BEROTRALSTAT CAP,ORAL
Clinical Criteria Summary
Exclusion Criteria
- Angioedema or abdominal pain not associated with C1 inhibitor deficiency
Inclusion Criteria (ALL must be met)
- Restricted to VA / VA Community Care allergy/immunology or dermatology provider; or for use in Emergency Medicine/Urgent Care
- Diagnosis of Hereditary Angioedema due to C1 inhibitor deficiency (HAE-C1INH) as established by laboratory testing
Additional Inclusion Criteria (ONE must be met)
- Long-term prophylaxis for HAE-C1INH attacks after consideration of either an attenuated androgen or antifibrinolytic
Clinical Context & Decision-Making Requirements
- Prior consideration of an attenuated androgen or antifibrinolytic must be discussed with the patient using shared decision-making, including efficacy, routes of administration, and side effects of each therapy
- Baseline attack rate criteria may include at least 2 attacks per month or baseline attack rate in clinical trials
- Need for long-term prophylaxis should be determined using shared decision-making