CurrentCignaPolicy IP0351

Testosterone

Cigna coverage policy governing prior authorization and medical necessity criteria for injectable and implantable testosterone products (Aveed, Azmiro, Testopel, Xyosted) for eligible members, with plan-specific variations and state/federal mandate considerations.

Policy Summary

PayerCigna

PolicyTestosterone

Policy CodePolicy IP0351

Change TypeAdded product; minor formatting

Effective Date03/01/2025

Next Review Date

Key ActionObtain prior authorization and submit required documentation including two early-morning serum testosterone measurements for initial therapy.

SourceLink

POLICY UPDATE CHANGES

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

Minor policy format updates and addition of dosage form to products in the preferred product table.

Updated policy title.

4named injectable/implantable products

1 yrstandard approval duration

2required pre-treatment measurements

11980,J3145,S0189example codes listed

Coverage Criteria for Injectable and Implantable Testosterone

Initial and Other FDA-Supported Uses

Testosterone injectable and implantable pellet products are medically necessary when ONE of the following is met:

FDA-Approved Indications

Initial Therapy (A): Patient has persistent signs and symptoms of androgen deficiency; AND two pre-treatment early-morning serum testosterone measurements on separate days; AND both testosterone levels are low per laboratory reference values; AND preferred product criteria is met.two low morning testosterone measurements
Signs/symptoms include depressed mood, decreased energy, progressive decrease in muscle mass, osteoporosis, and loss of libido.
Currently Receiving Testosterone Therapy (B): Patient has persistent signs and symptoms of androgen deficiency; AND at least one pre-treatment serum testosterone (total or bioavailable) level which was low per laboratory reference values.one low pre-treatment test
Approve for 1 year.
Delayed Puberty (2): Male age ≥14 with delayed puberty or need for induction of puberty — product-specific approval for Azmiro or Testopel for 6 months.
Refer to dosing section for Azmiro and Testopel dosing regimens.
Gender-Dysphoric/FTM (3): Patient is undergoing female-to-male gender reassignment (endocrinologic masculinization) and therapy is prescribed by, or in consultation with, an endocrinologist or clinician who specializes in transgender care.
Approve for 1 year; see dosing options for product-specific regimens.

Product-Specific Step or Fail-First Requirements

For certain employer, value, or individual plans the following product-specific requirements apply:

Azmiro (employer plans): Documentation of failure, contraindication, or intolerance to ONE of: Depo-testosterone (testosterone cypionate IM) OR Delatestryl (testosterone enanthate IM).

Applies to employer plans as specified.

Azmiro (individual/family plans): Documentation of failure, contraindication, or intolerance to ONE of: Depo-testosterone (testosterone cypionate IM) OR Delatestryl (testosterone enanthate IM).

Applies to individual and family plans as specified.

Xyosted (employer/value/other plans): Documentation of failure, contraindication, or intolerance to ONE of: Depo-testosterone (testosterone cypionate IM) OR Delatestryl (testosterone enanthate IM).

Applies to Standard/Performance/Value/Advantage/Total Savings Drug List Plans and other specified plan types.

The following use is specifically not medically necessary and is excluded from coverage: use of injectable or implantable testosterone products to enhance athletic performance. Such indications are excluded from a typical pharmacy benefit and may be denied.

Any use that is not explicitly described in the policy’s medically necessary criteria is considered not medically necessary. The policy’s exclusion list is not exhaustive; members seeking coverage for indications outside the stated criteria may have claims denied.

Initial Therapy Criteria

Initial Therapy

Covered when ALL of the following are met:

Initial Therapy Criteria: (i) Persistent signs and symptoms of androgen deficiency (pre-treatment); AND (ii) Two pre-treatment early-morning serum testosterone (total or bioavailable) measurements on separate days; AND (iii) Both serum testosterone levels are low as defined by the laboratory reference values; AND (iv) Preferred product criteria is met.two low morning testosterone measurements

Signs/symptoms include depressed mood, decreased energy, progressive decrease in muscle mass, osteoporosis, and loss of libido. Approve for 1 year.

Continuation Therapy Criteria

Continuation Therapy

Criteria for patients currently receiving therapy

Currently Receiving Testosterone Therapy: Patient has persistent signs and symptoms of androgen deficiency; AND at least one pre-treatment serum testosterone (total or bioavailable) level which was low as defined by the laboratory reference values.one low pre-treatment test

Approve for 1 year.

Step Therapy / Fail-First Requirements

Product	Applicable Plan Types	Fail‑first Requirement
Azmiro (testosterone cypionate IM)	Employer plans; Individual and Family plans	Documentation of failure, contraindication, or intolerance to ONE of: (1) Testosterone cypionate IM (Depo‑testosterone) OR (2) Testosterone enanthate IM (Delatestryl).
Xyosted (testosterone enanthate SC)	Standard/Performance/Value/Advantage/Total Savings Drug List plans; Individual and Family plans	Documentation of failure, contraindication, or intolerance to ONE of: (1) Testosterone cypionate IM (Depo‑testosterone) OR (2) Testosterone enanthate IM (Delatestryl).

Billing and Coding

Considered Medically Necessary CodesmixedCovered

11980	Subcutaneous hormone pellet implantation (implantation of estradiol and/or testosterone pellets beneath the skin)
J3145	Injection, testosterone, undecanoate, 1 mg.
S0189	Testosterone pellet, 75 mg

Total testosterone diagnostic threshold (guideline suggested)

Diagnostic thresholdTotal testosterone below 300 ng/dL (American Urological Association guideline suggested)

Confirmatory testingTwo total testosterone measurements on separate occasions, both collected in the early morning

Clinical correlationDiagnosis requires compatible signs and symptoms of testosterone deficiency in addition to low measurements

Provider Actions and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior Authorization Required for specific injectable testosterone products. Prior authorization is required for Aveed, Azmiro, Testopel, and Xyosted. All approvals are provided for the duration noted in the clinical criteria and because of specialized evaluation, certain approvals require prescription by or consultation with a specialist in the treated condition.

Affected products: Aveed, Azmiro, Testopel, Xyosted
Approvals provided for the duration noted in clinical criteria
Specialist prescribing/consultation may be required

Step Therapy

Fail‑first Requirement for Specific Products

Fail‑first (step) requirement applies for certain products on some plans. Documentation must show failure, contraindication, or intolerance to the specified comparator product(s) before coverage of the requested product will be approved.

Azmiro (testosterone cypionate intramuscular injection): documentation of failure, contraindication, or intolerance to ONE of: Depo-testosterone (testosterone cypionate IM) OR Delatestryl (testosterone enanthate IM).
Xyosted (testosterone enanthate subcutaneous injection): documentation of failure, contraindication, or intolerance to ONE of: Depo-testosterone (testosterone cypionate IM) OR Delatestryl (testosterone enanthate IM).
Applies to Employer Plans, Individual and Family Plans, and specified formulary tiers (Standard/Performance/Value/Advantage/Total Savings Drug List Plans where noted).

Documentation Required

Required Clinical Documentation

Required clinical documentation must be submitted with the prior authorization request to demonstrate medical necessity for injectable testosterone therapy.

Signs and symptoms of androgen deficiency (pre-treatment) — e.g., depressed mood, decreased energy, progressive decrease in muscle mass, osteoporosis, loss of libido.
Pre-treatment serum testosterone measurements: Initial therapy requires TWO morning serum testosterone (total or bioavailable) measurements on separate days that are both low per laboratory reference ranges; patients currently receiving testosterone therapy require at least ONE pre-treatment morning serum testosterone level that was low.
Specify whether request is for Initial Therapy or Continuation (Currently Receiving Testosterone Therapy) and indicate which criterion is met (A or B and relevant subcriteria).
If product-specific preferred product criteria apply, document how preferred product criteria are met.
For delayed puberty/induction of puberty (males ≥14 years), document indication and applicable dosing justification.

Denial Risk

Excluded Indication

Excluded indications are not covered under the pharmacy benefit. Any use not meeting the medical necessity criteria is considered not medically necessary.

Use to enhance athletic performance is explicitly excluded and will be denied as not medically necessary.
Other non‑covered uses not listed may also be excluded; criteria will be updated as new evidence becomes available.

Product-Specific Dosing and Quantity Limits

Aveed — dosing schedule

Dose schedule (standard)750 mg IM initial, then 750 mg at 4 weeks, then 750 mg every 10 weeks

Administration routeIntramuscular injection

Approval durationApprove for 1 year when medical necessity criteria met

Azmiro — dosing

Maximum dosingUp to 400 mg every 1 to 4 weeks

Safety frequency limitNot to exceed 400 mg every 2 weeks

RoutesSubcutaneous or intramuscular administration

Testopel — dosing

Dose range150 to 450 mg subcutaneously

IntervalEvery 3 to 6 months

Indications notedApproved for delayed puberty (≥14 years) or other covered indications per criteria

Xyosted — dosing

DoseUp to 100 mg subcutaneously once weekly

Administration routeSubcutaneous injection

Approval durationApprove for 1 year when medical necessity criteria met

Site of Care Considerations

Note

Ensure site of care and dosing are reasonable and clinically supported

When coverage is available and medically necessary, the site of care, dosing, frequency, and duration should be reasonable, clinically appropriate, and supported by evidence; adjust based on severity, alternative treatments, and prior response.

Site of care (including infusion or clinic settings) must be clinically appropriate and supported by evidence-based literature.
Dosage, frequency, and duration should be individualized and adjusted as clinically appropriate.

Definitions

Specified gender (policy statement)

Definition used for criteriaSpecified gender is defined by biological traits (males/females) regardless of gender identity or expression

Application noteAn asterisk (*) appears in clinical criteria to indicate the specified gender context

Prescriber requirementCertain approvals require prescription by or consultation with a specialist due to specialized evaluation needs

Hypogonadism — diagnosis and testing

DefinitionHypogonadism: clinical diagnosis of androgen deficiency with compatible signs/symptoms and low serum testosterone

Suggested laboratory thresholdTotal testosterone below 300 ng/dL (AUA guideline) confirmed on testing

Confirmatory testingTwo early-morning total testosterone measurements on separate days (both low) before diagnosis; continuation may require one prior low test

Background

Testosterone replacement therapy is indicated for treatment of male hypogonadism (primary or secondary) when patients have compatible signs and symptoms of androgen deficiency and confirmatory laboratory testing. Clinical features may include decreased energy, depressed mood, reduced muscle mass, osteoporosis, and loss of libido. Diagnosis requires early-morning serum total testosterone measurements with guideline-recommended thresholds (commonly below 300 ng/dL per professional guidance) confirmed on two separate days for initial therapy; a single prior low value may suffice for patients already receiving therapy. Approvals for FDA-supported indications such as hypogonadism are typically authorized for 1 year, with product- and indication-specific dosing, duration, and specialist consultation requirements described elsewhere in the policy.

Revision History

2025-03-01addedLatest

Azmiro was added to the policy and is included among covered injectable testosterone products with the same criteria applied as other testosterone products.

2024-12-01clarified

Minor policy format updates and addition of dosage form to products in the preferred product table; no clinical criteria changes.

2025-03-01revised_title

Policy effective date set to 03/01/2025 and policy title updated to 'Testosterone'.