CurrentMass General Brigham Health PlanPolicy N/A

Androgen Therapy — Testopel (testosterone pellets) Coverage Criteria

Defines prior authorization, coverage criteria, and authorization durations for Testopel (testosterone pellets) for Mass General Brigham Health Plan members across Commercial/Exchange and MassHealth UPPL plans.

Policy Summary

PayerMass General Brigham Health Plan

PolicyAndrogen Therapy — Testopel (testosterone pellets) Coverage Criteria

Policy CodePolicy N/A

Change TypeMaterial revision

Effective DateJun 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization and provide two lab results showing low testosterone (dated <3 months apart and within 1 year of the request) plus supporting documentation and specialist notes when required.

SourceLink

POLICY UPDATE CHANGES

Updated to remove the requirement to provide reference ranges and expanded to require two low testosterone levels be provided; incorporated off-label criteria.

2025-06-01policy effective date

2required low testosterone lab tests

300 ng/dLtotal testosterone threshold

6 moinitial approval (delayed puberty)

1 yr

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initial approval (other)

Coverage Criteria for Testopel (Testosterone Pellets)

Hypogonadism (Adult)

Authorization may be granted when ALL of the following are met and documentation provided:

Hypogonadism diagnosis: Diagnosis of primary hypogonadism OR hypogonadotropic hypogonadism (congenital or acquired) as defined in policy (e.g., testicular failure, pituitary/hypothalamic causes)

See diagnosis list in overview

Laboratory confirmation: Two lab tests dated <3 months apart and drawn within one year of the PA request documenting low testosterone (total serum testosterone < 300 ng/dL) OR low free testosterone with performing lab reference ranges provided2 tests

Appendix allows low free testosterone with reference ranges; required labs must be provided

Delayed Puberty (Off-label)

Delayed puberty (off-label) — Authorization may be granted when ALL of the following are met:

Diagnosis of delayed puberty

Individual drug PA criteria must be met first where applicable

Age and staging: Member is >= 12 and < 17 years of age with Tanner stage I or II

Provide Tanner staging documentation

Supporting findings: One of: arm span > height by >5 cm; abnormal testicular growth (testicular volume < 4 mL); or bone age less than chronological age

Must provide documentation of the selected finding

Laboratory confirmation: Two lab tests dated <3 months apart and drawn within one year of the PA request documenting low testosterone (total serum testosterone < 300 ng/dL)2 tests

See appendix for guidance on low free testosterone or differing lab reference ranges

Gender Dysphoria / Transgender Therapy (Off-label)

Authorization may be granted when ONE of the following diagnoses is documented:

Allowed diagnoses: Diagnosis of gender dysphoria (gender identity disorder), transgenderism, or therapy after gender reassignment surgery

Documentation of the diagnosis is required

Continuation of Therapy and Reauthorization

Continuation and duration

Delayed puberty reauthorization: Reauthorizations beyond six months require documentation of low testosterone levels after discontinuation of therapy

Initial approval for delayed puberty is 6 months; provide labs after stopping therapy per guidance

Other diagnoses reauthorization: Reauthorization for all other diagnoses will be granted for up to 1 year and physician reauthorization will infer a positive clinical response to therapy

Initial and reauthorization duration for non-pediatric indications is 1 year

For members who are new to the plan and are already receiving Testopel, authorization may be reviewed on a case‑by‑case basis. Exceptions allowing continued coverage may apply when the medication was obtained as samples or through a manufacturer's patient assistance program. Absent those exceptions, prior treatment alone does not guarantee automatic approval and the request will be evaluated against standard coverage criteria.

The policy requires documentation to support medical necessity; lack of required documentation may lead to non‑authorization. In particular, requests without sufficient clinical records (including the laboratory confirmation described in the criteria) may be denied when they do not meet the documentation standards for coverage.

Key Values and Thresholds

inv-07: Total serum testosterone — numeric threshold for low level.

Total serum testosterone threshold< 300 ng/dL

Required lab confirmation countTwo tests dated <3 months apart and drawn within one year of the PA request

Acceptable alternative when total normalLow free testosterone acceptable if lab reference ranges provided (see appendix)

inv-08: Age for delayed puberty PA — age range for pediatric off-label use.

Age range for delayed puberty PA>= 12 and < 17 years

Required Tanner stageTanner stage I or II

Prescriber requirement

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for Testopel (testosterone pellets) when billed under the medical benefit. Note: Testopel is also available on the pharmacy benefit — refer to the MassHealth Drug List for coverage and pharmacy criteria when applicable.

Medical benefit prior authorization required for Testopel
Pharmacy availability: see MassHealth Drug List

Step Therapy

Step Therapy Note

Step therapy or individual drug prior authorization criteria apply where indicated. For products with individual drug PA requirements, those criteria must be satisfied before approval is considered.

Step therapy/individual drug PA criteria must be met when applicable
Confirm whether the requested product requires individual drug PA prior to approval

Background

Testopel is an implantable testosterone formulation used for androgen replacement. Clinical use includes treatment of primary hypogonadism and hypogonadotropic hypogonadism, management of delayed puberty in males (off‑label), and use in gender dysphoria or post‑gender reassignment therapy (off‑label). Prior authorization and appropriate documentation, including laboratory confirmation of low testosterone, are required for coverage.

Definitions

inv-15: Hypogonadism / Delayed puberty — definitions and diagnostic categories used in the policy.

Primary hypogonadismTesticular failure due to causes such as cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter syndrome, chemotherapy, or toxic damage

Hypogonadotropic hypogonadismPituitary or hypothalamic causes including congenital deficiencies or acquired injury from tumors, trauma, or radiation

Delayed puberty (policy definition)Males >=12 and <17 years with Tanner stage I or II and supporting findings (e.g., testicular volume <4 mL or bone age < chronological age)

Gender dysphoria / post‑surgery therapyDiagnosis may include gender dysphoria, transgenderism, or status-post transgender surgery as an off-label indication

Policy Summary

PayerMass General Brigham Health Plan

PolicyAndrogen Therapy — Testopel (testosterone pellets) Coverage Criteria

Policy CodePolicy N/A

Change TypeMaterial revision

Effective DateJun 1, 2025

Next Review DateN/A

SourceLink

On This Page

Specialist involvement: Prescriber is a pediatric endocrinologist or consult notes from a pediatric endocrinologist or other specialist are provided

Specialist evaluation recommended for pediatric patients

Prescriber is a pediatric endocrinologist or consult notes from a specialist are provided

inv-09: Testicular volume for delayed puberty — clinical threshold.

Testicular volume threshold< 4 mL

Other supporting physical findingsArm span > height by >5 cm

Bone age findingBone ages documented as less than the member's current age

inv-15: Hypogonadism / Delayed puberty definitions — diagnostic categories referenced in criteria.

Hypogonadism (adult) diagnostic categoriesPrimary hypogonadism (testicular failure) and hypogonadotropic hypogonadism (pituitary/hypothalamic causes)

Delayed puberty (pediatric) definitionChronological age >=12 and <17 years with Tanner stage I or II and supporting findings (e.g., testicular volume <4 mL)

Gender dysphoria / transgender therapyGender dysphoria, transgenderism, or therapy after gender reassignment surgery (off-label indication)

Documentation Required

Required Documentation

Documentation supporting the diagnosis and necessity of therapy must be provided. Required documentation includes specialty consult notes when applicable and laboratory test results confirming low testosterone.

Diagnosis documentation (e.g., primary hypogonadism, hypogonadotropic hypogonadism, gender dysphoria, delayed puberty)
Two testosterone lab tests dated < 3 months apart and drawn within one year of the PA request showing total serum testosterone < 300 ng/dL (or low free testosterone with reference ranges attached)
Specialist documentation: prescriber is a pediatric endocrinologist for delayed puberty or consult notes from a specialist when required

Denial Risk

New-to-Plan Review May Trigger Denial

Authorizations for members who are new to the plan may be reviewed case-by-case and can be denied if the member is not currently receiving the medication, except when the product was obtained only as samples or through manufacturer patient assistance programs.

New-to-plan requests may be denied if member is not currently receiving the medication
Exceptions: ongoing therapy documented or medication obtained via samples or manufacturer patient assistance programs may be considered