Advice

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 details

Medicine name:
ropeginterferon alfa-2b (Besremi)
SMC ID:
SMC2421
Indication:

As monotherapy in adults for the treatment of polycythaemia vera without symptomatic splenomegaly.

Pharmaceutical company
AOP Orphan Pharmaceuticals AG
Submission type
Full
Status
Not recommended
Date advice published
09 May 2022