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The Kennedy report: Appraising the value of innovation and other benefits
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The Kennedy report: Appraising the value of innovation and other benefits
Report synopsis
This July has seen the publication of the Kennedy report, narrowly preceded by the Life Sciences Blueprint statement from the newly established Office for Life Sciences.
Written by Professor Sir Ian Kennedy and entitled Appraising the value of innovation and other benefits —a short study for NICE, the Kennedy report includes 25 recommendations aimed at improving relations between the National Institute for Health and Clinical Excellence (NICE), the pharmaceutical industry and the general public.
Sir Ian is keen to recognise that NICE is doing a good job in very difficult circumstances. However, he does criticise NICE for failing to communicate to the wider world how it works and why it makes the decisions it does. He says “NICE rarely appears to be on the front foot in terms of setting and discussing the agenda of resource allocation. Instead, it too frequently finds itself responding to the characterisations (and caricatures) of others... it finds itself regarded as blocking patients’ access to drugs, rather than holding the ring between conflicting demands.”
Broadly speaking, the report recommendations boil down to the following:
- NICE needs to find ways of encouraging innovative research and development within the pharmaceutical industry and to work in partnership more with manufacturers
- Social benefits—such as increased productivity due to return to work—should be included in incremental cost-effectiveness ratios/quality-adjusted life-year (ICER/QALY) calculations rather than added on as a second stage
- Innovation needs better definition. Everybody is agreed that innovation is important, but there is little agreement as to what actually constitutes innovation
- To help NICE to encourage innovation, innovative products should be flagged early by manufacturers
- The ‘innovation pass’, as detailed in the Life Sciences Blueprint, is a potentially useful way of bypassing normal NICE appraisal and making certain products available via ring-fenced public funding
- The ‘innovation pass’ should be available to a product:
- With only ‘conditional marketing authorisation’
- Which in the view of a committee of experts is very innovative—such as constituting a new mechanism of action, or reaching a new target
- Which, where relevant, is accompanied by evidence relating to stratification
- Where the body of evidence is still relatively limited and immature, but strong enough to suggest a high degree of effectiveness
- Which is intended for a relatively small population of patients
- There should be a fixed time, probably of 3 years, for which the product enjoys freedom from NICE appraisal
- If at the end of 3-years ‘grace’ the product is not approved by NICE, patients already receiving it should continue to do so at the manufacturer’s expense
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Taken from the Issue 9/September 2009 issue of Cancer Services Forum.
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