NICE 'office for innovation' would smooth path of new drugs
NICE has just unveiled far-reaching proposals for a 'new approach' to managing the entry of drugs onto the NHS.
The National Institute for Health and Care Excellence is responding to a government consultation on how the cost effectiveness watchdog should update its methodologies and processes in evaluating new drugs.
The government had wanted NICE to integrate a 'Valued Based Assessment' criteria into its methods, but says it could find no common ground among the stakeholders consulted on the plans.
Consequently, NICE is putting forward its own plans, aimed at addressing some of the long-standing complaints about how it works – often from patient groups and pharma companies who say it says 'no' to too often.
NICE says its new proposals will allow it to position itself for a wider role in the way drugs are developed, evaluated and taken up in the NHS.
Following the consultation, the institute has decided to undertake further work before making changes to the way it appraises new medicines and other technologies for use by the NHS. It argues that any changes to NICE's methods need to be made as part of a wider review of the innovation, evaluation and adoption of new treatments (including those for cancers) involving patients, people working in or with the NHS, the life sciences industries and health researchers.
Alongside any changes to its methods, NICE proposes:
• an office for innovation inside NICE to provide companies with a 'flight path' through the stages of the development, evaluation and adoption of their products into the NHS
• agreement between NICE, NHS England and the Department of Health, on the NHS's willingness to pay for new treatments, which would take account of any special cases, such as ultra-orphan conditions and cancer
• more productive sharing of risk between companies and the NHS. The aim would be to progressively reflect the value of new treatments as our knowledge of what they can offer to patients increases (NHS England's "commissioning through evaluation" process could be used to for this).
The institute's proposals follow a detailed examination of its role in determining which new technologies the NHS should pay for. In 2013, the Department of Health asked the institute to consider additional "terms of reference" in the appraisal of new health technologies. The aim was to supplement the existing NICE methodologies.
Earlier this year, NICE published its proposals on "value-based assessment" for consultation. They were intended to give more direction to the independent committees which appraise new technologies on behalf of the institute.
NICE's Board of Directors, which has met at a public meeting in Kendal, has considered the results of the 3 month consultation of stakeholders – including patient groups, the Department of Health, companies, learned societies, charities and researchers.
The Board found no agreement in responses on the proposed changes. The chief executive of NICE, Sir Andrew Dillon, explained:
"We've been looking in detail at how to change the way we appraise medicines and other technologies on behalf of the NHS. Following an extensive consultation, it's clear that just changing NICE's methods will not overcome concerns about how the NHS accesses new treatments.
"We also need to look at other processes, including the model of pharmaceutical research and development, the expectations that companies and patient groups have about how risk and reward is shared between the industry and a publicly funded NHS, and in the arrangements for commissioning expensive new treatments.
"There have been exciting changes in research and development of new medicines and other health technologies which is increasingly challenging all those involved in bringing new treatments to patients. This requires a wider review of the NHS' arrangements for supporting innovation and evaluating and adopting new treatments. And it's essential that industry also recognises its role in making innovative treatments available to people at a fair price."
The plans are likely to be welcomed by the UK pharmaceutical industry and patient groups, although as always, most stakeholders will reserve judgement until fuller details of the proposals are revealed.
