Natesto — CareFirst (Caremark)

Initial criteria

• Diagnosis of primary or hypogonadotropic hypogonadism must be established by clinical features and confirmed low serum testosterone levels.
• Patient must be male, unless for breast cancer indication as noted.
• The drug must NOT be prescribed for age-related hypogonadism (late-onset hypogonadism).
• For breast cancer indication: patient is premenopausal with breast cancer who has benefited from oophorectomy AND is considered to have a hormone-responsive tumor AND the request is for intramuscular testosterone enanthate injection (generic Delatestryl).
• For delayed puberty: patient is male with clearly delayed puberty not secondary to a pathologic disorder; use conservative doses and monitor bone age every 6 months.
• For gender dysphoria: use consistent with compendial support for transgender and gender diverse persons.

Reauthorization criteria

• Continuation of therapy requires ongoing medical necessity and documented benefit or maintenance of serum testosterone within physiologic range.
• Therapy should continue only if no evidence of adverse events or contraindications (e.g., prostate cancer, polycythemia).

Approval duration

12 months