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Testosterone products (multiple formulations/brands) - OpenPayer

CurrentNeighborhood Health Plan of Rhode IslandPolicy 1210-A

Testosterone products (multiple formulations/brands)

Policy governs authorization/coverage criteria for testosterone products (topical, nasal, injectable, oral, pellets) for specified indications including primary hypogonadism, hypogonadotropic hypogonadism, delayed puberty, gender dysphoria, certain breast cancer uses, and inoperable metastatic breast cancer; excludes age-related (late-onset) hypogonadism. Applies to all listed brand and generic testosterone products and dosage forms.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyTestosterone products (multiple formulations/brands)

Policy CodePolicy 1210-A

Change Typeclarified

Effective Date

Next Review Date

Key ActionRequests must meet the specific indication-based criteria (e.g., two morning testosterone levels for hypogonadism; formulation-specific requirements for certain indications) to be authorized; Duration of approval is 36 months.

POLICY UPDATE CHANGES

Duration of approval (DOA) specified as 36 months (Reference 1210-A).

36 monthsDuration of Approval

MultipleProducts Listed

2Required morning testosterone measurements for hypogonadism

Coverage Summary

Policy governs authorization and coverage (status: covered with criteria) for a broad set of testosterone products and formulations — topical, nasal, injectable, oral, and implant pellets — listed in the policy (e.g., Androgel, Natesto, Depo-Testosterone, Testopel, Jatenzo, Kyzatrex, Tlando, Xyosted and others). Coverage is limited to FDA-supported indications including primary hypogonadism and hypogonadotropic hypogonadism, and to specific compendial or formulation-based uses for delayed puberty, gender dysphoria, certain premenopausal breast cancer settings, and inoperable metastatic breast cancer. The policy explicitly excludes use for age-related (late-onset) hypogonadism.

Initial Therapy Criteria (by indication)

Primary or Hypogonadotropic Hypogonadism (Initial and Continuation)

Authorization may be granted when ALL of the following criteria are met:

ALL of the following

The requested drug is NOT being prescribed for age-related hypogonadism (also referred to as late-onset hypogonadism)
Before the start of testosterone therapy, the patient has at least TWO confirmed low morning testosterone levels according to current practice guidelines or your standard lab reference valuesAt least TWO confirmed low morning testosterone levels

Breast Cancer (Hormone-Responsive Tumor)

Authorization may be granted when ALL of the following criteria are met:

ALL of the following

The requested drug is NOT being prescribed for age-related hypogonadism (also referred to as late-onset hypogonadism)
The request is for intramuscular testosterone enanthate injection (generic Delatestryl)
The requested drug is being prescribed for a premenopausal patient with breast cancer who has benefited from oophorectomy AND is considered to have a hormone-responsive tumor

Delayed Puberty

Authorization may be granted when ALL of the following criteria are met:

ALL of the following

The requested drug is NOT being prescribed for age-related hypogonadism (also referred to as late-onset hypogonadism)
requested formulation
- The request is for intramuscular testosterone enanthate injection (generic Delatestryl)
- The request is for testosterone propionate implant pellet (Testopel)

Gender Dysphoria

Authorization may be granted when ALL of the following criteria are met:

ALL of the following

The requested drug is NOT being prescribed for age-related hypogonadism (also referred to as late-onset hypogonadism)
The patient has been educated on ANY contraindications AND side effects to therapy
The patient’s comorbid conditions are reasonably controlled
Before the start of therapy, the patient has been informed of fertility preservation options
The requested drug is prescribed by, or in consultation with, a provider specialized in the care of transgender youth (e.g., pediatric endocrinologist; family or internal medicine physician; obstetrician-gynecologist) that has collaborated care with a mental health provider

Inoperable Metastatic Breast Cancer

Authorization may be granted when ALL of the following criteria are met:

ALL of the following

The requested drug is NOT being prescribed for age-related hypogonadism (also referred to as late-onset hypogonadism)
The patient is 1 to 5 years postmenopausal1 to 5 years postmenopausal
The patient had an incomplete response to other therapy for metastatic breast cancer
The request is for intramuscular testosterone enanthate injection (generic Delatestryl)