ModifiedCareSourcePolicy N/A

MEDICAL POLICY

Defines prior authorization recommendations, clinical criteria, dosing, covered indications (male hypogonadism, delayed puberty, breast cancer in females, gender-affirming masculinization), exclusions, documentation requirements, and dosing limits for listed injectable testosterone products.

Policy Summary

PayerCareSource

PolicyMEDICAL POLICY

Policy CodePolicy N/A

Change TypeSelected revision (added Azmiro)annual revision

Effective DateSep 11, 2024

Next Review Date

Key ActionSubmit prior authorization with required documentation (morning serum testosterone measurements per criteria); approvals provided for specified durations per indication.

SourceLink

POLICY UPDATE CHANGES

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

Annual Revision performed with review date 09/11/2024.

Policy initially created with review date 09/06/2023.

6Listed Products

3Primary covered indications

1Breast cancer indication (oncologist consult)

<300Diagnostic testosterone cutoff (AUA)

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Coverage Summary

Overview: This policy covers prior authorization recommendations and coverage criteria for injectable testosterone (medical benefit) with a covered_with_criteria stance. It applies to listed products and indications including male hypogonadism, delayed puberty, breast cancer in females (oncologist consult required), and gender-affirming masculinization. Status: MODIFIED. Effective/last review dates: Effective 2024-09-11, Last review 2023-09-06 (policy history includes annual and selected revisions up to 12/04/2024).

Surface quick policy facts

Listed Products6

Primary covered indications3

Breast cancer indication (oncologist consult required)1

Diagnostic threshold (AUA)< 300 ng/dL

Recommended Authorization Criteria

FDA-Approved Indications - Hypogonadism (Primary or Secondary) in Males

Approve for 1 year if the patient meets ONE of the following (A or B): Note that morning measurements are required where indicated.

ALL of the following

A) Initial Therapy (ALL required)
- Patient has had persistent signs and symptoms of androgen deficiency (pre-treatment)
- Patient has had two pre-treatment serum testosterone (total or bioavailable) measurements
  Each taken in the morning on two separate days [documentation required].
- The two serum testosterone levels are both low, as defined by the normal laboratory reference values< 300 ng/dL per AUA guidance (reasonable diagnostic cutoff)
  [documentation required]
B) Alternative (both required)
- Patient has had persistent signs and symptoms of androgen deficiency (pre-treatment)
- Patient has had at least one pre-treatment serum testosterone (total or bioavailable) level which was low, as defined by the normal laboratory reference values< 300 ng/dL reasonable cutoff; lab reference values apply
  [documentation required]

Dosing Criteria for FDA-Approved Indications

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

ANY of the following

Testosterone enanthate intramuscular injection: Up to 400 mg administered subcutaneously or intramuscularly every 1 to 4 weeks, not to exceed 400 mg every 2 weeks.
Depo-Testosterone / Azmiro: Depo-Testosterone (testosterone cypionate intramuscular injection, generics) or Azmiro: Up to 400 mg administered subcutaneously or intramuscularly every 1 to 4 weeks, not to exceed 400 mg every 2 weeks.
Aveed: 750 mg administered intramuscularly, followed by 750 mg injected after 4 weeks, then 750 mg injected every 10 weeks thereafter.
Testopel: Up to 150 mg to 450 mg subcutaneously every 3 to 6 months.

Covered Products / Codes

Covered products (listed in policy)mixedCovered

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

Provider Actions & Billing Implications

Prior Authorization

Prior authorization required (recommended)

Prior authorization is recommended for medical-benefit coverage of injectable testosterone. Approval durations vary by indication (commonly 6 months for some indications and 1 year for others) and are specified in the policy; requests outside established dosing/authorization conditions will be reviewed case-by-case.

Documentation Required

Laboratory documentation for hypogonadism diagnosis

For diagnosis of male hypogonadism provide morning serum total or bioavailable testosterone measurements. Initial therapy requires two separate morning pre-treatment measurements (taken on different days). An alternative pathway may be supported by at least one pre-treatment morning measurement that is low per the laboratory reference range. Lab reports and related documentation are required.

Chart notes
Laboratory reports
Prescription claims records / prescription receipts

Documentation Required

Specialist prescribing/consultation requirement for some indications

Some indications require specialist prescribing or consultation. Breast cancer indication requires the drug be prescribed by or in consultation with an oncologist. Gender-affirming (female-to-male) therapy and certain other indications require prescription by or consultation with an endocrinologist or a physician who specializes in transgender care.

Billing Rule

Dose limits enforced

Dose limits in the policy are enforced. Common caps include not to exceed 400 mg every 2 weeks for testosterone cypionate or enanthate regimens. Specific product schedules include Aveed (750 mg IM, then 750 mg at 4 weeks, then every 10 weeks), Testopel (150–450 mg subcutaneously every 3 to 6 months), and Xyosted (up to 100 mg subcutaneously once weekly). Requests for dosing outside these documented regimens will be reviewed on a case-by-case basis by clinician review.

Background & Evidence

Background: The policy addresses injectable testosterone formulations used for testosterone replacement therapy and other FDA-labeled uses. The diagnosis of male hypogonadism requires both signs/symptoms of androgen deficiency (examples include depressed mood, decreased energy, progressive loss of muscle mass, osteoporosis, and loss of libido) and low serum testosterone laboratory values. Product-specific dosing schedules per labeling and the policy include: Aveed — 750 mg IM, then 750 mg at 4 weeks, then 750 mg every 10 weeks; Testopel — pellets 150 mg to 450 mg subcutaneously every 3 to 6 months; Xyosted — subcutaneous administration (policy lists up to 100 mg once weekly for gender-affirming use). Other injectable options (e.g., Depo-Testosterone or Azmiro and testosterone enanthate) have dosing regimens up to 50–400 mg given intramuscularly or subcutaneously at intervals commonly every 1 to 4 weeks with typical caps (not to exceed 400 mg every 2 weeks for cypionate/enanthate regimens).

Key guideline evidence

AUA guideline testosterone cutoffTotal testosterone < 300 ng/dL

Endocrine Society diagnostic recommendationSymptoms plus unequivocally low serum total and/or free testosterone

Definitions: For purposes of this policy, the terms males and females refer to individuals with the biological traits of a male or female, respectively, regardless of a person’s gender identity or expression; these definitions are used where a specified gender is noted in the clinical criteria and policy statement.