Idarucizumab (Praxbind, Boehringer) can be used commercially in England, Ireland and Wales, following the agreement of each country’s respective health technology appraisal bodies.
The agreement of the National Institute for Health and Care Excellence (NICE, England), the All Wales Medicines Strategy Group (AWMSG, Wales) and the National Centre for Pharmoeconomics (NCPE, Ireland) has granted the drug eligibility for full reimbursement, without the need for a full appraisal in these countries.
Idarucizumab rapidly and specifically reverses the anticoagulant effect of dabigatran etexilate (Pradaxa) for patients needing emergency surgery, or in situations of life-threatening or uncontrolled bleeding.
Idarucizumab received European Commission marketing authorisation in November 2015. It is the first and only specific reversal agent for a novel anticoagulant to be granted a licence in the European Union, according to a Boehringer press release.
Klaus Dugi, medical director and managing director, Boehringer UK and Ireland, says “There are going to be very rare circumstances when rapid reversal of the anticoagulation effect of dabigatran is beneficial. That the decision by NICE, AWMSG and NCPE supports availability of Idarucizumab to doctors in England, Wales and Ireland is fantastic news. While we do not anticipate that it will be used regularly, there can be no doubt that its availability will provide added confidence for prescribers when choosing dabigatran for their patients.”