UK Members of Parliament have told the National Institute for Health and Clinical Excellence that it should assess all new medicines as they are launched, in order for doctors to be able to start prescribing “useful and cost effective” drugs as soon as they become available. However, they add that, during this early assessment, a lower cost per quality-adjusted life year (QALY) should be used than the current maximum of around £30,000; if a drug costs more than this, NICE generally says that it should not be prescribed on the National Health Service.
The House of Commons Health Select Committee, reporting today on its recent investigation into NICE, also raises “serious” concerns over the financial threshold used by NICE in its full assessments, pointing out that it is not based on hard science or directly related to the NHS budget and is also higher than the thresholds used by Primary Care Trusts (PCTs) in deciding whether or not they will fund a treatment. This situation is “incoherent,” Committee chairman Kevin Barron told reporters, and the report calls for the threshold to be reviewed, with further research into comparing those used by NICE and PCTs. Moreover, it says, an independent body should determine the threshold used by NICE when making judgements of the value of technologies to the NHS.
The Association of the British Pharmaceutical Industry was sceptical about what it called “faster, ‘quick and dirty’ assessments of medicines against tougher cost-effectiveness hurdles,” which, warned ABPI director general Richard Barker, would actually worsen UK patients access to new medicines, which is already inferior to others in Europe.
“What we most need is an innovative NHS, not one more determined to ration care before we even know how patients will benefit from it,” said Dr Barker, adding: “the fact that some PCTs apparently find NICE recommendations unaffordable is more a reflection of poor forward planning for innovations in the NHS than it is of the poor value they deliver.”
The MPs are also critical of NICE’s topic selection, which they say is too limited, and point out that they were told by witnesses to the enquiry that its focus on acute treatments “could skew NHS spending towards selected new and expensive (NICE-approved) drugs for acute illness.” The MPs are also severely critical of the Institute’s failure to act on disinvestment, saying they find it “unacceptable” that it has ignored repeated recommendations to evaluate older, possibly cost ineffective therapies. NICE’s statement that “few interventions have absolutely no benefit” may be true but is irrelevant, says the report, adding: “many treatments currently used are not cost-effective as many studies attest. NICE should adopt a similar standard of cost-effectiveness in assessing such treatments as it uses in its technology appraisals. The organisation must now give more emphasis to disinvestment.”
The Committee is not convinced of the benefits of risk-sharing schemes, which it says should be used “with caution” and not as “a catch-all in cases of uncertainty over a drug’s benefit.” Such uncertainty would be better addressed by a publicly-funded randomised controlled clinical trial, and better use should be made of NICE’s “only in research” recommendation, it says.
Another criticism is that NICE assessments do not take account of the treatment’s wider benefits to society such as the costs borne by carers and social care services, although the MPs acknowledge that to do so would require a decision by Parliament.
Moreover, the report finds that the Institute does not have all the information it needs to assess and compare treatments, and it calls for it to be granted the right to see all the evidence used by the Medicines and Healthcare products Regulatory Agency (MHRA) when making its decisions. It also needs to work more closely with the pharmaceutical industry to encourage companies to produce the type of information which NICE needs to carry out it assessments; according to Mr Barron, the data supplied by industry is “often weak, inadequate or distorted.”
Despite these criticisms, the report concludes that NICE “does a vital job in difficult circumstances.” It calls for more help for PCTs to implement the Institute’s non-mandatory guidance, better monitoring in the level of uptake and for elements of its clinical guidelines to be made mandatory.
The report reserves special criticism for ministerial interference, discussing in detail the concerns raised by witnesses to the enquiry over ex-Secretary of State for Health Patricia Hewitt’s involvement in the public battles for access to Roche’s breast cancer treatment Herceptin (trastuzumab). In the Committee enquiry’s final evidence session, however, Minister of State Dawn Primarolo assured the MPs that “it is not the role for ministers to contradict, override or directly seek to influence a process where NICE are already engaged in consideration,” and, she added: “NICE’s final guidance will be final.”
‘It is essential that NICE is left to do its job without ministerial interference, at the same time, it must have the support of ministers when it makes difficult decision,” Mr Barron told reporters.
PharmaTimes is organising an ‘extraordinary’ meeting to discuss the Health Select Committee’s report on NICE. Taking place on the 5 February at the House of Commons (2.15pm), the lead speaker is Kevin Barron MP, who is also chair of the Health Select Committee. Responding on behalf of the pharmaceutical industry is David Fisher, Commercial Director, ABPI, plus additional comment from industry and patient associations. All enquiries to pharma@pharmatimes.com.
