WHA

Vyleesi (bremelanotide)

Indications for Prior Authorization

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

Criteria

Vyleesi

Prior Authorization (Initial Authorization)

Length of Approval: 3 Months [C]

  • Diagnosis of one of the following:
    • Acquired, generalized hypoactive sexual desire disorder (HSDD) [A-B, 2]
    • Female sexual interest/arousal disorder [D]
    AND
  • Symptoms of HSDD or female sexual interest/arousal disorder have persisted for at least 6 months [A, 2]
    • AND
  • Patient is premenopausal
    • AND
  • HSDD is not attributed to one of the following[1]
    • A co-existing medical or psychiatric condition
    • Problems within a relationship
    • Effects of a medication or other drug substance
Vyleesi

Prior Authorization (Reauthorization)

Length of Approval: 6 Month(s)

  • Patient demonstrates positive clinical response to therapy as evidenced by ONE of the following:
    • Improvement in number of satisfying sexual events from baseline
    • Improvement in sexual desire from baseline
    AND
  • Patient continues to be premenopausal

  • Guideline ID
    GL-149098

  • Formulary
    premium

  • Effective date
    Oct 1, 2024

  • P&T approval date
    Oct 16, 2019

P & T Revisions

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

  1. Vyleesi Prescribing Information. Palatin Technologies, Cranbury, NJ. Mar 2021.
  2. 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.
  3. 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.
  4. Per clinical consult with OB/GYN, September 27, 2019.
  5. 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.
  1. The diagnostic criteria for Hypoactive Sexual Desire Disorder (HSDD) includes: (a) A persistently or recurrently deficient (or absent) sexual/erotic thoughts or fantasies and desire for sexual activity. The judgment of deficiency is made by the clinician, taking into account factors that affect sexual functioning, such as age and general and sociocultural contexts of the individual’s life. (b) The symptoms in criterion (a) have persisted for a minimum duration of approximately 6 months. (c) The symptoms in criterion (a) cause clinically significant distress in the individual. (d) The sexual dysfunction is not better explained by a nonsexual mental disorder or as a consequence of severe relationship distress or other significant stressors and is not attributable to the effects of a substance/medication or another medical condition. [2]
  2. In the clinical trials, acquired HSDD was defined as HSDD that developed in patients who previously had no problems with sexual desire. Generalized HSDD was defined as HSDD that was not limited to certain types of stimulation, situations or partners. [1]
  3. Vyleesi should be discontinued after 8 weeks if the patient does not report an improvement in her symptoms. [1] An additional month is added to the initial authorization duration to allow for patient follow-up with the provider.
  4. The diagnostic category HSDD (DSM-IV) was used in the FDA report and in the associated studies, but is no longer used and has been replaced by the redefined term female sexual interest/arousal disorder (FSIAD) which includes HSDD and Female Sexual Arousal Disorder (FSAD) [DSM-5]. The OB/GYN clinical consultant confirmed that it is appropriate to include both diagnoses given that it is difficult to separate the desire and arousal components in FSIAD. [2-4]
  • 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.