BESREMI (ropeginterferon alfa-2b) - Polycythaemia vera

The clinical benefit of BESREMI (ropeginterferon alfa-2b) is substantial only as monotherapy in adults for the treatment of polycythaemia vera without symptomatic splenomegaly, in the event of intolerance or failure to respond to hydroxycarbamide or when the use of hydroxycarbamide is not appropriate (young patients or those planning a pregnancy). 

Considering: 

• inconclusive data from the PROUD-PV study, and the methodological limitations of the CONTINUATION-PV extension study, not enabling evaluation of the contribution of this treat ment in this disease,
• the lack of robust efficacy and safety data compared to the other alternatives,
• the absence of robust data on quality of life,
• the safety protocol marked, in particular, by haematological adverse events (anaemia, leukopenia, lymphopenia), flu-like symptoms, gastrointestinal symptoms (diarrhoea, nausea), asthenia, but taking into account the well-established medical use of peginterferon alfa-2a, another pegylated interferon alpha in the treatment of polycythaemia vera, 

the Committee deems that BESREMI (ropeginterferon alfa-2b) provides no clinical added value (CAV V) in the care pathway for the treatment of polycythaemia vera, in adult patients without symptomatic splenomegaly, in the event of intolerance or failure to respond to hydroxycarbamide or when the use of hydroxycarbamide is not appropriate (young patients or those planning a pregnancy).