Dawnzera (donidalorsen) — Medica

Initial criteria

• Patient is age ≥ 12 years
• Patient has HAE type I or type II as confirmed by both of the following diagnostic criteria: (a) low levels of functional C1-INH protein (≤ 50% of normal) at baseline [documentation required]; AND (b) lower than normal serum C4 levels at baseline [documentation required]
• Note: A diagnosis of HAE with normal C1-INH (also known as HAE type III) does NOT satisfy this requirement
• Medication is prescribed by or in consultation with an allergist/immunologist or a physician who specializes in the treatment of HAE or related disorders

Reauthorization criteria

• Patient has a diagnosis of HAE type I or type II [documentation required]
• Note: A diagnosis of HAE with normal C1-INH (also known as HAE type III) does NOT satisfy this requirement
• According to the prescriber, the patient has had a favorable clinical response since initiating Dawnzera prophylactic therapy compared with baseline (examples include decrease in HAE acute attack frequency, severity, or duration)
• Medication is prescribed by or in consultation with an allergist/immunologist or a physician who specializes in the treatment of HAE or related disorders

Approval duration

1 year