Dawnzera — Blue Cross Blue Shield of Oklahoma

Initial criteria

• The prescriber states the patient has been treated with the requested agent (starting on samples is not approvable) within the past 90 days AND is at risk if therapy is changed OR
• The patient has a diagnosis of HAE due to C1INH deficiency evidenced by decreased C1-INH levels or mutation in the C1-INH gene
• The requested agent is prescribed for HAE prophylaxis
• The 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)
• The patient's age is within FDA labeling for the requested indication OR there is support for use at the patient's age
• If Takhzyro is requested, one of the following age- and therapy-duration-based conditions is met (age ≥2 years, with appropriate dosing adjustment based on attack-free duration)
• Medications known to cause angioedema (ACE inhibitors, estrogens, angiotensin receptor blockers) have been evaluated and discontinued when appropriate
• The prescriber is a specialist in the area of the patient’s diagnosis (e.g., allergist, immunologist) or has consulted with a specialist
• The patient will NOT be using the requested agent in combination with another agent indicated for prophylaxis of HAE attacks (Andembry, Cinryze, Dawnzera, Haegarda, Orladeyo, Takhzyro)
• The patient does NOT have any FDA labeled contraindications to the requested agent

Reauthorization criteria

• The patient has been previously approved for the requested agent through the plan’s prior authorization process
• The prescriber is a specialist or has consulted with one in the area of the patient’s diagnosis
• The patient has had clinical benefit with the requested agent as indicated by a decrease in the frequency of acute HAE attacks from baseline or decrease in use of on-demand therapy
• The patient will not be using the requested agent in combination with another prophylaxis agent (Andembry, Dawnzera, Cinryze, Haegarda, Orladeyo, Takhzyro)
• If Takhzyro is requested, one of the following age- and therapy-duration-based conditions is met (age ≥2 years, with appropriate dosing adjustment based on attack-free duration)
• The patient does not have any FDA labeled contraindications to the requested agent

Approval duration

3–12 months (varies by plan and agent)