National Institute for Health and Clinical Excelence

The Health Committee is highly critical of the delay in setting out precisely what a value-based pricing system for drugs entails. There is also uncertainty about the implications of the changes proposed for the Cancer Drugs Fund which was introduced in 2011 to allow clinicians to use drugs that had not been approved by NICE, and which will be superseded by the value-based pricing system. The Committee 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; and clarity about how drugs which have been paid for by the Fund will continue to be available to individual patients. There is also concern about the implications for the effectiveness of NICE of recent evidence about access to information from clinical drug trials. 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. The pharmaceutical industry should introduce a new code of practice to make this commitment effective and the GMC should reiterate its guidance to doctors on the conduct of drug trials. Is important for the credibility of NICE that Patient voice is effectively and openly represented in all its work; and that NICE guidance should continue to be guidance rather than an instruction and that the NHS should continue to allow local discretion, but variations from NICE guidance should be open, transparent and accountable.