Medical Policy: 05.01.33
Original Effective Date: March 2011
Reviewed: April 2020
Revised: January 2020
This policy contains information which is clinical in nature. The policy is not medical advice. The information in this policy is used by Wellmark to make determinations whether medical treatment is covered under the terms of a Wellmark member's health benefit plan. Physicians and other health care providers are responsible for medical advice and treatment. If you have specific health care needs, you should consult an appropriate health care professional. If you would like to request an accessible version of this document, please contact customer service at 800-524-9242.
Benefit determinations are based on the applicable contract language in effect at the time the services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary based on contract, and individual member benefits must be verified. Wellmark determines medical necessity only if the benefit exists and no contract exclusions are applicable. This medical policy may not apply to FEP. Benefits are determined by the Federal Employee Program.
This Medical Policy document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy will be reviewed regularly and be updated as scientific and medical literature becomes available.
Egrifta is a growth hormone releasing factor (GRF) analog indicated for the reduction of excess abdominal fat in HIV-infected patients with lipodystrophy by a once daily self-administered subcutaneous injection. Although Egrifta is FDA-approved for the reduction of excess abdominal fat in HIV-infected patients with lipodystrophy, long-term cardiovascular safety and clinical benefit has not been established.
Lipodystrophy, or fat redistribution, is defined as an abnormal production, use, or storage of fat in the body. It is not known whether the virus, the drugs used to treat the virus, or genetics is the exact cause of lipodystrophy in HIV infected patients. Egrifta is highly specific for reducing visceral fat in the abdomens of HIV infected patients and has been shown to spare subcutaneous adipose tissue. Chronic treatment is needed to maintain the reduction in visceral fat. In addition to being cosmetically disfiguring, HIV lipodystrophy syndrome is associated with metabolic disorders including hyperlipidemia, insulin resistance, hyperinsulinemia, and hyperglycemia.
Egrifta was studied in two double-blinded, multicenter, randomized placebo-controlled trials that showed a decrease in abdominal fat, but the effects were modest and not sustained upon discontinuation of the drug. The most common adverse events seen with Egrifta treatment in clinical trials were hypersensitivity reactions, arthralgia, peripheral edema, hyperglycemia, and injection site reactions. Egrifta also poses serious potential safety concerns such as increased risk of malignancies and diabetes, which need to be further investigated. The European AIDS Clinical Society Guidelines concluded that pharmacological options for the management of lipodystrophy have not proven long-term effects and may cause new complications for patients.
Although Egrifta is FDA-approved for the reduction of excess abdominal fat in HIV-infected patients with lipodystrophy, a clinical benefit has not been established. The FDA prescribing information lists the following limitations of use:
Non-pharmacological options for treating excess abdominal fat in HIV-infected patients with lipodystrophy include diet/exercise modification and surgical removal. These options are comparably safer and more likely to produce sustainable results compared to Egrifta.
The use of injectable tesamorelin (Egrifta and Egrifta SV) is considered cosmetic for the treatment of HIV-infected patients with lipodystrophy due to reducing excess abdominal fat without long-term cardiovascular safety data or any other evidence showing a benefit on health outcomes or sustainable clinical efficacy. All other uses are investigational.
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Wellmark medical policies address the complex issue of technology assessment of new and emerging treatments, devices, drugs, etc. They are developed to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. Wellmark medical policies contain only a partial, general description of plan or program benefits and do not constitute a contract. Wellmark does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Wellmark or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. Our medical policies may be updated and therefore are subject to change without notice.
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