CurrentMass General Brigham Health PlanPolicy N/A

Testosterone Products Requiring Skilled Administration: Aveed (testosterone undecanoate) / Azmiro (testosterone cypionate)

Defines prior authorization, coverage criteria, and limitations for Aveed and Azmiro injections for testosterone replacement therapy in adult males, including primary hypogonadism, hypogonadotropic hypogonadism, and gender dysphoria; applies to plan pharmacy/medical benefits as specified.

Policy Summary

PayerMass General Brigham Health Plan

PolicyTestosterone Products Requiring Skilled Administration

Policy CodePolicy N/A

Change TypeAdded Azmiroremoved pretreatment testosterone requirement for gender dysphoria

Effective DateJul 1, 2025

Next Review DateN/A

Key ActionSubmit prior authorization with documentation of age (≥18), diagnosis, and required lab/maintenance documentation as specified.

SourceLink

POLICY UPDATE CHANGES

Added Azmiro to the policy and updated the policy title to 'Testosterone Products Requiring Skilled Administration.'

Policy updated to not require low pretreatment testosterone levels prior to initiating therapy for gender dysphoria.

Clarified that authorization may be granted for members new to the plan within 90 days who are currently receiving the medication (excluding samples or manufacturer assistance programs).

2brands covered

12 moapproval length

≥18minimum age

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Coverage Criteria

inv-01: Initial Authorization

Authorization may be granted when ONE of the following pathways is met:

Authorization pathways: Path A: Member new to the plan within the past 90 days and currently receiving the requested medication (excluding when the product is obtained as samples or via manufacturers patient assistance programs).

See documentation requirements and prior authorization policy.

Path B: Clinical criteria: All of the following must be met:

Provider must submit required documentation.

Path B details: Member is 18 years of age or older; AND ONE of the diagnostic groups below applies.

inv-02: Continuation of Therapy

Continuation of therapy is covered when ALL of the following are met:

Continuation requirements: Member is not currently receiving the requested therapy through samples or a manufacturer's patient assistance program; documentation shows the member's testosterone levels are maintained within the normal range; for gender dysphoria, member must meet all initial criteria (except pretreatment low testosterone requirement has been removed for initiation per policy changes).

Reauthorization approvals will be granted for 12 months.

Coverage will not be provided for members using the requested medication for age-related hypogonadism or late-onset hypogonadism.

Use of the requested testosterone products for age-related or late-onset hypogonadism is considered not covered / excluded from benefit.

Initial Therapy

inv-14: Initial Therapy

Initial authorization may be granted via the following clinical pathways when ALL required elements are documented:

Core eligibility: Member is 18 years of age or older; AND documentation supports one of the diagnostic indications below.

Provider must submit documentation as required by the policy (see documentation requirements).

Diagnostic group — ONE of: Primary hypogonadism (congenital or acquired) OR Hypogonadotropic hypogonadism (congenital or acquired) OR Endocrine treatment for gender dysphoria/gender incongruent persons.

For gender dysphoria, prior practice language required at least two pretreatment morning serum total testosterone concentrations; policy updated to remove the pretreatment low testosterone requirement for initiation (see changes).

Primary hypogonadism (examples): Testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter's syndrome, chemotherapy, or toxic damage.

Continuation / Reauthorization Criteria

inv-15: Continuation

Continuation/reauthorization is approved when ALL of the following are satisfied:

Reauthorization criteria: Member is not receiving the requested therapy solely through samples or a manufacturer's patient assistance program; documentation demonstrates testosterone levels are maintained within the normal range; for gender dysphoria, member continues to meet initial criteria (note pretreatment low testosterone is no longer required for initiation).

Reauthorization approvals will be granted for 12 months.

Laboratory & Documentation Coding / Values

Pretreatment morning serum total testosterone

RequirementAt least two confirmed low pretreatment morning serum total testosterone concentrations based on the reference laboratory range or current practice guidelines (required when applying the gender dysphoria initiation pathway per older criteria).

TimingPretreatment measurements must be morning serum total testosterone concentrations (time of draw per lab reference).

Source noteThis requirement applies to the endocrine treatment of gender dysphoria pathway when the older criteria are used; policy text was updated to remove this pretreatment low‑testosterone requirement for initiation in gender dysphoria (see policy changes).

Maintenance documentation

RequirementDocumentation showing the member's testosterone levels are maintained within the normal range is required for continuation (reauthorization).

Provider Actions & Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for these testosterone products. Authorization may be granted for members new to the plan within the past 90 days who are currently receiving the requested medication (excludes medication obtained as samples or via manufacturer patient assistance programs).

Effective Date: 2025-07-01
Contact (AII Plans - Skilled/Medical/Specialty): Phone 877-519-1908; Fax 855-540-3693
Contact (All Plans - Non-Specialty): Phone 800-711-4555; Fax 844-403-1029

Step Therapy

Program Type Note

Program type references step therapy, quantity limits, and specialty limitations. Specific step therapy steps are not detailed in this policy; quantity limits and specialty limitations apply as noted in the header (Quantity Limit; Medical and Specialty Medications).

Definitions

Primary hypogonadism — definition and example causes

DefinitionPrimary hypogonadism: testicular failure (congenital or acquired) causing deficiency or absence of endogenous testosterone.

Example causesCryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter's syndrome, chemotherapy, or toxic damage.

Clinical contextThese conditions are listed as covered indications for testosterone replacement in adult males.

Hypogonadotropic hypogonadism — definition and causes (pituitary/hypothalamic)

DefinitionHypogonadotropic hypogonadism: gonadotropin (LHRH) deficiency or pituitary‑hypothalamic injury (congenital or acquired) resulting in low testosterone with normal or low gonadotropin levels.

CausesPituitary‑hypothalamic injury from tumors, trauma, or radiation; congenital gonadotropin deficiency.

Background

Androgen replacement therapy with testosterone injections is indicated for adult males with primary hypogonadism (testicular failure) or hypogonadotropic hypogonadism (pituitary‑hypothalamic causes), and the policy also addresses endocrine treatment for gender dysphoria. Prior authorization is required; initial and reauthorization approvals are granted for 12 months. The policy expressly excludes coverage for use of these products when prescribed for age‑related or late‑onset hypogonadism.

Step Therapy / Utilization Management Notes

Program element	Policy detail
Program Type
Header lists 'Step Therapy' and other program elements (Quantity Limit; Pharmacy and Medical Benefit; Specialty Limitations N/A) but the document does not specify any step sequence, step-failure requirements, or detailed step therapy steps.

Site of Care / Administration Setting

Note

Administration requires skilled setting (office or infusion center)

Policy header lists the products as “Requiring Skilled Administration,” indicating these injections are intended to be administered in settings where skilled administration is required (e.g., office or infusion center); the policy does not provide additional specific site‑of‑care rules.

Header: “Testosterone Products Requiring Skilled Administration” (Aveed, Azmiro).
Site of care identified as office | infusion center; no further site restrictions specified in policy.