Azmiro — Blue Cross Blue Shield of Illinois

Initial criteria

• Patient is continuing therapy with sex hormone treatment AND ALL of the following: patient is monitored at least once per year AND patient is NOT continuing treatment in Alabama, Idaho, Indiana, Iowa, Louisiana, Mississippi, Oklahoma, Puerto Rico, South Carolina, South Dakota, Tennessee; state-specific continuation rules apply for Florida, Kentucky, North Carolina, North Dakota, and Texas per policy.
• OR patient is an adult (age ≥18 years) AND if in Alabama then age ≥19 years AND if in Puerto Rico then age ≥21 years AND ONE of the following: (A) initiating sex hormone treatment with documented persistent gender dysphoria/gender incongruence, exclusion of other causes, counseling on irreversible effects and fertility, informed consent, emotional/cognitive maturity, and addressed coexisting mental/physical conditions, and additional written informed consent requirements if in Florida; OR (B) currently on sex hormone treatment meeting testosterone level and monitoring criteria with corresponding informed consent requirements in Florida.
• If request is for delayed puberty: patient’s sex is male OR requested agent is medically appropriate.
• If request is for breast cancer: (A) patient 1–5 years postmenopausal with inoperable metastatic breast cancer OR (B) premenopausal patient benefited from oophorectomy with hormone‑responsive tumor.
• Request for endometriosis is amenable to hormone management.
• Request is for prevention of attacks of hereditary angioedema.
• For myelofibrosis-associated anemia: EPO ≥500 mU/mL or <500 mU/mL with inadequate response or loss of response to ESA; patient has no FDA‑labeled contraindications; agent not used in combination with aromatase inhibitors, antiestrogens, or SERMs unless not for appearance/performance enhancement; and combination therapy justified.
• For brand agents listed: ONE of the following—(1) patient diagnosed with stage 4 advanced metastatic cancer using agent for disease or associated condition AND use consistent with best practices and FDA approval; OR (2) patient currently stable on requested agent; OR (3‑9) patient has tried, not responded to, or cannot tolerate generic androgens/anabolic steroids supported for indication; or generic agents contraindicated, ineffective, or not in patient’s best interest; or prior discontinuation of drug in same class due to inadequate response or adverse event [chart notes required].
• Patient will not use requested agent in combination with another androgen/anabolic steroid unless supported by evidence.
• For BCBS NM Fully Insured or NM HIM members: patient has no contraindications, indication is a rare disease, and (A) indication is FDA‑labeled or compendia‑supported, OR (B) if Ohio Fully Insured/HIM Shop member, prescriber may submit two peer‑reviewed journal articles supporting the use.

Reauthorization criteria

• Continuation if patient remains stable on therapy, meets monitoring and state‑specific continuation criteria, and no contraindications present.

Approval duration

6 months (delayed puberty) or 12 months (all other indications)