A new decision framework to support NICE recommendations on the use of new drugs and devices in the NHS is published today by the Centre for Health Economics at the University of York.
NICE (National Institute for Health and Clinical Excellence) is increasingly making 'fast-track' recommendations to the NHS on the use of new drugs or devices soon after these products are first licensed.
Often these decisions are being made when the evidence base to support these technologies is limited. There may be substantial uncertainty surrounding overall effectiveness, the patients most likely to benefit, the potential for harms and whether they actually represent best use of resources for the NHS.
An underused option available to NICE is to make an 'only in research' recommendation; where a drug or device can only be used in the context of an appropriately designed programme of evidence development. Having further evidence can be valuable but guidance on how best to balance the benefits of access to a new drug or technology with the value of further evidence about its performance has been lacking.
Researchers from the Universities of York and Brunel University developed a transparent, consistent and methodologically robust approach to formalise a process NICE can use to produce its `only in research' recommendations.
Project lead, Professor Karl Claxton, from Centre for Health Economics at York, said: "Uncertainties about treatment effects can never be entirely eliminated but they can be reduced by further evidence. This in turn facilitates better decisions on patient outcomes and on best use of finite resources in the NHS, which are crucial at a time of financial constraint.
"Our research has established the key principles of what assessments are needed, as well as outlining how these assessments should be made. Our framework will enable NICE to make 'only in research' recommendations in an explicit and transparent manner."
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