NICE's response to the Kennedy study
NICE welcomed Sir Ian's study of valuing innovation, published on 22 of July 2009, which set out 25 recommendations for improving the way NICE operates.
Establishing the value of new technologies
Sir Ian recommended that NICE should consult all relevant parties and draw up a list of health-related benefits to be taken into account in its appraisals. NICE has agreed to develop a list of these as part of the scoping phase.
NICE will ask consultees to identify the nature of the data which they understand to be available so that the Appraisal Committee to take account of these benefits. Potential benefits will be identified in the scope if they are:
- considered to be plausible and
- are likely to be supported by appropriate data and
- can be accessed by the Institute
Demonstrably plausible health-related benefits for which data was available, or on which the Committee was able to make an assessment will be included in a table in a new section in:
- Appraisal Consultation Documents (ACDs)
- Final Appraisal Documents (FADs)
- Technology Appraisal Guidance
This table will document how the Appraisal Committee has taken account of each point. For example, it will show whether or not the Committee considered that the benefit was captured in the estimated gains in health-related quality of life, used in the QALY calculation. Where such benefits have not, or have not been reliably captured in the QALY calculation, the Committee will be asked to describe how it has evaluated them and how it has taken them into account in developing its guidance.
Sir Ian called for NICE to develop a definition of innovation, to establish a mechanism whereby pharmaceutical companies can signal as early as possible that a product may constitute an innovation, and then to only offer incentives for innovation when it is realised.
The scoping process
NICE proposed that where innovation is considered to be a specific and identifiable benefit of the technology, the scoping process will be used to explore the unique characteristics which support this proposition.
Where the Appraisal Committee has identified innovative characteristics during the scoping process it will investigate:
- its potential to make a significant and substantial impact on health-related benefits
- how it might improve the way that a current need is met.
This should be done either for the population for whom it is indicated or for one (or more) subgroups. The Appraisal Committee should satisfy itself that it can be regarded as a ‘step-change' in the management of the condition.
Where the Appraisal Committee is satisfied that the product represents a ‘step change', it will be expected to demonstrate either that that the product's identified innovative characteristics have been taken into account in the QALY calculation or, if not, how it has separately evaluated them.
A number of Sir Ian's other recommendations are already being implemented and NICE agreed with a number of other recommendations to which we will respond.
Explaining NICE's role and its decisions
NICE is being more active in explaining its role and decisions. NICE has already restructured its communications team to enhance corporate communication, and made improvements to the website and developments to the marketing strategy.
The effects of NICE's decisions on PCT budgetary planning
NICE will respond to Sir Ian's recommendation to enhance its efforts to understand the spending behaviour of PCTs and the effects of NICE's decisions on PCT budgetary planning. NICE is planning a project with selected PCTs with these objectives, and will publish the results.
Recommendations outside NICE's remit
NICE acknowledged that a number of the recommendations fall outside of its remit. For example, Sir Ian called for NICE to offer advice and support to newer pharmaceutical companies to facilitate competition, and for NICE to urge the Government to make appropriate adjustments to the supply side of medicines.
This page was last updated: 28 June 2010