Subject: Testosterone - Testosterone Enanthate TGC PA Policy 1368-A 03-2021

Drug

TESTOSTERONE PRODUCTS – INJECTABLE

DELATESTRYL  (testosterone enanthate injection)

XYOSTED  (testosterone enanthate injection)

Policy:

FDA-approved Indications          
Delatestryl
Males
Delatestryl (Testosterone Enanthate Injection) is indicated for replacement therapy in conditions associated with a deficiency or absence of endogenous testosterone.
Primary hypogonadism (congenital or acquired) - testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, or orchiectomy.
Hypogonadotropic hypogonadism (congenital or acquired) - gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation. (Appropriate adrenal cortical and thyroid hormone replacement therapy are still necessary, however, and are actually of primary importance).
If the above conditions occur prior to puberty, androgen replacement therapy will be needed during the adolescent years for development of secondary sexual characteristics. Prolonged androgen treatment will be required to maintain sexual characteristics in these and other males who develop testosterone deficiency after puberty.
Safety and efficacy of Delatestryl in men with “age-related hypogonadism” (also referred to as “late-onset hypogonadism”) have not been established.
Delayed puberty - Delatestryl (Testosterone Enanthate Injection) may be used to stimulate puberty in carefully selected males with clearly delayed puberty. These patients usually have a familial pattern of delayed puberty that is not secondary to a pathological disorder; puberty is expected to occur spontaneously at a relatively late date. Brief treatment with conservative doses may occasionally be justified in these patients if they do not respond to psychological support. The potential adverse effect on bone maturation should be discussed with the patient and parents prior to androgen administration. An X-ray of the hand and wrist to determine bone age should be obtained every six months to assess the effect of treatment on the epiphyseal centers.
Females
Metastatic Mammary Cancer - Delatestryl (Testosterone Enanthate Injection) may be used secondarily in women with advancing inoperable metastatic (skeletal) mammary cancer who are one to five years postmenopausal. Primary goals of therapy in these women include ablation of the ovaries. Other methods of counteracting estrogen activity are adrenalectomy, hypophysectomy, and/or anti-estrogen therapy. This treatment has also been used in pre-menopausal women with breast cancer who have benefited from oophorectomy and are considered to a have a hormone-responsive tumor. Judgment concerning androgen therapy should be made by an oncologist with expertise in this field.

Xyosted
Xyosted (testosterone enanthate) injection is an androgen indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone:
     •  Primary hypogonadism (congenital or acquired): testicular failure due to cryptorchidism,
         bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter’s syndrome,
         chemotherapy, or toxic damage from alcohol or heavy metals.  These men usually have low
         serum testosterone concentrations and gonadotropins (follicle-stimulating hormone [FSH],
         luteinizing hormone [LH]) above the normal range.
     •  Hypogonadotropic hypogonadism (congenital or acquired):  gonadotropin or luteinizing
         hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors,
         trauma, or radiation.  These men have low testosterone serum concentrations but have
         gonadotropins in the low or normal range.

Limitations of Use
     •   Safety and efficacy of Xyosted in males less than 18 years of age have not been established.

Compendial Uses
Gender Dysphoria^4,7-9

 
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
            ο    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
            ο    For continuation of testosterone therapy:  before the patient started testosterone
                  therapy, the patient had a confirmed low morning testosterone level according to
                  current practice 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
        OR
        •   Testosterone enanthate injection (generic Delatestryl) is being prescribed for inoperable
             metastatic breast cancer in a patient who is 1 to 5 years postmenopausal AND the patient
             had an incomplete response to other therapy for metastatic breast cancer
        OR
        •   Testosterone enanthate injection (generic Delatestryl) is being prescribed for a pre-
             menopausal patient with breast cancer who has benefited from oophorectomy and is
             considered to have a hormone-responsive tumor
        OR
        •   Testosterone enanthate injection (generic Delatestryl) is being prescribed for delayed
             puberty

Place of Service:

Outpatient

The above policy is based on the following references:

References

1. Delatestryl [package insert]. Malvern, PA: Endo Pharmaceuticals Solutions Inc.; October 2016.
2. Xyosted [package insert]. Ewing, NJ: Antares Pharma, Inc; November 2019.
3. Lexicomp Online, AHFS DI (Adult and Pediatric) Online, Hudson, Ohio: UpToDate, Inc.; 2021; Accessed February 2, 2021.
4. Micromedex (electronic version). IBM Watson Health, Greenwood Village, Colorado, USA. Available at: https://www.micromedexsolutions.com. Accessed February 2, 2021
5. 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.
6. 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.
7. 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.
8. Knezevich EL, Viereck LK, Drincic AT. Medical Management of Adult Transsexual Persons.  Pharmacotherapy.  2012;32(1):54-66.
9. 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 2021.

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 06, 2021