ModifiedMass General Brigham Health PlanPolicy N/A

Vyleesi (bremelanotide)

Defines prior authorization requirements, continuation criteria, quantity limits, and benefit applicability for Vyleesi (bremelanotide) under the pharmacy benefit for Commercial/Exchange members (includes provisions for members new to the plan).

Policy Summary

PayerMass General Brigham Health Plan

PolicyVyleesi (bremelanotide)

Policy CodePolicy N/A

Change TypeModified

Effective DateMar 1, 2025

Next Review Date

Key ActionPrior authorization is required under the pharmacy benefit for Vyleesi (bremelanotide) for Commercial/Exchange members; requests for members new to plan within 90 days who are currently receiving treatment may be authorized per policy.

SourceLink

POLICY UPDATE CHANGES

Updated verbiage for members who are new to the plan.

Updated reauthorization criteria to remove requirement that initial criteria are met.

1Drug covered under policy

8 pens/30 daysQuantity limit

90 daysNew-to-plan window

Coverage Summary

Coverage stance: covered_with_criteria. Scope: defines prior authorization requirements, continuation criteria, quantity limits, and benefit applicability for Vyleesi (bremelanotide) under the pharmacy benefit for Commercial/Exchange members, with provisions for members new to the plan. Indication: Vyleesi (bremelanotide) is indicated for treatment of acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women — HSDD is defined as low sexual desire that causes marked distress or interpersonal difficulty. Vyleesi is not indicated for postmenopausal women, men, or to enhance sexual performance. Exclusions: HSDD due to a coexisting medical or psychiatric condition, relationship problems, or the effects of a medication or drug substance are excluded. Policy effective date: 2025-03-01; last review: 2024-12-11.

Initial Therapy Criteria

Standard Initial Authorization Criteria

Authorization may be granted when ALL of the following criteria are met:

Premenopausal status: Member is premenopausal
Documented diagnosis of HSDD: 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
Exclusion of other causes: Member's HSDD is NOT due to a coexisting medical or psychiatric condition, problems with the relationship, or the effects of a medication or drug substance

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New-to-Plan Exception (Initial Authorization)

Eligibility for Authorization (new-to-plan exception)

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 when obtained as samples or via manufacturer's patient assistance programs

New-to-plan window: Member is new to the plan within the past 90 dayswithin the past 90 days
Currently receiving treatment: Member is currently receiving treatment with the requested medication
Excludes medication obtained as samples or via manufacturer's patient assistance programs

Members new to the plan within the past 90 days who are currently receiving treatment with Vyleesi may be authorized without meeting standard initial criteria, provided the medication was not obtained as samples or through manufacturer's patient assistance programs. This updated verbiage is reflected in the policy changes.

Continuation Therapy Criteria (Reauthorization)

Continuation of Therapy / Reauthorization

Requests for reauthorization will be approved when the following criteria are met:

Positive response to therapy: Documentation is submitted demonstrating member has had a positive response to therapy

Policy-level reauthorization change: reauthorization now requires only documentation demonstrating a positive response to therapy; the initial authorization criteria do not need to be re-demonstrated for renewal.

Provider Actions

Prior Authorization

Prior authorization required

Prior authorization is required under the pharmacy benefit for Vyleesi (bremelanotide) for Commercial/Exchange members; requests for members new to plan within 90 days who are currently receiving treatment may be authorized per policy.

Commercial/Exchange pharmacy benefit
New-to-plan exception: members new to the plan within the past 90 days who are currently receiving treatment (excludes samples or manufacturer patient assistance programs)

Documentation Required

Documentation of diagnosis and etiology

Provider must document member is premenopausal, has acquired generalized HSDD causing marked distress or interpersonal difficulty, and that the condition is not due to a medical/psychiatric condition, relationship problems, or medication/substance effects.

Premenopausal status
Documented acquired, generalized HSDD causing marked distress or interpersonal difficulty
Exclusion of HSDD due to medical or psychiatric condition, relationship problems, or effects of a medication or drug substance

Documentation Required

Documentation of positive response for reauthorization

For reauthorization, submit documentation demonstrating the member has had a positive response to therapy.

Billing Rule

Quantity limit

Limit of 8 Vyleesi 1.75mg/0.3mL pens per 30 days.

8 Vyleesi 1.75mg/0.3mL pens per 30 days

Background / Drug Information

Background: Vyleesi (bremelanotide) is a melanocortin receptor agonist indicated for treatment of acquired, generalized HSDD in premenopausal women. HSDD is defined as low sexual desire that causes marked distress or interpersonal difficulty. Vyleesi is not indicated for HSDD in postmenopausal women or in men, and it is not indicated to enhance sexual performance. HSDD due to a coexisting medical or psychiatric condition, relationship problems, or the effects of a medication or drug substance is excluded from the indication.

Evidence citation: Vyleesi (bremelanotide) [prescribing information], AMAG Pharmaceuticals Inc; March 2024.

Revision History

2024-12-11policy_revisedLatest

Updated verbiage for members who are new to the plan: 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 when the product is obtained as samples or via manufacturer's patient assistance programs.