following a resubmission:
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’s justification of the treatment’s cost in relation to its health benefits was not sufficient and in addition the 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.
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Medicine details
- Medicine name:
- ropeginterferon alfa-2b (Besremi)
- SMC ID:
- SMC2563
- Indication:
As a monotherapy in adults for the treatment of polycythaemia vera without symptomatic splenomegaly.
- Pharmaceutical company
- AOP Orphan Pharmaceuticals AG
- BNF chapter
- Malignant disease and immunosuppression
- Submission type
- Resubmission
- Status
- Not recommended
- Date advice published
- 10 July 2023