CurrentCareSourcePolicy N/A

Testosterone Injectable Products Utilization Management Medical Policy

Defines prior authorization, coverage criteria, dosing limits, and documentation requirements for injectable testosterone products for clinical indications (e.g., male hypogonadism, delayed puberty, transgender masculinization, select female breast cancer) for CareSource members.

Policy Summary

PayerCareSource

PolicyTestosterone Injectable Products Utilization Management Medical Policy

Policy CodePolicy N/A

Change TypeAdded product (Azmiro)

Effective DateN/A

Next Review DateDec 4, 2024

Key ActionObtain prior authorization and provide required documentation including two morning pre-treatment testosterone measurements for initial therapy unless alternate criteria apply.

SourceLink

POLICY UPDATE CHANGES

Azmiro (testosterone cypionate intramuscular injection) was added to the policy with the same criteria as testosterone cypionate products.

~8named injectable testosterone products listed

400 mgmax typical dose (cypionate/enanthate)

750 mgAveed dose per injection

1 yeartypical approval period

Recommended Authorization Criteria

Policy Summary

PayerCareSource

PolicyTestosterone Injectable Products Utilization Management Medical Policy

Policy CodePolicy N/A

Change TypeAdded product (Azmiro)

Effective DateN/A

Next Review DateDec 4, 2024

Key ActionObtain prior authorization and provide required documentation including two morning pre-treatment testosterone measurements for initial therapy unless alternate criteria apply.

SourceLink

On This Page

inv-01: Initial therapy — Hypogonadism

Covered when ALL of the following are met for hypogonadism initial therapy:

Initial Therapy for Hypogonadism: Patient has persistent signs and symptoms of androgen deficiency (e.g., depressed mood, decreased energy, progressive decrease in muscle mass, osteoporosis, loss of libido).clinical signs/symptoms documented pre-treatment

Documentation required

Laboratory confirmation: Patient has two pre-treatment morning serum testosterone measurements (total or bioavailable) on two separate days that are low per the laboratory reference range; documentation required.two low morning testosterone measurements on separate days

Approve for 1 year

inv-02: Alternative initial criteria

Covered when BOTH of the following are met for hypogonadism continuation or when only one pre-treatment level is available:

Persistent clinical features: Patient has persistent signs and symptoms of androgen deficiency (pre-treatment).clinical signs/symptoms documented pre-treatment

Documentation required

Single pre-treatment laboratory value: At least one pre-treatment serum testosterone (total or bioavailable) measurement taken in the morning that is low per the laboratory reference range; documentation required.one low pre-treatment morning testosterone measurement

Approve per policy

inv-03: Dosing regimens

Covered dosing regimens (approve if patient meets ONE of the following):

Depo-Testosterone / Azmiro: Depo-Testosterone (testosterone cypionate) or Azmiro: up to 400 mg administered subcutaneously or intramuscularly every 1 to 4 weeks, not to exceed 400 mg every 2 weeks.<=400 mg per dose; interval 1-4 weeks; not to exceed 400 mg every 2 weeks

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.<=400 mg per dose; interval 1-4 weeks; not to exceed 400 mg every 2 weeks

Aveed: 750 mg IM, followed by 750 mg at 4 weeks, then 750 mg every 10 weeks thereafter per product labeling.750 mg per IM dose with labeled schedule

inv-04: Other supported indications

Other uses with supportive evidence (covered with criteria):

Gender dysphoria (FTM): Prescribed for gender dysphoria / female-to-male masculinization: approve for 1 year if prescribed by or in consultation with an endocrinologist or clinician experienced in transgender care; dosing per approved regimens above.documentation of specialist involvement

Delayed puberty in males >=14: Delayed puberty or induction of puberty in males 14 years of age or older: approve testosterone (cypionate/enanthate or Testopel) for 6 months when indicated.6 months duration for puberty induction

Breast cancer (female): Breast cancer in females: approve testosterone enanthate for 6 months if prescribed by or in consultation with an oncologist.6 months; specialist consult

Coverage for injectable testosterone is limited to the indications and criteria listed in this policy. Requests for use outside the Recommended Authorization Criteria are not recommended for approval and are excluded from coverage. Providers should not expect coverage for indications that are not explicitly authorized by the criteria in this document.

Use of injectable testosterone for non-medical purposes such as cosmetic or performance enhancement is explicitly not recommended for approval and is excluded from coverage. Such enhancement indications fall outside the scope of the policy and are routinely denied.

Drug Names, Dosing Thresholds, and Diagnostic Codes

Named injectable testosterone productsmixed

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

Serum testosterone diagnostic threshold (inv-08)

Diagnostic thresholdTotal serum testosterone below ~300 ng/dL as a reasonable cut-off (per AUA guideline); diagnosis requires low levels plus signs/symptoms.

Confirmation requiredTwo pre-treatment total testosterone measurements obtained on separate early-morning occasions are required for initial therapy (unless alternative criteria apply).

Acceptable analytesTotal testosterone (or bioavailable/free when indicated) may be used per laboratory reference ranges.

Maximum dosing for cypionate/enanthate (inv-09)

Maximum per-dose limitUp to 400 mg administered subcutaneously or intramuscularly per dose for testosterone cypionate (Depo‑Testosterone/Azmiro) and testosterone enanthate.

Dosing frequency rangeDoses may be given every 1 to 4 weeks depending on regimen and clinical response.

Frequency ceilingNot to exceed 400 mg more frequently than every 2 weeks (i.e., cannot exceed 400 mg every 2 weeks).

Typical suggested dosingSuggested clinical dosing range is 50 to 400 mg every 2 to 4 weeks (per product labeling and clinical practice references).

Prior Authorization, Documentation, and Denials

Prior Authorization

Prior Authorization Required

Prior authorization required. Prior Authorization is recommended for medical benefit coverage of injectable testosterone. Approvals are provided for the duration noted in the authorization and may be extended if the patient continues to meet the Criteria and Dosing. Requests for doses outside the dosing documented in this policy will be considered on a case-by-case basis by a clinician (Medical Director or Pharmacist).

Typical approval duration: up to 1 year for FDA‑approved hypogonadism indications when criteria are met
Requests for dose exceptions or regimens not listed require case‑by‑case review

Note

Dose Exceptions — Case‑by‑Case Review

Dose exceptions: Requests for doses outside the dosing specified in this policy will be reviewed on a case‑by‑case basis by a clinician (e.g., Medical Director or Pharmacist). Document rationale and clinical justification to support the requested dose or regimen.

Include prior treatments, reason standard dosing is not appropriate, and supporting lab or specialty notes

Documentation Required

Documentation Requirements

Documentation required. Documentation is required for use of injectable testosterone as noted in the criteria. Required documentation may include, but is not limited to, chart notes, laboratory reports, prescription claims records, prescription receipts, and other supporting information. If required documentation has been previously received during a coverage review, the documentation requirement is considered met.

Pre‑treatment signs and symptoms of androgen deficiency when applicable (chart notes)
Serum testosterone measurements: typically two morning measurements on separate days for initial therapy (total or bioavailable) — lab reports required
Laboratory reference ranges demonstrating low testosterone as defined by the reporting laboratory
Prescription records or receipts and prior therapy history when relevant
Specialist consultation notes when policy requires prescription by or consultation with a specialist

Denial Risk

Excluded Indications and Denial Guidance

Excluded indications and denials. Coverage of injectable testosterone is not recommended for indications excluded from this policy (for example, use to enhance). Requests for indications not listed in the Recommended Authorization Criteria are not recommended for approval and will be denied.

Enhancement or cosmetic indications — not covered
Any use not meeting the Recommended Authorization Criteria — basis for denial

Clinical Background

Injectable testosterone products are indicated primarily for testosterone replacement in males with primary or secondary hypogonadism and for other specified clinical uses when supported by the criteria in this policy. Diagnosis of hypogonadism requires both a clinical syndrome of androgen deficiency (for example, low libido, decreased energy, loss of muscle mass, depressed mood, or osteoporosis) and consistently low serum total or free testosterone. Laboratory confirmation typically requires morning testosterone measurements on separate days; when documented criteria are met, approvals are generally granted for defined durations (commonly 1 year) and dosing is limited to the regimens specified in the policy (for example, up to 400 mg per dose for cypionate/enanthate preparations or product-specific schedules such as the Aveed regimen).

OpenPayer

Testosterone Injectable Products Utilization Management Medical Policy

Recommended Authorization Criteria

Drug Names, Dosing Thresholds, and Diagnostic Codes

Prior Authorization, Documentation, and Denials

Clinical Background

Key Definitions