NICE recommends Pradaxa for stroke prevention
pharmafile | March 15, 2012 | News story | Sales and Marketing | Boehringer Ingelheim, NICE, Pradaxa, atrial fibrillation
NICE has given a limited recommendation to Boehringer Ingelheim’s blood thinner Pradaxa.
The watchdog said in final guidance that Pradaxa (dabigatran) could be used as an option for the prevention of stroke and systemic embolism in people with atrial fibrillation.
But NICE has said that before patients start using the drug, they should be told about the treatment’s risks compared to the standard treatment warfarin.
Pradaxa has been the subject of a number of safety concerns in recent months, and in October last year the EMA issued a warning to doctors that the drug could cause renal problems.
Warfarin has been the only oral blood thinner available to treat stroke prevention in patients with AF, but requires regular monitoring and dose fixing due to the risk of bleeding.
Professor Carole Longson, NICE health technology evaluation centre director, said: “Atrial fibrillation can be a distressing condition and people with it have an increased risk of suffering a stroke.
“Many people with the condition find it difficult to comply with the most commonly used antithrombotic, warfarin, because, among other things, it requires regular INR monitoring and dose adjustments which can cause disruption and inconvenience.
“Because dabigatran does not require frequent blood tests to monitor treatment it represents a useful alternative option for people with atrial fibrillation.”
Pradaxa is already recommended for venous thromboembolism after hip or knee replacement surgery.
NICE’s expert committee said that the 150 mg twice daily dose of Pradaxa was more clinically effective than warfarin in reducing the risk of stroke or systemic embolism, ischaemic stroke and vascular mortality, and that this “represented an important development for people with atrial fibrillation”.
It also concluded that the lower 110 mg twice-daily dose had shown non-inferiority to warfarin. NICE said that that it was a cost effective use of NHS resources, being less than £20,000 per QALY gained.
The cost of 60 tablets of Pradaxa is set at £75.60 for both 110mg and 150mg doses. NICE estimates that the cost per day, per patient will be around £2.52.
This comes to a cost of £919.80 per year, an expensive treatment as warfarin currently costs the NHS just £0.04 a day, or £14.60 per year.
The watchdog was originally minded not to recommend the drug, but Boehringer persuaded NICE that it was a cost effective option for the NHS.
Pradaxa is the first of the new series of oral blood thinners to be recommended for stroke prevention in AF patients.
Bayer’s Xarelto is also undergoing NICE appraisal for this licence, with a decision on the drug due in in May.
Pfizer and BMS’ Eliquis is currently being considered for the same licence by the EMA, with a decision expected later this year.
Appeal
But in the midst of the appraisal NICE was accused by the Salford NHS Trust of not having GPs on its expert committee to assess the drug.
The Trust said that NICE was ‘not acting fairly’ in this regard, as a full assessment required the input of primary care professionals.
But the appeal panel disagreed and found that NICE had heard from a commissioner who was a GP, and therefore the watchdog had considered the views of a primary care doctor.
The Trust however had more concerns: it also alleged that NICE failed to take into consideration the known safety risk of the drug, and said that it had also not considered the impact on primary care trusts’ budgets, as Pradaxa is much more expensive than warfarin.
But the appeal panel found that NICE had acted properly in these regards, and said that NICE was required to take into account cost effectiveness, rather than affordability or budgetary impact.
The panel also concluded that the NICE had allowed for the known concerns about the drug’s safety as the Institute does not have a role in policing safety, which is a regulatory issue.
Ben Adams
Related Content
Digital mental health technologies – a valuable tool in supporting people with depression and anxiety
The potential benefits of digital mental health technology for managing depression, anxiety and stress, together …
Combination treatments: Takeda’s Implementation Framework and the broader landscape
Pharmafile talks to Emma Roffe, Oncology Country Head (UK & Ireland) about the combination treatment …
Boehringer Ingelheim and LEO Pharma partner to develop treatment for generalised pustular psoriasis
Boehringer Ingelheim and LEO Pharma have partnered to commercialise and further develop Spevigo (spesolimab), a …
