Pharmacy Prior Authorization Criteria

Vyleesi (bremelanotide)

For diagnosis of Acquired, generalized hypoactive sexual desire disorder (HSDD)
Indicated for the treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD), as characterized by low sexual desire that causes marked distress or interpersonal difficulty and is NOT due to: 1) A co-existing medical or psychiatric condition 2) Problems within the relationship or 3) The effects of a medication or drug substance
Acquired HSDD refers to HSDD that develops in a patient who previously had no problems with sexual desire. Generalized HSDD refers to HSDD that occurs regardless of the type of stimulation, situation or partner.
Limitations of Use: 1) Vyleesi is not indicated for the treatment of HSDD in postmenopausal women or in men 2) Vyleesi is not indicated to enhance sexual performance

Prior Authorization (Initial Authorization)

Length of Approval: 3 Months [C]

AND

Symptoms of HSDD or female sexual interest/arousal disorder have persisted for at least 6 months [A, 2]

AND

AND

Prior Authorization (Reauthorization)

Length of Approval: 6 Month(s)

Patient demonstrates positive clinical response to therapy as evidenced by ONE of the following:

AND

2024-06-28, 2023-10-04, 2023-07-20, 2022-08-02, 2021-07-06, 2020-12-02, 2020-08-27, 2019-10-02

Vyleesi Prescribing Information. Palatin Technologies, Cranbury, NJ. Mar 2021.
American Psychiatric Association. Sexual dysfunctions. In: Diagnostic and Statistical Manual of Mental Disorders, 5th ed. Arlington, Virginia: American Psychiatric Association; 2013. https://dsm.psychiatryonline.org/doi/10.1176/appi.books.9780890425596.dsm13.
Overview of sexual dysfunction in women: Management. UpToDate Web site. https://www.uptodate.com/contents/overview-of-sexual-dysfunction-in-women-management?search=HYPOACTIV%20SEXUAL%20DESIRE&source=search_result&selectedTitle=2~150&usage_type=default&display_rank=2. Updated April 4, 2022. Accessed August 1, 2022.
Per clinical consult with OB/GYN, September 27, 2019.
Edinoff, A., Sanders, N., et al. Bremelanotide for Treatment of Female Hypoactive Sexual Desire. Available at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8788464/. Accessed August 1, 2022.

2024-06-28: 2024 Annual Review
2023-10-04: Program update to standard reauthorization language. No changes to clinical intent
2023-07-20: 2023 Annual Review.
2022-08-02: 2022 Annual Review
2021-07-06: 2021 Annual Review
2020-12-02: Removed safety criteria as well as the criterion "patient is female".
2020-08-27: Annual review - removed drug name from reauthorization criteria. Updated references.
2019-10-02: New program.