MaxIntel Pharmacy Trend Alert

 


 

Addyi™ (Flibanserin)

 

 

Drug Approval and Market Entry[1],[2]

§  On July 24, 2015, the U.S. Food and Drug Administration (FDA) approved Addyi™ (flibanserin) to treat acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. It’s been dubbed the “female Viagra” by many.  Prior to the approval of Addyi™, there were no FDA-approved treatments for sexual desire disorders in women. Addyi™ will be marketed and available at pharmacies on October 17, 2015 by Sprout Pharmaceuticals.

§  The approved labeled indication specifies certain limitations. Addyi™ is not indicated to treat decreased sexual desire due to co-existing medical or psychiatric conditions, problems within the relationship, or decreased sexual desire resulting from the effects of medications or other drug substances.  Addyi™ is not indicated for the treatment of decreased sexual desire in postmenopausal women, nor is it indicated to enhance sexual performance.

§  The efficacy of Addyi™ was established in three 24-week, randomized, double-blind, placebo-controlled trials in over 2,375 premenopausal women who had decreased sexual desire for at least 6 months. The patients were treated with Addyi™100 mg once daily at bedtime (1,187 patients) or a placebo (1,188 patients). The completion rate across these trials was 69% for the Addyi™ group, and 78% for the placebo group.

§  These three trials had two primary efficacy endpoints; the first being a change in self-reported satisfying sexual events and the second being a change in self-reported sexual desire recorded via an electronic diary.  In all three trials, Addyi™ resulted in statistically significant improvements in the number of satisfying sexual events compared to placebo.  However, Studies 1 and 2 showed no statistical significance between Addyi™ and the placebo in increased sexual desire as measured by diary response scores. Study 3 showed a statistically significant improvement in reported sexual desire between Addyi™ and the placebo when using a different questionnaire.

 

Background

§  It is estimated that around 1 in 10 women develop hypoactive sexual desire disorder.[3]

§  The diagnosis and treatment of this disorder is complicated by the variability involved and unestablished treatment parameters. For example, the baseline level of normal desire has not been established.  What are considered to be norms in sexual desire vary depending on the culture, social time period, and can be significantly impacted by external non-medical factors such as interpersonal relationship issues, social judgments and pressures, feelings of inadequacy, work stress, and other life issues.[4]

 

Medication Details1

§  Addyi™ is available as 100 mg tablet, indicated to be taken as one tablet orally once per day at bedtime. Addyi™ is dosed at bedtime because administration during waking hours increases the risks of hypotension, syncope, accidental injury, and central nervous system (CNS) depression (such as somnolence and sedation).

§  Addyi™ is to be discontinued after 8 weeks of use if no improvement is experienced.

§  Addyi™ is contraindicated in persons also consuming alcohol, medications known to be moderate or strong cytochrome P450 3A4 (CYP3A4) inhibitors due to drug interactions, or people with hepatic impairment.

§  The most common side effects with Addyiare dizziness, somnolence, nausea, fatigue, insomnia, and dry mouth.  However, there are serious side effects listed as a black box warning that includes low blood pressure, fainting, somnolence, and sedation.

§  Prescribers wishing to prescribe Addyi™ as well as pharmacies wishing to dispense Addyi™ must complete special training and are required to counsel the patient regarding alcohol use and other side effects.

 

Anticipated Market Impact

§  The approval of Addyi is highly anticipated, as there have been a number of medications that have been approved by the FDA for male sexual dysfunction but none for women up to this point.  However, the application for approval of Addyi has been previously rejected twice by the FDA, the first time for lack of efficacy over the placebo, and the second time for failure to show the risks of side effects outweighs the modest efficacy of the medication.[5]

§  Now that it’s finally approved, the presence of a black box warning as well as the prescribing and dispensing requirements make it difficult to predict how well it will be received.

§  The average wholesale price (AWP) of Addyi is $32 per pill, making the monthly cost of therapy approximately $960.  It is anticipated that plans currently covering male sexual dysfunction medications will also cover Addyi.

 

MaxCare Management Options

§  Addyi
 will be added to the MaxCare Standard Quantity Limit program to ensure appropriate billing. 

§  Default Coverage - Unless otherwise instructed, MaxCare will align Addyi coverage with your plan’s coverage of male sexual dysfunction medications (Viagra, Levitra, etc.).  Therefore, if your plan benefit design currently excludes the category of sexual dysfunction medications, Addyiwill also be excluded.  If your plan benefit design currently covers sexual dysfunction medications, Addyi will be covered.

 



[1] Addyi Prescribing Information.  Sprout Pharmaceuticals. Available online:

http://www.addyi.com/wp-content/uploads/2015/09/Addyi-PI-9-28-15.pdf.

[2]FDA approves first treatment for sexual desire disorder. FDA News Release.  Available online: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm458734.htm.

[3] Nappi, Rosella E, et al. Management of hypoactive sexual desire disorder in women: current and emerging therapies. Int J Womens Health. 2010; 2: 167–175. Available online:http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2971736/

[4] McNamee, David. Will 'the female Viagra' really help women? Medical News Today. June 2015. Available online: http://www.medicalnewstoday.com/articles/294903.php?page=2

[5] Schulte, Brigid. From 1952-2015: The path to “female Viagra” has been a rocky one.  Washington Post.  August 18, 2015. Available online:  https://www.washingtonpost.com/news/to-your-health/wp/2015/08/17/female-viagra-could-get-fda-approval-this-week/