Medical Policy: 05.01.33
Original Effective Date: March 2011
Reviewed: January 2017
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 once daily self-administered subcutaneous injection. This drug 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. 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.
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.
The use of injectable tesamorelin (EGRIFTA ™) is considered not medically necessary for all applications because it lacks sustainable clinical efficacy and the potential risks do not outweigh the potential benefits.
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.
*CPT® is a registered trademark of the American Medical Association.