PCT managers have appealed against a NICE appraisal of the oral anticoagulant dabigatran, claiming the guidance will have ‘one of the largest impacts on the NHS to date'.
Dabigatran is the first in a number of new drugs to prevent stroke in patients with atrial fibrillation, but managers at NHS Salford have blocked its approval on the NHS by submitting an appeal that says safety data on the drug is ‘limited' and NICE estimates of its cost are unrealistic.
The drug is a likely alternative to warfarin treatment in many patients, with the NICE appraisal approving dabigatran for patients with atrial fibrillation patients after a previous stroke or transient ischaemic attack, and in patients aged 65 years or older with diabetes, hypertension or cardiovascular disease.
The results of an appeal hearing – held earlier this month – are yet to be released, but documents submitted in advance by NHS Salford accuse NICE of ‘exceeding its powers' and argue its proposals would require ‘significant anticoagulant service redesign' that would be required quickly.
A letter from NHS Salford reads: ‘The NICE costing template models a 20% uptake of dabigatran amongst the eligible population at five years. We and other PCTs consider this to be unrealistic and local networks estimate a higher and more rapid uptake, with more than 300,000 patients opting for dabigatran.'
‘The recommendations made in the technology appraisal will potentially have one of the largest impacts on the NHS of any NICE FAD published to date.'
The result of the appeal hearing will be sent to NICE for consideration in 15 days.