Addyi (flibanserin)
Indications for Prior Authorization
Addyi (flibanserin)
-
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, 3) or the effects of a medication or other 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) Addyi is not indicated for the treatment of HSDD in postmenopausal women or in men. 2) Addyi is not indicated to enhance sexual performance.
Criteria
Addyi
Prior Authorization (Initial Authorization)
Length of Approval: 3 Months [C]
- Diagnosis of one of the following:
- Acquired, generalized hypoactive sexual desire disorder (HSDD) [2-5, A-B]
- Female sexual interest/arousal disorder [D]
- Symptoms of HSDD or female sexual interest/arousal disorder have persisted for at least 6 months [2-5, A] AND
- Patient is premenopausal [2-4] 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
Addyi
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
- Patient continues to be premenopausal
P & T Revisions
2024-06-14, 2023-08-22, 2023-06-18, 2022-06-16, 2021-06-29, 2020-11-17, 2020-08-19, 2019-11-05
References
- Addyi Prescribing Information. Sprout Pharmaceuticals, Inc. Raleigh, NC. September 2021.
- Thorp J, Simon J, Dattani D, et al. Treatment of Hypoactive Sexual Desire Disorder in Premenopausal Women: Efficacy of Flibanserin in the DAISY Study. J Sex Med 2012;9:793–804.
- Katz M, DeRogatis LR, Ackerman R, et al. Efficacy of Flibanserin in Women with Hypoactive Sexual Desire Disorder: Results from the BEGONIA Trial. J Sex Med 2013;10:1807–1815.
- DeRogatis LR, Komer L, Katz M, et al. Treatment of Hypoactive Sexual Desire Disorder in Premenopausal Women: Efficacy of Flibanserin in the VIOLET Study. J Sex Med 2012;9:1074–1085.
- American Psychiatric Association. Sexual dysfunctions. In: Diagnostic and Statistical Manual of Mental Disorders, 5th ed. Arlington, Virginia: American Psychiatric Association; 2013. https://doi-org.proxy.cc.uic.edu/10.1176/appi.books.9780890425596.dsm13.
- Sexual dysfunction in women: Management. UpToDate Web site. http://www.uptodate.com/contents/sexual-dysfunction-in-women-management?source=search_result&search=addyi&selectedTitle=4~9. Updated April 2, 2022. Accessed June 15, 2022.
- Clayton, A., Goldstein, I. et al. The International Society for the Study of Women’s Sexual Health Process of Care for Management of Hypoactive Sexual Desire Disorder in Women. Vol 93, Issue 4, p 467-487, April 1, 2018. Available at https://www.mayoclinicproceedings.org/article/S0025-6196(17)30799-1/fulltext. Accessed June 15, 2022.
End Notes
- 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. [5]
- 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]
- Addyi 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.
- 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 term female sexual interest/arousal disorder (DSM-5). [5-6]
Revision History
- 2024-06-14: 2024 Annual Review.
- 2023-08-22: “Program update to standard reauthorization language. No changes to clinical intent.”
- 2023-06-18: 2023 Annual Review
- 2022-06-16: 2022 Annual Review
- 2021-06-29: 2021 Annual Review
- 2020-11-17: Removed criterion "patient is female".
- 2020-08-19: Annual review - removed drug name from reauthorization criteria for consistency. Updated references.
- 2019-11-05: Removed REMS provider requirement and alcohol-related criteria per recent updates in Addyi Prescribing Information.