Meeting with Sir Michael Rawlins, Chair of the National Institute for Health and Clinical Excellence

The new NICE guidance on appraising end of life medicines

Sir Michael said that NICE had historically tried to take end of life issues into account when appraising treatments, but had realised that with the rising cost of new drugs, they would be unable to approve new drugs for end of life care under their guidelines as they were. New guidelines were therefore issued at the beginning of this year. He explained that the new guidelines are intended for cases where:

• the treatment is indicated for patients with a short life expectancy, normally less than 24 months
• there is sufficient evidence to indicate that the treatment offers an extension to life, normally of at least an additional 3 months, compared to current NHS treatment
• no alternative treatment with comparable benefits is available through the NHS
• the treatment is licensed or otherwise indicated, for small patient populations

Sir Michael said that NICE was trying to 'meet the pharmaceutical industry half way' on the decisions to approve treatments. He said NICE understands that the industry need to charge more for rarer cancer drugs to cover development costs, but said as a result he would encourage them to keep down the cost of treatments for more common cancers. He praised the industry for recent risk-sharing agreements with the Department of Health, which aim to improve the availability of drugs on the NHS.

Sir Michael said that as a result of the new NICE guidelines on end of life medicines, the drug Sutent had been approved for first line treatment. He said that while NICE was taking steps to improve its processes for approving medicines, it is just not possible to approve everything as this would be at the detriment of other things that the NHS provides.

Q&A session

End of life guidance - Asked about where the pressure to change the guidelines for end of life medicines had come from, Sir Michael highlighted the work of both patient groups and others putting pressure on from below, and the will of those in NICE to also make the decision-making processes better.

Public meetings - On the decision to allow the public to appraisal committee meetings, Sir Michael said that it was something he very much supported and wished it had been the case from the start.

Independent decision making - Sir Michael was asked whether NICE existed to "get the Government off the hook", to which he responded that NICE makes decisions that elected politicians would find impossible to make. He said NICE did not want to be loved, just trusted.

Approving drugs for common cancers - Challenged on a perception that NICE approves drugs for rarer cancers and not for more common ones, Sir Michael said that NICE is about making decisions to spend money fairly. He said the decisions NICE makes ought to be those of the public. He said this was why they had set up the Citizens' Council.

Research and evidence base - Asked about how NICE compiles the evidence that is considered by its committees in drugs appraisals, Sir Michael said that they have sometimes asked for more research to be conducted – sometimes by pharmaceutical companies, and sometimes by the NHS. He said that it had been suggested that NICE has its own research facility, but said he was not in favour of this as there were already research bodies that could be relied upon.

Richards' report on improving access to medicines - Asked if he thought the outcome of the Richards' report would improve patient care, Sir Michael said that a combination of policies will help. 

Drugs trials for children and teenagers - Asked whether NICE could influence the number of drugs trials involving children and teenagers, Sir Michael acknowledged that more could be done to increase their availability, and said that NICE is currently exploring ideas with paediatricians on this.

Charity influence in drugs appraisals - Asked what he thought was the influence of charities in drug appraisals, Sir Michael said that they were very important in highlighting the reality of conditions for patients.

Consideration of wider societal cost benefits - Asked about the consideration of the wider cost benefits of approving certain drugs, Sir Michael said that NICE currently takes into account the cost to the NHS and to personal social services. He said that at the moment wider societal costs are not considered, e.g. loss of earnings, but that there is an argument for these being considered. He said that this would be a matter for Parliament.

Referral of drugs to NICE - On the issue of topic referral, Sir Michael said that it would be easier if NICE was able to make their own decisions on what to appraise.

Cost per QALY threshold - On the possibility of Parliament setting the cost per QALY threshold, Sir Michael said that NICE would still need to retain flexibility in applying a threshold set by an outside body.