CurrentMass General Brigham Health PlanPolicy N/A

Vyleesi (bremelanotide) coverage

Prior authorization policy governing pharmacy benefit coverage of Vyleesi (bremelanotide) for premenopausal women with acquired, generalized HSDD; affects Commercial/Exchange plan members and new-to-plan members under specified conditions.

Policy Summary

PayerMass General Brigham Health Plan

PolicyVyleesi (bremelanotide) coverage

Policy CodePolicy N/A

Change TypeRevised

Effective DateMar 1, 2025

Next Review DateN/A

Key ActionSubmit prior authorization showing member is premenopausal with acquired, generalized HSDD and documentation of positive response for reauthorization.

SourceLink

POLICY UPDATE CHANGES

Updated verbiage for members who are new to the plan and updated reauthorization criteria to remove requirement that initial criteria are met.

Prior AuthorizationProgram Type

PharmacyBenefit

8 weeksInitial approval duration

12 monthsReauthorization duration

8 pens/30d

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Coverage Criteria

Initial Therapy

Covered when ALL of the following are met

Initial Authorization: Member is premenopausal.

Initial Authorization: Member has a documented diagnosis of acquired, generalized hypoactive sexual desire disorder (HSDD) characterized by low sexual desire that causes marked distress or interpersonal difficulty.

Initial Authorization: The diagnosis is not due to a coexisting medical or psychiatric condition, relationship problems, or effects of a medication or drug substance.

New-to-Plan Continuity

Alternative authorization pathway

New-to-plan continuity: Authorization may be granted for members new to the plan within the past 90 days who are currently receiving treatment with the requested medication (excluding samples or manufacturer patient assistance program supplies).90 days

Continuity of care provision

Continuation Therapy

Reauthorization will be approved when ALL of the following are met

Reauthorization: Documentation is submitted demonstrating the member has had a positive response to therapy.

Reauthorization approvals are for 12 months

Vyleesi is not indicated for the treatment of hypoactive sexual desire disorder (HSDD) in postmenopausal women or in men. It is also not indicated to enhance sexual performance.

Initial Therapy

Initial Approval

Initial approval limits and duration

Initial approval duration: Initial approvals will be for 8 weeks.8 weeks

Quantity limit applies

Continuation / Reauthorization Criteria

Reauthorization

Reauthorization requirements and durations

Reauthorization criteria: Documentation is submitted demonstrating the member has had a positive response to therapy.

Reauthorization approvals are for 12 months

Coding and Quantity Limits

NDC-like product identifiermixed

1.75mg/0.3mL

Vyleesi pen strength (quantity limit entry treated as identifier)

inv-06: Quantity limit — 8 pens per 30 days

Quantity limit8 pens per 30 days

Measurement periodPer 30 days

Applies toVyleesi 1.75mg/0.3mL pens

inv-15: Vyleesi 1.75mg/0.3mL pens — quantity value

ProductVyleesi 1.75mg/0.3mL pens

Quantity identifier1.75mg/0.3mL (pen strength)

Associated limit8 pens per 30 days

Provider Actions & Documentation

Prior Authorization

Prior Authorization Required

Prior authorization required for Vyleesi (bremelanotide) under the pharmacy benefit for Commercial/Exchange members. Initial authorization may be granted when ALL of the following are documented: member is premenopausal; member has a diagnosis of acquired, generalized HSDD causing marked distress or interpersonal difficulty; and the HSDD is not due to a coexisting medical/psychiatric condition, relationship problems, or effects of a medication or substance.

Plan: Commercial/Exchange
Program Type: Prior Authorization
Benefit: Pharmacy Benefit

Step Therapy

No Step Therapy Requirement

No step therapy requirement is listed in this policy.

Definitions

inv-12: Acquired, generalized HSDD — Definition of acquired, generalized hypoactive sexual desire disorder (HSDD).

DefinitionAcquired, generalized hypoactive sexual desire disorder (HSDD): 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 a medication or drug substance.

PopulationPremenopausal women

ExclusionsNot indicated for postmenopausal women or men; not indicated to enhance sexual performance.

Background

Vyleesi (bremelanotide) is a melanocortin receptor agonist indicated for the treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD) characterized by low sexual desire that causes marked distress or interpersonal difficulty. The diagnosis must not be attributable to a coexisting medical or psychiatric condition, relationship problems, or the effects of a medication or drug substance. Vyleesi is not indicated for HSDD in postmenopausal women or in men and is not indicated to enhance sexual performance.

Quantity Limits

inv-15: Vyleesi 1.75mg/0.3mL pens — 8

Quantity limit (numeric)8

Unitpens

Timeframeper 30 days

Site of Care

Note

Covered under pharmacy benefit (home)

Vyleesi is covered under the pharmacy benefit; site-specific infusion rules do not apply.