CurrentMass General Brigham Health PlanPolicy N/A

Intrarosa (prasterone) prior authorization for dyspareunia

Pharmacy benefit prior authorization policy for Intrarosa (prasterone) for treatment of moderate to severe dyspareunia from vulvar and vaginal atrophy in postmenopausal women; governs Commercial/Exchange members and members new to the plan within 90 days.

Policy Summary

PayerMass General Brigham Health Plan

PolicyIntrarosa (prasterone) prior authorization for dyspareunia

Policy CodePolicy N/A

Change TypeRevised new-to-plan language

Effective DateMar 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization under the pharmacy benefit for Commercial/Exchange members and document current treatment or required prior-therapy trials.

SourceLink

POLICY UPDATE CHANGES

Updated language for members new to the plan regarding authorization within the past 90 days.

3 moInitial approval duration

12 moReauthorization duration

1 box/28 daysQuantity limit

PAProgram type

Commercial/Exchange

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Coverage Criteria for Intrarosa (prasterone)

Initial Authorization

Authorization may be granted under either of the following pathways:

Authorization pathways

Pathway A - New-to-plan continuation: Member is new to the plan within the past 90 days AND is currently receiving treatment with the requested medication (exclude if product was obtained only as samples or via manufacturer's patient assistance programs)
Support with documentation of current therapy
Pathway B - Clinical criteria: All of: 1) Member is a post-menopausal woman with a diagnosis of moderate to severe dyspareunia due to vulvar and vaginal atrophy; AND 2) Member tried and failed or has clinical inappropriateness documented for at least two alternative agents (examples: Premarin vaginal cream, Estrace vaginal cream, Estring, Vagifem)
Provide documentation of prior therapies or rationale for inappropriateness

Reauthorization

Continuation of Therapy

Reauthorization criteria: Documentation submitted demonstrating an improvement in the member's condition

Used to approve reauthorization

For members new to the plan, authorization under the new-to-plan pathway is limited to those who have been on the requested medication within the past 90 days and are currently receiving treatment. Authorization is not available when the member’s prior supply consisted only of samples or was provided through a manufacturer's patient assistance program.

Provider Actions, Prior Authorization, and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization required for Intrarosa (prasterone) under the pharmacy benefit for Commercial/Exchange members. Authorization may be granted when the clinical criteria in the coverage guidelines are met or per new-to-plan exceptions below.

Benefit: Pharmacy benefit (Commercial/Exchange)
Program Type: Prior Authorization
Contact — Pharmacy Benefit Phone: 800-711-4555, Fax: 844-403-1029

Step Therapy

No step therapy program is specified for this product in this policy.

Documentation Required

Background and Clinical Indication

Intrarosa (prasterone) is a steroid indicated for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy due to menopause.

Definitions

Definition — dyspareunia

TermDyspareunia

DefinitionModerate to severe dyspareunia — a symptom of vulvar and vaginal atrophy due to menopause

Clinical contextSymptom treated by Intrarosa (prasterone)

Denial Risk

Failure to Meet Clinical Criteria

Requests that do not document that the member is a postmenopausal woman with moderate to severe dyspareunia due to vulvar and vaginal atrophy, or that do not show prior trial and failure (or documented clinical inappropriateness) of at least two alternative local estrogen therapies (e.g., Premarin vaginal cream, Estrace vaginal cream, Estring, Vagifem), are at risk for denial.

Denial risk: Missing documentation of postmenopausal status and diagnosis of moderate to severe dyspareunia due to vulvar/vaginal atrophy
Denial risk: Missing documentation of trials and failures of ≥2 alternative agents or rationale for clinical inappropriateness

Note

New-to-Plan Eligibility

Members new to the plan are eligible for authorization only if they are currently receiving the medication at the time of plan enrollment and can document prior therapy; members whose prior supply was limited to samples or obtained solely through manufacturer patient assistance programs are excluded from new-to-plan authorization.

New-to-plan eligibility: Member must be currently receiving the medication and have documentation of prior therapy at enrollment (within past 90 days)
Exclusion: Prior supply from samples or manufacturer patient assistance programs alone does not qualify for new-to-plan authorization