following a full submission assessed under the orphan equivalent medicine process:
ropeginterferon alfa-2b (Besremi®) is not recommended for use within NHSScotland.
Indication under review: as monotherapy in adults for the treatment of polycythaemia vera without symptomatic splenomegaly.
In a phase III study, ropeginterferon alfa-2b failed to demonstrate non-inferiority to hydroxycarbamide in treatment-naïve patients who required cytoreductive therapy and in patients who had a partial response to hydroxycarbamide.
The submitting company did not present a sufficiently robust clinical and economic analysis to gain acceptance by SMC.
This advice takes account of the views from a Patient and Clinician Engagement (PACE) meeting.
- Medicine name:
- ropeginterferon alfa-2b (Besremi)
- SMC ID:
As monotherapy in adults for the treatment of polycythaemia vera without symptomatic splenomegaly.
- Pharmaceutical company
- AOP Orphan Pharmaceuticals AG
- Submission type
- Not recommended
- Date advice published
- 09 May 2022