Medical Policy Testosterone Therapy

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1 Medical Policy Testosterone Therapy Subject: Testosterone Therapy Effective Date: April 2015 Overview: Testosterone cypionate, testosterone enanthate, testosterone undecanoate, and testosterone pellet are forms of testosterone injection used to treat symptoms of low testosterone in men who do not produce enough natural testosterone. Testosterone enanthate and testosterone pellet are also used to stimulate puberty in males with delayed puberty. Testosterone is a hormone produced by the body that contributes to the growth, development, and functioning of the male sexual organs and typical male characteristics. Testosterone injection works by supplying synthetic testosterone to replace the testosterone that is normally produced naturally in the body. Policy and Coverage Criteria: Harvard Pilgrim considers injectable/infusible testosterone and testosterone implants medically necessary to treat low testosterone caused by: Primary or secondary hypogonadism; Human Immunodeficiency Virus; High-dose glucocorticoids Harvard Pilgrim considers injectable/infusible testosterone medically necessary for members with metastatic breast cancer. Harvard Pilgrim considers injectable/infusible testosterone and testosterone implants medically necessary for transgender members. Exclusions: HPHC does not cover testosterone therapy for conditions not outlined above. Supporting Information: 1. Technology Assessment: Testosterone cypionate, testosterone enanthate, and testosterone undecanoate injection come as a solution that is injected into the muscle. Testosterone injection may also come as a pellet that is injected under the skin. According to the prescribing information for Testopel: TESTOPEL Pellets (testosterone) are cylindrically shaped pellets 3.2mm (1/8 inch) in diameter and approximately 9mm in length. Each sterile pellet weighs approximately 78mg (75mg testosterone) and is ready for implantation INDICATIONS AND USAGE: Males Androgens are indicated for replacement therapy in conditions associated with a deficiency or absence of endogenous testosterone. a) Primary hypogonadism (congenital or acquired) - testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testes syndrome; or orchiectomy. b) Hypogonadotrophic hypogonadism (congenital or acquired) - idiopathic or gonadotropic LHRH deficiency, or pituitary - hypothalamic injury from tumors, trauma or radiation. 2. Literature Review: In their update on diagnosis and treatment of male hypogondaism, Darby and Anawalt (2005) list the potential benefits of androgen replacement therapy as: improved sexual function, enhanced sense of well-being, increased lean body mass, decreased body fat, and increased bone density. Weekly-to-biweekly injections of testosterone cypionate (cipionate) or testosterone enanthate (enantate) are widely used, as they are economical and generally

2 well tolerated. Intramuscular injection of testosterone undecanoate is an attractive newer therapy that can be administered quarterly. Haider et al. (2015) conducted an analysis of 3 parallel, prospective, ongoing, cumulative registry studies including 1,023 hypogonadal men who received testosterone therapy. Patients were treated when total testosterone was 12.1 nmol/l or less (350 ng/dl) and symptoms of hypogonadism were present. Maximum followup was 17 years (1996 to 2013) and median follow-up was 5 years. Patients received testosterone undecanoate injections in 12-week intervals. A total of 11 patients were diagnosed with prostate cancer in the 2 urology settings at proportions of 2.3% and 1.5%, respectively. The incidence per 10,000 patient-years was 54.4 and 30.7, respectively. No prostate cancer was reported by the andrology center. The authors concluded that testosterone therapy in hypogonadal men does not increase the risk of prostate cancer. If guidelines for testosterone therapy are properly applied, testosterone treatment is safe in hypogonadal men. Conaglen et al. (2014) retrospectively assessed the efficacy and safety of long-term testosterone undecanoate depot (TUD) therapy in the clinical setting and compare TUD with T pellet implants. Data was collected for 179 hypogonadal men treated with TUD for 2 years. 72% of trough total testosterone (TT) levels were in the normal range for TUD therapy compared with 53% of trough TT levels during TI therapy. TUD therapy was well tolerated with 162 men completing 2 years of treatment, and only seven men stopping TUD because of adverse effects. A rise in Hb and/or Hct occurred in 25 men, and a significant rise in PSA in 20 men at some stage during TUD therapy. At 2 years, 91% of men received the standard 1,000 mg TUD dose with 66% at the standard dosing interval of weekly. The authors concluded that TUD is an efficacious, safe, and well tolerated. Yassin et al. (2014) investigated whether treatment with testosterone undecanoate (TU) has a long-term and sustained effect on metabolic syndrome in men with late-onset hypogonadism and erectile dysfunction, to determine whether long-term testosterone treatment can improve overall health-related quality of life, and to establish the safety of long-term testosterone treatment. A prospective, observational, and longitudinal registry study including 261 patients diagnosed with late-onset hypogonadism and ED were treated with long-acting TU were analyzed. The men received intramuscular injections of 1,000 mg TU at day 1, week 6, and every 3 months thereafter. A significant improvement in obesity parameters and lowered total cholesterol, LDL cholesterol, triglycerides, fasting blood glucose, HbA1c, and blood pressure over the 5-year study were found. HDL cholesterol was increased. Sustained improvement in erectile function and muscle and joint pain, which contributed to an improvement in long-term health-related quality of life was found. There was no evidence that long-term treatment with TU increases the risk of prostate carcinoma. The authors concluded that long-term TU in men with late-onset hypogonadism and ED reduces obesity parameters and improves metabolic syndrome and health-related quality of life. Corona et al. (2014) conducted a meta-analysis of available evidence to assess the efficacy and safety of injectable testosterone undecanoate (TU). Injectable TU was significantly associated with a reduction of fat mass and HbA1c in both controlled and uncontrolled trials, in particular when hypogonadal subjects were enrolled. Similar results were observed for the improvement of erectile function. In addition, TU ameliorated several other outcomes, including blood pressure, lipid profile, waist circumference and body mass index in uncontrolled studies, but these data were not confirmed in placebo-controlled trials. The treatment was well tolerated and no risk of prostate cancer or cardiovascular disease was observed. The authors conclude that injectable TU is a safe and effective treatment for male HG. The possibility of a therapeutic intervention just four to five times per year frees the patient, at least partially, from having a chronic condition, thus maintaining a positive, active role in selfcaring. Zitzmann et al. (2013) assessed the safety and efficacy of injectable long-acting TU in hypogonadal men in daily clinical practice. A total of 1,438 patients who received TU were enrolled and analyzed. Scores of mental and psychosexual functions improved markedly, while mean waist circumference decreased from 100 to 96 cm. Blood pressure and lipid parameters were altered in a favorably and significantly. After four TU injection intervals, the percentage of patients with "low" or "very low" levels of sexual desire/libido decreased from 64% at baseline to 10%; moderate, severe, or extremely severe erectile dysfunction decreased from 67% to 19%. At the last observation, 89% of patients were "satisfied" or "very satisfied" with TU therapy. Adverse events and adverse drug reactions (ADRs) occurred in 12% and 6% of patients, respectively, mostly mild to moderate. The most common ADRs were increase in hematocrit, increase in PSA, and injection site pain (all <1%). No case of prostate cancer was observed. The authors concluded that injectable long-acting TU is effective and well tolerated. Jockenhovel et al. (2009) compared the effects of testosterone enanthate (TE) versus TU on sexual functioning and mood in 40 hypogonadal men over a period of 30 weeks. Both groups showed significant and similar

3 improvements in the sexual functioning variables. The authors concluded that both TE and TU are effective in improving sexual functions in hypogonadal men. Additionally, an advantage of TU over TE is the lower frequency of administration and its better tolerability and safety profile. Rabkin et al. (2000) evaluated the efficacy of testosterone in alleviation of hypogonadal symptoms in 70 men with symptomatic human immunodeficiency virus illness. A double-blind, placebo-controlled 6-week trial enrolled was conducted and patients received bi-weekly testosterone injections, followed by 12 weeks of open-label maintenance treatment. Response rates, defined as much or very much improved libido, were 74% for patients randomized to testosterone, and 19% for placebo-treated patients. Of the 62 patients with fatigue at baseline, 59% receiving testosterone and 25% receiving placebo reported improved energy. Among the 26 patients with an Axis I depressive disorder at baseline, 58% of the testosterone-treated patients reported improved mood compared with 14% of placebo-treated patients. With testosterone treatment, average increase in muscle mass over 12 weeks was 1.6 kg for the whole group, and 2.2 kg for the 14 men with wasting at baseline. Improvement on all parameters was maintained during subsequent open-label treatment for up to 18 weeks. The authors concluded that testosterone was well tolerated and effective in the short-term treatment of symptoms of clinical hypogonadism in men with symptomatic HIV illness, restoring libido and energy, alleviating depressed mood, and increasing muscle mass. Bhasin et al. (1997) conducted a study to determine the effects of testosterone enanthate (100 mg/week im injections for 10 weeks) on body composition in seven hypogonadal men. Body weight, fat-free mass measured by underwater weighing and deuterated water dilution, and muscle size measured by MRI were assessed before and after treatment. Energy and protein intake were standardized at 35 Cal/kg per day. Body weight increased significantly from after 10 weeks of testosterone replacement therapy. Fat-free mass, measured by underwater weighing, increased, but percent fat did not significantly change. Similar increases in fat-free mass were observed with the deuterated water method. Muscle strength, assessed by one repetition maximum of weight-lifting exercises increased significantly after testosterone treatment. There was no significant change in hemoglobin, hematocrit, creatinine, and transaminase levels. The authors concluded that replacement doses of testosterone increase fat-free mass and muscle size and strength in hypogonadal men. Behre et al. (1997) studied bone mineral density (BMD) in 72 hypogonadal patients (37 men with primary and 35 men with secondary hypogonadism) under testosterone therapy that continued for up to 16 years. At annual intervals, trabecular BMD of the lumbar spine was measured by quantitative computed tomography. Serum levels of testosterone increased to the normal range in all androgen-treated hypogonadal men. The most significant increase in BMD was seen during the first year of testosterone treatment in previously untreated patients. Long term testosterone treatment maintained BMD in the age-dependent reference range in all 72 hypogonadal men, independent of the type of hypogonadism. Transdermal testosterone patches applied to the scrotum were as effective in normalizing BMD as testosterone enanthate injections. The authors concluded that testosterone therapy increases BMD in hypogonadal men regardless of age. The greatest increase is seen during the first year of treatment in previously untreated patients with low initial BMD. In hypogonadal men, BMD can be normalized and maintained in the normal range by continuous, long term testosterone substitution. 3. Professional/Governmental Organizations: The Endocrine Society: Clinical Practice Guideline for Testosterone Therapy: We recommend making a diagnosis of androgen deficiency only in men with consistent symptoms and signs and unequivocally low serum testosterone levels. We suggest the measurement of morning total testosterone level by a reliable assay as the initial diagnostic test. We recommend confirmation of the diagnosis by repeating the measurement of morning total testosterone and, in some men in whom total testosterone is near the lower limit of normal or in whom SHBG abnormality is suspected by measurement of free or bioavailable testosterone level, using validated assays. We recommend testosterone therapy for men with symptomatic androgen deficiency to induce and maintain secondary sex characteristics and to improve their sexual function, sense of well-being, muscle mass and strength, and bone mineral density. We recommend against starting testosterone therapy in patients with breast or prostate cancer, a palpable prostate nodule or induration or prostate-specific antigen greater than 4 ng/ml or greater than 3 ng/ml in men at high risk for prostate cancer such as African-Americans or men with first-degree relatives with prostate cancer without further urological evaluation, hematocrit greater than 50%, untreated severe obstructive sleep apnea, severe lower urinary tract symptoms with International Prostate Symptom Score above 19, or uncontrolled or poorly controlled heart failure. When testosterone therapy is instituted, we suggest aiming at achieving testosterone levels during treatment in the mid-normal range with any of the approved

4 formulations, chosen on the basis of the patient's preference, consideration of pharmacokinetics, treatment burden, and cost. Men receiving testosterone therapy should be monitored using a standardized plan. Coding: Codes are listed below for informational purposes only, and do not guarantee member coverage or provider reimbursement. The list may not be all-inclusive. HCPCS Description Code J1071 J3121 J3145 References: Injection, testosterone cypionate, 1 mg Injection, testosterone enanthate, 1 mg Injection, testosterone undecanoate, 1 mg 1. Hayes, Inc. Search and Summary. Testopel (Auxilium Pharmaceuticals Inc.) Implantable Testosterone Pellet for Hypogonadism. Lansdale, PA: Hayes, Inc. November 13, Snyder, PJ. Testosterone treatment of male hypogonadism. In: UpToDate, Post, TW (Ed), UpToDate, Waltham, MA. (Accessed February 5, 2015). 3. Ellis, M., Naughton, MJ., Ma, CX. Treatment approach to metastatic hormone receptor-positive breast cancer: Endocrine therapy. In: UpToDate, Post, TW (Ed), UpToDate, Waltham, MA. (Accessed February 5, 2015). 4. Testosterone Injection. U.S. National Library of Medicine, Bethesda, MD. U.S. Department of Health and Human Services National Institutes of Health. Page last updated: 26 January Accessed February 12, Bhasin, S., Cunningham, GR., Hayes, FJ., Matsumoto, AM., Snyder, PJ., Swerdloff, RS., Montori, VM.;Task Force, Endocrine Society. Testosterone therapy in men with androgen deficiency syndromes: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2010; 95(6): Behre, HM., Kliesch, S., Leifke, E., Link, TM., Nieschlaq, E. Long-term effect of testosterone therapy on bone mineral density in hypogonadal men. J Clin Endocrinol Metabol. 1997; 82(8): Corona, G., Maseroli, E., Maggi, M. Injectable testosterone undecanoate for the treatment of hypogonadism. Expert Opin Pharmacother. 2014; 15(13): Haider, A., Zitzmann, M., Doros, G., Isbarn, H., Hammerer, P., Yassin, A. Incidence of prostate cancer in hypogonadal men receiving testosterone therapy: observations from 5-year median followup of 3 registries. J Urol. 2015; 193(1): Yassin, DJ., Doros, G., Hammerer, PG., Yassin, AA. Long-term testosterone treatment in elderly men with hypogonadism and erectile dysfunction reduces obesity parameters and improves metabolic syndrome and health-related quality of life. J Sex Med. 2014; 11(6): Conaglen, HM., Paul, RG., Yarndley, T., Kamp, J., Elston, MS., Conaglen, JV. Retrospective investigation of testosterone undecanoate depot for the long-term treatment of male hypogonadism in clinical practice. J Sex Med. 2014; 11(2): Zitzmann, M., Mattern, A., Hanisch, J., Gooren, L., Jones, H., Maggi, M. IPASS: a study on the tolerability and effectiveness of injectable testosterone undecanoate for the treatment of male hypogonadism in the worldwide sample of 1,438 men. J Sex Med. 2013; 10(2): Jockenhovel, F., Minnemann, T., Schubert, M., Freud, S., Hubler, D., Schumann, C., Christoph, A., Ernst, M. Comparison of long-acting testosterone undecanoate versus testosterone enanthate on sexual function and mood in hypogonadal men. Eur J Endocrinol. 2009; 160(5): Darby, E., Anawalt, BD. Male hypogonadism: an update on diagnosis and treatment. Treat Endocrinol. 2005; 4(5): Bhasin, S., Storer, TW., Berman, N., Yarasheski, KE., Clevenger, B., Phillips, J., Lee, WP., Bunnell, TJ., Casaburi, R. Testosterone replacement increases fat-free mass and muscle size in hypogonadal men. J Clin Endocrinol Metab. 1997; 82(2): Rabkin, JG., Wagner, GJ., Rabkin, R. A double-blind, placebo-controlled trial of testosterone therapy for HIVpositive men with hypogonadal symptoms. Arch Gen Psychiatry. 2000; 57(2):141-7.

5 Summary of Changes Date Revisions 5/17 Removed Deleted HCPCS codes and Benchmarks Approved by UMCPC: 5/10/17

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