NICE backs new oral anticoagulant for stroke prevention
BMJ 2012; 344 doi: https://doi.org/10.1136/bmj.e2111 (Published 16 March 2012) Cite this as: BMJ 2012;344:e2111All rapid responses
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The National Institute for Health and Clinical Excellence (NICE) prides itself for its rigorous, transparent, independent and inclusive approach to decision making [1]. It purports to be inclusive with respect to stakeholder involvement and the evidence it considers. In its most recent advice on the use of dabigatran for the prevention of strokes in patients with atrial fibrillation [2], NICE defended a point of appeal that it failed to involve general practitioners in its deliberations [3], but overlooked potentially relevant economic data that we brought to its attention (timeline, below). Whereas NICE has approved dabigatran within its whole licensed indication, our publicly-funded analysis concluded that it was not cost effective when compared to warfarin in patients whose INR is well controlled or in centres that achieve good INR control [4].
25th May 2011 Notified NICE project manager of economic analysis (unacknowledged)
10th July 2011 Second notification to appraisal executive lead (acknowledged)
19th July 2011 First NICE appraisal committee meeting
24th July 2011 E-mail from project manager suggesting submission to the consultation of the Appraisal Consultation Document
22nd August 2011 E-mail confirming Appraisal Consultation Document available for comment
6th September 2011 Paper [4] submitted to consultation via e-mail as submission via NICE website not possible (unacknowledged)
8th September 2011 Closing date for comments
20th September 2011 Second NICE appraisal committee meeting
1st November 2011 Final appraisal determination
5th December 2011 Appeal
15th March 2012 Final guidance
References
1. http://www.nice.org.uk/aboutnice/howwework/how_we_work.jsp
2. National Institute for Health and Clinical Excellence. Dabigatran etexilate for the prevention of stroke and systemic embolism in atrial fibrillation. TA249. March 2012. http://publications.nice.org.uk/dabigatran-etexilate-for-the-prevention-...
3. National Institute for Health and Clinical Excellence. Advice on the Single Technology Appraisal of dabigatran etexilate for the prevention of stroke and systemic embolism in atrial fibrillation (Appeal Panel Hearing). http://www.nice.org.uk/nicemedia/live/12225/58466/58466.pdf
4. Pink J, Lane S, Pirmohamed M, Hughes DA. Dabigatran etexilate versus warfarin in management of non-valvular atrial fibrillation in UK context: quantitative benefit-harm and economic analyses. BMJ. 2011 Oct 31;343:d6333
Competing interests: No competing interests
Re: NICE backs new oral anticoagulant for stroke prevention
NICE prides itself on its process for evaluating new medicines, which is the most rigorous anywhere in the world. Local NHS organisations can have confidence that implementing our recommendations is an effective use of their resources.
Not everyone agrees with the recommendations of TA 249, but they were made following due process and rigorous assessment of the evidence. Professor Hughes and colleagues’ findings did not differ substantially from the cost-effectiveness analyses considered by our Committee. They agree that dabigatran etexilate, used in accordance with its marketing authorisation, is cost-effective relative to warfarin for the whole patient group under consideration.
Hughes and colleagues explored the cost effectiveness of dabigatran compared with warfarin at different levels of INR control, as did the Committee. The Committee was aware of the need for guidance to apply equally to those already on warfarin and to the newly diagnosed. It also accepted that it was not reasonable to expect all patients to try warfarin first, for the purpose of selecting out a subgroup for whom dabigatran was less cost effective.
Our single technology process is only geared towards receiving submissions from the company involved and formal consultees. However, we advised Prof Hughes that he could contribute at the public consultation stage. We received his paper, but it was marked ‘in confidence’ and was not accompanied by any further explanation as to how the author felt the paper might affect the Committee’s conclusions. We were therefore left in a quandary as to what to do with it. We shared it with the Committee Chair, lead team (the Committee members who introduce the topic) and technical staff, but it was not circulated to the whole Committee. Our error was in not informing Prof Hughes of this course of action and for this we have apologised.
Competing interests: No competing interests