Subject: Serostim 1870-A SGM P2022

Drug

SEROSTIM  (somatropin)

Policy:

I.    INDICATIONS

The indications below including FDA-approved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy. 

FDA-Approved Indication
Serostim is indicated for the treatment of human immunodeficiency virus (HIV) patients with wasting or cachexia to increase lean body mass and body weight, and improve physical endurance. Concomitant antiretroviral therapy is necessary.

All other indications are considered experimental/investigational and not medically necessary. 

II.  CRITERIA FOR INITIAL APPROVAL 

Treatment of HIV patients with wasting or cachexia to increase lean body mass and body weight, and improve physical endurance
Authorization of 12 weeks may be granted for treatment of HIV-associated wasting/cachexia when all of the following criteria are met:
A.   Member is currently on antiretroviral therapy
B.   Trial with suboptimal response to alternative therapies (See Appendix A) or contraindication or intolerance to
      alternative therapies
C.   Body mass index (BMI) was less than 18.5 kg/m² prior to initiating therapy with Serostim (See Appendix B)

III. CONTINUATION OF THERAPY 

Treatment of HIV patients with wasting or cachexia to increase lean body mass and body weight, and improve physical endurance
Authorization of 12 weeks may be granted for continued treatment in members requesting reauthorization for treatment of HIV-associated wasting/cachexia when all of the following criteria are met:
A.   Member is currently on antiretroviral therapy
B.   Member is currently receiving treatment with Serostim excluding obtainment as samples or via manufacturer’s
      patient assistance programs
C.   Current BMI is less than 27 kg/m² (See Appendix B)

Special Notes:

IV. APPENDICES
      Appendix A – Alternative therapies for HIV Wasting
      o   Cyproheptadine
      o   Marinol (dronabinol)
      o   Megace (megestrol acetate)
      o   Testosterone therapy if hypogonadal

      Appendix B – Calculation of BMI
            Weight (pounds) x 703               Weight (kg)
BMI =   -------------------------------   OR     -----------------
            [Height (inches)]2                       [Height (m)]2

BMI classification:        Underweight                             < 18.5 kg/m²
                                    Normal weight                          18.5 – 24.9 kg/m²
                                    Overweight                               25 – 29.9 kg/m²
                                    Obesity (class 1)                       30 – 34.9 kg/m²
                                    Obesity (class 2)                       35 – 39.9 kg/m²
                                    Extreme obesity (class 3)           ≥ 40 kg/m₂

 

Place of Service:

Outpatient

The above policy is based on the following references:

1. Serostim [package insert]. Rockland, MA: EMD Serono, Inc.; June 2019.
2. Mangili A, Murman H, Zampini AM, et al. Nutrition and HIV infection: review of weight loss and wasting in the era of highly active antiretroviral therapy from the nutrition for healthy living cohort. Clin Infect Dis. 2006;42:836-42.
3. Grinspoon S, Mulligan K for the Department of Health and Human Services Working Group on the Prevention and Treatment of Wasting and Weight Loss. Weight loss and wasting in patients infected with human immunodeficiency virus. Clin Infect Dis. 2003;36(Suppl 2):S69-78.
4. Polsky B, Kotler D, Steinhart C. HIV-associated wasting in the HAART era: guidelines for assessment, diagnosis, and treatment. AIDS Patient Care STDS. 2001;15(8):411-23.
5. Schambelan M, Mulligan K, Grunfeld C, et al. Recombinant human growth hormone in patients with HIV-associated wasting: a randomized placebo-controlled trial. Ann Intern Med. 1996;125:873-882.
6. Evans WJ, Kotler DP, Staszewski S, et al. Effect of recombinant human growth hormone on exercise capacity in patients with HIV-associated wasting on HAART. AIDS Read. 2005;15:301-314.
7. Nemechek PM, Polsky B, Gottlieb MS. Treatment guidelines for HIV-associated wasting. Mayo Clin Proc. 2000;75:386-394.
8. National Heart, Lung, and Blood Institute. Obesity Education Initiative: The practical guide: identification, evaluation, and treatment of overweight and obesity in adults. Bethesda, MD: US Department of Health and Human Services, National Heart, Lung, and Blood Institute; 2000. NIH Publication No. 00-4084.

Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna 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 Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.

April 17, 2022