NICE: what you need to know

What is nice about NICE? Will we come to love NICE as much as we do the NHS? #MSBlog #MSResearch

“You will find the following article from Sir Michael Rawlins the chairman of NICE from April 1999 to April 2013 interesting. Love or hate it NICE is here to stay and its influence on health and wellness is undeniable. Its new remit in relation to social services will hopefully result in some joined up thinking; i.e. healthcare expenditure in MS may reduce social costs later on. Up until now NICE has only looked at the direct costs of DMTs to the NHS and have largely ignored any indirect or societal costs or savings. For example, keeping people in work or preventing them from needing  carers is not considered in the cost effectiveness assessments of MS DMTs.”

NICE has been rebranded three times:

1999: The National Institute for Clinical Excellence 
2005: The National Institute for Health and Clinical Excellence
2013: The National Institute for Health and Care Excellence

Michael Rawlins. NICE: Moving Onward. N Engl J Med 2013;369.


….. Since 2000, the Institute has been publishing technology appraisals — assessments of the clinical effectiveness and cost-effectiveness of (mainly) new pharmaceutical products, including whether providing them constitutes a good use of NHS resources…..

…… Contrary to popular mythology, NICE rejects less than 15% of technologies on the grounds of cost-ineffectiveness. In recent years, manufacturers have increasingly been offering the NHS, through NICE, “patient access schemes,” which can substantially reduce the price of products and render them more likely to be considered cost-effective. Such offers have sometimes led a product with a negative provisional assessment to gain a positive final one, and occasionally decisions have been reversed because manufacturers have submitted additional evidence about a product’s clinical effectiveness……

……. NICE’s clinical guidelines improve the quality of care provided to NHS patients……

……. NICE distinguishes clinical guidelines defining optimal care pathways for specific conditions from standards describing generic competencies for health care professionals. Professional standards may cover anything from treating patients with dignity and respect, to ways of avoiding bedsores, to the procedure for safely inserting a nasogastric tube…….

…….. I believe that NICE has largely succeeded in its mission, thanks to four key ingredients. The first has been the political and fiscal environment. There is now wide acceptance that no country seeking to provide universal health care has the resources necessary to achieve the highest possible standards of care for everyone. In 1999, when NICE was established, there was limited, tacit acceptance of this gloomy fact. Fourteen years later, there is greater honesty among politicians and health policymakers, owing in part to the global financial crisis. Priorities must be set on the basis of evidence of both clinical effectiveness and cost-effectiveness……..

……. priority setting in health care must encompass more than the technical and scientific demands of health technology assessment. It must also take account of the social values of the relevant communities. NICE therefore established a Citizens Council, with members drawn from the general public, to examine, deliberate over, and report on the social principles on which the Institute’s guidance should be based. Health care systems elsewhere need to develop their own approaches to eliciting social values, which won’t necessarily reflect the culture and preferences of the British public…….

……. NICE has adopted a methodologically rigorous approach to guidance development. All NICE guidance is based on a full systematic review of the available evidence, including not only the results of randomized, controlled trials, but also observational and analytic studies. Information on the Institute’s processes and methods is publicly available, and these processes undergo revisions every 3 years.The World Health Organization has reviewed them twice and found, overall, that NICE guidance is developed to the highest standards…….

……. inclusivity. The Institute has strived to involve its stakeholders — health care professionals, patients and their representative organizations, and relevant life-sciences companies — in all its programs. All stakeholders are invited to contribute to revisions of our processes and methods and encouraged to submit evidence on particular topics for consideration by the Institute’s advisory bodies…….

……. Despite a rocky beginning with the life-sciences industry and particularly the pharmaceutical industry, relations improved as it became clear that we supported the use of most new drugs but that health care systems globally can afford only cost-effective products…….

……. NICE has, from the outset, jealously guarded its independence from vested interests, whether government, the professions, patient organizations, or the life-sciences industries……

……. Institute has had strict conflict-of-interest rules covering both its staff and advisory-body members……..

……. NICE is now a permanent component of the British health care environment, having been reestablished on April 1, 2013, in legislation that also requires the Institute to develop guidelines and performance metrics for social services. This change, I hope, will help improve the integration of Britain’s health care and social services, whose interactions have too often been dysfunctional…..

…….. NICE’s experience may carry lessons for the United States, which has an abundance of the technical, scientific, and clinical skills needed to develop robust guidance for clinical practice — but which appears, at least to an outsider, to lack the political will to ensure the provision of universal health care and to accept that in so doing it will have to set priorities. The Affordable Care Act takes a modest step in this direction, but the current level of expenditure on health care in the United States is unsustainable. If the United States is to meet the needs of all its citizens, especially in the face of an increasingly elderly population, it will someday have to take both clinical effectiveness and cost-effectiveness into account in determining the contents of its package of universal health care. Our experience in the United Kingdom shows that, though sometimes uncomfortable, it is possible……..

16 Mar 2012
In its final draft guidance, out today (16 March), NICE, has recommended fingolimod, to help reduce the number of relapses for some MS’ers with highly-active MS. This positive recommendation is a change from NICE’s 
06 Aug 2012
According to NICE the STA process is much shorter than the MTA process; an MTA takes ~50 weeks from official invitation to participate to publication of the FAD, compared to ~34 weeks for the average STA – a 4 month delay 
02 Dec 2011
*NICE has rejected Novartis’ application to use fingolimod for MS’ers on the NHS. NICE has again stated that the cost-effectiveness of fingolimod does not hold up as a treatment for highly active relapsing remitting multiple 
28 Jul 2011
NICE has been notified about CCSVI and will consider it as part of the Institute’s work programme. The Interventional Procedures Advisory Committee (IPAC) will consider this procedure and NICE will issue an Interventional 
16 Aug 2011
Despite the excitement earlier this year over the launch of the drug, fingolimod, a sphingosine-1-phosphate receptor, NICE has announced in provisional draft guidance that not only is the drug not cost effective but there was a 
29 Mar 2012
Pity NICE didn’t comment on Zamboni’s conflicts of interest in relation to his CCSVI theory. If they did NICE encourages doctors to offer the treatment as part of research studies in order to explore its impact on patients.
15 Aug 2011
“The results of this survey are not what I expected. I can only assume that the majority of you agree with NICE because fingolimod is not cost-effective?” “I personally feel that fingolimod has several attributes that will make it a 
27 Aug 2011
1.2 NICE encourages further research on venoplasty for CCSVI in MS. Clinical trials should be controlled, ideally comparing venoplasty against sham. Technical success should be clearly defined and should include 
23 May 2011
Royal Society of Medicine Lecture – “The Nice Or Not So Nice Lecture”. In this lecture Sir Michael Rawlings talks about the role of NICE in medicine today; this has major implications for PwMS. Click here to watch lecture 
05 Aug 2011
Fingolimod: another lemon from NICE; not good news for MS’ers. “Fingolimod has not been recommended for the treatment of relapsing–remitting multiple sclerosis in the NHS.” “There are uncertainties over its clinical 

Leave a Reply

%d bloggers like this: