Medical Policy: 05.01.33 

Original Effective Date: March 2011 

Reviewed: April 2020 

Revised: January 2020 

 

Notice:

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 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.

 

Description:

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.

 

Clinical Rationale

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:

  • Long-term cardiovascular safety of Egrifta has not been established. Consider risk/benefit of continuation of treatment in patients who have not had a reduction in visceral adipose tissue.
  • Egrifta is not indicated for weight loss management as it has a weight neutral effect.
  • There are no data to support improved compliance with anti-retroviral therapies in HIV-positive patients taking Egrifta.

 

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.

 

Prior Approval:

Not applicable

 

Policy:

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.

 

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. Prevention and management of non-infectious co-morbidities in HIV. Accessed January 2020
  • European AIDS Clinical Society. European guidelines: prevention and management of metabolic diseases panel members Accessed January 2020.
  • Egrifta (tesamorelin) [prescribing information]. Montreal, Quebec, Canada: Theratechnologies; July 2019
  • Egrifta SV (tesamorelin) [prescribing information]. Montreal, Quebec, Canada: Theratechnologies; October 2019.
  • Falutz, J., Alias, S., Blot, K., Potvin, D., Kotler, D., Somero, M., et al. Metabolic Effects of a Growth Hormone Releasing Factor in Patients with HIV. New England Journal of Medicine. 2007; 357(23); 2359-2370.
  • Falutz J, Allas S, 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(14):1719-1728.
  • Falutz, J., Potvin, D., Mamputu, J.-C., Assaad, H., Zoltowska, M., Michaud, S.-E., et al. 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. 2010;53(3); 311-322.
  • Department of Health and Human Services. National Institutes of Health. Office of AIDS Research Advisory Council. Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. January 10, 2011;1-166. Accessed January 2020.
  • Finkelstein JL et al. (2015) HIV/AIDS and lipodystrophy: Implications for clinical management in resource-limited settings J. Int. AIDS Soc., 18:19033 
  • Chen D, Misra A, Garg A. Lipodystrophy in Human Immunodeficiency Virus-Infected Patients. J Clin Endocrinol Metab 2002;87(11):4845-4856.
  • Lundgren JD, Battegay M, Behrens G, et al. European AIDS Clinical Society (EACS) guidelines on the prevention and management of metabolic diseases in HIV. HIV Med 2008;9(2):72-81.
  • Stanley TL, Falutz J, et al. Reduction in visceral adiposity is associated with an improved metabolic profile in HIV-infected patients receiving tesamorelin. Clin Infect Dis. 2012 Jun;54(11):1642-51.
  • Stanley TL, Feldpausch MN, Oh J, et al. Effect of tesamorelin on visceral fat and liver fat in HIV-infected patients with abdominal fat accumulation: a randomized clinical trial. JAMA. 2014 Jul 23-30;312(4):380-9 Accessed January 2020.

 

Policy History:

  • April 2020 - Annual Review, Policy Renewed
  • January 2020 - Annual Review, Policy Revised
  • January 2019 - Annual Review, Policy Renewed
  • 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.