Vyleesi (bremelanotide) — Coverage Criteria
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.
No material clinical or coverage changes in this revision.
Coverage Criteria and Policy Stance
Not Covered
Policy stance
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
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Provider Actions, Prior Authorization, and Denial Guidance
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
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.
- Verify member eligibility and benefits prior to submitting requests or billing
- Coverage decisions follow contract terms, exclusions, and any applicable Federal Employee Program rules
Prior Authorization and Denial Guidance
Requests for Vyleesi will be denied for all indications; do not submit prior authorization expecting coverage unless a specific contract exception is documented and applicable.
- Prior authorization will be processed only to document the request but will not overturn the not-covered determination absent a contract exception
- If a contract exception is claimed, include supporting contract documentation with the request
Billing and Reporting Guidance
Use appropriate CPT, HCPCS, Revenue, and ICD-10 codes when reporting services. Ensure billing reflects the coverage determination (not covered) and document attempts to verify benefits and any contract exceptions.
- Report services with applicable CPT/HCPCS/Revenue/ICD-10 codes
- Do not bill the plan for Vyleesi when denied — follow member liability rules per contract
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
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