Prior Auth Protocol

FDA Approved Indications:

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:

A co-existing medical or psychiatric condition,
Problems within the relationship, or
The effects of a medication or other drug substance.

Health Net Approved Indications and Usage Guidelines:

Diagnosis of HSDD in premenopausal women

Coverage is Not Authorized For:

Non-FDA approved indications, which are not listed in the Health Net Approved Indications and Usage Guidelines section, unless there is sufficient documentation of efficacy and safety in the published literature.

General Information:

Severe hypotension and syncope can occur when Addyi is used with moderate or strong CYP3A4 inhibitors or in patients with hepatic impairment and use in these settings is contraindicated.
Use of Addyi and alcohol is contraindicated due to an increased risk of severe hypotension and syncope.
HSDD is characterized by a deficiency or absence of sexual fantasies and desire for sexual activity which causes marked distress or interpersonal difficulty, and is not better accounted for by another psychiatric disorder or due exclusively to the direct physiological effects of a substance or to the direct physiological effects of another medical condition. HSDD does not encompass normal (e.g. daily or weekly) fluctuations in levels of desire.
There is currently no published data demonstrating the efficacy of Addyi in the treatment of HSDD in postmenopausal women or in men.

Therapeutic Alternatives:

Drug	Dosing Regimen	Dose Limit/ Maximum Dose
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* Requires Prior Authorization

Recommended Dosing Regimen and Authorization Limit:

Drug	Dosing Regimen	Authorization Limit
Addyi	100 mg PO QD	8 week initial trial and treatment should be discontinued after 8 weeks if there is no improvement. Continued treatment will be approved for length of benefit.

Product Availability:

Addyi: 100 mg tablets

References:

1. Addyi [Prescribing Information]. Raleigh, NC: Sprout Pharmaceuticals, Inc; August 2015

2. Elsevier. (2015, 08 28). Clinical Pharmacology: Monographs. Retrieved 09 08, 2015, from Clinical Pharmacology: http://www.clinicalpharmacology-ip.com/Forms/Monograph/monograph.aspx?cpnum=4706&sec=mondesc&t=0

3. FDA. (2015). FDA Briefing Document. Joint Meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee (BRUDAC) and the Drug Safety and Risk Management (DSaRM) Advisory Committee. Silver Spring, MD: Department of Health and Human Services.