Select Committee on Health First Report

7  Conclusions

346. Healthcare budgets in England as elsewhere are limited. Difficult decisions have to be made about priorities. Patients cannot expect to receive every possible treatment. In other words rationing is essential. Dr Imogen Evans echoed the views of many witnesses when she stated, "the cost of healthcare weighs heavily on all national economies, and the need to set priorities is inescapable". Moreover, it would be sensible if any choices to be made were based on robust evidence, with the aim of offering patients the best available treatments. In this context NICE evidently has a key role to play.

347. The evidence we received indicated that since it was established in 1999 NICE has achieved much. Its work has led to a greater concentration on cost- as well as clinical effectiveness. Its evaluation processes are generally robust, and are well-regarded worldwide. However, there are failings.

348. The evaluation process was criticised on a number of grounds:

  • The speed of publication of guidance is a major problem; licensed medicines are often not prescribed while PCTs and clinicians wait for NICE to make a decision. Delayed access to products later found to be both cost and clinically effective harm both patients and the NHS.
  • Topic selection is also unsatisfactory. Selecting topics for assessment is appropriate for clinical and public health guidance, but not for technology assessments. While there needs to be an assessment of all new drugs, it is very important not to skew spending to expensive secondary care at the expense of public health and other clinical guidance. There is also far too little emphasis on disinvestment. Here we found NICE's responses to our questions disingenuous. While few older treatments may do no good at all, many will not be cost-effective.
  • The wider benefits of treatment to society, for example to carers, are not included in NICE's cost : benefit analyses; and
  • NICE often does not have all the information it needs to make a full assessment. It does not have access to all the information the MHRA uses and clinical trials are usually designed without NICE's work on cost-effectiveness in mind.

349. To improve the evaluation process, we recommend that:

  • All drugs be assessed at the time of licensing, so that clinicians can prescribe useful and cost-effective products as soon as they are launched;
  • There be more emphasis on disinvestment;
  • Our last report on NICE recommended that the legislation be changed to accommodate the need to ensure that assessments of products take account of the wider benefits to society; we make the same recommendation here;
  • NICE have access to the same material used by the licensing body, clinical trials be registered and there should be closer working between NICE and the industry to enable these early assessments to take place.

350. The affordability of NICE guidance and the range, measured in cost-per-QALY, it uses to decide whether a treatment is cost-effective is of serious concern. The threshold it employs is not based on empirical research and is not directly related to the NHS budget, nor is it at the same level as that used by PCTs in providing treatments not assessed by NICE, which tends to be lower. Some witnesses, including patient organisations and pharmaceutical companies, thought NICE should be more generous in the cost per QALY threshold it uses, and should approve more products. On the other hand, some PCTs struggle to implement NICE guidance at the current threshold and other witnesses argued that a lower level should be used. However, there are many uncertainties about the thresholds used by PCTs. Accordingly we cannot authoritatively at this stage recommend a change in NICE threshold. Nevertheless, we recommend that it be reviewed. We do recommend that an independent body determine the threshold used when making judgements of the value of drugs to the NHS.

351. The implementation of non-mandatory guidance is variable. This is due to a variety of causes, including the threshold used by NICE for determining cost-effectiveness, lack of clarity about the status of guidance, lack of involvement of PCTs in the development of guidance, clinicians' disagreement about the worth of some NICE guidelines. This is a particular problem when clinicians believe that NICE has not used the right experts or when different guidelines from other organisations are published about the same time as NICE guidance.

352. To improve the implementation of NICE guidance we recommend:

  • More help for PCTs to implement guidance;
  • Better assessment of the level of uptake;
  • That PCTs should play a larger role in the development of guidance;
  • Better use of experts in the development of guidance;
  • A change in the terminology used by NICE, to clarify to patients what they can and cannot expect by right from their local NHS organisation; and
  • That some elements of clinical guidelines be made mandatory.

353. Changes to the system of medicines pricing may follow the OFT's report on the PPRS. NICE should be involved in any new system, and to ensure full involvement in any such process, NICE should be adequately resourced.

354. We recommend that risk-sharing schemes be used with caution. They should not be used as a catch-all in cases of uncertainty over a drug's benefit. Uncertainty would be better addressed by the careful design and performance of a publicly funded randomised controlled clinical trial. Better use should be made of NICE's 'only in research' recommendation in this regard.

355. NICE does a vital job in difficult circumstances. The development of more and more health technologies and procedures, coupled with rising patient expectations and the ageing population, is going to make it even more difficult in the future. NICE can improve and we have recommended improvements. In the past it has changed and we are sure it can do so again. Given the difficult environment, NICE requires the backing of the Government. Ministers must support NICE, not seek to undermine it. NICE must not be left to fight a lone battle to support cost- and clinical effectiveness in the NHS.

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