Dawnzera — Blue Cross Blue Shield of Illinois

Initial criteria

• ONE of the following: (A) The requested agent is eligible for continuation of therapy AND prescriber states patient has been treated with the requested agent within the past 90 days (starting on samples not approvable) and is at risk if therapy is changed OR (B) ALL of the following:
• Diagnosis of hereditary angioedema (HAE) due to C1INH deficiency (Type 1 or Type 2) evidenced by ONE of the following: (A) Confirmed by measurement of C1-INH protein level, C1-INH function level, and C4 level: Type 1 HAE shows decreased C4, C1-INH protein, and function levels OR Type 2 HAE shows decreased C4 and function levels (C1-INH protein may be normal or elevated) OR (B) Diagnosis confirmed by mutation in the C1-INH gene altering protein synthesis or function
• Requested agent prescribed for HAE prophylaxis
• Patient has a history of at least three moderate to severe acute HAE attacks per month (e.g., airway swelling, severe abdominal pain, painful facial swelling)
• If the patient has an FDA labeled indication: ONE of the following: (A) Patient's age is within FDA labeling for the requested indication OR (B) There is support for using the requested agent for the patient’s age for the requested indication
• If TAKHZYRO is requested: follow age-based dosing criteria: (A) age ≥12 years OR (B) age 6 to <12 years OR (C) age 2 to <6 years, with timing and dose-adjustment logic per section
• Medications known to cause angioedema (ACE inhibitors, estrogens, angiotensin receptor blockers) have been evaluated and discontinued when appropriate
• Prescriber is a specialist in the area of the patient’s diagnosis (e.g., allergist, immunologist) or has consulted with such a specialist
• Patient will NOT be using the requested agent in combination with another agent indicated for prophylaxis of HAE attacks (i.e., Andembry, Cinryze, Dawnzera, Haegarda, Orladeyo, Takhzyro)
• Patient does NOT have any FDA labeled contraindications to the requested agent
• Alternative approval conditions for specified plan types (e.g., BCBS MT Fully Insured or HIM, BCBS NM Fully Insured, OH Fully Insured/HIM Shop) require absence of contraindications and evidence supporting safety and efficacy from two peer‑reviewed publications or compendia as described.

Reauthorization criteria

• Patient previously approved for the requested agent through plan’s prior authorization process
• Prescriber is a specialist in the area of the patient’s diagnosis (e.g., allergist, immunologist) or has consulted with a specialist
• Patient has had clinical benefit with the requested agent as indicated by ONE of the following: (A) decrease in frequency of acute HAE attacks from baseline OR (B) decrease in use of on‑demand therapy
• Patient will NOT be using the requested agent in combination with another agent indicated for prophylaxis of HAE attacks (i.e., Andembry, Dawnzera, Cinryze, Haegarda, Orladeyo, Takhzyro)
• If TAKHZYRO is requested: meets same age‑based and dose‑adjustment criteria as initial approval
• Patient does NOT have any FDA labeled contraindications to the requested agent

Approval duration

12 months (BCBSIL and BCBSMT); All other plans: Cinryze 3 months, Haegarda 4 months, Andembry or Orladeyo 6 months, Takhzyro 9 months