NICE Appraisal of Dronedarone (Multaq)
It’s time to make our voices heard!
Dear Member
Recent, extensive trials have shown that Dronedarone (Multaq), the first new anti-arrhythmic drug (AAD) in more than twenty years, is not only effective in treating AF in large numbers of Paroxysmal AF patients but also importantly demonstrated that it is currently the only anti-arrhythmic medication to improve long term cardiac health in AF patients. To the relief of all AF sufferers, trials also revealed that the new medication was well tolerated and did not appear to have adverse effects.
Patients in USA have been prescribed Dronedarone (Multaq) for AF since it was approved in summer 2009 and in the autumn, approval was also granted for its use in AF patients across Europe. The AFA Fact Sheet on Dronedarone (Multaq), can be viewed at
Extensive trials on Dronedarone (Multaq) have shown to reduce incidence of AF to a level at least equal to that of current AADs available, however, with far fewer side effects than commonly experienced by patients prescribed currently available drugs. Dronedarone (Multaq) is also suitable for up to 55% of AF patients diagnosed with Paroxysmal AF. Furthermore, in trials, the treatment has led to a reduction in hospitalisation and reduction in the incidence of stroke.
However, in a shock statement, issued by the National Institute for Health and Clinical Excellence (NICE) which has been considering the clinical and cost effectiveness of the treatment, the use of Dronedarone for patients in the UK has been denied. Despite AFA submitting written evidence to the committee, and two representatives attending to give oral evidence to the committee meeting on 25 November 2009, NICE, who waited until Christmas Eve to publish their draft guidance (known as the Appraisal Consultation Document) have regrettably announced that it is proposing to deny Dronedarone (Multaq) to patients with AF in England and Wales.
This is a shocking decision, based on cost saving and will be extremely detrimental to many people with AF currently struggling to manage AF who had looked to the launch of this innovative treatment as a chance to restore their long term health. Now, it seems, that without YOUR help, access to Dronedarone will only be available to patients living in many other parts of the world or to those who can afford to pay – another post code lottery. Details on the appraisal can be viewed at
That is why we are urgently calling for YOUR help. We have until 5pm on Thursday 28 January 2010 to respond to the consultation, after which the NICE Appraisal Committee will meet again to consider these responses (on 24 February 2010). We urgently need your support in making representations to NICE and Department of Health, alerting them to the retrograde step that the draft guidance would pose. It is imperative NICE, Department of Health, Ministers and MPs understand the scale of opposition to this draft guidance. We need as many patients, carers, supporters and health professionals to write to NICE and respond to the consultation.
The Atrial Fibrillation Association is calling on all AF patients and those involved in AF care and management to write to NICE by January 24th and ask that NICE re-think this preliminary decision and rule to allow this medication to AF patients in England and Wales.
Please write to NICE…
We would like you to write a letter to the Chairman of the NICE Appraisal Committee, Professor Peter Clark (double-click on the Word icon below). Your letter should ideally provide your personal experience of living with AF; the potential benefits that a new treatment could offer suitable patients; the need for clinicians to have a choice of treatment options; and the hope that will be afforded to patients including potential improvements in quality of life that this new treatment could offer. I hope you will be able to write a personal letter, as this will be powerful in demonstrating the strength of feeling about this draft decision, and appealing to NICE to review and change their decision.
If you are unable to write a personal letter, please use the attached letter as a template, although this may be less effective in alerting decision makers about the strength of opposition to this decision. The letter should be addressed to Professor Clark and emailed to:
… and your Member of Parliament
AFA members and supporters should also contact local Members of Parliament, as they too may write to NICE and the Department of Health. You can identify your MP by entering your postcode at this link: This will then provide contact details for your MP, and you should write in similar terms to them at:
Name MP
House of Commons
London
SW1A 0AA
In order to maximize awareness of the appraisal of Dronedarone (Multaq) and the potential risk to patients with AF in denying the treatment, we would urge you to post a copy of your letter to:
TRUSTEES - Prof A John Camm, Mrs Jayne Mudd, Prof Richard Schilling
Medical Advisory Committee – Dr Campbell Cowan, Dr Matthew Fay, Dr Andrew Grace, Prof Greg Lip
Chief Executive Officer: Mrs Trudie Lobban MBE, Support and Information Manager: Mrs Jo Jerrome
Registration Number: 1122442 ©2009
Professor Mike Rawlins
Chairman
National Institute for Health and Clinical Excellence
MidCity Place
71 High Holborn
London
WC1V 6NA
Rt Hon Andy Burnham MP
Secretary of State for Health
Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
TRUSTEES - Prof A John Camm, Mrs Jayne Mudd, Prof Richard Schilling
Medical Advisory Committee – Dr Campbell Cowan, Dr Matthew Fay, Dr Andrew Grace, Prof Greg Lip
Chief Executive Officer: Mrs Trudie Lobban MBE, Support and Information Manager: Mrs Jo Jerrome
Registration Number: 1122442 ©2009
Please, ACT NOW!
There is a great strength of feeling across the health and AF communities that the draft NICE guidance on Dronedarone (Multaq) would deny patients a first-in-class, first-in-a-generation treatment option. If NICE continues down this path of decision-making it will result in patients and the treatment being denied. Your experience must be heard and understood if NICE is to ensure effective guidelines are put into place. Please play your part in responding to the consultation and continue making your voice heard!
Thank you
Trudie
Trudie Lobban MBE
Founder & CEO
Atrial Fibrillation Association
Tel: +44 (0) 1789 450787, Direct Line: +44 (0) 1789 451821, Mobile: +44 (0) 7778 233999
TRUSTEES - Prof A John Camm, Mrs Jayne Mudd, Prof Richard Schilling
Medical Advisory Committee – Dr Campbell Cowan, Dr Matthew Fay, Dr Andrew Grace, Prof Greg Lip
Chief Executive Officer: Mrs Trudie Lobban MBE, Support and Information Manager: Mrs Jo Jerrome
Registration Number: 1122442 ©2009