On 22nd July, a report entitled Appraising the Value of Innovation and Other Benefits: A Short Study for NICE (344KB PDF; 52pp.) was published by Prof. Sir Ian Kennedy. In February 2009, Sir Ian was “asked by Sir Michael Rawlins, the Chairman of the National Institute for Health and Clinical Excellence, (NICCE)[…] to undertake a study in response to the views expressed by Sir David Cooksey in January 2009 in his Review and Refresh of Bioscience 2015. Sir David wrote that ‘Currently, the perceived problem for [the] UK [pharmaceutical] 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.’ As a response to this ‘perceived problem’ Sir David offered Recommendation 16. This reads:
There should be an independent inquiry to assess NICE’s long term impact on cost, access to, and uptake of, medicines in the UK. There should also be an independent review of the way in which NICE values medicines so that the current economic evaluation is complemented by clinician, patient and research inputs on the value of innovation from their perspectives
Sir Ian was asked by NICE to undertake the study in question as a direct response to the second recommendation calling for an independent review as described above. Not unreasonably, Sir Ian understood it to be “a condition of [his] study that there is a perceived problem concerning innovation. It is for others elsewhere to determine whether this is so” (p. 11).
His specific brief from NICE was “to carry out a short study of valuing innovation aimed at addressing the following questions” (p. 11):
- 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 report runs to 52 pages and makes 25 separate recommendations, and a detailed critique of it would run to about the same length. However, as you’ve been nice enough to persevere through the four paragraphs I’ve already written and I don’t want you to delete me from your RSS feed (you do use RSS, right? And I’m on it, yes?), I am not going to offer such an analysis here.
What I will do, however, is offer a bullet-pointed summary of an excellent podcast interview that NICE has posted in which Sir Ian outlines the fundamental issues and his key recommendations. His perspective is refreshingly straightforward, and he makes some insightful observations:
- The Cooksey report characterized NICE as the ‘fourth hurdle’ (p. 4) to market access and reimbursement for the pharmaceutical industry in the UK (the first three being a product’s safety, efficacy, and quality). Consequently, as far as the pharmaceutical industry is concerned, NICE’s activity is broadly speaking a disincentive to innovation, progress and improvement.
- NICE does not take sufficient account of the benefits that the industry offers to patients.
- NICE is not effective at explaining what is does, and is therefore caricatured as an agency standing between patients and the drugs they believe they need rather than an organization designed to (in Sir Ian’s words) “attend to the needs of patients we don’t know about, as much as the patients we do”
- On the one hand, the pharmaceutical industry in the UK needs to recognize that the “rules of the game” are governed by the collective allocation of scarce resources by the NHS (as payer), rather than serving the needs of the consumer (as payer) as it does in other markets, for example the USA.
- On the other hand, there are two categories of health benefits that the pharmaceutical industry brings that NICE does not take account of in a recognizable or transparent manner, namely, “those that relate to how patients may value their health”, and those that relate to how the health of different groups of patients is valued by society” (para. 3.8, pp. 24-25).
- NICE should incentivize “innovation”, tightly defined by Sir Ian as the delivery of a product that i) offers a “step-change” fulfilling a currently unmet need that is effective across at least 70% of the population, and ii) satisfies the defined needs of the NHS and government.
- The incentivization Sir Ian envisages must be results-based, or as he puts it, the industry should only expected to be rewarded when the glass of water it claims to have potential turns in a glass of wine.
- The nature of the incentive is not spelled out in the podcast, but the report suggests pp. 40-41 (para. 4.12, recommendation 15) accepting a higher price for the innovative product beyond the normal threshold, or agreeing a higher threshold for “a set period of time, eg 3-5 years, after which it must be adjusted to bring the product within the normal threshold”.
All of this is interesting enough.
However, a real opportunity for industry would appear to reside in its recognizing and acting upon the report’s recommendation to find “creative ways” of helping NICE become aware of its innovations in a timely manner by not only doing a better job of collecting and facilitating access to data itself, by also by supporting the collection of data by all interested parties (see recommendations 8 and 15).
[Thank you for having read this far.
It’s been a bit arid, hasn’t it?
Oh look! The big red light on your desk marked ‘social media’ has just started flashing!]
For example, the industry could utilize social media platforms and tools not only to share its own data as soon as it feels that it can, but also to help bring together health care professionals who may have undertaken adjacent informal studies of their patient population over a number of years, but for whatever reason have neither analyzed the data adequately, nor published them formally, nor contributed them to a broader study. The community’s discussion need not be restricted to emerging data; it could also provide a platform to assess and review older data which has been insufficiently scrutinized and may contain as yet undisclosed value. The community could share, analyze, review and discuss the data and move towards a number of possible ends and outcomes.
This is just one suggestion, of course, and there are many other ways in which this call to action may be answered.
In this regard, I’d be interested to hear what you made of the report, and what you think NICE and the industry could do in order to garner value from its recommendations and engender, in Sir Ian’s words, “détente, understanding, and [to lower] the temperature” between them.