Prior Auth Protocol

FDA Approved Indications:

For the reduction of excess abdominal fat in HIV-infected patients with lipodystrophy

Health Net Approved Indications and Usage Guidelines:

Diagnosis of excess abdominal fat in HIV- infected patients with lipodystrophy of the abdomen.

AND

Waist circumference ≥95 cm in men and ≥94 cm in women and waist-to-hip ratio ≥0.94 for males and ≥0.88 for females)

AND

Currently on highly active antiretroviral therapy (HAART)

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:

Studies have established the efficacy of Egrifta in reducing percent visceral adipose tissue (VAT) -20 (95%CI -24,-15) in one study and -12 (95%CI -16,-7) in another. Studies also show that Egrifta is effective in reducing waist circumference and improving lipid profiles. These effects are sustained during treatment but have not been shown to last upon discontinuation of treatment. The drug was well tolerated although long term safety and efficacy data beyond 1 year are not available yet.
Studies show that visceral adipose tissue is associated with cardiovascular disease and an increase in all-cause mortality.
Treatment response can be defined as reduction from baseline of VAT by ≥ 10.3% as measured by CT or MRI or a reduction in waist circumference of ≥1.4 cm. Treatment should be discontinued if patient has no response at 6 months.
Clinical trial average VAT reduction from baseline at 26 weeks showed 10.9% in the treatment arm and 0.6% in the placebo arm. Requirement of VAT reduction from baseline of ≥ 10.3% resulted from the difference between the two study arms in average VAT reduction.
Clinical trial average waist circumference (WC) reduction from baseline at 26 weeks showed 2.1% in the treatment arm and 0.9% in the placebo arm. Requirement of WC reduction from baseline of ≥1.4cm resulted from the difference between the two study arms in average WC reduction.

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
Egrifta	2mg SC once daily in the abdomen; rotate abdominal injection sites	HNCA: 6 months or to member’s renewal date, whichever is longer NATL: 6 months initial trial Continued treatment of 2 mg SC once daily in the abdomen will be approved for length of benefit upon written documentation of reduction of VAT by ≥ 10% (as measured by CT or MRI) or a reduction in waist circumference of ≥1 cm compared to baseline.

Product Availability:

Subcutaneous Powder for Solution: 1 mg, 2 mg

References:

1. Egrifta [package insert]. Rockland, MA: EMD Serono, Inc.; December 2014.
2. Falutz J, Allas S, Kotler D, et al. A placebo-controlled, dose-ranging study of a growth hormone releasing factor in HIV-infected patients with abdominal fat accumulation.AIDS. 2005; 19(12):1279. Web.08 Oct.2015.
3. Falutz J, Allas S, Blot K, et al.Metabolic Effects of a Growth Hormone-Releasing Factor in Patients with HIV. N Engl J Med. 2007; 357(23):2359.Web.08 Oct.2015.
4. Falutz J, Potvin D, Mamputu JC, et al. Effects of Tesamorelin, a Growth Hormone-Releasing Factor, in HIV-Infected Patients With Abdominal Fat Accumulation: A Randomized Placebo Controlled Trial With a Safety Extension. J Acquir Immune Defic Syndr. 2010; 53(3):311. Web.08 Oct.2015.
5. Falutz J, AllasS, Mamputu JC, et al. Long-term safety and effects of tesamorelin, a growth hormone-releasing factor analogue, in HIV patients with abdominal fat accumulation. AIDS.2008; 22:1719-1728. Web. 10 Oct. 2015.
6. Epidemiology, clinical manifestations, and diagnosis of HIV-associated lipodystrophy In:UpToDate,Post,TW(Ed),UpToDate, Waltham,MA,2015.
7. Scherzer R, Heymsfield SB, Lee D, etal. Decreased limb muscle and increased central adiposity are associated with 5-year all-cause mortality in HIV infection. AIDS.2011 July 17;25(11):1405-1414. Web. 08 Oct.2015.
8. Britton KA, Massaro JM, Murabito JM, et al. Body Fat Distribution, Incident Cardiovascular Disease, Cancer, and All-cause Mortality. J Am Coll Cardiol. 2013 September 3;62(10):921-925.Web 08. Oct. 2015.