following a full submission assessed under the orphan equivalent process:
berotralstat (Orladeyo®) is accepted for restricted use within NHSScotland.
Indication under review: routine prevention of recurrent attacks of hereditary angioedema (HAE) in adult and adolescent patients aged 12 years and older.
SMC restriction: patients who experience ≥ two clinically significant attacks per month.
In a phase III study in patients with HAE, berotralstat reduced the attack rate compared with placebo.
This advice applies only in the context of an approved NHSScotland Patient Access Scheme (PAS) arrangement delivering the cost-effectiveness results upon which the decision was based, or a PAS/ list price that is equivalent or lower.
This advice takes account of the views from a Patient and Clinician Engagement (PACE) meeting.
- Medicine name:
- berotralstat (Orladeyo)
- SMC ID:
Routine prevention of recurrent attacks of hereditary angioedema (HAE) in adult and adolescent patients aged 12 years and older.
- Pharmaceutical company
- BioCryst Pharmaceuticals
- BNF chapter
- Submission type
- Date advice published
- 07 March 2022