Prior Authorization Criteria — Veozah (fezolinetant)
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Prior authorization criteria for Veozah (fezolinetant) for treatment of moderate to severe vasomotor symptoms due to menopause for members of West Virginia Bureau for Medical Services.
No material clinical or coverage changes in this revision.
Coverage Criteria for Veozah (fezolinetant)
inv-01: Initial Therapy
Covered when ALL of the following are met
Initial approvals may be authorized for 90 days; further approvals may be granted for 1 year after continuation criteria are met.
inv-02: Continuation Therapy
Covered upon continuation when ALL of the following are met
Further approvals may be granted for 1 year after these criteria are met.
Patients with severe renal impairment or end-stage renal disease (ESRD) are excluded from coverage for Veozah (fezolinetant). Documentation that the patient does not have severe renal impairment or ESRD is required as part of the prior authorization criteria and may be a basis for denial if absent.
Laboratory and Threshold Guidance
Prior Authorization and Documentation Requirements
Prior authorization required for Veozah
Prior authorization is required for Veozah (fezolinetant). The request must document a diagnosis of menopause with moderate to severe vasomotor symptoms and that the patient is within the FDA‑recommended age range; baseline liver function tests must be provided and the patient must not have severe renal impairment or end‑stage renal disease. Initial approvals may be authorized for 90 days with further approvals for 1 year after continuation criteria are met.
Required prior therapy trials before initiation
Before authorization, the provider must document prior therapy trials: a 30‑day trial of one HRT agent (unless contraindicated) AND a 30‑day trial of one non‑hormonal therapy that failed to provide sufficient relief, or if HRT cannot be tolerated, two separate 30‑day trials of non‑hormonal therapies that failed.
- 30 days = duration per trial
- Non‑hormonal examples listed: SSRI, SNRI, gabapentin, pregabalin, clonidine
Documentation required for authorization
Required documentation for a prior authorization request must include the diagnosis of menopause with moderate to severe vasomotor symptoms, detailed frequency and severity of symptoms, documentation of the required prior therapy trials (HRT and non‑hormonal therapies), baseline liver function tests, and ongoing documentation of clinical response and liver enzymes for continuation.
- Frequency and severity of vasomotor symptoms
- Records showing 30‑day trial(s) of HRT and non‑hormonal therapy(ies) and outcomes
- Baseline LFTs prior to initiation and scheduled monitoring (monthly x3, then months 6 and 9)
- For continuation: documented compliance and positive clinical response (e.g., decreased frequency/improved severity)
Triggers for denial of authorization
Requests may be denied if required documentation is missing or if baseline or ongoing liver enzyme criteria are not met; presence of severe renal impairment or end‑stage renal disease also triggers denial.
- Missing documentation of diagnosis or frequency/severity of vasomotor symptoms
- Absent or insufficient documentation of required 30‑day prior therapy trials
- Baseline ALT or AST equal to or exceeding 2× ULN (do not start)
- Treatment‑restricting hepatic adverse effects during therapy (e.g., ALT or AST > 3× ULN)
- Severe renal impairment or end‑stage renal disease
Background
Veozah (fezolinetant) is a neurokinin 3 (NK3) receptor antagonist indicated for the treatment of moderate to severe vasomotor symptoms (VMS) due to menopause. Prior authorization requires documentation of diagnosis, symptom frequency and severity, appropriate prior therapy trials (hormone replacement and non-hormonal agents as specified), baseline liver function tests, and adherence to the monitoring schedule because therapy should not be started if baseline ALT or AST is ≥ 2× ULN.
Definitions
Initial Authorization Requirements
inv-11: Initial Therapy
Initial authorization requirements
Initial approvals may be authorized for 90 days.
Continuation of Therapy
inv-12: Continuation of Therapy
Requirements for ongoing coverage
Further approvals may be granted for 1 year after these criteria are met.
Step Therapy Requirements
| Step | Required trial(s) | Duration per trial | Failure definition | Notes |
|---|---|---|---|---|
| 1 | One 30-day trial of ONE hormone replacement therapy (HRT) agent (unless contraindicated) AND one 30-day trial of ONE non-hormonal therapy (e.g., SSRI, SNRI, gabapentin, pregabalin, or clonidine) | 30 days each | Failed to provide sufficient relief | Do not start VEOZAH if ALT or AST ≥ 2× ULN; baseline LFTs required prior to initiation and monitoring monthly x3, then months 6 and 9; initial approvals may be for 90 days |
| 2 | OR — TWO 30-day trials of non-hormonal therapies if hormonal therapy cannot be tolerated | 30 days each | Failed to provide sufficient relief | Only applicable when HRT cannot be tolerated; same LFT requirements and approval durations apply |
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