Cigna Drug and Biologic Coverage Policy

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1 Cigna Drug and Biologic Coverage Policy Subject Testosterone Therapy Table of Contents Coverage Policy... 1 General Background... 6 Coding/Billing Information... 7 References... 7 Effective Date... 1/1/2018 Next Review Date... 1/1/2019 Coverage Policy Number Related Coverage Resources Infertility Services Male Sexual Dysfunction Treatment: Nonpharmacologic Treatment of Gender Dysphoria INSTRUCTIONS FOR USE The following Coverage Policy applies to health benefit plans administered by Cigna Companies. Certain Cigna Companies and/or lines of business only provide utilization review services to clients and do not make coverage determinations. References to standard benefit plan language and coverage determinations do not apply to those clients. Coverage Policies are intended to provide guidance in interpreting certain standard benefit plans administered by Cigna Companies. Please note, the terms of a customer s particular benefit plan document [Group Service Agreement, Evidence of Coverage, Certificate of Coverage, Summary Plan Description (SPD) or similar plan document] may differ significantly from the standard benefit plans upon which these Coverage Policies are based. For example, a customer s benefit plan document may contain a specific exclusion related to a topic addressed in a Coverage Policy. In the event of a conflict, a customer s benefit plan document always supersedes the information in the Coverage Policies. In the absence of a controlling federal or state coverage mandate, benefits are ultimately determined by the terms of the applicable benefit plan document. Coverage determinations in each specific instance require consideration of 1) the terms of the applicable benefit plan document in effect on the date of service; 2) any applicable laws/regulations; 3) any relevant collateral source materials including Coverage Policies and; 4) the specific facts of the particular situation. Coverage Policies relate exclusively to the administration of health benefit plans. Coverage Policies are not recommendations for treatment and should never be used as treatment guidelines. In certain markets, delegated vendor guidelines may be used to support medical necessity and other coverage determinations. Coverage Policy Testosterone therapy includes the following products: Androderm (testosterone transdermal system) AndroGel (testosterone Aveed (testosterone undecanoate injection) Axiron (testosterone topical solution) Fortesta (testosterone gel ) Natesto (testosterone nasal Striant (testosterone buccal system) Testim (testosterone gel ) Vogelxo (testosterone gel ) *Includes generic formulations, as available, of the above listed medications Cigna covers testosterone therapy as medically necessary in males when the following criteria are met: Diagnosis of hypogonadism or hypogonadotropic hypogonadism (congenital or acquired) in an individual 18 years of age or older as confirmed by BOTH of the following: o o Documentation of signs and symptoms of androgen deficiency Two early morning, low total serum testosterone levels (below the testing laboratory's normal reference range) drawn on different days. Low serum testosterone level is defined as ANY of the following: Page 1 of 9

2 Below the laboratory s normal reference range Total testosterone level less than 280 ng/dl (9.7 nmol/l) Free testosterone level less than 5 pg/ml (0.17 nmol/l) Use of certain medications may require additional medical necessity determination; see criteria, if any, under specific medication listing Drug Axiron (testosterone topical solution) Specific Additional Criteria Documented failure / inadequate response, intolerance, or not a candidate for BOTH of the following: AndroGel and testosterone gel Fortesta (testosterone gel ) Natesto (testosterone nasal Testim (testosterone gel ) Vogelxo (testosterone gel ) Cigna does not cover the use of testosterone therapy for any other indication because it is considered experimental, investigational or unproven When coverage is available and medically necessary, the dosage, frequency, duration of therapy, and site of care should be reasonable, clinically appropriate, and supported by evidence-based literature and adjusted based upon severity, alternative available treatments, and previous response to testosterone therapy. The use of testosterone therapy for the treatment of gender dysphoria is addressed in a separate coverage policy. Please refer to the related coverage policy link above (Treatment of Gender Dysphoria). Note: Receipt of sample product does not satisfy any criteria requirements for coverage FDA Approved Indication Drug Aveed (testosterone undecanoate injection) Androderm (testosterone transdermal system) AndroGel (testosterone Axiron (testosterone topical solution) Fortesta (testosterone Indications 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 Hypogonadotropic hypogonadism (congenital or acquired):gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitaryhypothalamic injury from tumors, trauma, or radiation. These men have low testosterone serum concentrations but have gonadotropins in the normal or low range. Natesto (testosterone nasal Striant (testosterone buccal system) * Aveed should only be used in patients who require testosterone replacement therapy and in whom the benefits of the product outweigh the serious risks of pulmonary oil microembolism and anaphylaxis. Testim (testosterone Page 2 of 9

3 Drug Vogelxo (testosterone Aveed (testosterone undecanoate injection) Axiron (testosterone topical solution) Indications Limitations of use: Safety and efficacy of in men with age-related hypogonadism (also referred to as late-onset hypogonadism ) have not been established. Safety and efficacy of in males <18 years old have not been established. Fortesta (testosterone Natesto (testosterone nasal Striant (testosterone buccal system) Androderm (testosterone transdermal system) AndroGel (testosterone Testim (testosterone Limitations of Use: Safety and efficacy of men with age-related hypogonadism (also referred to as late-onset hypogonadism ) have not been established. Safety and efficacy of in males less than 18 years old have not been established Topical testosterone products may have different doses, strengths, or application instructions that may result in different systemic exposure Vogelxo (testosterone FDA Recommended Dosing and Drug Availability Drug FDA Recommended Dosing Drug Availability Prior to initiating Androderm, confirm the Androderm (testosterone transdermal system) AndroGel (testosterone The recommended starting dose is one Androderm 4 mg/day system (not two 2 mg/day systems) applied nightly for 24 hours, delivering approximately 4 mg of testosterone per day Prior to initiating AndroGel 1%, confirm the diagnosis of hypogonadism by ensuring that serum testosterone concentrations have been measured in the morning on at least two separate days and that these serum testosterone concentrations are below AndroGel 1% is 50 mg of testosterone (two 25 mg packets or one 50 mg packet), applied topically once daily in the morning to the shoulders and Androderm (testosterone transdermal system) 2 mg/day. Each system contains 9.7 mg testosterone USP for delivery of 2 mg of testosterone per day Androderm (testosterone transdermal system) 4 mg/day. Each system contains 19.5 mg testosterone USP for delivery of 4 mg of testosterone per day AndroGel 1% is supplied in unit-dose aluminum foil packets in cartons of 30. Each packet of 2.5 g or 5 g gel contains 25 mg or 50 mg testosterone, respectively. Page 3 of 9

4 Aveed (testosterone undecanoate injection) Drug FDA Recommended Dosing Drug Availability upper arms and/or abdomen area (preferably at the same time every day). Prior to initiating Aveed, confirm the separate days and that the serum The recommended dose of Aveed is 3 ml (750 mg) injected intramuscularly, followed by 3 ml (750 mg) injected after 4 weeks, then 3 ml (750 mg) injected every 10 weeks thereafter. Dosage titration is not necessary. Inject Aveed deeply into the gluteal muscle following the usual precautions for intramuscular administration; care must be taken to avoid intravascular injection. Intravascular injection of Aveed may lead to pulmonary oil microembolism. Aveed is available as 750 mg/3 ml (250 mg/ml) per vial. Because of the risks of serious POME (pulmonary oil microembolism) reactions and anaphylaxis, Aveed is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the Aveed REMS Program. Axiron (testosterone topical solution) Fortesta (testosterone Natesto (testosterone nasal Prior to initiating Axiron, confirm the Axiron (testosterone) topical solution is 60 mg of testosterone (2 pump or 2 twist actuations) applied once daily. Prior to initiating, Fortesta confirm the Fortesta is 40 mg of testosterone (4 pump actuations) applied once daily to the thighs in the morning The recommended dose of Natesto is 11 mg of testosterone (2 pump Axiron (testosterone) topical solution is available as a metered-dose pump containing 110 ml of solution. The pump is capable of dispensing 90 ml of solution in 60 metered pump or twist actuations. One actuation delivers 30 mg of testosterone in 1.5 ml of solution. Each metered-dose pump is supplied with an applicator. The bottle and the applicator cup are not made with natural rubber latex Fortesta is supplied in 60 g canisters with a metered dose pump that delivers 10 mg of testosterone per complete pump actuation. The metered dose pump is capable of dispensing 120 metered pump actuations. One pump actuation dispenses 0.5 g of gel. Natesto (testosterone) nasal gel is available as a metered dose pump Page 4 of 9

5 Drug FDA Recommended Dosing Drug Availability actuations; 1 actuation per nostril) administered intranasally three times daily for a total daily dose of 33 mg. Striant (testosterone buccal system) Serum total testosterone concentrations should be checked periodically, starting as soon as one month after initiating treatment with Natesto. When the total testosterone concentration consistently exceeds 1050 ng/dl, therapy with Natesto should be discontinued. If the total testosterone concentration is consistently below 300 ng/dl, an alternative treatment should be considered. Prior to initiating, Striant confirm the containing 11 grams of gel dispensed as 60 metered pump actuations. One pump actuation delivers 5.5 mg of testosterone in grams of gel. Striant (testosterone buccal system) mucoadhesive is supplied in transparent blister packs containing 10 doses. It is white to off-white colored with a flat edge on one side and a convex surface on the other. Testim (testosterone Vogelxo (testosterone The recommended dosage for Striant is the application of one buccal system (30 mg) to the gum region twice daily; morning and evening (about 12 hours apart). Prior to initiating, Testim confirm the Testim is 50 mg of testosterone (one tube) applied once daily (preferably in the morning) to clean, dry intact skin of the shoulders and/or upper arms. Prior to initiating Vogelxo, confirm the Vogelxo is 50 mg of testosterone (one tube, one packet, or 4 pump Testim is supplied in unit-dose tubes in cartons of 30. Each tube contains 50 mg testosterone in 5 g of gel. Vogelxo is supplied in unit-dose tubes in cartons of 30 and unit-dose packets in cartons of 30. Each tube or packet contains 50 mg testosterone in 5 g of gel. Vogelxo is also supplied in a metered-dose pump that delivers 12.5 mg of testosterone per complete pump actuation. Each 88 g metered-dose pump is capable of dispensing 75 g of gel or 60-metered Page 5 of 9

6 Drug FDA Recommended Dosing Drug Availability actuations) applied topically once daily at approximately the same time each pump actuations. Each pump actuation delivers 1.25 g of gel. The day to clean, dry intact skin of the metered-dose pump is supplied in shoulders and/or upper arms. cartons of 2. General Background Pharmacology Endogenous androgens, including testosterone and dihydrotestosterone (DHT) are responsible for the normal growth and development of the male sex organs and for maintenance of secondary sex characteristics. These effects include the growth and maturation of prostate, seminal vesicles, penis, and scrotum; the development of male hair distribution, such as facial, pubic, chest, and axillary hair; laryngeal enlargement, vocal cord thickening, and alterations in body musculature and fat distribution. Male hypogonadism, a clinical syndrome resulting from insufficient secretion of testosterone, has two main etiologies. Primary hypogonadism is caused by defects of the gonads, such as Klinefelter s syndrome or Leydig cell aplasia, whereas secondary hypogonadism is the failure of the hypothalamus (or pituitary) to produce sufficient gonadotropins (FSH, LH). Clinical Efficacy There is no direct comparative data for the testosterone products. FDA Warning As of October 2016, the FDA approved class-wide labeling changes for all prescription testosterone products, adding a new Warning and updating the Abuse and Dependence section to include new safety information from published literature and case reports regarding the risks associated with abuse and dependence of testosterone and other AAS. The Anabolic Steroids Control Act of 1990 placed AAS, including testosterone, in Schedule III of the Controlled Substances Act. Testosterone and other AAS are abused by adults and adolescents, including athletes and body builders. Abuse of testosterone, usually at doses higher than those typically prescribed and usually in conjunction with other AAS, is associated with serious safety risks affecting the heart, brain, liver, mental health, and endocrine system. Reported serious adverse outcomes include heart attack, heart failure, stroke, depression, hostility, aggression, liver toxicity, and male infertility. Individuals abusing high doses of testosterone have also reported withdrawal symptoms, such as depression, fatigue, irritability, loss of appetite, decreased libido, and insomnia. The new Warning will alert prescribers to the abuse potential of testosterone and the serious adverse outcomes, especially those related to heart and mental health that have been reported in association with testosterone/aas abuse. In addition to the new Warning, all testosterone labeling has been revised to include information in the Abuse and Dependence section about adverse outcomes reported in association with abuse and dependence of testosterone/aas, and information in the Warning and Precautions section advising prescribers of the importance of measuring serum testosterone concentration if abuse is suspected. Prescription testosterone products are FDA-approved as hormone replacement therapy for men who have low testosterone due to certain medical conditions. Examples of these conditions include failure of the testicles to produce testosterone because of genetic problems, or damage to the testicles from chemotherapy or infection. (FDA, 2016) Guidelines Diagnosis of androgen deficiency should include a comprehensive health examination in order to rule out other diseases and use of medications that may impact testosterone synthesis or metabolism. In order to diagnose androgen deficiency, The Endocrine Society recommends obtaining a morning total testosterone level and confirming those results with an additional sample. For individuals with total testosterone levels in the lower range of normal, obtaining a free or bioavailable testosterone level is advised. Individuals should refrain from these lab measurements during periods of illness. To differentiate between primary and secondary hypogonadism, LH and FSH levels are suggested. (Bhasin et al, 2010) Page 6 of 9

7 In treating adult males with hypogonadism, current guidelines suggest a preference for prescribing intramuscular or topical testosterone agents over the oral formulations (tablets or capsules) due to the unsatisfactory androgen effects and side effect profile of the oral route. Deciding which particular testosterone therapy to use should be made by the physician and a well- informed patient, taking into consideration factors such benefits versus risks, patient preferences, and pharmacokinetics of the drug formulation. Individuals should be monitored for response to treatment, adverse events and discontinued if there is no response. Although the guidelines suggest initiating therapy with a short-acting formulation, they are silent regarding preference for either topical or injectable testosterone formulations. In regards to adverse events, use of the long acting injectable form could be problematic because of the prolonged wash out period. (Bhasin et al, 2010; Dohle et al, 2015; Petak et al, 2002; Wang et al, 2009) Coding/Billing Information Note: 1) This list of codes may not be all-inclusive. 2) Deleted codes and codes which are not effective at the time the service is rendered may not be eligible for reimbursement Covered when medically necessary: HCPCS Codes J3145 Description Injection, testosterone undecanoate, 1 mg *Current Procedural Terminology (CPT ) 2014 American Medical Association: Chicago, IL. References 1. AbbVie Inc. AndroGel (testosterone prescribing information. AbbVie Inc. North Chicago, IL. October Actient Pharmaceuticals LLC. Striant (testosterone buccal system) prescribing information. Actient Pharmaceuticals LLC. Malvern, PA. October Allergan USA, Inc. Androderm (testosterone transdermal system) prescribing information. Allergan USA, Inc. Parsippany, NJ. October Auxilium Pharmaceuticals, Inc. Testim (testosterone prescribing information. Auxilium Pharmaceuticals, Inc. Malvern, PA. October Aytu BioScience, Inc. Natesto (testosterone) nasal gel prescribing information. Englewood, CO. October Bhasin S, Cunningham GR, Hayes FJ, Matsumoto AM, Snyder PJ, Swerdloff RS, et al. The Endocrine Society. Testosterone therapy in adult men with androgen deficiency syndromes: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2010;95(6): Dohle G, Arver S, Bettocchi C, et al. European Association of Urology Guidelines on Male Hypogonadism. March Available at: Accessed January 6, Endo Pharmaceuticals Solutions, Inc. Aveed (testosterone undecanoate) prescribing information. Endo Pharmaceuticals Solutions, Inc. Malvern, PA.. October Endo Pharmaceuticals, Inc. Fortesta (testosterone) gel prescribing information. Endo Pharmaceuticals, Inc Malvern, PA. October Page 7 of 9

8 10. Petak SM, Nankin HR, Spark RF, Swerdloff RS, Rodriguez-Rigau, LJ; American Association of Clinical Endocrinologists. Medical Guidelines for Clinical Practice for the Evaluation and Treatment of Hypogonadism in Adult Male Patients. Endocr Pract Dec;8(6): Upsher-Smith Laboratories, Inc. Vogelxo (testosterone) gel prescribing information. Upsher-Smith Laboratories, Inc. Maple Grove, MN. October Wang C, Nieschlag E, Swerdloff RS, et al. ISA, ISSAM, EAU, EAA and ASA recommendations: investigation, treatment and monitoring of late-onset hypogonadism in males. The Aging Male. 2009;12(1):5-1 Page 8 of 9

9 Cigna Companies refers to operating subsidiaries of Cigna Corporation. All products and services are provided exclusively by or through such operating subsidiaries, including Cigna Health and Life Insurance Company, Connecticut General Life Insurance Company, Cigna Behavioral Health, Inc., Cigna Health Management, Inc., QualCare, Inc., and HMO or service company subsidiaries of Cigna Health Corporation. The Cigna name, logo, and other Cigna marks are owned by Cigna Intellectual Property, Inc Cigna. Page 9 of 9

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