The UK National Institute for Health and Clinical Excellence acts in the best interests of the National Health Service (NHS) and the patients it serves, but not the pharmaceutical industry “or anyone else for that matter,” NICE chairman Professor Sir Michael Rawlins has told the House of Commons Select Committee’s first oral evidence session, held as part of its new inquiry into the Institute.
Responding to a suggestion by Labour Member of Parliament Dr Doug Naysmith that “there is quite a feeling around that, somehow or other, the pharmaceutical industry has at least a role in setting the agenda” for the treatments which NICE considers, Sir Michael replied that of course companies produce the drugs, and decide which indications to look at and which studies to undertake, but they do not decide whether the drug is selected for NICE appraisal. When the Institute first started, it was asked what would happen if a company did not want to cooperate “and we said we would do it without them,” he added.
He also robustly dismissed Labour MP Dr Howard Stoate’s view that NICE’s decision to recommend Roche’s breast cancer treatment Herceptin (trastuzumab) was driven to some extent by pressure from patient groups which, said Dr Stoate, “we have to assume was at least in part influenced by the drug industry.” Sir Michael replied that the independent members of the NICE advisory committees would not have been influenced by this pressure, if they had felt that Herceptin was not cost-effective they would have said so and, “in light of all the hoo-ha,” they might even have enjoyed doing so, he told Dr Stoate.
Herceptin furore 'absurd'
He went on to describe the Herceptin furore as “an absurd situation. From April 2005 until late 2006 there was nothing in the public domain about [the drug's] efficacy or safety except on the investors’ website of Roche, and that is not a place you find out the details or the effectiveness or safety of a product,” he told the panel.
Liberal Democrat MP Charlotte Atkins wondered why the NHS does not have more clout in negotiating drug prices. “We do not have the purchasing power you might think,” Sir Michael replied; the UK accounts for only 3% of the world market, and some companies would rather lose that 3% in order to sustain higher prices elsewhere in the world.
However, he added, the world is changing, and he believes the industry broadly now accepts that with most countries planning to establish their own versions of NICE, simply setting prices at what the market will bear will no longer work. “It is interesting that the Americans are thinking of having a NICE,” he mused.
Sir Michael and NICE chief executive Andrew Dillon rejected proposals from some members of the panel that manufacturers should be charged for using the NICE appeal process, in order to discourage “frivolous” appeals. The officials did acknowledge that there have been instances of “gaming appeals,” in which a manufacturer appeals the fact that its product has not been selected as the best of a class appraisal of several different drugs. Such appeals have to be heard but have always been rejected, and there have been far fewer of them in the last two or three years. ‘I think companies have realised that we are not up for that,” said Sir Michael.
Rules are rules
Mr Dillon pointed out that patient groups as well as companies have the right of appeal, and they are nowhere near the same position as a drugmaker to afford a fee. “We could not have a rule for a pharmaceutical company and a rule for a small, national patient advocacy group,” he said.
The appeal is also, in a sense, a lightening rod for companies, patient organisations and professional groups to express where they think the process has gone wrong, added Sir Michael.
Also giving evidence was Mike Richards, National Cancer Director, who said that “we are at a very exciting time” in terms of cancer R&D, with over half of all drugs in the pharmaceutical industry’s combined pipelines being developed for the disease. Everyone recognises that the new generation of targeted drugs is putting pressure on budgets but, he said, we need to look at where money is not being spent efficiently.
One area where the UK could do a lot better is in the length of time patients are kept in hospital, which is longer than in other countries. “I think we really need to bear down on that," for the benefit of patients and the NHS, Prof Richards told the MPs, adding: “if we can do that, we give ourselves more headroom to be able to introduce the very good new drugs that are coming through.”
This report is based on the uncorrected transcript of the evidence
session. Neither the witnesses nor Members have have the opportunity
to correct the record