and will require prior authorization. Class‑level policy options include selecting a minimum number of preferred chemical entities and placing any new chemical entities under prior authorization until reviewed by the P&T Advisory Committee.

Initial Therapy Requirements

inv-25: Vutrisiran initial — Vutrisiran initial therapy requirements

Vutrisiran initial therapy requirements

Vutrisiran initial: See prior authorization initial approval criteria: vitamin A supplementation during therapy; exclusion of use in combination with other TTR-reducing agents; definitive hATTR/FAP diagnosis by biopsy and pathogenic TTR variant; polyneuropathy demonstrated by >=2 specified methods; exclusion of other neuropathy causes; baseline objective muscle strength documentation (e.g., MRC); no prior orthotopic liver transplant.

All conditions required.

inv-26: Relyvrio initial — Relyvrio initial therapy requirements

Relyvrio initial therapy requirements

Relyvrio initial: See prior authorization initial approval criteria: diagnosis of ALS per validated criteria; no hypersensitivity to components; adequate trial of riluzole for >=8 weeks; baseline objective disease severity assessment (e.g., ALSFRS-R); no requirement for permanent assisted ventilation; prescribed by or in consultation with a neurologist; prescriber attests to review of medical history and interactions.

Continuation / Renewal Requirements

inv-27: Vutrisiran continuation — Vutrisiran renewal conditions

Vutrisiran renewal conditions

Vutrisiran continuation: Continues to meet initial authorization criteria; absent unacceptable toxicity from the drug; stabilization or improvement in >=1 neuropathy measure compared to baseline (e.g., signs/symptoms of neuropathy, MRC muscle strength).

All conditions required.

inv-28: Relyvrio continuation — Relyvrio renewal conditions

Relyvrio renewal conditions

Relyvrio continuation: Continues to meet initial approval criteria; demonstrates disease stabilization or improvement in slope of decline on objective measure (e.g., ALSFRS-R); no unacceptable toxicity from treatment.

All conditions required.

inv-29: Lenacapavir continuation — Lenacapavir renewal conditions

Provider Action Items and Documentation Requirements

Prior Authorization

Vutrisiran initial prior authorization requirements

Initial prior authorization for vutrisiran requires documentation that the patient will receive vitamin A supplementation at the recommended daily allowance during therapy; a definitive diagnosis of hATTR/FAP documented by amyloid deposition on tissue biopsy and identification of a pathogenic TTR variant; demonstration of polyneuropathy by ≥2 of: suggestive subjective symptoms, abnormal nerve conduction studies, or abnormal neurological exam; exclusion of other causes of neuropathy; baseline strength/weakness documented with an objective tool (e.g., MRC); and that the patient has not received an orthotopic liver transplant. Also ensure vutrisiran is not used in combination with other TTR‑reducing agents.

Document vitamin A supplementation plan (recommended daily allowance).
Provide tissue biopsy and molecular genetic testing showing pathogenic TTR variant.
Provide evidence of ≥2 methods demonstrating polyneuropathy.
Confirm exclusion of alternative neuropathy causes and baseline objective strength measurement.
Confirm no prior orthotopic liver transplant.
Do not prescribe concurrently with other TTR‑reducing agents (e.g., inotersen, tafamidis, patisiran).

Coding & Laboratory Thresholds

Baseline viral load

Baseline viral load threshold≥ 400 copies/mL

Documentation requirementBaseline viral load must be documented on current antiretroviral regimen

Applicable drugLenacapavir (Sunlenca) consideration and approval criteria

Step Therapy Requirements

Step	Requirement	Notes
1	Prescriber must document trial and therapeutic failure, allergy, contraindication, or intolerance of 2 preferred agents before eflapegrastim (Rolvedon) approval.	Required for chemotherapy-induced neutropenia prophylaxis in adults with nonmyeloid malignancy receiving myelosuppressive anti-cancer drugs; patient must be ≥ 18 years.

Quantity Limits and Fill Restrictions

Vutrisiran (Amvuttra) — Quantity limit

Quantity limit1 syringe per 3 months

ProductVutrisiran (Amvuttra)

Indication (policy context)Treatment of the polyneuropathy of hereditary transthyretin‑mediated (hATTR) amyloidosis in adults

Lenacapavir (Sunlenca) — Quantity limits

Tablet formulation limit300 mg tablets: 5 tablets per fill

Vial formulation limit463.5 mg/1.5 mL vial: 2 vials per 6 months

Product

Definitions and Diagnostic Criteria

hATTR/FAP

DefinitionHereditary transthyretin‑mediated amyloidosis (hATTR) / familial amyloidotic polyneuropathy (FAP) confirmed by amyloid deposition on tissue biopsy and identification of a pathogenic TTR variant by molecular genetic testing

Typical clinical manifestationPolyneuropathy of hATTR as the treated indication

Documentation required for approvalDefinitive diagnosis must be documented by tissue biopsy showing amyloid deposition and pathogenic TTR variant identification

ALSFRS-R

DefinitionAmyotrophic Lateral Sclerosis Functional Rating Scale - Revised (ALSFRS‑R): an objective tool used to assess baseline disease severity and to document stabilization or improvement for renewal of therapy

Use in policy

Background and Scope

This document summarizes proposed coverage criteria and prior authorization options for multiple specialty agents. It includes vutrisiran (Amvuttra) for the treatment of the polyneuropathy of hereditary transthyretin‑mediated amyloidosis (hATTR/FAP), with specific initial and renewal requirements including vitamin A supplementation and exclusion of combination TTR‑reducing therapies; sodium phenylbutyrate/taurursodiol (Relyvrio) for amyotrophic lateral sclerosis (ALS) with requirements such as an ≥8‑week trial of riluzole and objective baseline assessment (e.g., ALSFRS‑R); eflapegrastim (Rolvedon) for febrile neutropenia prophylaxis with step requirements of trial/failure of preferred agents; and lenacapavir (Sunlenca) for heavily treatment‑experienced HIV‑1 with class‑level preferences and baseline viral load documentation. The report also outlines class‑level preferred agent selection processes whereby agents not chosen as preferred will be treated as non‑preferred and subject to prior authorization.