Earlier this year Sir Ian Kennedy was asked by Sir Michael Rawlins, the chairman of NICE, to undertake a study into medical innovation, in response to views expressed by Sir David Cooksey in January 2009 in his Review and Refresh of Bioscience 2015.
Sir David wrote: “Currently, the perceived problem for UK industry is that NICE appraisals do not operate in a way that is supportive of innovation, or uptake and access to medicines and therefore dissuade companies from investing in the UK.”
The ensuing Kennedy Study of Valuing Innovation presumes that there is a problem concerning innovation and addresses the following questions: What approach should be adopted by NICE to ensure that innovation is properly taken into account when establishing the value of new health technologies? Should particular forms of value be considered more important than others? How should innovation in health technologies be defined? What is the relationship between innovation and value?
The following is a summary of its key recommendations:
1. NICE should be more active in explaining its role and decisions and develop a strategy to achieve this.
2. It should work with pharma and others to identify how the costs of research and development are distributed in the global market.
3. Its appraisals should continue to be based on the icer/qaly approach into which is incorporated explicit consideration of relevant benefits.
4. NICE should consult all relevant parties and draw up a list of those health-related benefits to be taken into account in its appraisals. And NICE should research whether the instruments used to calculate qalys and capture health benefits are appropriate to its needs and whether they are applied consistently.
5. NICE should work closely with pharma to ensure that it’s is made aware at the earliest possible opportunity of any claim by pharma regarding benefits and that data relevant to its appraisals is generated as part of pharma’s research.
6. NICE should enhance its efforts to understand the spending behaviour of PCTs and the effects of its decisions on PCT’s budgetary planning.
7. NICE should work with others to develop an active policy on disinvestment by the NHS in products which do not offer value for money.
8. NICE should build on its reputation as the leading the world in the appraisal of products to establish itself also as a world leader in promoting innovation and the early adoption of treatments.
9. NICE should urge government to make appropriate adjustments to the supply side, as recommended by Sir David Cooksey, to encourage innovation on behalf of the NHS and patients.
10. It should consider establishing a formal and transparent process to offer incentives to pharma when a product is said to have the promise of innovation.
11. NICE should make urgent representations to government that its ability to effectively evaluate the value of products depends on the existence of data and information from appropriate research and study. It should also urge government to examine the funding of research and further study, working with pharma and all other relevant parties, particularly academic health science centres, so as to generate data enabling NICE to evaluate products as effectively as possible.
12. It should urge the Department of Health to support the funding of post-marketing surveillance of products’ efficacy as well as safety.
13. NICE, through its medical technology advisory committee, should play an increasingly active role in encouraging research into medical technologies to be carried out in the UK.
14. NICE should work with others, particularly academic health science centres, to ensure that a sound infrastructure for research into the effectiveness of psychological therapies is established.
The full list of recommendations were reported to the NICE board in May. It will consider a response at its public meeting in September. Another study, Citizens Council Report: Innovation, is also being considered by the NICE board. If the recommendations are approved, the board’s response will be subject to a three month public consultation.
