Aveed (testosterone undecanoate)
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Policy governing medical benefit coverage and prior authorization requirements for Aveed (testosterone undecanoate) injections for testosterone replacement therapy in adult males across Geisinger Health Plan lines of business.
No material clinical or coverage changes in this revision.
Coverage Criteria for Aveed (testosterone undecanoate)
inv-01: Initial therapy — Commercial/Exchange/CHIP
Covered when ALL of the following are met:
Authorization duration: initial approval for up to 12 months; subsequent approvals require medical record documentation of continued disease improvement or lack of disease progression; discontinue if toxicity or worsening.
inv-02: Gender dysphoria — additional requirements
For cases related to gender dysphoria, ALL of the following are required in addition to diagnostic and step/failure criteria:
inv-03: Initial therapy — Medicare
Medicare coverage when ALL of the following are met:
Authorization duration: initial approval for 12 months or less; subsequent approvals for additional 12-month periods or less with documentation of continued disease improvement or lack of progression; discontinue if toxicity or worsening.
Eligibility and contract specific benefit limitations and/or exclusions will apply. Coverage statements found in the line-of-business specific benefit document will supersede this policy.
Use of Aveed in patients who do not require testosterone replacement therapy or when the risks outweigh the benefits (including the risks of pulmonary oil microembolism and anaphylaxis) would not meet medical necessity. Aveed should only be used in patients who require testosterone replacement therapy and in whom the benefits of treatment outweigh these serious risks.
Prior Authorization, Step Therapy, and Documentation Requirements
Prior authorization required (Commercial/Exchange/CHIP)
Prior authorization is required for Aveed for commercial, exchange, and CHIP lines of business; submit a prior authorization request documenting that all diagnostic and trial/failure criteria are met for testosterone replacement therapy in adult males.
Medicare prior authorization requirements
Prior authorization is required for the Medicare line of business; include documentation that all Medicare-specific diagnostic criteria are met and, when applicable for gender dysphoria cases, that a WPATH-aligned behavioral health evaluation and post-pubertal status are documented.
Step therapy — failure of injectables required
Coverage requires therapeutic failure on, intolerance to, or contraindication to both testosterone cypionate AND testosterone enanthate before Aveed will be authorized.
- Must document failure, intolerance, or contraindication to testosterone cypionate AND testosterone enanthate.
Required documentation to support authorization
Provide medical record documentation of the diagnosis and of therapeutic failure, intolerance, or contraindication to both comparator injectables; for gender dysphoria cases include a psychological evaluation meeting WPATH-aligned qualifications and documentation that the member is post-pubertal.
- Diagnosis: primary hypogonadism OR hypogonadotropic hypogonadism documented in the record.
- Therapeutic failure, intolerance, or contraindication to testosterone cypionate AND testosterone enanthate.
- For gender dysphoria: psychological evaluation by a behavioral health professional meeting WPATH-aligned qualifications (see policy) and documentation the member is post-pubertal.
Denial triggers (Commercial/CHIP)
A denial may be triggered if the medical record lacks documentation of primary hypogonadism or hypogonadotropic hypogonadism, or if there is no documentation of therapeutic failure, intolerance, or contraindication to both testosterone cypionate and testosterone enanthate.
- Absence of diagnostic documentation for primary or hypogonadotropic hypogonadism.
- No documentation showing failure, intolerance, or contraindication to both testosterone cypionate and testosterone enanthate.
Initial Therapy
inv-14: Initial therapy — Initial approval conditions
Initial approval conditions
Authorization duration: initial approval for up to 12 months; subsequent approvals require documentation of continued disease improvement or lack of disease progression; medication will no longer be covered if patient experiences toxicity or worsening.
Continuation Therapy
inv-15: Continuation therapy — Subsequent approvals
Subsequent approvals
Step Therapy Requirements
| Step | Requirement |
|---|---|
| 1 | Therapeutic failure on, intolerance to, or contraindication to both comparator testosterone injectable products: testosterone cypionate AND testosterone enanthate (medical record documentation required). |
Definitions and Terminology
Background
Aveed (testosterone undecanoate) is an intramuscular androgen indicated for testosterone replacement therapy in adult males with deficiency or absence of endogenous testosterone, including primary hypogonadism and hypogonadotropic hypogonadism. Use is limited to patients who require replacement therapy and only when the clinical benefits outweigh serious safety concerns such as pulmonary oil microembolism and anaphylaxis.
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