CurrentUnitedHealthcarePolicy 2024 P 2178-5

Vyleesi (bremelanotide) prior authorization / medical necessity

UnitedHealthcare prior authorization and medical necessity criteria for initial and reauthorization coverage of Vyleesi (bremelanotide) for premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD) or female sexual interest/arousal disorder, including clinical exclusions and reauthorization requirements.

Policy Summary

PayerUnitedHealthcare

PolicyVyleesi (bremelanotide) prior authorization / medical necessity

Policy CodePolicy 2024 P 2178-5

Change TypeAnnual review; reference updates

Effective DateFeb 1, 2025

Next Review Date

Key ActionObtain prior authorization/medical necessity review for initial and reauthorization of Vyleesi and document positive clinical response for reauthorization.

POLICY UPDATE CHANGES

Annual review and updated references as of 11/2024; no clinical policy statement changes indicated.

2Covered Indications (diagnoses allowed)

6 monthsMinimum symptom duration required

12Reauthorization interval (months)

2Key cardiovascular/medical exclusions

Coverage Summary & Criteria

UnitedHealthcare prior authorization and medical necessity criteria for Vyleesi (bremelanotide) apply to initial and reauthorization requests for premenopausal women diagnosed with acquired, generalized hypoactive sexual desire disorder (HSDD) or female sexual interest/arousal disorder. Coverage is contingent on documentation that low sexual desire causes marked distress or interpersonal difficulty and is not due to a co-existing medical or psychiatric condition, relationship problems, medication or other substance effects. Patients must have been female at birth, be premenopausal, and not have uncontrolled hypertension or known cardiovascular disease. Reauthorizations require documentation of a positive clinical response and are issued for 12 months.

Initial Authorization

Vyleesi will be approved based on all of the following criteria:

ALL of the following

Diagnosis
- Acquired, generalized hypoactive sexual desire disorder (HSDD)
- Female sexual interest/arousal disorder
Duration requirement: Symptoms of HSDD or female sexual interest/arousal disorder have persisted for at least 6 months>= 6 months
Duration requirement
Exclusion: medical/psychiatric: Low sexual desire is NOT due to a co-existing medical or psychiatric condition
Exclusion: medication/substance: Low sexual desire is NOT due to the effects of a medication or other substance
Exclusion: relationship: Low sexual desire is NOT due to problems within the relationship
Demographic: sex at birth: Patient was female at birth
Reproductive status: Patient is premenopausal
Cardiovascular exclusion: hypertension: Patient does not have uncontrolled hypertension
Cardiovascular exclusion: known CVD: Patient does not have known cardiovascular disease

Reauthorization (Continuation)

Vyleesi will be approved for reauthorization based on all of the following criteria:

ALL of the following

Response: Documentation of positive clinical response to Vyleesi therapy
Provider must document positive clinical response for reauthorization
Reproductive status: Patient continues to be premenopausal

Administrative: Reauthorization interval12 months

Reauthorization will be issued for 12 months

Prior Authorization, Documentation & Billing Impacts

Prior Authorization

Prior authorization required

Prior authorization/medical necessity review required for initial and reauthorization of Vyleesi per UnitedHealthcare Pharmacy Clinical Pharmacy Programs; automated approvals may be granted based on prior claim/medication history, diagnosis codes and claim logic.

initial and reauthorization required; automated approvals possible based on prior claim/diagnosis logic

Documentation Required

Documentation of treatment response for reauthorization

Provider must document positive clinical response to Vyleesi therapy to qualify for reauthorization.

authorization period = 12 months

Denial Risk

Exclusion for medical/psychiatric causes and cardiovascular risk

Claims may be denied if low sexual desire is due to a co-existing medical or psychiatric condition, medication/substance effects, problems within the relationship, or if the patient has uncontrolled hypertension or known cardiovascular disease.

Low desire due to a co-existing medical or psychiatric condition
Low desire due to the effects of a medication or other substance
Low desire due to problems within the relationship
Uncontrolled hypertension
Known cardiovascular disease

Billing Rule

Supply limits may apply

Supply limits may be in place per plan-level management; providers should verify member-specific benefit plan coverage and state mandates.

Verify member-specific benefit plan coverage and applicable state mandates

Evidence & Definitions

Acquired HSDD: HSDD that develops in a patient who previously had no problems with sexual desire.

Generalized HSDD: HSDD that occurs regardless of the type of stimulation, situation or partner.

Primary reference: Vyleesi [package insert], Palatin Technologies; February 2021.

Clinical review source: UpToDate — Overview of Sexual dysfunction in females: Management (updated February 1, 2023).

DSM reference: DSM-5: Sexual dysfunctions (2013).