SUMMACARE COMMERCIAL MEDICATION REQUEST GUIDELINES TESTOSTERON. Generic Brand HICL GCN Exception/Other ROUTE MISCELL.

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1 Generic Brand HICL GCN Exception/Other ANDRODERM ROUTE MISCELL. ANDROGEL AXIRON FORTESTA NATESTO STRIANT TESTIM VOGELXO DEPO ROUTE MISCELL. CYPIONATE TESTOSTERON E GCN DELATESTRYL ROUTE MISCELL. ENANTHATE METHYLTESTOSTERO NE GUIDELINES FOR USE TESTRED ANDROID METHITEST ROUTE MISCELL. 1. Is the request for a male patient with a diagnosis of primary or secondary hypogonadism (hypotestosteronism or low testosterone) who meets ONE of the following criteria? The patient has a previously approved prior authorization for testosterone or has been receiving any form of testosterone replacement therapy as indicated per physician attestation or claims history OR The patient has AT LEAST ONE of the following laboratory values confirming low testosterone levels: o Total serum testosterone level of less than 300 ng/dl (10.4 nmol/l) o Low total serum testosterone level as indicated by a lab result with a reference range obtained within the past 90 days o Free serum testosterone level of less than 5 pg/ml (0.17 nmol/l) If yes, continue to #2. If no, continue to #4. Revised: 09/29/2017 Page 1 of 13

2 GUIDELINES FOR USE (CONTINUED) 2. Is the request for Androderm, Fortesta, Natesto, Striant, Testim, Vogelxo, Testred, Android, or Methitest and has the following criteria been met? The patient has previously tried or has a contraindication to Androgel AND Axiron If yes, approve the requested agent for lifetime by GPID with the following quantity limits: Androderm (testosterone): (2mg, 2.5mg, 4mg or 5mg patches) 30 patches per 30 days. Fortesta (testosterone): up to 120 grams per 30 days (2 of the 60-gram pumps). Natesto (testosterone): up to grams (3 bottles) per 30 days. Striant (testosterone): 60 systems (tablets) per 30 days. Testim (testosterone): ([1%] 50mg per 5 gram gel tube) up to 2 tubes per day per 30 days. Vogelxo (testosterone): ([1%] 50mg per 5 gram gel tube) up to 2 tubes per day per 30 days; (50mg/5 gram gel packet) up to 2 packets per day per 30 days; (12.5mg/1.25 gram pump) up to 4 of the 75 gram pumps per 30 days. Testred (methyltestosterone): (10mg capsules) 5 capsules per day. Android (methyltestosterone): (10mg capsules) 5 capsules per day. Methitest (methyltestosterone): (10mg tablets) 5 tablets per day. If no, continue to #3. 3. Is the request for AndroGel 1%, AndroGel 1.62%, Axiron, Depo-Testosterone (testosterone cypionate), or testosterone enanthate (Delatestryl)? If yes, approve the requested agent for lifetime by GPID with the following quantity limits: AndroGel 1% (testosterone): (2.5 gram packet) up to 5 grams per day per 30 days; (5 gram packet) up to 10 grams per day per 30 days; or up to 4 of the 75 gram pumps. AndroGel 1.62% (testosterone): (1.25 gram packet) up to 1.25 grams per day per 30 days; (2.5 gram packet) up to 5 grams per day per 30 days; or up to 2 of the 75 gram pumps per 30 days. Axiron (testosterone): (30mg per pump, 60 pumps per container) up to 180mL per 30 days (2 of the 90mL metered-dose pumps). Depo-Testosterone (testosterone cypionate): (100mg/mL, 200mg/mL 10mL vial) up to 1 vial per 30 days. Depo-Testosterone (testosterone cypionate): (200mg/mL, 1mL vial) up to 10 vials per 30 days. Revised: 09/29/2017 Page 2 of 13

3 Testosterone enanthate (Delatestryl): (200mg/mL, 5mL vial) 1 vial per 30 days. If no, do not approve. DENIAL TEXT: See the denial text at the end of the guideline. Revised: 09/29/2017 Page 3 of 13

4 GUIDELINES FOR USE (CONTINUED) 4. Is the request for a male patient with a diagnosis of delayed puberty not secondary to a pathological disorder who meets ONE of the following criteria: The request is for testosterone enanthate (Delatestryl) The request is for methyltestosterone (Testred, Android, or Methitest) AND the patient had a previous trial of or contraindication to Delatestryl If yes, approve the requested agent for lifetime by GPID with the following quantity limits: Delatestryl (testosterone enanthate): (200mg/mL, 5mL vial) 1 vial per 30 days. Testred (methyltestosterone): (10mg capsules) 5 capsules per day. Android (methyltestosterone): (10mg capsules) 5 capsules per day. Methitest (methyltestosterone): (10mg tablets) 5 tablets per day. If no, continue to #5. 5. Is the request for testosterone cypionate (Depo-Testosterone) for a diagnosis of gender dysphoria and the patient is at least 18 years of age? If yes, approve the requested agent for 12 months by GPID with the following quantity limits: Testosterone cypionate (Depo-Testosterone) 100mg/mL, 200mg/mL 10mL vial: 1 vial per 30 days. Testosterone cypionate (Depo-Testosterone) 200mg/mL, 1mL vial: 10 vials per 30 days. If no, continue to #6. 6. Is the request for a female patient with a diagnosis of metastatic breast cancer who meets ONE of the following criteria? The request is for testosterone enanthate (Delatestryl) The request is for methyltestosterone (Testred, Android, or Methitest) AND the patient had a previous trial of or contraindication to Delatestryl If yes, approve for requested agent for lifetime by GPID with the following quantity limits: Delatestryl (testosterone enanthate): (200mg/mL, 5mL vial) 1 vial per 30 days. Testred (methyltestosterone): (10mg capsules) 20 capsules per day. Android (methyltestosterone): (10mg capsules) 20 capsules per day. Methitest (methyltestosterone): (10mg tablets) 20 tablets per day. If no, do not approve. DENIAL TEXT: See the denial text at the end of the guideline. Revised: 09/29/2017 Page 4 of 13

5 Revised: 09/29/2017 Page 5 of 13

6 GUIDELINES FOR USE (CONTINUED) DENIAL TEXT: The guideline named requires a diagnosis of primary or secondary male hypogonadism (hypotestosteronism or low testosterone), delayed puberty in males not secondary to a pathological disorder, gender dysphoria, or metastatic breast cancer. For a diagnosis of metastatic female breast cancer or delayed puberty in males not secondary to a pathological disorder, only testosterone enanthate (Delatestryl) or methyltestosterone (Testred, Android, or Methitest) may be approved. For patients with gender dysphoria, only testosterone cypionate (Depo-Testosterone) may be approved. In addition, the following criteria must also be met. For male patients with a diagnosis of primary or secondary hypogonadism, approval requires that the following criteria must also be met. The patient has a previously approved prior authorization for testosterone or has been receiving any form of testosterone replacement therapy as indicated per physician attestation or claims history OR The patient has AT LEAST ONE of the following laboratory values confirming low testosterone levels: o Total serum testosterone level of less than 300ng/dL (10.4 nmol/l) o Low total serum testosterone level as indicated by a lab result with a reference range obtained within 90 days o Free serum testosterone level of less than 5 pg/ml (0.17 nmol/l). For requests of Androderm, Fortesta, Natesto, Striant, Testim, Vogelxo, Testred, Android, or Methitest, approval requires that the following criteria must also be met. The patient has previously tried or has a contraindication to Androgel and Axiron For patients with a diagnosis of gender dysphoria, approval requires: The patient is at least 18 years old. For male patients requesting methyltestosterone (Testred, Android or Methitest) for a diagnosis of delayed puberty not secondary to a pathological disorder, approval requires a previous trial of or contraindication to testosterone enanthate (Delatestryl). Please note that Delatestryl requires a prior authorization. For female patients requesting methyltestosterone (Testred, Android or Methitest) for a diagnosis metastatic breast cancer, approval requires a previous trial of or contraindication to testosterone enanthate (Delatestryl). Please note that Delatestryl requires a prior authorization. Revised: 09/29/2017 Page 6 of 13

7 RATIONALE Ensure appropriate diagnostic, utilization, and safety criteria. Normal testosterone level is defined for males as between 300-1,200ng/dL per the National Institute on Aging. Low free serum testosterone level is defined as less than 50ng/L per Adult Men with Androgen Deficiency Syndrome: An Endocrine Society Clinical Practice Guideline. Coverage for gender dysphoria is medically accepted for testosterone cypionate only as indicated in MicroMedex DrugDex. MicroMedex DrugDex has a therapeutic indication of female-to-male transsexual-gender identity disorder for testosterone cypionate. Other testosterone products do not have a medically accepted indicate for gender dysphoria or gender identity disorder. Testosterone Enanthate and methyltestosterone have an FDA indication of metastatic (skeletal) mammary cancer. The other testosterone products do not have a medically accepted indication for metastatic mammary cancer. FDA APPROVED INDICATIONS ANDRODERM (testosterone transdermal system) is indicated for testosterone replacement therapy in men 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, orchidectomy, Klinefelter s Syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone concentrations accompanied by gonadotropins (FSH, LH) above the normal range. Secondary, i.e., hypogonadotropic hypogonadism (congenital or acquired) - idiopathic gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation. These men have low serum testosterone concentrations without associated elevation in gonadotropins. ANDROGEL, an androgen, is indicated for 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 levels and gonadotropins (FSH, LH) above the normal range. Hypogonadotropic Hypogonadism (Congenital or Acquired) - idiopathic gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitaryhypothalamic injury from tumors, trauma, or radiation. These men have low testosterone serum levels but have gonadotropins in the normal or low range. AXIRON, an androgen is indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterones: Primary Revised: 09/29/2017 Page 7 of 13

8 hypogonadism (congenital or acquired); Hypogonadotropic hypogonadism (congenital or acquired). Not indicated in males <18 years of age. Revised: 09/29/2017 Page 8 of 13

9 FDA APPROVED INDICATIONS (CONTINUED) DEPO- 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 cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome; or orchidectomy. Hypogonadotropic hypogonadism (congenital or acquired) - idiopathic gonadotropin or LHRH deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation. DELATESTRYL (Testosterone Enanthate Injection, USP) is indicated for replacement therapy in conditions associated with a deficiency or absence of endogenous testosterone. May be used secondarily in woman with advancing inoperable metastatic (skeletal) mammary cancer who are one to five years postmenopausal. FORTESTA is indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone including primary hypogonadism (congenital or acquired) and hypogonadotropic hypogonadism (congenital or acquired). Important limitation of use: safety and efficacy of FORTESTA in males <18 years old have not been established. NATESTO is an androgen indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone: Primary hypogonadism (congenital or acquired) Hypogonadotropic hypogonadism (congenital or acquired) Limitations of use: safety and efficacy of Natesto in males less than 18 years old have not been established. STRIANT is indicated for replacement therapy in 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, orchidectomy, Klinefelter's syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone levels and gonadotropins (FSH, LH) above the normal range. Hypogonadotropic hypogonadism (congenital or acquired) - idiopathic gonadotropin or LHRH deficiency, or pituitary hypothalamic injury from tumors, trauma, or radiation. These patients have low serum testosterone levels but have gonadotropins in the normal or low range. Revised: 09/29/2017 Page 9 of 13

10 FDA APPROVED INDICATIONS (CONTINUED) TESTIM is 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 levels and gonadotropins (FSH, LH) above the normal range. Hypogonadotropic hypogonadism (congenital or acquired) - idiopathic gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitaryhypothalamic injury from tumors, trauma, or radiation. These men have low testosterone serum levels but have gonadotropins in the normal or low range. Testim has not been clinically evaluated in males less than 18 years of age. TESTRED, ANDROID, AND METHITEST are androgens, indicated for replacement therapy in the following patients: Males with conditions associated with a deficiency or absence of endogenous testosterone: o Primary hypogonadism (congenital or acquired) - testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testes syndrome: or orchidectomy. o Hypogonadotropic hypogonadism (congenital or acquired) - idiopathic or gonadotropic LHRH deficiency, or pituitary- hypothalamic injury from tumors, trauma or radiation. o Androgens 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 later. Brief treatment with conservative doses may occasionally be justified in these patients if they do not respond to psychological support. Females: may be used secondarily in woman with advancing inoperable metastatic (skeletal) mammary cancer who are one to five years postmenopausal. VOGELXO, an androgen, indicated for replacement therapy in males for conditions in conditions associated with a deficiency or absence of endogenous testosterone: Primary hypogonadism (congenital or acquired). Hypogonadotropic hypogonadism (congenital or acquired). Revised: 09/29/2017 Page 10 of 13

11 REFERENCES Lilly USA, LLC. Axiron Package Insert. Indianapolis, IN. July, Auxilium Pharmaceuticals, Inc. Testim package insert. Malvern, PA. September Bartor Pharmacal Co.; Inc. Testopel package insert. Rye, NY. January Columbia Laboratories, Inc. Striant package insert. Livingston, NJ. February Conway AJ, Handelsman DJ, Lording DW, Stuckey B, Zajac JD. Use, misuse and abuse of androgens. MJA. 2000; 172: Endo Pharmaceuticals. Fortesta package insert. Chadds Ford, PA. April, Francis S. Greenspan and David G. Gardner eds. Lange Basic and Clinical Endocrinology. 7th ed. McGraw-Hill Companies, Inc.; Gould DC, Petty R, Jacobs HS. The male menopause: does it exist? BMJ. 2000; 320: Endo Pharmaceuticals, Inc. Delatestryl package insert. Chadds Ford, PA. June, Lui PY, Swerdloff RS, Wang C. Relative testosterone deficiency in older men: Clinical definition and presentation. Endocrinol Metab Clin N Am. 2005; 34: Miller KK. Special Articles: Hormones and Reproductive Health. J Clin Endocrinol Metab 2001; 86(6): National Institute on Aging. Scientific task force to examine usefulness of testosterone replacement therapy in older men [online]. NIH News Release. November 6, Available at: htm [Accessed July 21, 2009]. Valeant Pharmaceuticals. Testred package insert. Aliso Viejo, CA. June 2014 Petak SM. 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): Pharmacia & Upjohn Company. Depo-Testosterone package insert. New York, NY. September Shalender B, Glenn, Cunningham, FJ, et al. Adult Men with Androgen Deficiency Syndrome: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab, June 2010, 95(6): Available at: [Accessed July 25, 2011]. The Formulary Monograph Service, Facts and Comparisons, St Louis, Missouri, Abbott Laboratories. Androgel 1% package insert. North Chicago, IL. November, Abbott Laboratories. Androgel 1.62% package insert. North Chicago, IL. April, Watson Pharma, Inc. Androderm package insert. Parsippany, NJ. October Upsher-Smith Laboratories, Inc. Vogelxo Package Insert. Maple Grove, MN. June, Revised: 09/29/2017 Page 11 of 13

12 UpToDate, Inc. Testosterone treatment of male hypogonadism. UpToDate [database online]. Waltham, MA. Available at: edtitle=1%7e50&sectionrank=1&anchor=h #h1. Accessed on March 17, 2015 Revised: 09/29/2017 Page 12 of 13

13 REFERENCES (CONTINUED) Bhasin S, Cunningham GR, et al. Testosterone therapy in adult men with androgen deficiency syndromes: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab, June 2010, 95(6): Trimel Pharmaceuticals Press Release: Trimel Receives FDA Approval for Natesto Nasal Gel to Treat Men with Low Testosterone. May 28, Available at: Natesto-Nasal-Gel-to-Treat-Men-with-Low-Testosterone. Accessed on March 17, 2015 Sexson E, Knezevich J. Male Hypogonadism: A Review of the Disease and Its Treatment. US Pharm. 2010; 35(6):HS7-HS16. Available at: Accessed on March 17, 2015 Dandona P, Rosenberg MT. A practical guide to male hypogonadism in the primary care setting. Int J Clin Pract May; 64(6): Available at: Accessed on March 17, Food and Drug Administration. Background documents for the joint meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee. September 17, Available at: ugs/reproductivehealthdrugsadvisorycommittee/ucm pdf. Accessed on November 4, 2014 Food and Drug Administration. 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. March 3, Available at: alproducts/ucm htm. Accessed on March 17, Natesto [Prescribing Information]. Malvern, PA: Endo Pharmaceuticals Inc.; November Valeant Pharmaceuticals. Testred package insert. Bridgewater, NJ. April Commercial X Market Place X Created: 11/16 Effective : 1/1/18 Client Approval: P&T Approval: Revised: 09/29/2017 Page 13 of 13

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