Testim — Blue Cross Blue Shield of Alabama

Preferred products

• generic androgen or anabolic steroid agents (supported for use for requested indication)

Initial criteria

• ONE of the following: patient eligible for continuation of therapy (treated within past 90 days or prescriber attests) OR meets initial diagnostic criteria below.
• Diagnosis-based criteria: • For Androderm, Androgel, Jatenzo, Kyzatrex, Fortesta, Natesto, Testim, testosterone topical solution, Tlando, Vogelxo – primary or secondary hypogonadism OR gender dysphoria/gender incongruence. • For danazol – endometriosis amenable to hormone management OR hereditary angioedema (prophylaxis) OR myelofibrosis-associated anemia. • For methyltestosterone or Methitest – primary or secondary hypogonadism OR breast cancer OR delayed puberty in an adolescent.
• For primary or secondary hypogonadism: – If not currently on testosterone therapy: patient has sign/symptom of hypogonadism AND total testosterone <300 ng/dL or below lab normal range OR free testosterone below normal range. – If currently on therapy: total testosterone within or below normal range or <300 ng/dL OR free testosterone within or below normal range.
• For gender dysphoria/gender incongruence: patient age ≥18 years AND evaluated by TWO qualified mental health professionals (one with doctoral degree, one with evaluative-only role) documenting understanding of risks/benefits and that comorbid conditions are controlled AND for patients new to therapy, completion of ≥12 continuous months of real-life experience in congruent gender role.
• For delayed puberty in adolescent: patient is male OR evidence therapy is medically appropriate for sex.
• For breast cancer: – Postmenopausal (1–5 years) with inoperable metastatic breast cancer OR – Premenopausal benefited from oophorectomy AND hormone-responsive tumor.
• For myelofibrosis-associated anemia: serum EPO ≥500 mU/mL OR EPO <500 mU/mL with no/loss of response to ESA.
• Patient has no FDA-labeled contraindications to requested agent.
• For brand agents (Androderm, Androgel/Testosterone gel, Fortesta/Testosterone gel, Jatenzo, Kyzatrex, Methitest, Natesto, Testim, Tlando, Undecatrex, Vogelxo/Testosterone gel): – Tried and had inadequate response OR intolerance/hypersensitivity OR FDA-labeled contraindication to all generic androgen/anabolic steroid agents supported for use.
• Patient will NOT use requested agent in combination with another androgen/anabolic steroid unless supported.
• Length of approval: 12 months.

Reauthorization criteria

• Patient previously approved through plan’s PA process.
• Patient has had clinical benefit with requested agent.
• For hypogonadism: current testosterone total or free level within/below normal range or <300 ng/dL.
• For gender dysphoria/gender incongruence: monitored at least annually AND testosterone within/below normal range for gender identity or support for continuing therapy.
• For other diagnoses: continue if no FDA-labeled contraindications.
• For brand agents: same step-therapy requirements as initial (inadequate response, intolerance, or contraindication to generics).
• Patient not using in combination with another androgen unless justified.
• Length of approval: 12 months.

Approval duration

12 months