PHARMACY COVERAGE GUIDELINES ORIGINAL EFFECTIVE DATE: 1/01/2015 SECTION: DRUGS LAST REVIEW DATE: 5/20/2021 LAST CRITERIA REVISION DATE: 5/20/2021 ARCHIVE DATE: TESTOSTERONE REPLACEMENT THERAPY: ANDRODERM® transdermal patch ANDROGEL® pump transdermal gel and transdermal gel FORTESTA® transdermal gel JATENZO® (testosterone undecanoate) oral capsule METHITEST™ (methyltestosterone) oral tablet Methyltestosterone oral capsule NATESTO™ nasal gel STRIANT® buccal mucoadhesive system TESTIM® transdermal gel VOGELXO® pump transdermal gel and transdermal gel Testosterone pump transdermal gel and transdermal gel XYOSTED™ (testosterone enanthate) solution auto-injector Coverage for services, procedures, medical devices and drugs are dependent upon benefit eligibility as outlined in the member's specific benefit plan. This Pharmacy Coverage Guideline must be read in its entirety to determine coverage eligibility, if any. This Pharmacy Coverage Guideline provides information related to coverage determinations only and does not imply that a service or treatment is clinically appropriate or inappropriate. The provider and the member are responsible for all decisions regarding the appropriateness of care. Providers should provide BCBSAZ complete medical rationale when requesting any exceptions to these guidelines. The section identified as “Description” defines or describes a service, procedure, medical device or drug and is in no way intended as a statement of medical necessity and/or coverage. The section identified as “Criteria” defines criteria to determine whether a service, procedure, medical device or drug is considered medically necessary or experimental or investigational. State or federal mandates, e.g., FEP program, may dictate that any drug, device or biological product approved by the U.S. Food and Drug Administration (FDA) may not be considered experimental or investigational and thus the drug, device or biological product may be assessed only on the basis of medical necessity. Pharmacy Coverage Guidelines are subject to change as new information becomes available. For purposes of this Pharmacy Coverage Guideline, the terms "experimental" and "investigational" are considered to be interchangeable. BLUE CROSS®, BLUE SHIELD® and the Cross and Shield Symbols are registered service marks of the Blue Cross and Blue Shield Association, an association of independent Blue Cross and Blue Shield Plans. All other trademarks and service marks contained in this guideline are the property of their respective owners, which are not affiliated with BCBSAZ. This Pharmacy Coverage Guideline does not apply to FEP or other states’ Blues Plans. Information about medications that require precertification is available at www.azblue.com/pharmacy. Page 1 of 12 PHARMACY COVERAGE GUIDELINES ORIGINAL EFFECTIVE DATE: 1/01/2015 SECTION: DRUGS LAST REVIEW DATE: 5/20/2021 LAST CRITERIA REVISION DATE: 5/20/2021 ARCHIVE DATE: TESTOSTERONE REPLACEMENT THERAPY Some large (100+) benefit plan groups may customize certain benefits, including adding or deleting precertification requirements. All applicable benefit plan provisions apply, e.g., waiting periods, limitations, exclusions, waivers and benefit maximums. Precertification for medication(s) or product(s) indicated in this guideline requires completion of the request form in its entirety with the chart notes as documentation. All requested data must be provided. Once completed the form must be signed by the prescribing provider and faxed back to BCBSAZ Pharmacy Management at (602) 864-3126 or emailed to [email protected]. Incomplete forms or forms without the chart notes will be returned. Section A. Testosterone Replacement Therapy See Section B. for Jatenzo (testosterone undecanoate) criteria Criteria: Criteria for initial therapy: For male individuals Testosterone Replacement Therapy is considered medically necessary and will be approved when ALL of the following criteria are met: 1. Prescriber is a physician specializing in the patient’s diagnosis or is in consultation with an Endocrinologist, Urologist, HIV/AIDS Specialist, or Infectious Disease depending upon indication or use 2. A confirmed diagnosis of ONE of the following: a. Male individual 18 years of age or older with an established diagnosis of hypogonadism with multiple clinical signs and symptoms consistent with hypogonadism, must have at least one specific sign and symptom of hypogonadism (See Definitions section) with persistently low testosterone levels b. HIV-infected male individual 18 years of age or older with documented unexplained involuntary weight loss of greater than 10% baseline body weight with persistently low testosterone levels c. Male individual 18 years of age or older on chronic corticosteroid treatment (daily dose of at least 5- 7.5 mg of prednisone or equivalent for at least 6 weeks) with persistently low testosterone levels d. Individual 14 years or older with delayed male puberty and pre-pubertal testis 3. Has persistently low baseline testosterone levels defined as ONE of the following: a. Total testosterone level less than the reference lab normal value on two separate occasions (copy of laboratory data must be submitted with the request), must be obtained from the same laboratory or from a laboratory using the same assay b. Serum free testosterone level and total testosterone less than reference lab normal on the same day (copy of laboratory data must be submitted with the request) 4. Androgen/testosterone deficiency diagnosis is not made during an acute or sub-acute illness Page 2 of 12 PHARMACY COVERAGE GUIDELINES ORIGINAL EFFECTIVE DATE: 1/01/2015 SECTION: DRUGS LAST REVIEW DATE: 5/20/2021 LAST CRITERIA REVISION DATE: 5/20/2021 ARCHIVE DATE: TESTOSTERONE REPLACEMENT THERAPY 5. Documented failure, contraindication per FDA label, intolerance to Testim (brand or generic) (documentation from the prescriber must be submitted) 6. Documented failure, contraindication per FDA label, intolerance to intramuscular testosterone injection (documentation from the prescriber must be submitted) 7. ALL of the following baseline tests have been completed before initiation of treatment with continued monitoring as clinically appropriate: a. For Methitest and methyltestosterone: Liver function tests b. Digital prostate examination done within the last 12 months with continued monitoring as clinically appropriate for age, race, and risk factors for prostate cancer c. Prostate specific antigen (PSA) measurement done within the last 12 months with continued monitoring as clinically appropriate for age, race, and risk factors for prostate cancer d. Hematocrit 8. Individual does not have ANY of the following a. Active breast or prostate cancer b. Palpable prostate nodule or prostate-specific antigen (PSA) greater than 4 ng/mL or PSA more than 3 ng/mL in a man at high risk of prostate cancer (such as such as African-Americans, or those with first-degree relative with prostate cancer or an unevaluated prostate nodule or induration) c. Hematocrit greater than 48% d. Untreated severe obstructive sleep apnea e. Severe lower urinary tract symptoms ([AUA]/ IPSS greater than 19) f. Uncontrolled or poorly controlled heart failure 9. There are NO FDA-label contraindications, such as: a. Men with known carcinoma of the breast or known or suspected carcinoma of the prostate Initial approval duration: 6 months Criteria for initial therapy: For female individuals Testosterone Replacement Therapy is considered medically necessary and will be approved when ALL of the following criteria are met: 1. Prescriber is a physician specializing in the patient’s diagnosis or is in consultation with an Oncologist 2. Women with a diagnosis of metastatic / inoperable breast cancer 3. There are NO FDA-label contraindications, such as: a. Woman of child bearing potential who is pregnant or not currently using effective contraception b. Woman who is breast feeding an infant or child Initial approval duration: 6 months Page 3 of 12 PHARMACY COVERAGE GUIDELINES ORIGINAL EFFECTIVE DATE: 1/01/2015 SECTION: DRUGS LAST REVIEW DATE: 5/20/2021 LAST CRITERIA REVISION DATE: 5/20/2021 ARCHIVE DATE: TESTOSTERONE REPLACEMENT THERAPY Criteria for continuation of coverage (renewal request): Testosterone product is considered medically necessary and will be approved when ALL of the following criteria are met: 1. Individual continues to be seen by a physician specializing in the patient’s diagnosis or is in consultation with an Endocrinologist, Urologist, HIV/AIDS Specialist, Infectious Disease, or Oncologist depending upon indication or use 2. The individual has met all of the initial criteria for Testosterone Replacement Therapy 3. The individual’s condition responded while on therapy a. Response is defined as: i. For hypogonadism with clinical signs and symptoms consistent with hypogonadism 1. Testosterone levels are within the normal range with therapy 2. Clinical symptoms have improved 3. Hematocrit is less than 48% ii. For HIV-infected male individual 18 years of age or older with documented weight loss 1. Increase in weight over baseline of 1.1-1.54 kg body weight OR increase 1.4 kg fat- free mass OR increase 1.22-1.3 kg lean body mass 2. Hematocrit is less than 48% iii. For male individual 18 years of age or older on chronic corticosteroid treatment 1. Continues to require chronic corticosteroid therapy 2. Hematocrit is less than 48% iv. For individual 14 years or older with delayed male puberty and pre-pubertal testis 1. Secondary male sex characteristics have developed