Prior Auth Protocol

FDA Approved Indications:

Myalept is a leptin analog indicated as an adjunct to diet as replacement therapy to treat the complications of leptin deficiency in patients with congenital or acquired generalized lipodystrophy.

Health Net Approved Indications and Usage Guidelines:

Diagnosis of complications of leptin deficiency in patients with congenital or acquired generalized lipodystrophy dystrophy

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 obesity not associated with congenital leptin deficiency.

General Information:

Myalept has not been shown to be effective in treating general obesity, and the development of anti-metreleptin antibodies with neutralizing activity has been reported in obese patients treated with Myalept. Consequences could include inhibition of endogenous leptin activity and loss of Myalept efficacy. Worsening metabolic control and/or severe infection have been reported.
The safety and effectiveness of Myalept for the treatment of complications of partial lipodystrophy and treatment of liver disease (including nonalcoholic steatohepatitis) have not been established.
Myalept is not indicated for use in patients with the following: Human Immunodeficiency Virus (HIV)-related lipodystrophy and metabolic disease (without concurrent evidence of generalized lipodystrophy).
Myalept is only available through a restricted program called the Myalept Risk Evaluation and Mitigation Strategy (REMS) Program. For more information, call 1-855-6MYALEPT or go to www.myaleptrems.com.

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
Myalept	Body weight ≤ 40 kg: 0.06 mg/kg/day SC, increase or decrease by 0.02 mg/kg to a max of 0.13 mg/kg/day Males > 40 kg: 2.5 mg/day SC, increase or decrease by 1.25-2.5 mg/day, max of 10 mg/day Females > 40 kg: 5 mg/day SC, increase or decrease by 1.25-2.5 mg/day, max of 10 mg/day	Length of Benefit

Product Availability:

Vial: 11.3 mg metreleptin per vial

References:

Myalept [Prescribing Information]. San Diego, CA: Amylin Pharmaceuticals; February 2014.
Myalept (systemic). In: DrugPoints^R System [Internet database]. Greenwood Village, Colo: Thomson Healthcare. Updated periodically. Accessed June 1, 2015.