CurrentBlue Cross Blue Shield - IowaPolicy 05.02.83

Vyleesi (bremelanotide) — Coverage Criteria

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This policy governs coverage determination for Vyleesi (bremelanotide) for treatment of hypoactive sexual desire disorder (HSDD) and applies to Wellmark/Blue Cross Blue Shield - Iowa members whose benefits permit coverage determinations under the contract.

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyVyleesi (bremelanotide) — Coverage Criteria

Policy CodePolicy 05.02.83

Change TypeNo material change

Effective DateNov 1, 2019

Last ReviewJun 1, 2025

Next Review DateJun 1, 2025

Key ActionRequests for Vyleesi (bremelanotide) will be denied for all indications; prior authorization will not result in coverage except as allowed by contract.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

not coveredcoverage stance for Vyleesi

40%

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CurrentBlue Cross Blue Shield - IowaPolicy 05.02.83

Vyleesi (bremelanotide) — Coverage Criteria

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Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyVyleesi (bremelanotide) — Coverage Criteria

Policy CodePolicy 05.02.83

Change TypeNo material change

Effective DateNov 1, 2019

Last ReviewJun 1, 2025

Next Review DateJun 1, 2025

Key ActionRequests for Vyleesi (bremelanotide) will be denied for all indications; prior authorization will not result in coverage except as allowed by contract.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

not coveredcoverage stance for Vyleesi

40%

Coverage Criteria and Policy Stance

Not Covered

Policy stance

Not covered: Vyleesi (bremelanotide) is considered not covered for all indications, including the treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD)

Policy cites limited clinical benefits demonstrated in trials, high cost, and increased risk of nausea as reasons for noncoverage

Vyleesi (bremelanotide) is not indicated for the treatment of HSDD in postmenopausal women or in men. The agent is also not indicated to enhance sexual performance.

Use of Vyleesi is considered not medically necessary because clinical trials have shown only modest improvement in sexual desire for some women, with little or no benefit on the number of satisfying sexual events, while exposing patients to an unfavorable adverse effect profile (notably an increased risk of nausea) and substantial cost. These factors—limited clinical benefit, high cost, and safety concerns—are the basis for the noncoverage determination.

Procedures, Billing, and Scoring Ranges

Procedures and Billing Guidancemixed

No codes listed

Co-primary endpoint score ranges — FSFI Desire domain and FSDS-DAO Q13

FSFI Desire domain score range1.2 - 6.0 (derived from FSFI Question 1 & 2 response scaling)

FSFI Question 1 response options1 = Almost never or never; 2 = A few times; 3 = Sometimes; 4 = Most times; 5 = Almost always or always

FSFI Question 2 response options1 = Very low or none at all; 2 = Low; 3 = Moderate; 4 = High; 5 = Very high

FSDS-DAO Q13 score range0 - 4 (0 = Never bothered; 4 = Always bothered)

FSDS-DAO Q13 response options0 = Never; 1 = Rarely; 2 = Occasionally; 3 = Frequently; 4 = Always

Provider Actions, Prior Authorization, and Denial Guidance

Denial Risk

Coverage Denial for Vyleesi

Vyleesi (bremelanotide) requests will be denied for all indications. Prior authorization will not result in coverage except where an individual contract exception applies.

All indications, including treatment of premenopausal women with acquired, generalized HSDD
Denial applies due to limited clinical benefit, high cost, and increased risk of nausea

Documentation Required

Benefit Determinations and Verification

Benefit determinations are based on the member's contract in effect at the time services are rendered. Verify individual member benefits, exclusions, limitations, and exceptions prior to rendering services. Wellmark (Blue Cross Blue Shield - Iowa) determines medical necessity only when the benefit exists and no contract exclusions apply. This policy may not apply to FEP members.

Background

Hypoactive sexual desire disorder (HSDD) describes persistently low sexual desire that causes marked personal distress or interpersonal difficulty. Vyleesi (bremelanotide) is a melanocortin receptor agonist approved by the FDA for premenopausal women with acquired, generalized HSDD, but the mechanism by which it may improve desire is not well understood.

Clinical evidence indicates Vyleesi produces only modest increases in desire for a subset of patients and may slightly reduce distress related to low desire, but it does not increase the number of satisfying sexual events. The drug must be self-administered by subcutaneous injection approximately 45 minutes before sexual activity and is associated with a notable incidence of nausea and other adverse effects.

Because of the limited efficacy data, unresolved safety questions (including long‑term risks and use in populations such as postmenopausal women or women with psychiatric comorbidities), and high cost, this policy does not provide coverage for Vyleesi.

Definitions

HSDD / FSIAD definitions — definition and DSM-5 context

Definition of HSDDHypoactive sexual desire disorder (HSDD): low sexual desire that causes marked distress or interpersonal difficulty; previously a stand-alone DSM‑IV diagnosis and now incorporated into DSM‑5 female sexual interest/arousal disorder (FSIAD)

DSM‑5 context (FSIAD)In DSM‑5, HSDD is included within female sexual interest/arousal disorder (FSIAD), defined as lack of or significantly reduced sexual interest/arousal for ≥6 months with at least 3 of 6 diagnostic criteria

Clinical applicationVyleesi FDA approval applies to premenopausal women with acquired, generalized HSDD not due to medical/psychiatric conditions, relationship problems, or medication/substance effects

Vyleesi (bremelanotide) — pharmacologic description and receptor activity

Drug class and generic nameVyleesi (bremelanotide), a melanocortin receptor (MCR) agonist