REFIXIA (nonacog beta pegol), antihaemophilic factor (factor IX)

Insufficient clinical benefit to justify its reimbursement in haemophilia B due to uncertainties as to the long-term consequences of the accumulation of PEG in tissue

• REFIXIA has MA in the treatment and prevention of bleeding episodes in patients over 12 years with haemophilia B.

• It is a factor IX with half-life extended by conjugation with a 40 kD polyethylene-glycol (PEG) molecule. The FIX with half-life extension already on the market do not contain PEG.

• In the current state of knowledge, we cannot rule out the potential long-term risks related to the accumulation of PEG molecules in tissue, especially in the plexus choroideus.