Faster decisions by the National Institute for Health and Clinical Excellence would not help primary care trusts fulfil the requirement that they should implement its guidance within the statutory three months, MPs have been told.
Decisions that come in rapidly are very difficult for PCTs to deal with, Gill Morgan, chief executive of the NHS Confederation, told the House of Commons Health Select Committee’s inquiry into NICE last week. For example, she said, they may have to stop providing important and valuable services in order to make room for the newly-approved treatments.
A slower assessment process enables more information to be gathered about a product’s risks, she added. However, one problem is that, at present, NICE cannot start work on evaluating a product until a license is issued. Allowing it to start looking at technologies while they are going through the licensing process could speed things up, she suggested.
The Committee heard a similar proposal from Richard Barker, director-general of the Association of the British Pharmaceutical Industry, who pointed out that, while PCTs are trying to balance the provision of very high-cost medicines with more routine services, the new treatments are a long time in development and there are years of notice that they are coming through, so their arrival on the market should not come out of the blue. NICE evaluations should start much earlier in the process, as should planning for the introduction of new medicines, so that PCTs don’t have to choose between providing, for example, either Herceptin or a diabetic clinic, he said.
Problem of uncertainty
At an earlier session, Peter Smith, director of the Centre for Health Economics at the University of York, discussed work now underway by his colleagues on decision rules that would enable NICE to make quick decisions when justified. “The key problem is that of uncertainty,” he said. “One can never be fully certain about the effects of a drug and the cost of it but, broadly, there are three approaches to take. One is to wait and do more research, one is to take a provisional decision that one may reverse in the future, and the other is in some way to get the companies to share the risks of taking the drug early.”
Prof Smith welcomed the recently-agreed cost-sharing initiative for Millennium/Janssen Cilag’s cancer drug Velcade (bortezomib), and urged NICE to “look quite imaginatively” at all ways possible to speed up the process “and protect the NHS from making adverse decisions in a rush but also to encourage companies to continue to come forward with new treatments.”
Earlier involvement would help the industry focus its R&D, added Kiran Patel of the South Asian Health Federation. The research questions which emerge from NICE guidelines put on the table what the issues are in the UK today, helping to address which technologies and drugs are relevant to particular patient groups. “If that happens a lot earlier, instead of evaluating the research once it has been published and developed, one can take a step back and forecast the relevant issue tomorrow…and, if on the horizon there is a group of cancer drugs that should be considered today, whether industry can help in developing the right research in that area,” said Dr Patel.
MPs were also warned that it was not yet clear whether the new fast-track Single Technology Appraisal process was leading to speedier issuance of guidance. The process is not quite as rapid as had been predicted, said Stirling Bryan, director of the economics facility at the University of Birmingham, who told the panel that, in almost all the STAs in which he has been involved so far, the committee has made a “minded no” recommendation. This means there is remaining uncertainty, the committee has concerns about the analysis conducted and the company is required to conduct further work.
“I share the concern about the need for timeliness, but there are alterative ways to bring about improvements in the speed with which decisions are made by NICE,” said Prof Bryan, adding: “we should be careful before assuming that speed is everything.” The conclusions of NICE’s current evaluation of this policy change are needed before it can be judged whether STAs have been a significant improvement, he cautioned.
Dr Patel also warned of the “real danger” that, by the time some NICE guidance is published, it is outdated. “There are organisations and individuals who really want their patients to benefit from a therapy tomorrow,” and the process should not take two or three years, “by which time the therapy is outdated or has been superseded,” he said.
Ian Beaumont of patient group Bowel Cancer UK agreed, pointing out that for ImClone Systems/Bristol-Myers Squibb’s Erbitux (cetuximab), which NICE had refused on appeal in January this year, the Institute had estimated that the average life expectancy which the drug added was five months. However, at the end of June, researchers had reported that the life expectancy of people who have benefited from the drug was an average of 14 months. Information and developments are moving too fast, he said, adding: “NICE needs to be more fluid and adaptable in the way it evaluates drugs.”
Mr Beaumont also attacked the process by which, he claimed, effective new bowel cancer drug treatments which are readily available in Europe and America in a private setting are, more often than not, being denied to UK patients.
“NICE, the NHS and the Department of Health knew way before the drugs got to the NICE process what was coming down the track,” said Mr Beaumont; Bowel Cancer UK had told PCTs in 2003 that important drugs were coming and called on them to make provision for them in their budgets. However, he added: “it is not our fault or that of our patients that these economic considerations were not taken into account at the time when something could have been done. It is now payback time and it is our patients who are suffering as a result of other people’s bad financial management.”
And the situation will only get worse, said Mr Beaumont. “For cancer alone there are hundreds of drugs in the pipeline and the system will only become more crowded. We need to find long-term solutions, otherwise we will hit some pretty substantial walls,” he warned the MPs.
Penalties for being too slow?
Meantime, questioned at last week’s session about what sanctions can be taken against PCTs for moving too slowly on NICE decisions, the NHS Confederation’s Dr Morgan stressed that PCTs “do not set out not to implement NICE guidance.” However, she added, this is a complex issue. For example, clinicians may not want to use the newly-recommended treatment, if it has very severe side effects.
Clinical decision-making is at the heart of this, she said; many clinicians take time to feel competent with newly-recommended treatments, especially as the evidence is often about the negatives, emphasising the side-effects rather than patient outcomes. Moreover, where cost issues are significant, Strategic Health Authorities cannot instruct PCTs to breach their statutory financial limits, she reminded the legislators.
This report includes comments taken from the uncorrected transcripts of the Committee’s oral evidence sessions, which neither the witnesses nor the Members have had the opportunity to correct.