CurrentCignaPolicy IP0351

Testosterone (Injectable) Products

Defines Cigna coverage, prior authorization criteria, dosing, and coding for injectable testosterone products (Aveed, Azmiro, Testopel, Xyosted) including FDA-approved indications (male hypogonadism, delayed puberty) and treatment for gender dysphoria (FTM). Applies to health benefit plans administered by Cigna Companies subject to plan-level variances.

Policy Summary

PayerCigna

PolicyTestosterone (Injectable) Products

Policy CodePolicy IP0351

Change TypeCoding updatesproduct additionsannual revisions

Effective DateDec 15, 2025

Next Review Date

Key ActionSubmit prior authorization with required documentation (signs/symptoms and required pre-treatment testosterone measurements) per criteria; approvals provided for specified durations.

SourceLink

POLICY UPDATE CHANGES

No criteria changes; minor policy format updates and addition of dosage form to products in the preferred product table.

Added Azmiro to the policy with the same criteria as other testosterone products.

Annual revision updated policy statement and employer/individual plan preferred product criteria and Conditions Not Covered statement.

Coding Information updated: added HCPCS J1072 and J1073 (note: J1073 effective 1/1/2026); updated S0189 description with effective-through date.

4Named Products Covered

3Primary Covered Indications

Athletic PerformanceNot Covered Example

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Coverage Summary

scope_summary: Defines Cigna coverage, prior authorization criteria, dosing, and coding for injectable testosterone products (Aveed, Azmiro, Testopel, Xyosted) including FDA‑approved indications (male hypogonadism, delayed puberty) and treatment for gender dysphoria (FTM). Applies to health benefit plans administered by Cigna Companies subject to plan‑level variances.

coverage_stance: mixed — coverage varies across plans; gender‑dysphoria and whether products are covered as medical or pharmacy benefit are plan dependent.

stats: Named Products Covered: 4; Primary Covered Indications: 3; Not Covered Example (Athletic Performance): 1; Plan‑Dependent Step Therapy Requirements: 2.

dates: Effective 12/15/2025 (policy effective date); last review 12/15/2025.

Thresholds & Policy Info

Serum testosterone measurementsInitial therapy: Two early-morning pre-treatment measurements on separate days, both low per laboratory reference; Patients currently receiving therapy: at least one pre-treatment low measurement

Age for Delayed Puberty IndicationMale patients 14 years of age or older (approve Azmiro or Testopel for 6 months)

Policy numberIP0351

Effective date12/15/2025

Last review12/15/2025

StatusCURRENT

Medical Necessity Criteria for Injectable Testosterone

Injectable Testosterone is considered medically necessary when ONE of the following is met (1, 2, or 3):

ANY of the following

A or B
- A
  - i. Patient has had persistent signs and symptoms of androgen deficiency (pretreatment).
    Signs/symptoms include depressed mood, decreased energy, progressive decrease in muscle mass, osteoporosis, and loss of libido
  - ii. Patient has had TWO pre-treatment serum testosterone (total or bioavailable) measurements, each taken in the early morning, on two separate days.
  - iii. The two serum testosterone levels are both low, as defined by the normal laboratory reference values.

Dosing Criteria (Referenced in approvals)

Employer / Individual & Family Plan Preferred Product Criteria (Step)

For certain plans, trial of preferred agents is required before Azmiro or Xyosted is approved:

ALL of the following

1) Testosterone cypionate intramuscular injection (Depo-testosterone)
2) Testosterone enanthate intramuscular injection (Delatestryl)

Step Therapy

Step Therapy for Azmiro and Xyosted (plan-dependent)

For certain Employer and Individual & Family plans, prior trial of a preferred intramuscular comparator is required before Azmiro or Xyosted will be approved. The prescriber must attest the patient had inadequate efficacy or significant intolerance to one listed comparator prior to approval of Azmiro or Xyosted. This requirement is plan-dependent.

Continuation Therapy & Dose Exceptions

Prior Authorization

Prior Authorization Required

Prior authorization is required for benefit coverage of injectable testosterone. Approvals are provided for the durations specified in the clinical criteria: 1 year for hypogonadism and for FTM (gender-dysphoric/FTM) indications; 6 months for delayed puberty. PA must be obtained for coverage.

Documentation Required

Laboratory Documentation Required

Documentation must be submitted with initial therapy showing persistent signs/symptoms of androgen deficiency and TWO early-morning pre-treatment serum testosterone measurements on separate days, with both levels low per the laboratory reference. For patients already receiving testosterone therapy, documentation of at least ONE pre-treatment serum testosterone level that was low per the laboratory reference is required.

Not Medically Necessary / Exclusions

Not Medically Necessary (Exclusions)

Injectable Testosterone for any other use is considered not medically necessary, including but not limited to:

To Enhance Athletic Performance. Injectable testosterone products are not recommended for approval because this indication is excluded from coverage in a typical pharmacy benefit.

Applicable Codes

Considered Medically Necessary when criteria metmixedCovered

11980	Subcutaneous hormone pellet implantation (implantation of estradiol and/or testosterone pellets beneath the skin)
J1072	Injection, testosterone cypionate (Azmiro), 1 mg
J1073	Testosterone pellet, implant, 75 mg (Code effective 1/1/2026)
J3145	Injection, testosterone, undecanoate, 1 mg
S0189	Testosterone pellet, 75 mg (Code effective until 12/31/2025)

A material coding update (Selected Revision dated 12/15/2025) added HCPCS J1072 and J1073 (note: J1073 effective 1/1/2026), and updated the description/effective‑through date for S0189.

Clinical Evidence & References

Evidence & Dosing

AUA guideline cut-offTotal testosterone < 300 ng/dL is a reasonable cut-off to support diagnosis (AUA 2018)

Aveed dosing (label)750 mg IM initial, repeat at 4 weeks, then 750 mg every 10 weeks thereafter

Injectable testosterone products are indicated for testosterone replacement in adult males with hypogonadism (primary or hypogonadotropic), for delayed puberty in males, and for masculinizing hormone therapy in transgender males (FTM). Diagnosis should be based on clinical signs/symptoms plus low serum testosterone; multiple guidelines recommend confirmatory early‑morning testing (two measurements on separate days for initial therapy).

Definitions

Males/Females (policy context): individuals with biological traits of a male regardless of gender identity/expression; females: individuals with biological traits of a female regardless of gender identity/expression.

Revision History

12/01/2024clarified

No criteria changes; minor policy format updates and addition of dosage form to products in the preferred product table.

03/01/2025added

Added Azmiro to the policy with the same criteria as other testosterone products.

11/15/2025revised

Annual revision updated the policy statement, employer/individual plan preferred product criteria, and the Conditions Not Covered statement.