Prior authorization and coverage criteria for Vyleesi (bremelanotide)
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This document is a prior authorization/step-edit request form and clinical criteria for coverage of Vyleesi (bremelanotide) for members of AvMed. It governs prescriber submission requirements and clinical eligibility for Vyleesi therapy.
No material clinical or coverage changes in this revision.
Coverage Criteria
Initial Authorization
Covered when ALL of the following are met
To support each checked criterion, provide documentation (labs, diagnostics, chart notes, or pharmacy paid claims) as applicable.
Documentation requirements
- Prescribing physician must sign and clearly print name on the request form (preprinted stamps not valid).
- Include member and prescriber information, drug form/strength, dosing schedule, length of therapy, diagnosis with ICD code, weight, and date as requested on the form.
- Chart notes must document an unsuccessful 8-week trial of Addyi if claimed; pharmacy paid claims may be used to verify previous therapies.
Coverage for Vyleesi (bremelanotide) excludes members with uncontrolled hypertension or any known cardiovascular disease. This cardiovascular safety exclusion must be assessed and documented prior to authorization; members meeting either condition are not eligible under the policy.
Initial Therapy
Initial Therapy
Covered when ALL of the following are met
Chart notes, diagnostics, labs, and/or pharmacy claims must be provided to support each criterion; prior authorization form must be complete and signed by the prescribing physician.
Provider Submission & Actions
Prior Authorization Required
Prior authorization is required. All clinical criteria must be documented and submitted with the request; incomplete or illegible information may delay processing or cause denial.
- Fax completed form to 1-305-671-0200
- Prescriber signature (preprinted stamps not valid) is required
- Include phone and fax numbers for office contact
Step Therapy Requirement
An unsuccessful 8-week trial of Addyi (flibanserin) is required prior to approval. Documentation of the prior trial must be submitted.
- Chart notes documenting the trial and lack of response, or
- Paid pharmacy claims showing prior Addyi fills that indicate treatment and lack of effectiveness
Required Submission Information
Provide complete prescriber and patient information and drug details. Missing fields or illegible entries may delay or jeopardize the authorization.
- Prescriber signature and date (required)
- Member name, AvMed ID, and date of birth
- Prescriber name, DEA or NPI number, office contact, phone and fax
- Drug form/strength, dosing schedule, length of therapy, quantity requested
- Diagnosis and ICD code, patient weight, and relevant chart notes/labs
Clinical Criteria Unmet — Denial Risk
If clinical criteria are not all met or documented, the request may be denied.
- Member must be pre-menopausal and ≥ 18 years old
- Diagnosis of HSDD with symptoms for ≥ 6 months and causing marked distress or interpersonal difficulty
- HSDD not secondary to other medical/psychiatric conditions, substance abuse, or relationship issues
- Documented unsuccessful 8-week trial of Addyi
- No uncontrolled hypertension or known cardiovascular disease
- Limit use to ≤ 8 doses per month and no more than one dose in 24 hours
Coding & Related Criteria
| Quantity Limit: 8 doses (2.4 mL) per 30 days | Specified quantity limit for Vyleesi |
Quantity Limits
Step Therapy Requirements
| Step | Requirement |
|---|---|
| 1 | Documented unsuccessful 8-week trial of Addyi (flibanserin) with chart notes or pharmacy paid claims submitted to verify failure |
Definitions
Background
Vyleesi (bremelanotide) is indicated for treatment of Hypoactive Sexual Desire Disorder (HSDD) in premenopausal women. This prior authorization form captures clinical eligibility and documentation requirements to determine coverage, including baseline measurement of satisfying sexual events, verification of an unsuccessful 8-week trial of Addyi (flibanserin) when applicable, and limits on dosing. The form is used to confirm that the member is premenopausal, at least 18 years of age, has HSDD symptoms for the required duration, does not have excluded cardiovascular conditions, and will not exceed the dosing limit of 8 doses per 30 days or more than one dose in 24 hours.
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