Pharmacy Prior Authorization Criteria

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.

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 [2-5, A]

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

2024-06-14, 2023-08-22, 2023-06-18, 2022-06-16, 2021-06-29, 2020-11-17, 2020-08-19, 2019-11-05

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.

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.