National Institute for Health and Clinical Excellence - Health Committee Contents


Summary

On 19 July 2012, the then Secretary of State for Health wrote to the Chair of the Committee noting that the appointment of the current Chair of NICE was due to expire on 31 March 2013 and asking the Committee to undertake a pre-appointment hearing with the Department's preferred candidate. In preparation for the hearing, the Committee decided to issue a call for written evidence and then hold two sessions of oral evidence.

Social care and integrated care

From April 2013, NICE will have new responsibilities in relation to social care, which will be reflected in its new name: the National Institute for Health and Care Excellence. This is a significant change, and one that reflects the developing recognition that in order to improve the quality of care, and to make budgets go further, greater integration of services across health and social care is necessary.

We welcome the fact that NICE is to take on responsibility for producing clinical guidance and quality standards in relation to social care. There is a real opportunity for NICE to help evolve a different model of care by creating integrated standards and clinical guidance. We agree that this should not just be about providing guidance to people in different disciplines who are treating and caring for people with a specific condition, but should also involve advising about the most common associated co-morbidities, including mental illness. This broader guidance will also need to take account of what individuals want for themselves. This approach would reflect an important development of a philosophy which emphasises treatment of people not conditions.

One of the key themes of the Committee's work in this Parliament has been the need to move to a more integrated system in order to maintain both quality of care and access to care. As NICE takes on its new responsibilities in relation to social care, it is important for it to work with the full range of health and care providers to ensure that an adequate evidence base is created on which it can base its guidance.

NICE should be proactive in assessing interventions where evidence exists to support efficacy and cost effectiveness, and should ensure that its appraisal of cost effectiveness is based on an assessment of quality of life as well as increased life expectancy.

It is not just clinicians and care staff who need guidance to help build integrated care. Commissioners also have a key role. The Committee has repeatedly underlined the pivotal role which it believes commissioners should play in the development of the more integrated care system which is required. The Committee has also repeatedly stated that it believes that more integrated care delivery requires more integrated commissioning. We therefore agree with Sir Michael Rawlins that NICE should initiate the production of guidance for commissioners and that the emphasis of that advice should be on how to deliver integrated care.

The move to value-based pricing

Much of the discussion in the Committee's meetings related to the proposed move to value-based pricing of drugs. Defining what that actually means, however, has not been straightforward. The Government says that there must be a much closer link between the price the NHS pays and the value that a medicine offers as opposed to the current system, in which NICE makes its assessment based on the manufacturer's suggested price. The Committee understands that, in practice, discussions do take place between the sponsors of a new drug and NICE about the price at which the drug would satisfy cost effectiveness criteria and the Committee agrees with NICE that this flexibility is desirable. Against that background it is far from clear what substantive change is implied by the concept of value-based pricing.

There has been extensive discussion of the principle of value-based pricing but it remains a source of concern that so little progress has been made on defining this nebulous concept. In any event, with a limited number of health technology appraisals for new drugs and treatments taking place each year (around 30), the majority of drugs will for the foreseeable future continue to be procured under a variant of the current Pharmaceutical Price Regulation System.

The consultation document on this issue was issued two years ago in December 2010, and the response to the consultation was published in July 2011. We do not regard it as acceptable that the arrangements for value-based pricing have still not been settled and that those who will have to work with those arrangements are still unclear about what value-based pricing will mean in practice. Industry needs certainty about how it should bring its products to the NHS, and patient groups and clinicians need to understand what their role will be and how they can make their views heard. Given the length of time since the consultation began, the apparently modest implications of the proposed changes, and the fact that the new regime is due to be effective from January 2014, we recommend that the Department of Health should bring this uncertainty to an end no later than the end of March 2013.

Cancer Drugs Fund

The Cancer Drugs Fund was established to help provide cancer treatments which would not otherwise be available in the period up to January 2014, when it was considered that the introduction of the new value-based pricing system, with its perceived greater flexibility than the current NICE approach, would mean that it would no longer be required. On the evidence of our inquiry, the Committee considers that three things need to be done before the Fund ceases to operate:

  • There needs to be an assessment of the outcomes for those patients whose treatment has been paid for by the Fund, to see what impact it has had;
  • If there is clear evidence of beneficial outcomes, then that evidence needs to be built on in constructing the new value-based pricing scheme, and applied to treatments for conditions other than cancer;
  • A defined funding mechanism needs to be developed which will allow drugs which have been paid for by the Fund to continue to be available to individual patients.

Research data

It has recently been argued that some pharmaceutical companies keep information about drugs trials out of the public domain and thereby undermine the quality of information available to regulators, clinicians and patients about the efficacy and safety of drugs. The Committee believes there should be both a professional and legal obligation to ensure that all regulators, including NICE, have access to all the available research data about the efficacy and safety of pharmaceutical products All information arising from drug trials should be in the public domain in an accessible and properly anonymised form, including any negative information - as Stephen Whitehead of the ABPI said, "negative trials often give you as much information that is helpful as positive trials."

We recommend that the pharmaceutical industry should introduce a new code of practice covering research. This should include an obligation to make public all data about drugs which are in current clinical use once they have been through an appropriate peer review process. These are measures that pharmaceutical companies can take now without waiting for the new Clinical Trials Regulation to be approved.

The Committee also recommends that the GMC reiterates its guidance on drug trials to its members, and reminds them that failure to abide by these principles could lead to fitness to practice proceedings being taken against them.

We do not believe it should be either legal or considered ethical to withhold research data about pharmaceutical products. We are therefore concerned that this simple principle is not universally applied in practice, and also concerned by the implication of Sir Andrew Dillon's evidence to us that NICE are making appraisals of drugs without having access to all relevant data. The Committee welcomes the current review of these issues by the House of Commons Science and Technology Committee and recommends that that Committee should examine the nature of both the legal and ethical principles which should cover these issues and how to make those principles enforceable in practice.

Patient voice

It is clearly very important that those who have particular conditions should have their views represented in any discussions within NICE on whether or not to approve drugs designed improve that condition. It was argued in evidence that there is currently no clear role for patient groups. NICE did not agree that their role was not clear, but accepted that the experience could be improved. It is important for the credibility of NICE and for the decisions that it makes that the patient voice is effectively and openly represented in all its work.

Clinical guidance

We recommend that NICE clinical guidance should continue to be guidance rather than instruction. There will always be local variations and doctors and their patients must be able to come to individual judgements about what is the best treatment. Clinical guidance also needs to evolve and allow for innovation. The Committee does recommend, however, that a clinician or commissioner who decides to depart from NICE guidelines should be expected both to report and explain the departure. Local and individual discretion is valuable and right - but it should be exercised in a disciplined and accountable manner.

We consider that guidance is a process not an event, and therefore a regular re-examination of guidance is clearly very important to ensure that it remains best practice.




 
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Prepared 16 January 2013