A State of Fear ...
Fatima Moncrieffe examines health technology assessment
By on Apr 24, 2008Fatima Moncrieffe examines health technology assessment
I am currently reading one of Michael Crichtons bestsellers, State of Fear. Its about a bunch of eco-warriors trying to make the point, rather dramatically, that climate change is happening now. Actually, there is a subplot of the authors about the theory of global warming being only just that a theory. Now before you begin to wonder if somehow you have found yourself in a book club-type piece, please read on, as I am hoping to prepare you so that you can avoid any kind of state of fear.
Fear of what exactly? Well fear of your beloved product never getting off the ground because your payers dont want it rather like Pfizers inhaled insulin Exubera for diabetes. And the reason this might happen is because of health technology assessment (HTA).
Actually there is nothing new about HTA, as it has been around a long time. What is new is that instead of earnest researchers just doing it, organisations are doing it and they are doing it to you. And its actually all the fault of the UKs ex-Prime Minister and now international lecturer Tony Blair. Why?
Well, one of his first creations after coming into government was NICE. The National Institute for Health and Clinical Excellence was born in April 1999 and although bruised from a few falls (and legal challenges!), it is now growing up into a rather strapping young lad. NICEs growth pains have been watched rather assiduously around the world; many governments and healthcare systems have quite liked the way that the Institute has gone about making determinations on the clinical and cost effectiveness of medicines. And those of you more connected with HTA will know that similar organisations have fairly recently been established in France, Ireland and Germany. And to be fair to Sweden, there has been a similar organisation there working away for years before NICE was born.
HTA is now spreading more widely across the European Union, including the newer member states like Poland. And some commentators have even conjectured that the HTA world will conquer all of Europe with a more centrally based EuroNICE, and eventually cross the Atlantic and invade North America (actually Canada already has a similar body there and headed by a Brit). But the real fear has to be about a US NICE but more of that later.
First, lets just go back in time a bit and see how we got here. When the UK House of Commons Health Select Committee held an Inquiry into NICE in 2002, the Institute said in its memorandum of evidence that, The Board is aware that NICEs work is watched by many healthcare providers in Europe, North America and Australia and the Institutes work has gained an international reputation. NICE is perceived as being the cutting edge of health technology assessment, and it is expected that international agencies might adopt NICE recommendations And when the European office of the World Health Organisation checked out NICE in 2003, it said, ..... NICE has developed a well-deserved reputation for innovation and methodological developments that represent an important model for technology appraisal internationally....Published NICE appraisals are already being used as international benchmarks." So even then, the Institutes influence had begun to extend far beyond the UK and today it still seems to be the tallest kid in the HTA playground.
But what about any stirrings of some kind of EuroNICE? Well actually these stirrings have been happening for some time. As far back as 2000, an EU-sponsored project began to try and create a firmer network for HTA throughout the Union. The European Collaboration for Assessment of Health Interventions involved all the then 15 Member States of the EU. For more details please see Sassi.F., The European way to HTA (Intl. J. of Technology Assessment in Health Care, 2000, 16:1, 282-290), and for a much more detailed overview on HTA in Europe at that time, please see the special section in the International Journal of Technology Assessment 2000 (Vol 16:2, pps 299 639), where some 16 countries are described in some detail.
Things then went quite well for a while, but in 2003 a high level process of reflection was co-ordinated within EU members, which led to an invitation to the Commission to consider how to create a more sustainable HTA Network across member states. Then in 2004, the European Council was asked to follow this up and a concept paper was produced. Then in early 2006, a European Network for HTA (EUnetHTA) was finally set up to bring together the work of the many HTA Agencies operating across EU-25, with EU funding until at least this year.
The aim of the Network has been to connect all publicly funded national HTA Agencies, research institutions and health ministries to enable more effective exchange of information and to support policy decisions by health ministers. The Network also aims to reduce any duplication of efforts and thus promote the more efficient use of scarce resources. Further within EU 25, the idea is that the Network would support those countries with limited experience of HTA thats basically all of the new member states and even some of the older members. Other objectives of EUnetHTA have been to develop and implement generic tools for adapting assessments done in one setting (country) and aid their transfer to other jurisdictions; to develop effective tools to transfer HTA results into applicable health policy advice in member states, including systems for identification and prioritisation of topics for HTA; to effectively disseminate HTA results; to information share and to co-ordinate HTA activities by acting as a clearing house and to more closely monitor emerging health technologies Phew!
The Danish HTA Agency (DACEHTA) has been the co-ordinating secretariat, although most HTA agencies across the EU have been involved to some extent. But please note that EUnetHTA has actually involved some 60 partner organisations from 31 countries, and not just within the EU. The US, Canada, Australia and Israel have also been represented as well as Norway, Iceland and Switzerland (not part of the EU). So please see www.eunethta.net for details of all the work programmes. And for a more detailed overview, please see Eurohealth 2006; 12; 1; 36-38. Finn Borlum Kristensen from DACEHTA says in this paper, In the future, preventing the duplication of HTA activities across Europe and increasing standardisation of HTA methodologies and procedures will allow a wider range of HTAs in Europe to be undertaken and also help improve links between technology assessment and decision making.
So is a EuroNICE of some kind on its way then? Well its probably quite important to understand that there are actually two major steps in the evaluation of medicines post-licence. First, there is the process of health technology assessment, the collection and evaluation of the evidence base; and then there is the process of health technology appraisal, which is more a value judgment based step, depending on the healthcare setting. NICE basically takes HTAs and turns them into health technology appraisals.
Bottom line then, because of different funding mechanisms and structures across EU-25, it is probably highly unlikely that there will ever be an EMEA-like organisation for both processes. But for the first process of assessment and the collection of one EU evidence package by one EU HTA Agency feeding into 25 separate appraisals, well thats a very different story indeed To help you check out where we are here, you might like to know that a EUnetHTA conference, 'HTA's Future in Europe', is being held at the Pasteur Institute in Paris on November 20th this year. This is, no doubt, the first real stirrings of a EuroNICE.
And also please be aware of other HTA groups. So, for example, the 20 or so other HTA agencies operating within the EU network globally through the International Network of Agencies for Health Technology Assessment (INAHTA) - see www.inahta.org. There is also a European early warning system for new technologies (EuroScan), whose secretariat is based at the University of Birmingham in the UK. EuroScan is an EU collaborative involved in exchanging information on emerging health technologies. These horizon scanning systems are important, as they are essentially the first stage in the process of health technology assessment and they too aim to facilitate the rational adoption of new health technologies by providing policy makers with timely information on the potential consequences of the introduction of new technologies into a health care system (see www.euroscan.bham.ac.uk).
But as said, a very real big industry fear here would have to be around this movement spreading to the United States. The US is certainly very late to the HTA party but as in a number of other areas, when it sneezes. Sub-prime mortgages come to mind here... So I was really intrigued by what I heard at a fringe session at the Annual NICE conference in the UK held back in December 2007. The session title was Will the US get its own NICE and what would it look like? The session featured Andrea Sutcliffe, previous Deputy Chief Executive of NICE and Steve Pearson, Senior Fellow, Health Insurance Plans, Washington DC. Andrea had visited the US for two months in 2007 and Steve had previously been a visiting fellow at NICE.
So why might the US be interested in a NICE? Well the evidence of US interest in NICE is certainly very strong with both high NICE website traffic and regular trips to the Institute from US visitors, as well as a recognition that there has been a global impact of NICE decisions and approaches. Certainly there is the potential to use a NICE approach in US healthcare decision-making since if nothing changes by 2030, healthcare costs are expected to consume one in every three dollars. Already 16% of GDP is spent, involving trillions of dollars and crippling some US companies. And yet the US is 37th in the world in terms of health outcomes and some 16% of the population is currently uninsured.
As Andrea commented, the US system is very pluralistic and highly fragmented and there is currently no national direction in terms of the implementation of evidence-based medicine, with US Federal efforts in this whole area historically having been very weak. So one can assume that some action definitely might be required to rein in costs and this could manifest in a process to assess the effectiveness and value of new technologies, leading possibly to more value-based insurance plans, for example. Andrea found that there is strong Congressional interest in NICE and already some work on comparative effectiveness.
So whats on the table and whats on the horizon? Well Hilary Clinton is apparently very interested and it has been suggested that a NICE-like public/private body might be a part of her healthcare reform plans, should she become President.. Steve himself seems actively involved here and an Institute for Clinical and Economic Review is already running at Harvard - the name (ICER) is not an accidental play on words - and supposedly many millions of dollars are already being readied.
So one might want to be prepared then better to have known knowns than unknown unknowns I would think in order to remove any state of fear! ...
As I mentioned earlier, the UK House of Commons Health Select Committee closely examined NICE back in 2002. What I didnt say was that this led to some changes in the way that NICE works. If NICE is the international HTA model, then for those of you outside the UK, you might like to know, therefore, that the HSC has recently held a second inquiry into NICE and the Committee has made a large number of new recommendations on how it believes NICE can continue to improve its ways of working (please see http://www.publications.parliament.uk/pa/cm200708/cmselect/cmhealth/27/2...). And for more independent comment, you might also want to have a look at an editorial in the British Medical Journal entitled Parliamentary review asks NICE to do better still (BMJ 2008;336:56-57 12th January). The UK Government has also now responded to the HSCs NICE Inquiry report.
The terrain does continue to move doesnt? But it was ever thus!
Author: Fatima Moncrieffe
Fatima Moncrieffe is a UK-based independent healthcare policy analyst and adviser. Her consultancy specialises in healthcare policy issues for both the Pharmaceutical Industry and the National Health Service and aims to support organisations in steering the right strategic course through a rapidly changing and turbulent healthcare environment.