The UK government has warned Members of Parliament who want the National Institute for Health and Clinical Excellence to conduct “quick and dirty” evaluations of all new drugs at launch that such an approach might not stand up in a court of law.

It could also make final NICE guidance even longer to produce, says the government, in its response to the findings of the House of Commons Health Select Committee’s inquiry into NICE.

The Committee wants NICE to assess all new medicines at launch so that doctors can start prescribing “useful and cost effective” drugs as soon as they are available, and calls for a lower cost per quality-adjusted life year (QALY) to be used during this early assessment than the current maximum of around £30,000.

In its response, however, the government points out that NICE’s reputation is built largely on the transparency and robustness of its processes and that, in considering the MPs' proposal, it would have to "consider carefully whether an interim process with more limited stakeholder engagement and a lower threshold would be sufficiently robust to be credible with stakeholders and defensible against any legal challenge. It would also be important to consider whether a requirement to run two separate appraisal processes might mean that final NICE guidance takes longer to produce."

Discrimination against elderly?
The government is more cautiously welcoming of the MPs’ suggestion that the wider benefits and costs associated with a product’s use, such as costs to carers and social services, should be more fully incorporated into NICE’s assessment. This suggestion “has instinctive appeal,” the government agrees, but also points to a number of “complexities and potential perverse effects;” for example, attaching greater weight to impacts on economic productivity would effectively prioritise interventions for adults of working age and deprioritise those for the elderly or people who are too ill to return to work even with treatment. “The impact on the consistency, manageability and timeliness of NICE’s appraisal process also needs to be considered,” it adds.

Nevertheless, the government agrees that there is a need to examine further how NICE takes account of wider benefits and costs, and it is planning to hold talks on the issue with key stakeholders, including the National Health Service, patient representatives and the pharmaceutical industry.

David Fisher, commercial director at the Association of the British
Pharmaceutical Industry welcomed this proposal. “The price paid for a medicine or any other treatment has to be seen in the context of the overall value it brings - including benefits such as savings in hospital care and social services as well as quality of life improvements for patients,” he commented, adding: “NICE’s decisions have been made on far too narrow a basis, with the result that many innovative medicines have not been made available to all patients who could benefit from them. We shall eagerly participate in these discussions with the aim of putting that right.”

The industry is also likely to be happy with the government’s rejection of the MPs’ call for NICE to have the right to see all the evidence used by the Medicines and Healthcare products Regulatory Agency when making its decisions.

When giving evidence to the inquiry, NICE’s chairman Sir Michael
Rawlins and chief executive Andrew Dillon had said it was “relatively straightforward” to identify whether evidence from specific trials had been omitted from manufacturers’ submissions and to discuss access to confidential information where it was required for, the government reminds the MPs. “NICE is currently able to treat information as commercial in confidence if requested to do so by the manufacturer, and has not asked the Department of Health for powers to compel companies to provide more information. We do not believe that a persuasive case for taking such powers has yet been made,” it says.

UK action on trials ‘would contravene EU law’
Turning to the MPs’ backing for mandatory registration of all clinical trials, the government points out that most trials take place abroad, and that for the UK to unilaterally take action to mandate the registration or publication of all trial data would not significantly improve access to evidence. “Our legal advice is that such a move would in any event be incompatible with EU [European Union] law,” it adds.

The government is also not convinced that the MPs’ arguments for establishing a separate mechanism to advise on the cost per QALY range used by NICE outweigh the likely disadvantages of such an initiative. Additional process costs would be generated, and the evidence on QALYS available to a separate body would not be any better than that available to NICE, it says, adding that, as NICE is already an independent NHS body, it is not clear whether another body would have a greater practical or perceived independence.

Nor does it believe there would be any benefit in the MPs’ call to distinguish between recommendations made following technology appraisals by calling them “NICE directives,” with everything else referred to as “guidelines” or “guidance.” The re-branding of appraisal decisions as “directives” might be taken to imply that they are intended to override clinicians’ decision-making in the treatment of individual patients, which is not the case, the government cautions.

It also takes issue with the Select Committee’s assertion that Primary Care Trusts are struggling to afford to implement NICE technology appraisals as well as clinical guidelines, pointing out that the NHS would face pressure to fund new drugs even if NICE did not exist. Moreover, NICE technology appraisals are not an unfunded pressure on the NHS, it says; their impact is taken into account in forecasting likely trends in drugs expenditure, and these forecasts inform PCT allocations.

As NICE approaches its tenth year, it “continues to break new ground, keeping the NHS at the forefront of international approaches to the evaluation of health-related interventions,” says the government. It acknowledges that implementing NICE guidance is “not always straightforward,” and commends the Institute “for the considerable steps it has taken to develop better implementation support for the NHS.”

To help all stakeholders understand the Government's response to the Health Select Committee's Report on NICE, Pharmatimes is holding a special meeting on April 1 that brings together the key stakeholders to give their views and discuss implications. Click here for more information.