Recommended Authorization Criteria — Addyi (flibanserin)
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Recommended prior authorization criteria for pharmacy coverage of Addyi (flibanserin) for treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD)/female sexual interest/arousal disorder (FSIAD). Applies to prescribers requesting coverage through Medical Mutual - Ohio.
No material clinical or coverage changes in this revision.
Coverage Criteria for Addyi (flibanserin)
inv-01: Initial Therapy
Covered when ALL of the following are met
inv-02: Continuation of Therapy
Covered for continuation when ALL of the following are met
Use of Addyi (flibanserin) is not recommended for the following situations: treatment of HSDD/FSIAD in men; use solely to enhance sexual performance; and any indications or circumstances that are not listed in the Recommended Authorization Criteria.
Clinical evidence for Addyi is limited or not supportive for certain populations. Data do not support routine use in men, and evidence for postmenopausal women is limited; accordingly, Addyi is not recommended for enhancement-of-performance indications or other uses outside the stated authorization criteria.
Initial Therapy — Authorization Conditions
inv-11: Initial Therapy
Initial approval is recommended when criteria are met.
Initial approval duration 60 days
Continuation Therapy — Renewal Conditions
inv-12: Continuation Therapy
Continuation approval requires ongoing benefit and absence of serious adverse events.
Extended approval duration 180 days may be considered per policy guidance
Provider Requirements and Administrative Notes
Prior authorization required when coverage criteria met
Prior authorization is recommended for pharmacy benefit coverage of Addyi; approval is recommended when the patient meets the specified criteria for diagnosis and other clinical conditions (see Coverage Criteria and Initial/Continuation Therapy requirements). Initial approvals are provided for the initial approval duration and reauthorization requires a response to therapy unless otherwise noted.
No step therapy requirements
No step therapy requirements are specified in this policy.
Provide documentation on request to support medical necessity
The Company may request additional documentation to support medical necessity as part of its coverage determination; requested documentation must be made available upon request.
- Documentation may include patient records, test results, and provider credentials.
- Provide requested materials promptly to support the coverage determination.
Denial risk for non‑medical necessity, investigational use, or out‑of‑scope services
The Company may deny reimbursement if the drug or services are not medically necessary, are investigational/experimental, are not within the member's benefit scope, or if inappropriate/excessive billing is found.
- Denial may occur for uses not listed in the policy unless medical necessity and efficacy are shown on review.
- A pattern of inappropriate or excessive billing may also result in denial.
Key Definitions
Background
Addyi (flibanserin) is indicated for treatment of acquired, generalized hypoactive sexual desire disorder (HSDD)/female sexual interest/arousal disorder (FSIAD) in premenopausal women. The policy restricts authorization to this population and requires that the low sexual desire be causing marked distress or interpersonal difficulty and not be secondary to medical/psychiatric conditions, relationship problems, or effects of medications or substances. Safety considerations noted in the policy include the risk of hypotension and syncope with alcohol and contraindications such as hepatic impairment and concurrent use of CYP3A4 inhibitors.
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