The Scottish Medicines Consortium (SMC) has accepted Pradaxa (dabigatran etexilate) for routine use within the National Health Service (NHS) of Scotland for its currently licensed indication: the prevention of venous thromboembolic events in adults who have undergone total hip or knee replacement surgery.
Also the Danish Institute for Rational Pharmacotherapy (IRF) which belongs to the Danish Medicines Agency has endorsed Pradaxa as a good alternative to low molecular weight heparins (LMWH) both with respect to efficacy and ease of use.
The European Commission granted marketing authorisation for Pradaxa in all 27 EU member states in March 2008.
These decisions on Pradaxa are the first by European health technology assessment bodies and their positive outcomes are likely to be viewed favourably by decision makers considering the implementation and reimbursement of Pradaxa across the EU as they indicate Pradaxa has fulfilled all clinical and cost-effectiveness criteria necessary for use within the NHS in Scotland and clinical criteria necessary for use in Denmark.
Data from the phase III RE-NOVATE and RE-MODEL studies showed oral, once daily administration of both 150 and 220 mg Pradaxa was as effective and safe as injectable enoxaparin (40 mg) in preventing venous thromboembolism (VTE) and all cause mortality following total hip and total knee replacement surgery.
In contrast to low molecular weight heparins (LMWH), which require subcutaneous injection, Pradaxa is administered as a fixed, oral dose making it significantly easier to administer both in the hospital setting and, more importantly, in the home setting after discharge.
Unlike both LMWH and warfarin, Pradaxa does not require monitoring.