CurrentCentenePolicy CP.PMN.289

Fezolinetant (Veozah) for vasomotor symptoms of menopause

Defines Centene's medical necessity criteria, prior authorization and continuation requirements for fezolinetant (Veozah) to treat moderate-to-severe vasomotor symptoms due to menopause for applicable lines of business.

Policy Summary

PayerCentene

PolicyFezolinetant (Veozah) for vasomotor symptoms of menopause

Policy CodePolicy CP.PMN.289

Change TypeStep therapy clarificationIL HIM bypassboxed warning update

Effective Date09.01.23

Next Review DateN/A

Key ActionSubmit prior authorization with documentation showing diagnosis of vasomotor symptoms due to menopause, age ≥18, failure of two formulary estrogen products (unless contraindicated), and dose ≤45 mg/day.

SourceLink

POLICY UPDATE CHANGES

Added step therapy bypass for Illinois HIM per IL HB 5395.

Clarified initial approval requires failure of two formulary estrogen products (not general hormonal therapy products).

Updated boxed warning to note risks of hepatotoxicity.

45 mgmaximum daily dose

12 moapproval duration

2failed estrogens required

≥18minimum age

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Coverage Criteria for Fezolinetant (Veozah)

Initial Approval - Vasomotor Symptoms

Covered when ALL of the following are met:

Initial Approval - Vasomotor Symptoms: 1. Diagnosis of vasomotor symptoms associated with menopause; 2. Age ≥ 18 years; 3. Failure of two formulary estrogen products (not contraceptives), unless contraindicated or clinically significant adverse effects are experienced; For Illinois HIM requests, the step therapy requirements do not apply as of 1/1/2026 per IL HB 5395; 4. Dose does not exceed 45 mg (1 tablet) per day.dose <= 45 mg/day

Approval duration: 12 months

Continued Therapy - Vasomotor Symptoms

Continued therapy is covered when ALL of the following are met:

Continued Therapy - Vasomotor Symptoms: 1. Member meets one of the following: (a) currently receiving medication via Centene benefit or previously met initial approval criteria; OR (b) currently receiving medication and enrolled in a state/product with continuity of care regulations; 2. Member is responding positively to therapy as evidenced (e.g., vasomotor symptom reduction); 3. If request is for a dose increase, new dose does not exceed 45 mg (1 tablet) per day.dose <= 45 mg/day

Approval duration: 12 months

Other Indications / Label Changes

When requested use is not listed under authorized indications:

Other Indications: 1. If the drug has undergone a label change within the last 6 months that is not yet reflected in this policy, refer to the relevant no-coverage or non-formulary policy for the applicable line of business (see policy references).; 2. If the requested use (diagnosis, age, dosing) is NOT specifically listed under section III and criterion 1 does not apply, refer to the off-label use policy for the relevant line of business.

See referenced policies: CP.CPA.190, HIM.PA.33, CP.PMN.255, HIM.PA.103, CP.PMN.16, CP.CPA.09, HIM.PA.154, CP.PMN.53

Non-FDA approved indications not addressed in this policy are not authorized for coverage unless the provider submits sufficient documentation demonstrating efficacy and safety per the referenced off-label use policies. See CP.CPA.09 (Commercial), HIM.PA.154 (Health Insurance Marketplace), and CP.PMN.53 (Medicaid) or applicable evidence-of-coverage documents for requirements to support off-label use.

Fezolinetant (Veozah) has specific safety exclusions and warnings that must be considered prior to authorization. It is contraindicated in members with known cirrhosis, severe renal impairment or end-stage renal disease, and in those receiving concomitant therapy with CYP1A2 inhibitors. The product carries a boxed warning for the risks of hepatotoxicity and should not be used when these contraindications or the boxed warning apply.

Requests for use of fezolinetant for indications that are not FDA-approved and are not specifically addressed by this policy will be considered not authorized unless the request is supported by the applicable off-label use policies referenced herein (CP.CPA.09, HIM.PA.154, CP.PMN.53) or other evidence-of-coverage documentation.

Coding and Dosage

No procedure/coding specifiedmixed

N/A	No CPT/HCPCS/ICD codes provided in document.

Maximum daily dose — 45 mg per day

Maximum daily dose45 mg per day (1 tablet daily).

Dosing regimen1 tablet PO once daily for vasomotor symptoms. (Product available as a 45 mg tablet).

Approval duration related to doseInitial and continued approval durations are 12 months when dose does not exceed 45 mg/day.

Provider Actions, Prior Authorization and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for initial therapy. Requests must meet all initial approval criteria (diagnosis, age, step therapy failures, and dosing limits). Approval duration: 12 months.

Applies to initial requests for vasomotor symptoms associated with menopause
Dose limit: ≤ 45 mg (1 tablet) per day
Approval duration: 12 months

Documentation Required

Documentation Required to Support Request

Provider must submit documentation (such as office chart notes, lab results, or other clinical information) supporting that the member has met all approval criteria. Failure to provide sufficient documentation may result in denial.

Examples: office visit notes demonstrating diagnosis and symptom severity, prior medication history showing trials and failures, relevant labs or imaging if applicable

Background

Fezolinetant (Veozah) is a selective neurokinin 3 (NK3) receptor antagonist approved for the treatment of moderate-to-severe vasomotor symptoms associated with menopause. The prescribing information notes important safety considerations, including a boxed warning for hepatotoxicity and contraindications in patients with known cirrhosis, severe renal impairment or end-stage renal disease, and those taking CYP1A2 inhibitors.

Definitions and Contraindications

NK3 — Neurokinin 3 receptor; fezolinetant is an NK3 receptor antagonist

DefinitionNeurokinin 3 receptor (NK3).

Mechanism/agentFezolinetant is an NK3 receptor antagonist (Fezolinetant (Veozah)).

Indication contextApproved for treatment of moderate-to-severe vasomotor symptoms associated with menopause (per policy context).

Contraindications — Known cirrhosis; severe renal impairment or end-stage renal disease; concomitant use with CYP1A2 inhibitors

Known cirrhosisContraindication: known cirrhosis.

Severe renal impairment / ESRDContraindication: severe renal impairment or end-stage renal disease.