CurrentAvMedPolicy N/A

Prior authorization and coverage criteria for Vyleesi (bremelanotide)

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.

Policy Summary

PayerAvMed

PolicyPrior authorization and coverage criteria for Vyleesi (bremelanotide)

Policy CodePolicy N/A

Change TypeNo material clinical or coverage changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit a completed prior authorization with prescriber signature, required patient/prescriber details, documentation of an unsuccessful 8‑week Addyi trial, and supporting chart notes to avoid denial.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

8 dosesquantity limit per 30 days

>=18minimum age requirement

6 monthssymptom duration

8-weekrequired failed trial

No uncontrolled CV diseasecardiovascular exclusion

Coverage Criteria

Initial Authorization

Covered when ALL of the following are met

Vyleesi PA criteria: Member is pre-menopausal; Member is 18 years of age or older; Member has a diagnosis of Hypoactive Sexual Desire Disorder (HSDD) with symptoms that have persisted for at least 6 months; Member's HSDD is not related to any other medical or psychiatric condition, substance abuse, or relationship issue; Member has had an unsuccessful 8-week trial of Addyi (flibanserin) documented (chart notes or pharmacy claims); The prescribing physician has determined and documented the average pre-treatment number of satisfying sexual events for the patient to evaluate treatment efficacy; Member does not have uncontrolled hypertension or known cardiovascular disease; Use is limited to no more than 8 doses per 30 days and no more than one dose within a 24-hour time frame.all must be 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).

Policy Summary

PayerAvMed

PolicyPrior authorization and coverage criteria for Vyleesi (bremelanotide)

Policy CodePolicy N/A

Change TypeNo material clinical or coverage changes

Effective DateN/A

Next Review DateN/A

SourceLink

On This Page

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

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

Covered when ALL of the following are met

Initial therapy criteria: Member is pre-menopausal; Age 18 years or older; Diagnosis of Hypoactive Sexual Desire Disorder (HSDD) with symptoms persisting at least 6 months causing marked distress or interpersonal difficulty; HSDD not attributable to other medical/psychiatric conditions, substance abuse, or relationship issues; Documented unsuccessful 8-week trial of Addyi (flibanserin); Prescriber has recorded the average pre-treatment number of satisfying sexual events to establish baseline; No uncontrolled hypertension or known cardiovascular disease; Limit therapy to no more than 8 doses per 30 days and no more than one dose within any 24-hour period.all must be 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

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

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

Documentation Required

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

Denial Risk

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 limitsNDC | internalCovered

Quantity Limit: 8 doses (2.4 mL) per 30 days

Specified quantity limit for Vyleesi

inv-04: Symptom duration for HSDD

Minimum symptom duration6 months

ContextApplies to diagnosis of Hypoactive Sexual Desire Disorder (HSDD) with symptoms persisting at least 6 months

DocumentationChart notes or other documentation supporting symptom duration must be provided

Quantity Limits

inv-15: Vyleesi (bremelanotide) — quantity limit

Quantity limit (per 30 days)8 doses (2.4 mL)

Maximum dosing frequencyNo more than one dose within a 24-hour time-frame

Documentation noteUse limited to <=8 doses per month must be documented on authorization form

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

inv-12: HSDD definition — Hypoactive Sexual Desire Disorder

DefinitionHypoactive Sexual Desire Disorder (HSDD): low sexual desire that causes marked distress or interpersonal difficulty

Duration criterionSymptoms have persisted for at least 6 months

Attribution criterionHSDD is not related to other medical or psychiatric conditions, substance abuse, or relationship issues

PopulationApplies to premenopausal members aged 18 years or older when other criteria are met

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.