Subject: Testosterone - Depo-Testosterone TGC PA Policy 976-A 03-2021

Drug

TESTOSTERONE PRODUCTS - INJECTABLE

DEPO-TESTOSTERONE  (testosterone cypionate injection)

Policy:

FDA-approved Indications  
Depo-Testosterone Injection is indicated for replacement therapy in the male in conditions associated with symptoms of deficiency or absence of endogenous testosterone:
Primary hypogonadism (congenital or acquired) - testicular failure due to conditions such as cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, or orchiectomy.
Hypogonadotropic hypogonadism (congenital or acquired) - gonadotropin or LHRH deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation.

Limitations of Use
Safety and efficacy of Depo-Testosterone in men with “age-related hypogonadism” (also referred to as “late-onset hypogonadism”) have not been established.

Compendial Uses
Gender Dysphoria^{2-3, 6-8}

COVERAGE CRITERIA
The requested drug will be covered with prior authorization when the following criteria are met:

• The requested drug is NOT being prescribed for age-related hypogonadism

AND

• The requested drug is being prescribed for primary or hypogonadotropic hypogonadism
  AND
• Before the start of testosterone therapy, the patient has at least two confirmed low morning testosterone levels according to current practice guidelines or your standard lab reference values OR
  
• For continuation of testosterone therapy: before the patient started testosterone therap, the patient had a confirmed low morning testosterone level according to current practic guidelines or your standard lab reference values

OR

• The requested drug is being prescribed for gender dysphoria in a patient who is able to make an informed decision to engage in hormone therapy

Place of Service:

Outpatient

The above policy is based on the following references:

1. Depo-Testosterone [package insert]. New York, NY: Pharmacia and Upjohn Company; September 2018.
2. Lexicomp Online, AHFS DI (Adult and Pediatric) Online, Hudson, Ohio: UpToDate, Inc.; 2021; Accessed February 2, 2021.
3. Micromedex (electronic version). IBM Watson Health, Greenwood Village, Colorado, USA. Available at: https://www.micromedexsolutions.com. Accessed February 2, 2021.
4. Petak S, Nankin H, Spark R, et al. American Association of Clinical Endocrinologists Medical Guidelines for Clinical Practice for the Evaluation and Treatment of Hypogonadism in Adult Male Patients – 2002 update. Endocrine Practice 2002;8(6):439-456.
5. Bhasin S, Cunningham G, Hayes F, et al. Testosterone Therapy in Men with Hypogonadism: An Endocrine Society Clinical Practice Guideline. Journal of Clinical Endocrinology & Metabolism 2018;103(5):1715-1744.
6. Hembree WC, Cohen-Kettenis P, Delemarre-van de Waal HA, et al; Endocrine Society.  Endocrine Treatment of Gender Dysphoric/Gender-Incongruent Persons:  An Endocrine Society Clinical Practice Guideline.  Journal of Clinical Endocrinology & Metabolism 2017;102(11):3869-3903.
7. Knezevich EL, Viereck LK, Drincic AT.  Medical Management of Adult Transsexual Persons.  Pharmacotherapy.  2012;32(1):54-66.
8. Coleman E, Bockting W, Botzer M, et al. Standards of Care for the Health of Transsexual, Transgender, and Gender Nonconforming People. World Professional Association for Transgender Health. Last Updated 2012. Available at: https://www.wpath.org/media/cms/Documents/Web%20Transfer/SOC/Standards%20of%20Care%20V7%20-%202011%20WPATH.pdf. Accessed February 2020.

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.

August 09, 2021