CurrentmhnPolicy CP.PHAR.434

Clinical Policy: Bremelanotide (Vyleesi)

Defines medical necessity criteria, prior authorization and continuation requirements for bremelanotide (Vyleesi) for premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD) for Centene-affiliated health plans (Commercial and Medicaid).

Policy Summary

Payermhn

PolicyClinical Policy: Bremelanotide (Vyleesi)

Policy CodePolicy CP.PHAR.434

Change TypeNo material changes noted

Effective DateAug 7, 2019

Next Review DateN/A

Key ActionSubmit prior authorization with documentation showing DSM-5 HSDD diagnosis with ≥6 months symptom persistence and evidence of a 3-month bupropion trial or reason for contraindication/intolerance.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1.75 mgsingle-dose strength

8max doses/month

12 moMedicaid duration

6 moCommercial duration

≥6 momin symptom duration

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inv-01: Initial Therapy — Covered when ALL of the following are met

Covered when ALL of the following are met:

HSDD initial criteria: 1) Diagnosis of hypoactive sexual desire disorder (HSDD) in premenopausal women; 2) Age ≥ 18 years; 3) Failure of a 3-month trial of bupropion at up to maximally studied effective doses unless contraindicated or intolerant (see Appendix B); 4) HSDD symptoms have persisted for a minimum of 6 months; 5) HSDD is not attributable to a co-existing medical or psychiatric condition, relationship problems, or effects of a medication or other drug substance; 6) Not prescribed concurrently with flibanserin (Addyi); 7) Dose does not exceed 1.75 mg (one injection) per day and maximum of 8 doses per month.see text

Provider must submit supporting documentation (e.g., office chart notes, labs) to demonstrate criteria are met.

inv-02: Continuation Therapy — Covered when ALL of the following are met

Covered when ALL of the following are met:

HSDD continuation criteria: 1) Member currently receiving medication via the Centene benefit or previously met initial approval criteria (or continuity of care applies); 2) Member is responding positively to therapy; 3) If request includes a dose increase, the new dose must not exceed 1.75 mg (one injection) per day and 8 doses per month.see text

Approval durations differ by line of business (Medicaid 12 months; Commercial 6 months or duration of request, whichever is less).

Non‑FDA approved indications for bremelanotide (Vyleesi) that are not explicitly addressed in this policy are excluded from coverage unless the provider submits sufficient documentation of efficacy and safety in accordance with the plan’s off‑label use policies (CP.CPA.09 for Commercial and CP.PMN.53 for Medicaid) or other applicable evidence of coverage documents.

HSDD that is attributable to a co‑existing medical or psychiatric condition, relationship problems, or the effects of a medication or drug/substance is excluded from eligibility unless the provider documents that these contributing causes have been addressed or ruled out per the product labeling and policy requirements. The policy was updated in 4Q2022 to explicitly add this exclusion and to reference Appendix D examples for conditions and medications associated with low sexual desire.

Bremelanotide (Vyleesi) is not indicated for use in postmenopausal women or in men, and it is not indicated for enhancement of sexual performance. These uses are therefore not authorized under this policy.

Requests for treatment that do not document DSM‑5 symptom persistence of at least 6 months or where HSDD is clearly attributable to other medical/psychiatric conditions, relationship issues, or the effects of medications/substances may be considered not medically necessary and are at risk for denial. The policy incorporated the DSM‑5 6‑month persistence requirement in the 4Q2021 review and continues to reference this diagnostic duration in authorization determinations.

Initial Therapy

inv-22: Initial Therapy — Initial coverage requires all criteria below

Initial coverage requires all criteria below.

Initial bremelanotide criteria: Diagnosis of HSDD in premenopausal women; age ≥ 18; failure of a 3-month trial of bupropion at up to maximally studied effective doses unless contraindicated or intolerant (see Appendix B); symptoms persist ≥ 6 months; HSDD not due to co-existing medical/psychiatric conditions, relationship problems, or medication/substance effects; not used concurrently with flibanserin (Addyi); dosing per product labeling: 1.75 mg SC at least 45 minutes before anticipated sexual activity, not to exceed 1.75 mg/day and 8 doses/month.see text

Provider must submit documentation (office chart notes, labs, or other clinical information) supporting that member has met all approval criteria.

inv-23: Initial therapy — updates require diagnostic duration and exclusion of other causes

Initial therapy — updates require documentation of diagnostic duration and exclusion of other causes.

Initial therapy criteria (updated): Documentation that patient meets DSM-5 diagnostic criteria for HSDD with symptom persistence of at least 6 months, and documentation that low sexual desire is not attributable to co-existing medical or psychiatric conditions, relationship problems, or effects of medications/substances as referenced in the prescribing information.minimum 6 months

Criterion for 6-month symptom persistence and exclusion of other causes was added in prior reviews (see policy history).

Continuation Criteria

inv-24: Continuation — requires evidence of benefit and prior authorization continuity rules

Continuation requires evidence of benefit and prior authorization continuity rules apply.

Continuation: 1) Member is currently receiving medication via Centene benefit or previously met initial criteria (or continuity of care applies); 2) Member demonstrates a positive clinical response to therapy; 3) Dose limits maintained (≤ 1.75 mg/day and ≤ 8 doses/month).see text

Approval duration: Medicaid = 12 months; Commercial = 6 months or duration of request, whichever is less. Prior authorization required and continuity rules apply.

inv-25: Continued therapy duration — revised durations referenced in prior updates

Continued therapy durations have been revised in prior updates.

Continued therapy duration: For Commercial line of business, continued therapy approval duration was revised to 6 months or duration of request, whichever is less (change noted in 4Q2023); Medicaid approval duration remains 12 months. Earlier revisions referenced 12-month durations and added DSM-5 6-month symptom persistence requirement in 2021.Commercial: 6 months or duration of request; Medicaid: 12 months

Policy history documents timing of these changes.

Provider Actions & Requirements

Prior Authorization

Prior Authorization Requirement

Prior authorization is required. Provider must demonstrate the member meets all HSDD criteria and submit documentation supporting that the member has met the approval criteria.

Submit office chart notes, relevant labs, and other clinical information supporting diagnosis and treatment history.
Document DSM-5 diagnostic criteria, including symptom persistence for a minimum of 6 months.
Include evidence that HSDD is not attributable to a co‑existing medical/psychiatric condition, relationship problems, or effects of a medication/substance.

Prior Authorization

Prior authorization requirements

Prior authorization requests must include documentation of DSM-5 diagnostic criteria and related elements to support approval.

Document diagnosis of HSDD in a premenopausal woman and age ≥ 18 years.
Document HSDD symptom duration (≥ 6 months) per DSM-5.
If continuing therapy, document current positive response to therapy and prior approval or continuity of care status as applicable.

Step Therapy

Prior Therapy Documentation

Requests lacking required prior therapy documentation or not meeting the bupropion step will be subject to denial.

Provide documentation of a 3‑month trial of bupropion at maximally studied effective doses (see Appendix B) unless contraindicated or intolerant.
If bupropion was not used, provide clinical justification for contraindication or intolerance.
If prior therapy documentation is absent or insufficient, the request may be denied.

Denial Risk

Criteria Noncompliance / Denial Triggers

Requests that do not meet core HSDD criteria or required documentation are at risk for denial.

Denial risk if patient is not a premenopausal female or is < 18 years of age.
Denial risk if HSDD symptoms have persisted < 6 months or DSM‑5 persistence not documented.
Denial risk if HSDD may be better explained by a medical/psychiatric condition, relationship problems, or medication/substance effects and exclusion not documented.
Denial risk if dose limits are exceeded ( >1.75 mg per day or >8 doses per month ) or if Vyleesi is prescribed concurrently with Addyi.

Documentation Required

Required Documentation

Providers must submit supporting chart notes, laboratory or other clinical information that substantiate the diagnosis, prior therapies, contraindications/intolerances, and response to therapy.

Include clinical notes documenting symptom history, DSM‑5 criteria assessment, and duration of symptoms.
Include documentation of prior bupropion trial (dose, duration, response) or documentation of contraindication/intolerance.
For continuation requests, document positive therapeutic response and adherence to dose limits.

Step Therapy Requirements

Step	Requirement	Notes
1	Trial of bupropion for 3 months at up to maximally studied effective doses is required prior to bremelanotide	Unless contraindicated or clinically significant adverse effects are experienced; see Appendix B for bupropion dosing limits (e.g., IR 450 mg/day, SR 400 mg/day, ER HCl 450 mg/day, ER HBr 522 mg/day)

Step	Historical guidance	Current policy implication
1	Earlier reviews and appendix updates referenced consideration of other causes of low sexual desire (medical/psychiatric conditions, relationship problems, or medication effects) and prior therapies	Policy now explicitly requires documentation that HSDD is not attributable to co‑existing medical/psychiatric conditions, relationship problems, or medication/substance effects as part of initial criteria

Background

Hypoactive sexual desire disorder (HSDD) is defined as a deficiency or absence of sexual fantasies and desire for sexual activity that causes marked distress or interpersonal difficulty and is not better explained by another psychiatric or medical disorder, relationship problems, or the effects of a substance. Bremelanotide (Vyleesi) is FDA‑approved for premenopausal women with acquired, generalized HSDD meeting these diagnostic criteria; it is not indicated for postmenopausal women or men. The policy revisions note the requirement for symptom persistence per DSM‑5 (minimum 6 months) and exclusions for other causes per the prescribing information.

Definitions

inv-20: HSDD definition — deficiency or absence of sexual fantasies and desire causing marked distress, not better accounted for by other causes

DefinitionHypoactive sexual desire disorder (HSDD): deficiency or absence of sexual fantasies and desire for sexual activity causing marked distress or interpersonal difficulty

Exclusion noteHSDD must not be better accounted for by another psychiatric disorder or be due exclusively to the physiological effects of a substance or another condition

Population contextPolicy applies to acquired, generalized HSDD in premenopausal women per indication

inv-21: DSM-5 requirement — 6 months of persistent symptoms required for HSDD diagnosis

DSM-5 persistence requirementDiagnosis requires symptoms persistent for at least 6 months

Policy adoptionCriterion for 6-month symptom persistence was added to the policy in 4Q2021 annual review

Implication for authorizationRequests lacking documentation of 6 months of persistent symptoms may be denied or considered not medically necessary

OpenPayer

Clinical Policy: Bremelanotide (Vyleesi)

Coverage Criteria

Initial Therapy

Continuation Criteria

Provider Actions & Requirements

Coding & Limits

Step Therapy Requirements

Quantity Limits

Site of Care

Background

Definitions