UK NICE recommends Boehringer's Pradaxa for stroke prevention

In final draft guidance published today (November 1), the UK’s drug watchdog the National Institute of Health and Clinical Excellence (NICE) has recommended German independent drugmaker Boehringer Ingelheim’s Pradaxa (dabigatran), in accordance with its licensed indications, for the prevention of stroke and systemic embolism in people with atrial fibrillation.

The draft guidance also recommends that the decision about whether to start treatment with dabigatran should be made after an informed discussion about the risks and benefits of dabigatran compared with warfarin, and in light of a person’s current level of international normalised ratioi (INR) control if they are already taking warfarin.

The positive recommendation follows the receipt of further information about the product from the manufacturer that had been requested by NICE in its previous draft guidance, in particular with respect to seeking clarification on the cost effectiveness of the licensed regimen.