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Inside NICE

Controversial maybe, but transparent and fair is how NICE's CEO describes its role

As 2007 begins, the National Institute for Health and Clinical Excellence (NICE) is facing its first judicial review. Eisai, supported by its co-promotion partner Pfizer, has applied for judicial review of the process by which NICE developed guidance on the use of drugs for treating Alzheimer's disease.

We are disappointed that Eisai has taken this step. We consider the company's claim without foundation and it will require us to divert energy and funding from the work we do to help patients and health professionals to get the most out of the resources available to the NHS.

The reality is that, for Alzheimer's disease, drugs are only part of the care that needs to be offered. NICE has a challenging job and a high profile generated primarily by our responsibility for advising the NHS on the clinical and cost-effectiveness of drugs and other treatments. While headlines in the national papers can be black and white - 'Sufferers denied wonder drug', for example - the facts are often somewhat different.

Since we began issuing guidance in 2000, we have issued 118 separate appraisals on health technologies. Of these, we have recommended 78 for selective use, 39 for routine use and just eight for use in research settings only.

In six years, NICE has rejected only three technologies from use in any of these settings.

Health service funding is limited, and it is our job to assess the clinical and cost-effectiveness of both drug and non-drug interventions to ensure that NHS money is well spent.

Public scrutiny
The arrangements we have put in place have evolved as our experience of working with a diverse community of interested parties has grown. Our processes and methods are developed in consultation with our stakeholders and with the independent experts who sit on our advisory committees. Drafts of our process and methods documents are exposed to public consultation, and the comments received, together with the final versions of the documents, are approved by the NICE Board in public session.

We also take the view that those who rely on our guidance should be able to understand how it has been developed. To this end, each of our programmes displays a common set of characteristics. Each programme secures a comprehensive evidence base, either by contracting the work to an independent body or by undertaking the work in-house, and stakeholders are invited to check that all relevant evidence has been considered.

In addition, ensuring that our advisory bodies have access to clinical expertise and patient and carer perspectives, as they interpret evidence, is crucial both to the relevance of the recommendations and to their credibility.

The guidance that NICE publishes is prepared by independent standing committees (for technology appraisals and interventional procedures) and individual development groups (for clinical guidelines). All our advisory bodies include healthcare professionals working in the NHS and people who are familiar with the issues affecting patients and carers. The standing advisory committees also include people who are currently working in the healthcare industries.

All NICE guidance undergoes widespread genuine consultation with stakeholders and the public. 'Genuine' means that our advisory bodies will respond to reasoned argument that can stand up to independent scrutiny and, if necessary, change their original thinking.

Technology appraisal guidance and clinical guidelines are reviewed at regular intervals to ensure that they remain current. Review dates are set on the basis of the advisory body's understanding of the anticipated pace of change in the evidence base.

As a result our consultation, decision-making and appeals processes are transparent and fair. We share our methodology and enable our stakeholders to see the basis on which our experts arrive at their decisions. We invite patients, medical professionals and anyone who has an interest - including those working in the pharma industry - to express their views and comment on our proposals.

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Topic selection
It is essential that NICE develops guidance on topics that are relevant to those working in the NHS, so we also ask our stakeholders to suggest topics on which NICE should develop guidance.

The Department of Health carried out a public consultation on the topic selection process from March to June 2006, and as a result we were asked to manage the administration of the early stages of the topic selection process. Topics suggested from January 2006 onwards, through a range of routes including online via the NICE website, will be managed by NICE under the new process.

NICE reviews each of the suggestions received to ensure they are appropriate and to check whether they are already included in its work. The suggestions are filtered according to the Department of Health's selection criteria which were developed in response to the public consultation, including:

  • Burden of disease (population affected, morbidity, mortality)

  • Resource impact (the cost impact on the NHS or the public sector)

  • Policy importance (whether the topic falls within a government priority area)

  • Whether there is inappropriate variation in practice across the country

  • Factors affecting the timeliness or urgency for guidance to be produced.

The suggestions are then reviewed by consideration panels composed of experts in the topic area, generalists with a good knowledge of the health service, public health and the public sector, and patient and carer representatives. The panels' recommendations go to the Department of Health and a health minister makes the final decision on which topics are referred to NICE for guidance to be produced.

Manufacturers wanting to suggest that NICE develops guidance on a new healthcare technology (one that is not yet licensed or used within the NHS), should contact the National Horizon Scanning Centre. This is responsible for letting the Department of Health know of key new and emerging healthcare technologies that might need to be referred to NICE.

When NICE was set up in 1999 we developed the Multiple Technology Appraisal (MTA) process which looks at groups of drugs that are already on the market in order to compare them to one another. In 2003, the MTA process was independently reviewed by the World Health Organisation which noted the Institute's commitment to using rigorous methodology, concluding that: 'Published NICE appraisals are already being used as international benchmarks - an obvious recognition of their credibility.'

The process involves reviewing an extensive evidence base and takes 18 months on average.

We are rightly proud of our MTA process, but in 2005 we came under fire for taking too long to make decisions about life-saving drugs that have already been licensed and on new medicines that are close to becoming available. As a result, we have introduced a new, rapid process - the Single Technology Appraisal (STA) - that enables NICE to provide faster assessments of both single new drugs, and existing drugs with new indications, by asking for a single submission of evidence from the drug's manufacturer, carrying out an independent assessment of this evidence more speedily and moving quickly to the final (appeal) stage of the process where the draft recommendations are in line with the licence. Using this new process NICE is able to issue guidance on new drugs within 12 weeks of licensing.

Sometimes, however, drugs are only part of the care that needs to be offered in a healthcare setting. Non-drug interventions also have an important part to play. That is why, in November 2006, we issued, with the Social Care Institute for Excellence, joint guidance on the treatment and care of people with all forms of dementia and the support that should be provided for carers.

For the first time, healthcare professionals working within the NHS are following the same guidelines as the social workers and care workers in nursing homes, creating core standards for care that will make a real difference for patients and their families.

The appraisal system

1. Provisional appraisal topics chosen
The Department of Health produces a list of provisional appraisal topics

2. Consultees and commentators identified
National organisations including groups representing patients and carers, bodies representing health professionals, manufacturers and research groups

3. Scope prepared
NICE works with the Department of Health to develop a scope. This document sets out what the appraisal will cover and the questions that need to be asked. Consultees and commentators comment on the draft scope

4. Appraisal topic referred
The Department of Health refers technology appraisal topics to NICE

5. Assessment report prepared
NICE commissions an independent academic centre to review published evidence on the technology and
prepare an assessment report. Consultees and commentators are invited to comment on the report

6. Evaluation report prepared
The assessment report and comments on it are drawn together in the evaluation report

7. Appraisal consultation document (ACD) produced
An independent appraisal committee considers the evaluation report. It hears evidence from nominated clinical experts, patients and carers, before making its first recommendations in the ACD. Consultees and
commentators have four weeks to comment on the ACD. The ACD is also made available online so health professionals and members of the public can comment on it

8. Final appraisal determination (FAD) produced
The independent appraisal committee considers the comments on the ACD, then makes its final recommendations in the FAD. The FAD is submitted to NICE for approval. Consultees can appeal against the final recommendations in the FAD

9. Guidance issued
If there are no appeals, or an appeal is not upheld, the final recommendations are issued as NICE guidance

The author
Andrew Dillon, CBE, CEO of NICE

12th February 2007

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