A number of key decisions need to be taken swiftly in order to ensure a smooth change-over to a new system of pricing for the drugs used by the NHS the Health Committee reports today, following an inquiry into the work of the National Institute for Health and Clinical Excellence (NICE). It also urges greater openness about the results of clinical drug trials, and welcomes the new role that NICE will have from April this year in producing guidance for the social care sector.
The Committee is highly critical of the delay in setting out precisely what a value-based pricing system for drugs entails. Given that the Government opened its consultation on the issue in December 2010, the Committee says that it is unacceptable that the arrangements for value-based pricing have still not been settled and that those who will have to work with those arrangements are still unclear about what value-based pricing will mean in practice. Industry, patient groups and clinicians all need clarity about how a new system will work and how they can make their views heard, the MPs say; they call for decisions to be taken no later than the end of March this year.
Cancer Drugs Fund
The Committee also notes that there is uncertainty about the implications of the changes proposed for the Cancer Drugs Fund which was introduced by the Government in 2011 to allow clinicians to use drugs that had not been approved by NICE, and which will be superseded by the value-based pricing system. It calls for:
- an assessment of the outcomes for those patients whose treatment has been paid for by the Cancer Drugs Fund
- evidence of beneficial outcomes which should inform the new value-based pricing scheme and applied to treatments of conditions other than cancer
- Clarity about how drugs which have been paid for by the Fund will continue to be available to individual patients.
Access to clinical trials data
The MPs also express concern about the implications for the effectiveness of NICE of recent evidence about access to information from clinical drug trials. They argue that there should be both a professional and legal obligation to ensure that all regulators, including NICE, have access to all available research data about the efficacy and safety of pharmaceutical products which are in use in the UK. All information arising from drug trials concerning drugs that are in clinical use should be in the public domain in an accessible form. The Committee urges the pharmaceutical industry to introduce a new code of practice to make this commitment effective and calls on the GMC to reiterate its guidance to doctors on the conduct of drug trials.
The Committee argues that it should be neither legal nor ethical to withhold research data about pharmaceutical products which are in clinical use. It is concerned that the fact that this simple principle is not universally applied in practice undermines the effectiveness of NICE; the Committee welcomes the current review of these issues by the House of Commons Science and Technology Committee and recommends that that Committee should examine the nature of both the legal and ethical principles which should cover these issues and how to make those principles enforceable in practice.
Guidance on social care and integrated care
One of the key themes of the Committee’s work in this Parliament has been the need to move to a more integrated system in order to maintain both quality of care and access to care. It therefore welcomes the fact that NICE is to take on responsibility for producing clinical guidance and quality standards in relation to social care. It argues that there is a real opportunity for NICE to help evolve a different model of care by creating integrated standards and clinical guidance.
The MPs say that this should not just be about providing guidance to people in different disciplines who are treating and caring for people with a specific condition, but should also involve advising about the most common associated co-morbidities, including mental illness, and will also need to take account of what individuals want for themselves. Such an approach would be an important step towards a philosophy which emphasises treatment of people not conditions.
The Committee also makes recommendations about two other significant issues:
It recommends that is important for the credibility of NICE that Patient voice is effectively and openly represented in all its work
It also recommends that NICE guidance should continue to be guidance rather than an instruction and that the NHS should continue to allow local discretion and individual judgments of doctors and patients, but that variations from NICE guidance should be open, transparent and accountable.
Launching the report, the Chair of the Health Committee, Stephen Dorrell MP, said:
"What we were told during our inquiry indicates that the move to value-based pricing of drugs will be a more modest change than has been suggested, but there is a lack of clarity around the whole issue which has persisted for too long. Decisions need to be taken, and the details of the scheme made public to avoid problems with the transition to the new system at the beginning of 2014. We hope the Government will respond positively to our suggestion that this situation should be clarified before the end of March this year. Similarly, there needs to be a proper assessment of what benefits the Cancer Drugs Fund has brought, with those benefits being applied to the treatment of other conditions, as well as providing a clear mechanism for the future funding of treatment for patients whose drugs have been paid for from the Cancer Drugs Fund.
We are also concerned about the evidence we have received that some of the data supplied from clinical trials has been selective and incomplete. This situation cannot be allowed to continue, and we set out a number of practical steps that could be taken now to increase transparency about the results of clinical drug trials and which would benefit everyone: patients, clinicians and the pharmaceutical industry.
We welcome the fact that NICE has been given the role of developing guidance on social care and integrated care. This could make a substantial contribution to the establishment of new models of care which focus on the treatment of people rather than conditions, which will be vital if the health and care sectors are to continue to provide comprehensive high quality care in the coming years."