CurrentBlue Cross Blue Shield - MassachusettsPolicy 014

Veozah (fezolinetant) step therapy and quantity limit policy for vasomotor symptoms of menopause

Commercial BCBSMA formulary policy governing step therapy, quantity limits (Quality Care Dosing), prior authorization, documentation, and individual consideration for medications used to treat vasomotor symptoms (VMS) of menopause, with specific formulary placement and requirements for Veozah (fezolinetant). Applies to specified commercial plan types and Rx/medical benefit pathways.

Policy Summary

PayerBlue Cross Blue Shield - Massachusetts

PolicyVeozah (fezolinetant) step therapy and quantity limit policy for vasomotor symptoms of menopause

Policy CodePolicy 014

Change TypeRevised: formulary placement & prior use requirement

Effective Date

Next Review Date

Key ActionObtain prior authorization showing prior use of one step medication or prior Veozah use within 130 days, or submit an exception request with supporting documentation; ensure baseline and follow-up liver function tests per product label.

SourceLink

POLICY UPDATE CHANGES

Policy updated to include Veozah (fezolinetant) as ST and QCD with prior use requirement within 130 days.

Reformatted policy entries in 10/2023 and 11/2023.

1Target drug (Veozah) listed

130Prior use lookback (days)

4Required LFT checks (baseline + follow-ups)

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Coverage Summary

Coverage requirements for Veozah (fezolinetant)

Covered when ALL of the following are met:

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title

Coverage stance: covered_with_criteria — Veozah (fezolinetant) is managed on the Commercial BCBSMA formulary with Step Therapy (ST) and Quality Care Dosing (QCD) requirements (Policy #014 / BCBSA Reference NIA). The policy applies to specified commercial plan types and covers medications under both Rx and medical benefit pathways. Approval requires documentation of prior use of one step medication (a covered formulary alternative) or documentation of prior Veozah use within the previous 130 days, and if prescription claim records are unavailable the provider must supply supporting documentation. Liver monitoring is required per the product label at baseline and at 3, 6, and 9 months after initiation (and when symptoms suggest liver injury).

Initial Therapy / Step Therapy Requirements

{

"operator":"any",

"text":"Prior use requirement: Member has prescription claim evidence of prior use of ONE step medication within the previous 130 days OR prior use of Veozah (fezolinetant) within the previous 130 days.",

"note":"Prescription claims may be used to verify prior use; if claims data are not available or insufficient, additional provider documentation is required to demonstrate prior use or clinical reasons preventing trials of formulary alternatives."

}

Step Therapy

Prior Authorization Required per Step Therapy

Prior authorization (step therapy) is required. Approval requires documentation of prior use of ONE step medication within the previous 130 days or prior use of Veozah within the previous 130 days, or a completed exception (individual consideration) request documenting clinical reasons why step therapy cannot be met.

Documentation Required

Documentation of Prior Trials and Failures

Documentation of prior trials/failures must include specific medication details and may be supported by prescription claim records.

Include medication name(s) and strength(s).
Include dates of trial/fill if available (prescription claim dates acceptable).
Describe specifics of treatment failure or intolerance (reason for discontinuation).
If prescription claim records are not available or do not establish prior use, provide clinical records documenting prior therapy or rationale for inability to trial formulary alternatives.

Note

How to Request Coverage or Exceptions

How to request coverage or an exception: use the contact methods below and submit the Massachusetts Standard Form for Medication Prior Authorization Requests when applicable.

Phone: Blue Cross Blue Shield of Massachusetts Pharmacy Operations 1-800-366-7778
Fax: 1-800-583-6289
Mail: Pharmacy Operations Department, 25 Technology Place, Hingham, MA 02043
Use the Massachusetts Standard Form for Medication Prior Authorization Requests (eForm #434) when applicable.

Note

Liver Monitoring per Product Label

Liver function monitoring is required per the product label for Veozah (fezolinetant): obtain baseline liver function tests prior to initiation and follow-up tests at approximately 3 months, 6 months, and 9 months after initiation, and any time symptoms suggest liver injury. Documentation of monitoring per label should be included with requests when available.

Safety Monitoring and Documentation

Note

The policy references the product label for liver monitoring recommendations and cites the product information (Veozah [Product Information], Astellas Pharma US, Inc., 2023) as the source for testing frequency. The label requires baseline liver function tests and follow-up testing at 3 months, 6 months, and 9 months after initiation and when symptoms suggest liver injury. Providers are expected to document relevant test results when submitting prior authorization or individual consideration (exception) requests.

Formulary Exception / Individual Consideration

Formulary exception / Individual consideration

Exception requests (individual consideration) will be reviewed when ALL of the following apply:

ref

title

When available, prescription claims may be used to establish prior use or trial-and-failure of step medications in lieu of additional provider documentation. If claim data are insufficient or unavailable, acceptable supporting documentation includes: clinical notes detailing prior trials and outcomes, the name and strength of alternatives tried and failed with dates if available, citations to clinical literature or guidelines, and references from recognized compendia (e.g., AHFS‑DI, Lexi‑Drug, Clinical Pharmacology, Micromedex, Drugdex).

Policy Identifiers & Codes

Policy identifiersmixed

Policy Number: 014	BCBSMA internal policy identifier
BCBSA Reference Number: NIA	Reference number

Clinical Evidence & References

SKYLIGHT1Lancet 2023 phase 3 RCT (Fezolinetant) showing efficacy for moderate–severe VMS

ProductLblVeozah product label — baseline LFTs and follow-up at 3, 6, 9 months; monitor if symptoms suggest liver injury

Evidence summary: • SKYLIGHT1 RCT — Fezolinetant phase 3 randomized controlled study (Lancet 2023). • Product label — Veozah [Product Information], Astellas Pharma US, Inc., 2023 (this label is the source for the liver monitoring recommendations).

Background

Background: Veozah (fezolinetant) is a first-in-class non-hormonal NK3 receptor antagonist indicated for moderate to severe vasomotor symptoms of menopause and offered as an alternative for women who cannot or will not take hormone therapy. Hormone therapy remains the most effective treatment for vasomotor symptoms, but its benefit–risk profile varies with age and time since menopause.

Key Thresholds & Lookback Windows

Surface thresholds

Prior use lookback window130 days

Required LFT follow-upsBaseline, 3 months, 6 months, 9 months (and as clinically indicated)

Prior use optionsPrior use of one step medication OR history of prior Veozah use within previous 130 days

LFT requirement sourcePer product label: baseline and follow-up tests at 3, 6, and 9 months and when symptoms suggest liver injury

Surface stat - Prior use lookback130 days

Surface stat - Required LFT tests4 follow-up checks (baseline + 3 at 3/6/9 months)

Revision History

2023-09/2023-11material_changeLatest

Policy updated to include Veozah (fezolinetant) as ST and QCD with prior use requirement within 130 days. Detail: Document lists Veozah as 'ST, QCD' and specifies prior use/prior Veozah within 130 days meets step requirement.