CurrentCareSourcePolicy N/A

Injectable Testosterone Therapy — Coverage Criteria

Policy governing prior authorization and medical benefit coverage of injectable testosterone products for adults and select pediatric indications (delayed puberty), affecting prescribers and reviewers under CareSource.

Policy Summary

PayerCareSource

PolicyInjectable Testosterone Therapy — Coverage Criteria

Policy CodePolicy N/A

Change TypeAdded product

Effective DateN/A

Next Review DateSep 11, 2024

Key ActionObtain prior authorization and provide documentation of signs/symptoms plus two morning serum testosterone measurements when requesting coverage.

SourceLink

POLICY UPDATE CHANGES

Azmiro (testosterone cypionate intramuscular injection Azurity) was added to the policy; the same criteria apply as for testosterone cypionate products.

1 yearstandard approval duration for hypogonadism and gender-affirming indications

up to 400 mgmaximum commonly-authorized dose for enanthate/cypionate per administration

750 mgAveed loading and maintenance dose (mg per injection)

150–450 mgTestopel pellet dose range and interval

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Recommended Authorization Criteria

Initial Therapy for Male Hypogonadism

Covered when ALL of the following are met for hypogonadism:

Initial diagnostic requirements: Patient has persistent signs and symptoms of androgen deficiency (pre-treatment)

Signs/symptoms include depressed mood, decreased energy, progressive decrease in muscle mass, osteoporosis, and loss of libido

Laboratory confirmation (preferred pathway): Two pre-treatment serum testosterone (total or bioavailable) measurements, each taken in the morning on two separate daysBoth measurements low per laboratory reference values

Documentation required

Alternate laboratory pathway: At least one pre-treatment serum testosterone (total or bioavailable) level documented as lowLow per laboratory reference values

Documentation required (used when alternate pathway applied)

Permitted dosing regimens

Approve if the patient meets ONE of the following dosing regimens:

Cypionate (Depo-Testosterone / Azmiro) or Enanthate: Depo-Testosterone (testosterone cypionate) or Azmiro or testosterone enanthate: up to 400 mg administered subcutaneously or intramuscularly every 1 to 4 weeks, not to exceed 400 mg every 2 weeks≤400 mg per administration; interval 1–4 weeks (not to exceed 400 mg every 2 weeks)

Aveed: 750 mg IM, then 750 mg at 4 weeks, then 750 mg every 10 weeks thereafterPer product labeling

Testopel (pellet): Testopel: 150–450 mg subcutaneously every 3 to 6 months150–450 mg; interval 3–6 months

Special indications and prescriber requirements

Covered for specific indications with prescriber requirements:

Delayed puberty / Induction of puberty in males >=14: Approve for 6 months for delayed puberty or induction of puberty in males 14 years of age or older when using specified products (testosterone cypionate, Azmiro, testosterone enanthate, or Testopel)6 months approval

Refer to dosing regimens for product- and age-specific doses

Breast cancer in females: Approve testosterone enanthate IM for 6 months if prescribed by or in consultation with an oncologist6 months

Oncology-related reviews (e.g., EviCore) may apply

Gender-affirming (FTM) testosterone therapy: Approve for 1 year if prescribed by or in consultation with an endocrinologist or a physician who specializes in transgender care

Requests for injectable testosterone intended to enhance athletic performance are not recommended for approval. The policy excludes use of these products for performance enhancement and similar off‑label goals when those uses are not listed in the Recommended Authorization Criteria.

Coverage is not recommended for circumstances that are not specifically listed in the Recommended Authorization Criteria. These non‑covered situations will be updated as new published data become available; providers should submit requests only for indications and dosing that meet the policy criteria and supporting documentation requirements.

Products, Codes, and Laboratory Criteria

Covered injectable testosterone products listed by brand/formulationmixedCovered

Azmiro	testosterone cypionate intramuscular injection (Azurity)
Depo-Testosterone	testosterone cypionate intramuscular injection (Pfizer, generic)
testosterone enanthate	testosterone enanthate intramuscular injection (Hikma, generic)
Testopel	testosterone subcutaneous pellet (Endo)
Aveed	testosterone undecanoate intramuscular injection (Endo)
Xyosted	testosterone enanthate subcutaneous injection (Antares)

inv-07: Serum total testosterone — Two morning measurements showing low testosterone per laboratory reference ranges.

Required measurementsTwo pre-treatment serum testosterone (total or bioavailable) measurements, each taken in the morning on two separate days

Laboratory thresholdBoth measurements must be low as defined by the laboratory reference range (guideline cutoff commonly cited as <300 ng/dL)

DocumentationDocumentation of the two morning measurements is required for prior authorization and medical necessity review

Alternate pathwayIf only one pre-treatment low serum testosterone level is available, policy allows an alternate pathway when documentation is provided

Prior Authorization, Documentation, and Review

Prior Authorization

Prior authorization required

Prior authorization is recommended for medical benefit coverage of injectable testosterone. Approvals are provided for the duration noted in the policy (commonly 1 year when criteria and dosing are met); extended approvals may be allowed if the patient continues to meet the Criteria and Dosing.

Step Therapy

Dose exceptions reviewed by clinician

Requests for doses outside the dosing established in this policy will be considered on a case‑by‑case basis by a clinician (e.g., Medical Director or Pharmacist).

Documentation Required

Required documentation to support criteria

Clinical Background

Injectable testosterone products are used primarily for testosterone replacement in males with primary or secondary hypogonadism. Regimens include intramuscular and subcutaneous formulations with product‑specific dosing schedules; typical agents referenced in the policy include testosterone cypionate/enanthate preparations, long‑acting testosterone undecanoate, subcutaneous pellets, and subcutaneous formulations for weekly dosing. Diagnosis of hypogonadism requires both clinical signs or symptoms and laboratory confirmation with morning serum testosterone measurements per guideline recommendations.

Key Definitions

inv-13: Hypogonadism — Definition including signs/symptoms and diagnostic combination requirements.

DefinitionHypogonadism is a clinical syndrome characterized by signs and symptoms of androgen deficiency (e.g., depressed mood, decreased energy, progressive decrease in muscle mass, osteoporosis, loss of libido) combined with consistently low serum total and/or bioavailable testosterone concentrations

Diagnostic requirementsDiagnosis requires both persistent signs/symptoms of androgen deficiency (pre-treatment) AND laboratory confirmation with low testosterone levels

Laboratory confirmationInitial diagnostic pathway requires two pre-treatment morning serum testosterone measurements on separate days, both low per laboratory reference ranges; an alternate pathway may accept one documented low level with supporting documentation

Clinical contextGuideline recommendations (AUA, Endocrine Society) support using morning total testosterone measurements and correlating biochemical low levels with clinical signs/symptoms before initiating therapy

inv-14: Gender-dysphoric / Gender-incongruent persons — Gender-affirming (FTM) use and diagnostic confirmation requirements.