CurrentCignaPolicy IP0117

Vyleesi (bremelanotide) for Hypoactive Sexual Desire Disorder (HSDD)

Defines medical necessity criteria, limitations, and exclusions for coverage of Vyleesi (bremelanotide subcutaneous injection) for treatment of acquired, generalized HSDD/FSIAD in premenopausal women for Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyVyleesi (bremelanotide) for Hypoactive Sexual Desire Disorder (HSDD)

Policy CodePolicy IP0117

Change TypeAnnual revision — clinical criteria updated (08/01/2024)administrative note (04/15/2025)

Effective DateN/A

Next Review DateN/A

Key ActionPrescriber must document that the patient is premenopausal for both initial and continuation approvals.

SourceLink

POLICY UPDATE CHANGES

Added IFP to the policy.

Removed criterion requiring the patient to be female at birth.

Updated the criterion related to depression to 'patient has not been diagnosed or treated with depression within the previous 6 months.'

Updated the continuation of therapy approach by requiring the patient to be premenopausal.

Annual Revision dated 08/01/2024 summarized multiple clinical criteria changes (see above).

Annual Revision dated 4/15/2025 noted 'No criteria changes.'

1Covered Indication (premeno HSDD/FSIAD)

1Not Covered Population (postmenopausal)

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Coverage Summary

Policy Number IP0117 — Subject: Vyleesi (bremelanotide) for Hypoactive Sexual Desire Disorder (HSDD). This policy defines medical necessity criteria, limitations, and exclusions for coverage of Vyleesi for treatment of acquired, generalized HSDD/FSIAD in premenopausal women and the documentation required for approval.

Covered population: Vyleesi is covered with criteria for premenopausal women with acquired, generalized HSDD/FSIAD whose symptoms and clinical history meet the policy’s specified initial or continuation criteria (e.g., symptom duration ≥ 6 months, prior normal sexual desire, and documentation that alternative causes have been ruled out).

High-level limitations: Coverage is limited to the FDA-indicated premenopausal population and is subject to specific initial and continuation requirements (initial approvals are for 8 weeks; continuation approvals for responders are for 6 months). The policy excludes postmenopausal patients and requires that patients not have been diagnosed with or treated for depression within the previous 6 months. Documentation of premenopausal status and ruling out alternative causes are required.

Threshold summary

Symptom duration>= 6 months

Initial approval duration8 weeks

Continuation approval duration6 months

Depression-free intervalNo diagnosis or treatment for depression within the previous 6 months

Medical-Necessity Criteria

General Operational Statements

ALL of the following

Dosage, frequency, duration of therapy, and site of care should be reasonable, clinically appropriate, and supported by evidence-based literature and adjusted based upon severity, alternative available treatments, and previous response to therapy
Receipt of sample product does not satisfy any criteria requirements for coverage

Provider Actions / Documentation Requirements

Documentation Required

Document premenopausal status

Prescriber must document that the patient is premenopausal for both initial and continuation approvals.

Documentation Required

Document symptom history and prior normal desire

Prescriber must document that symptoms of HSDD/FSIAD have persisted for at least 6 months and that the patient had normal sexual desire prior to the diagnosis.

Documentation Required

Rule out alternative causes

Prescriber must document that other known causes of HSDD/FSIAD have been evaluated and ruled out, including co-existing medical or psychiatric conditions, problems within the relationship, effects of medications (e.g., antidepressants), or drug abuse.

Coding

Policy Identifiermixed

IP0117

Coverage Policy Number

Background & Evidence

Vyleesi (bremelanotide) is FDA-indicated for the treatment of acquired, generalized HSDD in premenopausal women characterized by low sexual desire that causes marked distress or interpersonal difficulty and is not due to a co-existing medical or psychiatric condition, relationship problems, or effects of medications or substances.

In the pivotal trials, patients were excluded if they were diagnosed with or being treated for depression, psychosis, bipolar disorder, or substance abuse within 6 months before screening. The prescribing information for Vyleesi also notes that therapy should be discontinued after 8 weeks if the patient does not report an improvement in symptoms.

Revision history notes in the policy include addition of IFP, removal of the criterion requiring the patient to be female at birth, and updating the depression-related criterion to require that the patient "has not been diagnosed or treated with depression within the previous 6 months."

Definitions

Evidence & References

Revision History

08/01/2024annual_revision

Added IFP to the policy.

08/01/2024annual_revision

Removed criterion requiring the patient to be female at birth.

08/01/2024criteria_update

Updated the criterion related to depression to 'patient has not been diagnosed or treated with depression within the previous 6 months.'