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Leela Barham looks at NICE's new position statement, which seeks to set out a little more clearly how it works with industry.
It’s likely that if you work in the pharmaceutical industry - even outside of the UK - you will have heard of the National Institute for Health and Care Excellence (NICE).
NICE has become not only a key agency that shapes access to medicines in England, but it is also influential internationally. Some countries have formalized how they draw on NICE’s recommendations on drugs; Romania for example (see Box 1) draws on NICE and other Health Technology Assessment (HTA) agency reports to decide whether they reimburse a drug or not. Given NICE’s reports are freely available from their website you can bet that their reports get read by those making the same – difficult – decisions across the globe.
This international reach of just one agency means that how it approaches making recommendations on which drugs should be used and in which patients matters a great deal. That also means it matters whether and how it is open to making improvements to its processes and methods. It also matters whether it sets a precedent that working with stakeholders – and industry being a key one – is a core or peripheral activity.
NICE has sought to set out a little more clearly how it works with industry through a new position statement, published in January 2017. The five-page document sets out how NICE works with the industry and the ambition about the contribution NICE can make to the development of a successful life sciences industrial policy (there’s more than a little bit of positioning going on so that NICE can be seen to be making the most of the ‘opportunities’ of Brexit).
Key in the document is the NICE contribution to major initiatives that have affected the industry – the Early Access to Medicines Scheme (EAMS) and the Cancer Drugs Fund (CDF) – as well as international work. NICE cites work on optimizing Real World Evidence and ‘establishing best practice and infrastructure for the implementation of regulatory pathways to facilitate timely patient access to cost-effective medicines’. The latter is presumably their work to support Adaptive Pathways and MAPPs more generally.
NICE outlines the several ways it works with industry already. They include reviews - NICE has a formal process for methods and processes used as part of Technology Appraisals - as well as consultations when there are major changes. NICE’s consultation on introducing a budget impact threshold is an example.
NICE is rightly proud of its work, citing their report on the assessment and appraisal of regenerative medicines and cell therapies. They could be a little more humble though, as there are always points to learn, as illustrated by an Office for Health Economics (OHE) report on the very same work. This type of work is of interest across many companies in the industry.
NICE also offers industry opportunities to work with NICE on specific issues for specific drugs too. They offer Scientific Advice as well as the Office for Market Access. Scientific advice is popular but the Office for Market Access has only just got going really. Both services come at a cost for companies.
NICE suggests that it can improve product value propositions, contribute to UK economic growth and help position the UK as a premier global life sciences destination. Such lofty ambitions!
There is a reality check needed to the position statement. NICE can and does work with industry. However it needs to go beyond just the position statement. Simple steps include publishing the minutes from the NICE/Industry Council – set up as part of the 2014 Pharmaceutical Price Regulation Scheme (PPRS) - who have met at least two times according to a freedom of information response from NICE. NICE can also ask industry how they are doing. NICE has plans in train on tracking its reputation with stakeholders. It seems to have stalled though, but this may provide some useful insights in the future. The take-away is that NICE has more to do to deliver on the ambition of a positive future with the life sciences industry….
Leela Barham is providing input as a subject matter expert into medicines pricing policy development with a UK government client and for the duration of her involvement in that project, she is restricted on what she can write about.