CurrentMass General Brigham Health PlanPolicy N/A

Addyi (flibanserin) — Pharmacy Coverage Criteria

Defines prior authorization, quantity limits, and continuation criteria for Addyi (flibanserin) under the pharmacy benefit for Mass General Brigham Health Plan members.

Policy Summary

PayerMass General Brigham Health Plan

PolicyAddyi (flibanserin) — Pharmacy Coverage Criteria

Policy CodePolicy N/A

Change TypeAdministrative — no material clinical changes

Effective DateJul 1, 2025

Next Review DateJun 11, 2025

Key ActionObtain prior authorization and document premenopausal status, age ≥18, and a clinically assessed diagnosis of acquired generalized HSDD.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1/dayquantity limit for Addyi

8 wksinitial approval duration

12 moreauthorization duration

premenopausalindicated population

Coverage Criteria for Addyi (flibanserin)

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Initial Authorization Criteria: Member is 18 years of age or older.

Initial Authorization Criteria: Member is premenopausal.

Initial Authorization Criteria: Member has a diagnosis of acquired, generalized hypoactive sexual desire disorder (HSDD) that is appropriately documented (evaluated by a complete clinical assessment, e.g., DSM-IV, interviews/questionnaires).

Initial Authorization Criteria: HSDD is NOT caused by a co-existing medical or psychiatric condition, problems within the relationship, or the effects of a medication or other drug substance.

Exception for members new to plan: Member is new to the plan within the past 90 days and is currently receiving the requested medication (excluding samples or manufacturer's patient assistance program supplies).

Temporary authorization permitted only under this exception.

inv-02: Continuation / Reauthorization

Requests for reauthorization will be approved when the following criterion is met

Reauthorization Criteria: Documentation of improvement in the member's condition.

Reauthorizations are granted for 12 months.

Members who are new to Mass General Brigham Health Plan may receive a temporary authorization for Addyi if they have been receiving the medication within the past 90 days. This exception does not apply when the current supply was obtained as samples or through a manufacturer's patient assistance program.

For all other members, prior authorization is required and will be granted only when ALL initial authorization criteria are met: the member is at least 18 years of age, is premenopausal, has a documented diagnosis of acquired, generalized hypoactive sexual desire disorder (HSDD) based on a complete clinical assessment (e.g., DSM‑IV, interviews/questionnaires), and the HSDD is not attributable to a co‑existing medical or psychiatric condition, relationship problems, or the effects of medications or other substances.

Initial Therapy

inv-11: Initial therapy

Initial authorization duration and criteria

Initial therapy: Initial approvals will be granted for 8 weeks for members meeting the Initial Authorization criteria (age ≥18, premenopausal, documented acquired generalized HSDD not due to other causes).

Quantity limit: 1 tablet per day.

Continuation and Reauthorization

inv-12: Continuation

Reauthorization requirements and durations

Continuation requirements: Documentation of clinical improvement is required for reauthorization.

Reauthorizations are granted for 12 months per policy limitations.

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Addyi (flibanserin) for members covered by Mass General Brigham Health Plan. A limited exception may apply for members who are new to the plan within 90 days of enrollment; otherwise prior authorization must be obtained before coverage.

Prior authorization required for Addyi (flibanserin).
Exception: members new to plan within 90 days may have limited prior authorization exception.

Documentation Required

Documentation Requirements

Documentation must include a confirmed diagnosis and a comprehensive clinical assessment. The assessment should document that the member has acquired, generalized hypoactive sexual desire disorder (HSDD) and that HSDD is not due to a co-existing medical or psychiatric condition, relationship problems, or effects of medication/substance. Documentation must show the member is premenopausal and is 18 years of age or older.

Required documentation: diagnosis of acquired, generalized HSDD with comprehensive clinical assessment (e.g., DSM criteria, interviews/questionnaires).
Document that HSDD is not secondary to medical/psychiatric conditions, relationship issues, or medications/substances.
Document member is premenopausal and ≥ 18 years of age.

Denial Risk

Potential Grounds for Denial

Requests may be denied if the member is not premenopausal, is under 18 years of age, or if the submission lacks adequate documentation of diagnosis and comprehensive clinical assessment demonstrating acquired, generalized HSDD and exclusion of secondary causes. Denials may also occur if continuation criteria (documentation of clinical improvement) are not met.

Grounds for denial include: member not premenopausal, member < 18 years of age, inadequate or missing documentation of diagnosis/clinical assessment.
Denials possible for failure to demonstrate that HSDD is not caused by other conditions, relationship problems, or medications/substances.
For continuation requests, lack of documented improvement may result in denial.

Step Therapy

Step therapy is not specified for Addyi in this policy.

No step therapy requirement listed.

Step	Requirement/Description
1	Step therapy not specified for Addyi in this policy.

Definitions

inv-09: Hypoactive sexual desire disorder (HSDD) — definition and diagnostic context

DefinitionAcquired, generalized low sexual desire that causes marked distress or interpersonal difficulty and is not due to co-existing medical or psychiatric conditions, relationship problems, or effects of medications/substances; diagnosis should be documented via clinical assessment (e.g., DSM-IV, interviews/questionnaires).

Required documentationDiagnosis must be appropriately documented by a complete clinical assessment (DSM-IV, interviews/questionnaires).

inv-10: Premenopausal — definition of required member status for coverage

Required member statusPremenopausal (member must be premenopausal to meet coverage criteria)

Age requirementMember must be 18 years of age or older

Indication contextIndicated population: premenopausal women with acquired, generalized HSDD

Background

Addyi (flibanserin) is a mixed serotonin agonist/antagonist indicated for the treatment of acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. HSDD is characterized by low sexual desire that causes marked distress or interpersonal difficulty and should be documented with a complete clinical assessment (for example, DSM‑IV criteria, clinical interviews, or validated questionnaires).