Medical Policy: 05.01.33 

Original Effective Date: March 2011 

Reviewed: January 2018 



Benefit Application:

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.


Prior Approval:

Not applicable



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.


Procedure Codes and Billing Guidelines:

To report provider services, use appropriate CPT* codes, Modifiers, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or diagnosis codes.

  • J3490/J3590 unclassified drug


Selected References:

  • European AIDS Clinical Society Guidelines for Prevention and Management of Non-Infectious Co-Morbidities in HIV.
  • Egrifta. (2010, September). [package insert]. Rockland, MA, USA: Theratechnologies Inc.
  • Falutz, J., Alias, S., Blot, K., Potvin, D., Kotler, D., Somero, M., et al. (2007). Metabolic Effects of a Growth Hormone Releasing Factor in Patients with HIV. New England Journal of Medicine , 357, 2359-70.
  • Falutz, J., Potvin, D., Mamputu, J.-C., Assaad, H., Zoltowska, M., Michaud, S.-E., et al. (2010). Effect of Tesamorelin, a Growth Hormone-Releasing Factor, in HIV-Infected Patients with Abdominal Fat Accumulation: A Randomized Placebo-Controlled Trial with a Safety Extension. Journal of Acquired Immune Deficiency Syndrome , 53, 311-322.
  • Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents (2009, December 1) Department of Health and Human Services.
  • Finkelstein JL et al. (2015) HIV/AIDS and lipodystrophy: Implications for clinical management in resource-limited settings J. Int. AIDS Soc., 18:19033


Policy History:

  • January 2018 - Annual Review, Policy Renewed
  • January 2017 - Annual Review, Policy Renewed
  • January 2016 - Annual Review, Policy Renewed
  • February 2015 - Annual Review, Policy Renewed
  • March 2014 - Annual Review, Policy Renewed
  • March 2013 - Annual Review, Policy Renewed
  • February 2012 - Annual Review, Policy Renewed
  • March 2011 - Annual Review, Policy Renewed

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.