PEGASYS (peginterféron alfa-2a) - Polycythaemia vera or essential thrombocythaemia,

The clinical benefit of PEGASYS (peginterferon alfa-2a) is substantial only in the treatment of polycythaemia vera or essential
thrombocythaemia, in adult patients with intolerance or failure to hydroxycarbamide or when the use of hydroxycarbamide is not appropriate (young patients or those planning a pregnancy). 

• Considering: 
  limited data from the literature having suggested an efficacy of PEGASYS (peginterferon alfa-2a) in terms of response rate,
• the lack of robust efficacy and safety data compared to the other alternatives,
• the well-established use of peginterferon alfa-2a in the treatment of polycythaemia vera and essential thrombocythaemia,
• 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, injection site reactions, peripheral sensory neuropathy, gastrointestinal symptoms (diarrhoea, nausea), psychiatric adverse events (depression), ocular adverse events, skin toxicity, hypertension and asthenia,

the Committee deems that PEGASYS (peginterferon alfa-2a) provides no clinical added value (CAV V) in the care pathway for the treatment of polycythaemia vera or essentialthrombocythaemia, in adult patients with intolerance or failure to hydroxycarbamide or when the use of hydroxycarbamide is not appropriate (young patients or those planning apregnancy). In the other situations of the MA: not applicable.