NICE said that, before it decided if dabigatran should be available on the NHS, it would need ‘more plausible’ estimates of cost-savings from eliminating the need to monitor patients’ anti-coagulation.

Patients with AF who are treated with dabigatran do not need to undergo the regular anticoagulation monitoring required for those on warfarin.

The drug has also been shown to be more effective than warfarin at preventing stroke, systemic embolism, ischaemic stroke and vascular mortality. It is being launched in the UK this week, but NICE will not make its final recommendations until December.

NICE said it accepted evidence of dabigatran’s superiority and that this represented ‘an important development for patients with AF’. But the institute has asked the drug’s manufacturer Boehringer-Ingelheim for ‘more robust data’ to estimate the drug’s cost-effectiveness.

NICE’s deputy chief executive Dr Gillian Leng said the institute’s independent appraisal committee had asked for ‘more plausible’ estimates of cost-savings from eliminating the need to monitor patients’ anti-coagulation.

‘It has requested cost-effectiveness analysis of this sequential regimen compared with warfarin using more robust data to estimate effectiveness, and a more plausible set of assumptions about the drug’s use in clinical practice,’ she said.

‘These include using lower costs for anticoagulation monitoring than that suggested in the manufacturer’s submission and modelling a patient population more representative of the AF patient population in the UK than was used in the manufacturer’s original analysis.’