CurrentCignaPolicy N/A

Testosterone (Injectable) Products Prior Authorization Policy

Cigna's coverage policy governing prior authorization for injectable and subcutaneous testosterone products for prescription benefit plans; affects prescribers and members under Cigna-administered plans.

Policy Summary

PayerCigna

PolicyTestosterone (Injectable) Products Prior Authorization Policy

Policy CodePolicy N/A

Change TypeAdded productminor administrative removal

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization and document persistent signs/symptoms plus required morning serum testosterone measurements for initial male hypogonadism therapy.

SourceLink

POLICY UPDATE CHANGES

Added Azmiro to the policy; the same criteria apply as for testosterone cypionate products.

Removal of the documentation requirement from the policy.

6listed injectable/subcutaneous testosterone products

1 yearapproval duration (adult hypogonadism, FTM)

6 monthsapproval duration (delayed puberty, breast cancer)

tworequired pre-treatment morning measurements

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Coverage and Medical Necessity Criteria

Coverage criteria for approved indications

Covered when ALL of the following are met for each indicated use as specified below:

Hypogonadism (Primary or Secondary) in Males - Approve for 1 year

A) Initial Therapy: All of: i) persistent signs and symptoms of androgen deficiency (pretreatment); AND ii) two pre-treatment serum testosterone (total or bioavailable) measurements, each taken in the morning on two separate days; AND iii) both serum testosterone levels are low per laboratory reference values.two morning low testosterone measurements
Signs and symptoms include depressed mood, decreased energy, progressive decreased muscle mass, osteoporosis, and loss of libido.
B) Currently Receiving Therapy: Both of: i) persistent signs and symptoms of androgen deficiency (pretreatment); AND ii) at least one pre-treatment serum testosterone (total or bioavailable) level which was low per laboratory reference values.at least one prior low testosterone measurement

Delayed Puberty or Induction of Puberty in Males >= 14 years: Approve Depo-Testosterone, Azmiro, testosterone enanthate intramuscular injection, or Testopel for 6 months.age >= 14 years

Refer to the Policy Statement.

Breast Cancer in Females: Approve testosterone enanthate intramuscular injection for 6 months if prescribed by or in consultation with an oncologist.

Refer to the Policy Statement.

Gender-Dysphoric/FTM Gender Reassignment: Approve for 1 year if prescribed by or in consultation with an endocrinologist or clinician who specializes in transgender care.

For patients undergoing female-to-male gender reassignment; refer to Policy Statement.

Injectable testosterone products listed in this policy are not medically necessary for any uses other than the specific, covered indications described elsewhere in the policy. Claims for indications that are not supported by the clinical criteria and documentation requirements in this policy will be denied as not covered under the applicable benefit plan.

Use of injectable testosterone products to enhance athletic performance is explicitly excluded from coverage and is considered not medically necessary. This exclusion applies to the listed products and to other unspecified non‑covered uses; the list of noncovered uses may be updated as new evidence becomes available.

Products and Testing Requirements

Covered products by nameNDC | mixed

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

inv-05: Serum testosterone — measurement requirements

Required measurementsTwo separate morning pre-treatment serum testosterone measurements (total or bioavailable) taken on two separate days, both low per the laboratory reference range.

When requiredInitial therapy for male hypogonadism (must accompany persistent signs/symptoms of androgen deficiency).

Alternative for patients already receiving therapyAt least one pre-treatment serum testosterone level that was low per laboratory reference values is sufficient for patients currently receiving testosterone therapy.

Type of assayTotal or bioavailable testosterone measurements are acceptable per policy wording.

Timing of drawEach measurement must be taken in the morning (early morning preferred) as specified by guideline-aligned policy language.

Prior Authorization, Documentation, and Denial Triggers

Prior Authorization

Prior Authorization Recommended

Prior Authorization is recommended for the listed injectable testosterone products. Approvals are provided for the durations stated in the policy (e.g., 1 year for most hypogonadism indications, 6 months for certain indications).

Applies to: Depo-Testosterone; Azmiro; testosterone enanthate (generic); Aveed; Testopel; Xyosted

Step Therapy

No step therapy requirements are specified in this policy for injectable testosterone products.

Documentation Required

Required Clinical Documentation

Clinical Background

Injectable testosterone preparations are primarily used for testosterone replacement in adults with documented primary or secondary hypogonadism and for other specific indications addressed in this policy (for example, induction of puberty in adolescent males, certain breast cancer situations, and masculinizing therapy for female‑to‑male gender‑affirming care). Therapeutic use requires meeting the policy’s clinical criteria, including appropriate diagnostic documentation and laboratory confirmation of low serum testosterone when specified.

Specified Terms and Gender Definitions

inv-12: Specified gender definition

Definition of malesMales are defined as individuals with the biological traits of a male, regardless of the individual's gender identity or gender expression.

Definition of femalesFemales are defined as individuals with the biological traits of a female, regardless of the individual's gender identity or gender expression.

Use in criteriaThe policy notes an asterisk next to the specified gender in clinical criteria and refers readers to this operational definition in the Policy Statement.

Policy Summary

PayerCigna

PolicyTestosterone (Injectable) Products Prior Authorization Policy

Policy CodePolicy N/A

Change TypeAdded productminor administrative removal

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization and document persistent signs/symptoms plus required morning serum testosterone measurements for initial male hypogonadism therapy.

SourceLink

On This Page

Documentation must demonstrate the FDA‑approved or supported indication and required baseline testing for initial therapy of male hypogonadism: persistent signs/symptoms of androgen deficiency and two morning pre‑treatment serum testosterone measurements on separate days that are both low per lab reference ranges. For patients currently receiving testosterone, at least one pre‑treatment low serum testosterone level plus persistent signs/symptoms is required. For delayed puberty, therapy durations and product-specific approvals must be documented.

Initial male hypogonadism: two morning pre‑treatment testosterone measurements on separate days, both low; documentation of persistent signs/symptoms.
Current testosterone recipients: at least one pre‑treatment low testosterone level and persistent signs/symptoms.
Delayed puberty: document indication and product; approvals vary (e.g., 6 months for certain products).

Documentation Required

Oncology / Specialist Consultation Requirement

For the breast cancer indication in females, and for other specialized indications (e.g., gender‑affirming care or other uses requiring specialist involvement), therapy must be prescribed by or in consultation with the appropriate specialist.

Breast cancer (females): prescribe by or in consultation with an oncologist; approve for 6 months.
Gender‑dysphoric/FTM care: prescribe by or in consultation with an endocrinologist or physician specializing in transgender care; approve for 1 year.

Denial Risk

Denial Triggers

Claims lacking a covered diagnosis/procedure code, or submitted for excluded indications (for example, to enhance athletic performance), will be denied as not covered/not medically necessary.

Excluded: enhancement of athletic performance — not covered under pharmacy benefit.
Claims without covered code(s) per the applicable benefit plan will be denied.