Prior Auth Protocol

FDA Approved Indications:

For symptomatic relief of non-infectious diarrhea in adult patients with HIV/AIDS on anti-retroviral therapy.

Health Net Approved Indications and Usage Guidelines:

Diagnosis of non-infectious diarrhea in patients with HIV/AIDS

AND

Failure or clinically significant adverse effects to loperamide or diphenoxylate/atropine

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:

In a 12 week double blind placebo controlled trial evaluating 3 doses (125 mg, 250 mg, 500 mg BID) of Fulyzaq in 242 patients with diarrhea predominant irritable bowel syndrome, Fulyzaq did not produce significant improvement in stool consistency, the primary endpoint.

Therapeutic Alternatives:

Drug	Dosing Regimen	Dose Limit/ Maximum Dose
loperamide (Imodium^R) (Coverage of OTC agents may vary with plan formulary and benefit design)	2 mg PO after each loose stool	16 mg/day
diphenoxylate/atropine (Lomotil^R)	2 tablets (5-0.05 mg) PO QID	20 mg/day (diphenoxylate)

* Requires Prior Authorization

Recommended Dosing Regimen and Authorization Limit:

Drug	Dosing Regimen	Authorization Limit
Fulyzaq	125 mg PO BID with or without food	Length of Benefit

Product Availability:

Tablets: 125 mg

References:

1. Fulyzaq [Prescribing Information] Raleigh, NC: Salix Pharmaceuticals; February 2013.

2. Mangel AW, Chaturvedi P. Evaluation of crofelemer in the treatment of diarrhea-predominant irritable bowel syndrome patients. Digestion 2008;78(4):180-186.

3. Clinical Pharmacology Web site. Available at: http://cpip.gsm.com/. Accessed June 21, 2015

4. Micromedex^R Healthcare Series [Internet database]. Greenwood Village, Colo: Thomson Healthcare. Updated periodically. Accessed June 21, 2015