James Raftery: Bypassing NICE for the sake of innovation?

Recent reports that NICE was to be bypassed by drugs which were “innovative,” with funding from a new separate budget, sent me in search of the source report – the Life Sciences Blueprint, a statement from the Office of Life Sciences .

This report outlines three “issues” relating to NICE, each with an OLS “solution.” (The entire report is written in that format.) The first issue concerns drugs for small populations with the potential for improved outcomes but which lack data to demonstrate cost effectiveness which can limit market access if referred to NICE. The OLS solution is to establish an “innovation pass” for selected medicines which will not be done through a NICE appraisal but instead will be funded for 3 years. NICE will play a key role in developing and applying criteria for the pass. The pass will be piloted with a budget of £25m in 2010/11. The pilot scheme will be developed with industry, NICE and the NHS. This will be subject of a consultation in November which will include discussion of funding for future years.

The second “issue” is “there is scope for a more constructive and appropriate dialogue between industry, NICE and the assessment teams whose work supports NICE appraisals.” The OLS “solution” is to allow companies to attend NICE appraisal meetings in order to respond to questions, and to comment on points of factual accuracy. At the end of each appraisal, the company will have a debriefing with NICE. Further, the evidence review groups will be asked to attend scoping meetings for NICE.

The third “issue” is the question of whether NICE’s methodologies take into account a wide enough range of factors in determining cost effectiveness. Since this is the subject of an inquiry led by Ian Kennedy due to be published on 22 July, this is not discussed further here.

These developments are clearly initiatives from the newly titled Business, Information and Science (BIS) department, formerly BERR and many other titles. The Office of Life Sciences is under the Minister for Science and Innovation, Paul Drayson, of PowderJect and racing car fame (or to some, notoriety).
The premise of the report is promotion of life sciences as an industry of vital importance to the UK.

Drayson might well protest that the blueprint is not just about industry. He recently twittered his vision for Britain: “My vision 4 UK in 140chars: Healthy Britain, Green Britain, Digital Britain (life, earth and computer sciences/technology) Tweet yours pls.”
Some of the responses he got were funny,  including one which suggested a Britain governed by elected politicians. Lord Drayson, of course, is a non-elected minister, one of five out of ten ministers in BIS.

The impact of the “Innovation Pass” could be considerable. It raises questions about the criteria for eligibility. Note that NICE will play a key role in developing and applying criteria for the pass. Some questions: should eligibility be limited to drugs owned by UK companies? What would the benefit be to life sciences UK from allowing non UK drugs to be included? The reference to small populations prompts queries about the links to NICE’s recent changes in relation to “end of life” drugs which also refer to small populations. With personalised medicines every disease can be broken down into small populations. More generally, what is the value of innovation other than cost effectiveness? Will the Innovation Pass be some sort of patient access scheme in which the relevant data are collected over the duration of the pass? If so it will be one of the less challenging patient access schemes to date .The consultation promises to be interesting!.

The second “issue” and “solution” above seem less controversial, not least because the “solution” has already been agreed by the NICE Board. However it is interesting in its implied criticism of the current dialogue between industry, NICE and the Evidence Review Groups. With Appraisal Committees meeting in public it will be interesting to see how often companies who attend are asked questions, some of which they may find uncomfortable (such as “Why is this drug priced so high?”). The views of the Evidence Review Groups to these developments are not known. But it seems clear that they are being asked to have develop different attitudes to industry. Some groups already have close links, others don’t … yet.

James Raftery is a health economist with several decades experience of the NHS. He is professor of health technology assessment at Southampton University. A keen “NICE watcher,” he has provided economic input to technical assessment reports for NICE but has never been a member of any of its committees. The opinions expressed here are his personal views. He welcomes comments to his blog.