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