NICE wants more information on Pradaxa
pharmafile | August 17, 2011 | News story | Sales and Marketing | NICE, Pradaxa
NICE has asked for more information on Pradaxa, after deciding in preliminary guidance that the drug is not cost-effective in preventing stroke and systemic embolism in people with atrial fibrillation.
The Institute wants Boehringer to re-do its sums and give more information on its sequential regimen for differing doses, otherwise it will not be able to recommend Pradaxa (dabigatran) for funding on the NHS.
Pradaxa is already approved by NICE for prevention of blood clots in patients who have had hip or knee replacement surgery.
More cost-effectiveness data needed
Dr Gillian Leng, NICE deputy chief executive and chief operating officer for NHS Evidence, said NICE’s independent appraisal committee has asked Boehrigner for additional information in a number of areas.
“In particular it is seeking clarification on the cost effectiveness of the licensed regimen, in which people aged under 80 years begin treatment with dabigatran 150 mg twice daily, and at age 80 years switch to dabigatran 110 mg twice daily.
“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.
“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.”
The drug can be used in either a 150mg twice daily dose for the under 80s population or 110mg twice daily for the over 80s.
In its first draft guidance the Institute said this sequential regimen – of switching patients from the high dose to the lower after a patient reaches 80 – would need a new cost-effectiveness analysis compared to standard treatment warfarin as this had not been included in the first draft guidance.
Pradaxa is estimated to cost £2.52 per day, per patient for either of the two doses – or £919.80 per year – whereas warfarin currently costs the NHS just £0.04 a day, or £14.60 per year.
Wedded to this however is the cost of regular anticoagulation monitoring, which Boehringer says adds £414.90 to the annual price of warfarin.
But NICE disputes this, saying the German firm has overestimated the cost of monitoring, believing it to average just £115.14, and has asked Boehringer to re-calculate using these lower figures.
Adverse events
The drug is currently looking to replace the 65-year old blood thinner warfarin, which can cause a number of inconveniences for patients, such as the need for regular monitoring, dose adjustments, and numerous food and drug interactions.
It is also associated with a number of serious side effects, including increased risk of potentially fatal intracranial haemorrhage and haemorrhagic stroke.
In recent studies Pradaxa has not shown a tendency to increase the risk of these events, but has been associated with an increased risk of gastrointestinal bleeding, which can also be fatal.
It has also been associated with higher rates of dyspepsia (disordered digestion), which will add to the overall annual cost of the drug.
Boehringer only factored in this additional cost for the first three months of treatment, but NICE believes this should be extended to the duration of treatment with Pradaxa, and will add this to its long list of information requests.
The next appraisal meeting for the drug is scheduled for September, with final guidance expected to be issued this December.
Ben Adams
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