CurrentNeighborhood Health Plan of Rhode IslandPolicy Testosterone Products TGC PA Policy 1210-A

Testosterone Products Prior Authorization Criteria

Prior authorization criteria for topical, nasal, oral, injectable, and implant testosterone products for adults (and select pediatric uses) including indications (primary hypogonadism, hypogonadotropic hypogonadism, gender dysphoria, delayed puberty, certain breast cancer uses) and documentation/confirmation requirements. Excludes use for age-related (late-onset) hypogonadism and pediatric males <18 except specific conditions.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyTestosterone Products Prior Authorization Criteria

Policy CodePolicy Testosterone Products TGC PA Policy 1210-A

Change TypeNo material change

Effective DateMar 1, 2023

Next Review Date

Key ActionPrior authorization is required and will be approved only if the documented indication and supporting documentation meet the policy criteria (see indication-specific requirements such as lab confirmation and specialist consultation).

POLICY UPDATE CHANGES

No material clinical or coverage changes in this update.

6Covered Indication Categories (primary, hypogonadotropic, gender dysphoria, delayed puberty, metastatic breast cancer, testopel delayed puberty)

2Required confirmed morning testosterone tests for new therapy

0Use for age-related hypogonadism

Coverage Summary

Coverage stance: Covered with criteria (prior authorization required) per policy Testosterone Products TGC PA Policy 1210-A (Status: CURRENT). Effective date: 2023-03-01; Last review: 2023-03-01. Scope: prior authorization criteria apply to topical, nasal, oral, injectable, and implant testosterone products for adults and select pediatric uses. Included FDA-indicated uses: primary hypogonadism, hypogonadotropic hypogonadism, delayed puberty, certain metastatic breast cancer indications, and gender-affirming hormone therapy. The policy excludes use for age-related (late-onset) hypogonadism and notes safety/efficacy have not been established for males <18 years except for specified indications (e.g., delayed puberty, select gender-affirming care) and subject to indication-specific documentation requirements.

Thresholds and Key Stats

Confirmed low morning testosterone levels (detail)At least two confirmed low morning testosterone levels before therapy start for new therapy; at least one confirmed low morning level prior to initiation for continuation requests (per current practice guidelines or standard lab reference values)

Postmenopausal interval for metastatic breast cancer1 to 5 years postmenopausal

Tanner stageTanner stage 2 or greater (required for patients <18 yrs when prescribing for gender dysphoria)

Covered Indication CategoriesPrimary, hypogonadotropic, gender dysphoria, delayed puberty, metastatic breast cancer, Testopel for delayed puberty

Required confirmed morning testosterone tests for new therapyAt least 2 confirmed morning tests before starting therapy

Use for age-related hypogonadismNot established / excluded (use for age-related or late-onset hypogonadism is not covered)

Continuation Therapy Criteria

Continuation Therapy — Primary or hypogonadotropic hypogonadism

Primary or hypogonadotropic hypogonadism (continuation)

The requested drug is being prescribed for primary or hypogonadotropic hypogonadism
The request is for continuation of therapy
Before the patient started testosterone therapy, the patient had a confirmed low morning testosterone level according to current practice guidelines or your standard lab reference valuesAt least one confirmed low morning testosterone level prior to initiation
Per guidelines or lab reference values

Provider Actions & Documentation Requirements

Prior Authorization

Prior authorization required

Prior authorization is required and will be approved only if the documented indication and supporting documentation meet the policy criteria (see indication-specific requirements such as lab confirmation and specialist consultation).

Documentation Required

Laboratory documentation of low testosterone

For primary or hypogonadotropic hypogonadism: for new therapy, submit at least two confirmed low morning testosterone levels per current practice guidelines or your standard lab reference values before therapy start. For continuation requests, submit documentation of a confirmed low morning morning testosterone level prior to therapy initiation (per guidelines or lab reference values).

Documentation Required

Gender dysphoria informed consent and counseling

Document that the patient is able to make an informed decision to engage in hormone therapy and has been educated on contraindications and side effects, that comorbid conditions are reasonably controlled, and that the patient was informed of fertility preservation options prior to starting therapy. For patients under 18, document that the drug is prescribed by or in consultation with a provider specialized in care of transgender youth with collaborative care from a mental health provider, and document that the patient has reached (or previously reached) Tanner stage 2 or greater.

Informed decision to engage in hormone therapy
Education on contraindications and side effects
Fertility preservation discussion prior to therapy
Comorbid conditions reasonably controlled
If <18: specialist prescribing/consultation and collaboration with a mental health provider
If <18: documentation of Tanner stage ≥2

Prior Authorization

Breast cancer specific requirements for Depo-Testosterone

For intramuscular testosterone enanthate (e.g., Depo-Testosterone) for inoperable metastatic breast cancer, document that the patient is 1 to 5 years postmenopausal with incomplete response to other therapy for metastatic breast cancer; alternatively, for premenopausal patients document benefit from oophorectomy and that the tumor is considered hormone-responsive.

Applicable Codes

No code groups were provided in the brief. If available, populate a code table with product-specific identifiers (e.g., NDC codes for individual testosterone formulations, CPT/HCPCS codes for administration, and relevant ICD-10 diagnosis codes linked to covered indications). Placeholder: add NDCs for listed products (Androderm, AndroGel, Natesto, Testopel, Jatenzo/Kyzatrex/Tlando, Delatestryl/Depo-Testosterone/Xyosted, etc.) and HCPCS/CPT codes for injections/implant procedures when available.

Clinical Evidence & Guidelines

Evidence and guideline references cited by the policy include the Endocrine Society 2018 clinical practice guideline (Bhasin et al.), the Endocrine Society 2017 guideline on endocrine treatment for gender dysphoria (Hembree et al.), the ACOG Committee Opinion No. 823 on health care for transgender and gender diverse individuals, and the Standards of Care for the Health of Transgender and Gender Diverse People (SOC, Version 8). The policy notes safety and efficacy of testosterone products are not established for age-related (late-onset) hypogonadism and for males <18 years except for the specific pediatric indications described in the policy.

Background

Background: This CVS Caremark-derived policy lists formulary testosterone products (examples: Androderm, AndroGel, Fortesta, Natesto, Testim, Testopel, Jatenzo, Kyzatrex, Tlando, Delatestryl/Depo-Testosterone, Xyosted, Vogelxo) and describes FDA-indicated uses for testosterone replacement: primary hypogonadism, hypogonadotropic hypogonadism, delayed puberty, certain metastatic breast cancer indications, and gender-affirming hormone therapy. The policy specifies that safety/efficacy of topical, nasal, oral, injectable, and implant testosterone products has not been established for age-related (late-onset) hypogonadism and for males <18 years except where specific pediatric indications (e.g., delayed puberty, select gender-affirming care with documented Tanner stage and specialist collaboration) are met. The scope summary frames prior authorization requirements and indication-specific documentation (laboratory confirmation of low morning testosterone levels, specialist consultation, informed decision/fertility discussion, and breast cancer-specific criteria such as 1–5 years postmenopausal status).

Definitions

Age-related hypogonadismAlso referred to as 'late-onset hypogonadism'; safety and efficacy of testosterone for this indication have not been established — use is excluded