Medication Policy Manual. Date of Origin: April 13, Topic: Testosterone cypionate, testosterone enanthate

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1 Medication Policy Manual Topic: Testosterone cypionate, testosterone enanthate Policy No: dru395 Date of Origin: April 13, 2015 Committee Approval Date: December 11, 2015 Next Review Date: April 2016 Effective Date: January 1, 2016 IMPORTANT REMINDER This Medication Policy has been developed through consideration of medical necessity, generally accepted standards of medical practice, and review of medical literature and government approval status. Benefit determinations should be based in all cases on the applicable contract language. To the extent there are any conflicts between these guidelines and the contract language, the contract language will control. The purpose of medication policy is to provide a guide to coverage. Medication Policy is not intended to dictate to providers how to practice medicine. Providers are expected to exercise their medical judgment in providing the most appropriate care. Description Testosterone replacement therapy (TRT) products are used in the treatment of hypogonadism (testosterone deficiency). The effectiveness of TRT is monitored by assessing serum testosterone levels, as well as improvement in sexual function, mood, fatigue, bone mineral density, and well-being. Dru395.2 Page 1 of 9

2 Policy/Criteria I. Most contracts require prior authorization approval of testosterone cypionate and testosterone enanthate prior to coverage. Testosterone cypionate and testosterone enanthate may be considered medically necessary when criteria A, B, C, or D below are met. A. A diagnosis of primary (Testicular) hypogonadism or secondary (Pituitary-Hypothalamic) hypogonadism caused by a condition listed in appendix 3 when documentation of at least two low testosterone levels (less than 300 ng/dl for total testosterone, or less than 9 ng/dl for free testosterone) drawn prior to 10 AM on two separate days is provided. OR B. As a continuous therapy for gender dysphoria when all of the following criteria are met: a. Clinical records document that the patient has the capacity to make fully informed decisions and consent for treatment. AND b. A licensed behavioral health practitioner has diagnosed gender dysphoria as defined by the DSM-5 criteria. AND c. At least one of the following criteria must be met for a period of 3 or more months prior to the initiation of hormone therapy i. Documentation of living as the desired gender; and/or ii. Psychotherapy with a licensed behavioral practitioner. OR C. To induce puberty in males with delayed puberty. OR D. Used secondarily in women with inoperable, metastatic breast cancer who are 1 to 5 years postmenopausal (testosterone enanthate only). II. Administration and Authorization Period A. OmedaRx considers testosterone cypionate and testosterone enanthate to be selfadministered medications or provider-administered products. B. Authorization shall be reviewed in the timeframes defined below: 1. Primary (Testicular) hypogonadism/secondary (Pituitary- Hypothalamic) hypogonadism: Authorization shall be reviewed after 6 months, and then at least annually to assure the testosterone level does not exceed 700 ng/dl (See Appendix 2, Lab Monitoring Guidelines for TRT Products). For patients with a testosterone level exceeding 700 ng/dl, ongoing coverage of testosterone replacement therapy will be authorized only when there is clinical documentation that the TRT dose will be adjusted for a goal level of less than 700 ng/dl. Dru395.2 Page 2 of 9

3 2. Gender reassignment therapy, induction of puberty, and metastatic breast cancer: authorization may be reviewed at least annually to confirm that current medical necessity criteria are met and that the medication is effective. III. Testosterone cypionate and testosterone enanthate are considered not medically necessary for the following: A. Age-related hypogonadism B. Low libido in women C. Weight gain in HIV-infected men Position Statement - Testosterone replacement therapy (TRT) is commonly used for treatment of hypogonadism in men and as part of gender reassignment therapy. All products are considered effective for increasing serum testosterone levels. [1] - There is no evidence demonstrating that any one TRT product is safer or more effective than less costly generic injectable options. There are no studies that directly compare the clinical effects of different TRT products. - Hypogonadism may be caused either by failure of the testicles to produce testosterone (primary), or by central defects in the hypothalamus or pituitary gland which lead to secondary testicular failure. - A diagnosis of hypogonadism is confirmed by measuring serum testosterone levels. [2] - Testosterone levels vary throughout the day and are highest in the morning. Normal ranges for serum testosterone levels are usually established using morning blood samples. [2] - Threshold testosterone levels below which adverse health symptoms occur are not known. Likewise, optimal levels of testosterone at which TRT improves outcomes are not known. For most symptoms in younger men, the average testosterone threshold corresponds to the lower limit of the normal range. [2] - Because testosterone levels vary significantly due to body rhythms, episodic secretion, and measurement variations, at least two levels should be obtained to confirm a diagnosis of hypogonadism. [2] - Normal ranges for testosterone vary among laboratories and assays. The Endocrine Society recommends that a lower limit for normal testosterone levels is 300 ng/dl for total testosterone and 9.0 ng/dl for free testosterone. [2] - The Endocrine Society Clinical Guideline recommends evaluating patients 3 to 6 months after initiating treatment to evaluate patients for side effects and to make sure total testosterone levels are between 400 ng/dl and 700 ng/dl. [2] - In March 2015, the FDA released a drug safety communication clarifying that the efficacy and safety of TRT have not been established for the treatment of low testosterone levels due to aging, even if a man s symptoms seem related to low Dru395.2 Page 3 of 9

4 testosterone. The communication also stated that there is a possible increased cardiovascular risk associated with testosterone use. [3] - Since the initial drug safety communication, a limitation of use has been added to the prescribing information for multiple testosterone replacement products. The updated labeling states that safety and efficacy has not been established for age-related hypogonadism (also referred to as late-onset hypogonadism). - Primary or Secondary hypogonadism not otherwise specified (NOS), including agerelated hypogonadism, is not a covered indication. For hypogonadism, testosterone replacement may be considered medically necessary when low testosterone levels are due to a documented medical cause as listed in Appendix 3. - Low-dose testosterone therapy is a standard treatment option for the management of delayed puberty in boys. Goals of therapy include the induction of secondary sexual characteristics or growth and the mitigation of psychosocial difficulties. [4] - Testosterone enanthate may be used secondarily in women with advancing inoperable metastatic breast cancer who are one to five years postmenopausal. Although testosterone enanthate is FDA-approved for this indication, newer, targeted therapies have largely replaced its use in this setting. [5] - Overall, TRT products are well tolerated. - TRT should not be started in men who are at high risk for, or who have, prostate cancer. Clinical Efficacy No single testosterone replacement therapy (TRT) product has been proven in reliable clinical studies to be more effective than another TRT product. - All TRT products appear to be similarly effective based on pharmacokinetic data. There is pharmacokinetic evidence that all topical testosterone products replete testosterone levels in men with hypogonadism. [6-16] - The FDA accepts open-label, non-comparative trials of new TRT formulations as sufficient to provide evidence of safety and efficacy. More clinically relevant endpoints would be trials with validated disease outcome measures, showing meaningful improvements in symptoms, such as low mood, sexual function, lean muscle mass, and energy levels. [1] - There are no trials comparing any branded TRT formulation, therefore there is no evidence that one branded TRT product is superior to another. - Long-term health outcomes of TRT, such as decreased incidence of fracture or cardiovascular risk, are uncertain. [1,3] - Clinical guidelines recognize TRT as standard of care and effective for treatment of hypogonadism in men. All products are considered effective in raising testosterone levels. Choice of TRT product is based on pharmacokinetics, patient preference, and cost. However, oral TRT is not recommended due to poor absorption and liver toxicity. [9,10] - The efficacy of TRT has not been established in men with age-related hypogonadism. [17] - There are no valid, reliable, clinically relevant endpoints for studies assessing the effect of testosterone on desire, frequency of sexual activity, erectile function, mood, energy, Dru395.2 Page 4 of 9

5 overall quality of life, body composition (lean and fat body mass), and bone mineral density in men with age-related hypogonadism. [1] Safety [6-16] - Overall, TRT is well tolerated. Common adverse effects ( 3%) include acne, gynecomastia, oral irritation (buccal formulation), headache, and enlarged prostate. [1] - TRT may be associated with increased risk of adverse cardiovascular outcomes (increased mortality, myocardial infarction, and stroke). Although findings in several large observational studies and meta-analyses are inconsistent, the FDA s Bone, Reproductive and Urologic Drugs Advisory Committee concluded that there is a small signal of risk. Based on these conclusions, the FDA subsequently released a drug safety communication related to the CV risk and has required labeling changes for all prescription testosterone products. [1,3,18-20] - TRT is contraindicated in men with known or suspected prostate cancer. - In 2009, the FDA issued a MedWatch safety alert of inadvertent (secondary) testosterone exposure with topical testosterone gel (Testim and AndroGel), based on eight case reports of exposure in children, age nine months to five years old. Signs of virilization (development of male secondary sexual characteristics) and bone aging were observed. Black box warnings are now required on all topical gel and solution formulations of testosterone, as well as educational REMS programs to reduce secondary exposure. [21] Appendix 1: Branded Testosterone Replacement Therapy (TRT) Products Topical testosterone topical solution 2% (Axiron ) testosterone topical gel 1% and 1.62% (AndroGel and AndroGel Pump ) testosterone topical gel 2% (Fortesta ) testosterone topical gel 1% (Testim Gel ) testosterone topical gel 1% (Vogelxo ) testosterone transdermal patch 2-4 mg/24 hours (Androderm ) Oral/Buccal methyltestosterone 10 mg capsule (Android, Testred ) methyltestosterone 10 mg capsule (Methitest ) testosterone 30 mg extended-release buccal tablets (Striant ) Injectable testosterone undecanoate injection (Aveed ) Dru395.2 Page 5 of 9

6 Appendix 1: Branded Testosterone Replacement Therapy (TRT) Products Nasal gel testosterone nasal gel 4.5% (Natesto ) Subcutaneous Pellet testosterone pellets 75 mg (Testopel ) Appendix 2: Lab Monitoring Guidelines for TRT Products Transdermal patches Androderm Measure morning testosterone (following application of the patch the previous evening) Transdermal gels and solutions AndroGel, AndroGel Pump, Testim Fortesta Axiron Vogelxo Measure pre-dose morning testosterone level Measure testosterone 2 hours after application Measure testosterone 2 to 8 hours after application Measure testosterone 4 to 8 hours after application Subcutaneous pellet Testopel Measure pre-dose level and periodically during therapy Buccal tablet Striant Measure pre-dose morning testosterone level Nasal gel Natesto Measure pre-dose level Injectable Aveed testosterone cypionate (generics) testosterone enanthate (generics) Measure pre-dose level and periodically during therapy Measure pre-dose level and periodically during therapy Measure pre-dose level and periodically during therapy Dru395.2 Page 6 of 9

7 Appendix 3: Causes of Primary (Testicular) and Secondary (Pituitary-Hypothalamic) hypogonadism Primary (Testicular) Hypogonadism due to testicular dysfunction, including but not limited to the following conditions: a Bilateral Torsion Cryptorchidism Disorders of androgen biosynthesis Klinefelter s syndrome or other chromosomal abnormalities Myotonic dystrophy Orchitis Toxic damage from chemotherapy, alcohol, or heavy metals Trauma to the testicles Vanishing testis syndrome Varicocele Secondary (Pituitary-Hypothalamic) hypogonadism due to pituitary-hypothalamic dysfunction, including but not limited to the following conditions Congenital GnRH deficiency Hyperprolactinemia Idiopathic gonadotropic or luteinizing hormone-releasing hormone deficiency Kallman Syndrome Pituitary-hypothalamic dysfunction (not otherwise specified) Pituitary-hypothalamic injury from tumors, trauma, or radiation a Primary (Testicular) or Secondary (Pituitary-Hypothalamic) Hypogonadism (not otherwise specified, including age-related) is not a covered indication. Dru395.2 Page 7 of 9

8 Cross References Testosterone Replacement Therapies, BlueCross BlueShield Association Medical Policy, , Issue 12:2014 Transgender Services, Medical Policy. Medicine, Policy No Preferred transdermal testosterone replacement therapy products (AndroGel, AndroGel Pump ), Medication Policy Manual, Policy No. dru411 Non-preferred transdermal testosterone products, Medication Policy Manual, Policy No. dru415 Non-preferred testosterone replacement products, Medication Policy Manual, Policy No. dru297 Codes Number Description HCPCS J1070 testosterone cypionate, 100mg HCPCS J1071 testosterone cypionate, 1mg HCPCS J1080 testosterone cypionate, 200mg HCPCS J3120 testosterone enanthate, 100 MG HCPCS J3121 testosterone enanthate, 1mg HCPCS J3130 testosterone enanthate, 100 MG References 1. U.S. Food and Drug Administration. FDA Briefing Information for the September 17, 2014 Joint Meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee Meeting. [cited 11/7/2014]; Available from: roductivehealthdrugsadvisorycommittee/ucm pdf. 2. Bhasin, S, Cunningham, GR, Hayes, FJ, et al. Testosterone therapy in men with androgen deficiency syndromes: an Endocrine Society clinical practice guideline. The Journal of clinical endocrinology and metabolism. 2010;95: PMID: U.S. Food and Drug Administration. Summary Minutes of the Joint Meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee. [cited 11/7/2014]; Available from: roductivehealthdrugsadvisorycommittee/ucm pdf. 4. Palmert, MR, Dunkel, L. Clinical practice. Delayed puberty. The New England journal of medicine Feb 2;366(5): PMID: Ellis, M, Naughton, MJ, Ma, CX. Treatment approach to metastatic hormone receptorpositive breast cancer: Endocrine therapy. In: UpToDate, Basow, DS (Ed). UpToDate, Waltham, MA, Androderm [package insert]. Parsippany, NJ: Watson Pharma; April Androgel 1% [package insert]. North Chicago, IL: Abbvie; November Androgel 1.62% [package insert]. North Chicago, IL: Abbvie; November Aveed [package insert]. Malvern, PA: Endo Pharmaceuticals; September Axiron [package insert]. Indianapolis, IN: Eli Lilly and Company; June 2014 Dru395.2 Page 8 of 9

9 11. Fortesta [package insert]. Malvern, PA: Endo Pharmaceuticals; June Natesto [package insert]. Malvern, PA: Endo Pharmaceuticals; November Testim [package insert]. Chesterbrook, PA: Auxilium Pharmaceuticals; June Testopel [package insert]. Chesterbrook, PA: Auxilium Pharmaceuticals; January Vogelxo [package insert]. Maple Grove, MN: Upsher-Smith Laboratories; June Striant [package insert]. Chesterbrook, PA: Actient Pharmaceuticals; June Testosterone Products: Drug Safety Communication - FDA Cautions About Using Testosterone Products for Low Testosterone Due to Aging; Requires Labeling Change to Inform of Possible Increased Risk of Heart Attack And Stroke. [cited 2015]; Available from: ucts/ucm htm 18. Vigen, R, O'Donnell, CI, Baron, AE, et al. Association of testosterone therapy with mortality, myocardial infarction, and stroke in men with low testosterone levels. United States, p Xu, L, Freeman, G, Cowling, BJ, Schooling, CM. Testosterone therapy and cardiovascular events among men: a systematic review and meta-analysis of placebo-controlled randomized trials. BMC Med. 2013;11:108. PMID: Finkle, WD, Greenland, S, Ridgeway, GK, et al. Increased risk of non-fatal myocardial infarction following testosterone therapy prescription in men. United States, p. e MedWatch. FDA news release: Testosterone Gel Safety Concerns Prompt FDA to Require Label Changes, Medication Guide. 7May2009. [cited 2/16/2011]; Available from: Revision Date Revision Summary 12/11/2015 Clarified that the cause of hypogonadism must be caused by a condition listed in appendix 3 Allowed for reauthorization if testosterone levels exceed 700 ng/ml. Reauthorization requires a documented plan to address the high level or adjust the dose. Updated appendix 3 with additional causes of hypogonadism Dru395.2 Page 9 of 9

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