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We have previously suggested on this site a growing need for pharma to connect to the world-wide health technology assessment (HTA) agenda (State of Fear, April 2008 [1]). [1] http://social.eyeforpharma.com/content/pharma-strategy/state-fear

We have previously suggested on this site a growing need for pharma to connect to the world-wide health technology assessment (HTA) agenda (State of Fear, April 2008). There, we mentioned in passing the growing interest in HTA in the United States (rather late to the HTA party), and thus, a fear that the HTA agenda might spread to the largest pharma market in the world. Certainly in the last administration, Congress appeared very interested in what the English National Institute of Clinical Excellence (NICE) was up to. Since then, of course, the US has a new president who appears to very interested indeed in the delivery of more affordable and equitable healthcare.

So is a new FBI about to be formed? Thats a Federal Bureau of Innovativeness Certainly at the time of this writing, the Obama administration appears to be getting ready to get stuck into comparative effectiveness, although NICE does not appear to be liked too much by the Republicans.

We also looked last time at the possibility of some kind of European HTA body (a EuroNICE) and examined the history of European Commission (EC) sponsored work in this area. We briefly described the European Network for HTA (EUnetHTA), aiming to harmonize HTA across member states, and pointed out that a major conference on HTA's future in Europe was to be held at the Pasteur Institute in Paris in November last year. This article reports on this wash-up conference of the initiative.

One of the first things to note was the large number of industry delegates attending. So clearly some kind of tipping point has been reached here with regard to interest by technology producers in HTA! The conference was opened by the French and Danish Health Ministers and they were both clear that in the future there would be big issues around not being able to afford all new technologies, that carefully assessing them would, therefore, be critically important, and that HTA would seem to be the right tool.

A massive amount of work has been done on this project. Some 400 participants have been involved from 64 organizations in 29 countries with some, like Canada, clearly being outside the European Union (EU). These have included both regional and national HTA Agencies, ministries of health and academic institutions. And the project has involved eight separate packages of work which have produced a number of really practical tools.

One key output has been the so-called HTA Core Model the methodology for producing structured HTA information for use beyond the local context, as well as to allow transparent shared work of producing HTAs across borders. Because HTAs are perceived differently across the EU member states, there has been an attempt here to standardize the various elements of an HTA.

Another work stream was around HTA adaptation tools, focused on the better use of HTA reports and the production of a toolkit to allow transfer from another setting, time and place. Another work stream has looked at dealing with promising new technologies and issues around uncertainty and the risks of making inappropriate decisions. Coverage with evidence development is a hot topic here (conditional marketing with possible revision of original decision and discontinuation of use) and the toolkit produced here should be very useful to those interested in market access.

An information system for emerging technologies is also being put in place, so watch out for an EU-wide e-newsletter that is to come. And please note too, that as a direct result of all the collaboration here, the European horizon scanning initiative (EuroScan) will now be much more global and international.

The interface between HTA and health policy was another workstream and one of the outputs here is a fine book Health Technology Assessment and Health Policy-Making in Europe (ISBN 978 92 890 4293 2). In fact, many of the presentations used figures and diagrams from the book.

Capacity building for HTA was another work stream more aimed at those member states with limited Institutionalization of HTA and designed to produce some minimum standards. The key output here was another handbook, but note that what this means for health technology producers is that current HTA outposts (new member states) are being quickly fastracked to more mainstream big country approaches. So, if HTA is seen as a threat by companies, the threat has just grown significantly. But if HTA is seen as an opportunity, well

So what about the total project experience and lessons learned?

Although the project ran for three years, it seems as if this is still early days with many of the tools and processes appearing not yet to have been tested in real life working situations. There was a firm recommendation from the collaborators to continue to develop and evaluate the tools in real settings.

A group of Foundation Partners is setting up a dedicated co-ordinating secretariat with an advisory committee, steering committee and various standing committees to ensure some permanence from 2009 onwards, with no additional EU funding expected. There also was a clear view expressed that all should remain as a network for the moment with no central EU organisation formed, as it was felt that this might inevitably result in undermining local/national autonomy.

But one suspects the way ahead for HTA in Europe over the longer term, certainly in the eyes of the European Commission, may well be quite different. The project mapped out three levels in a hierarchy of collaboration, with the top (level 3) being joint action across borders, and thus effectively a central agency. All of the speakers seemed to deliberately want to stay below this level, but again one could predict a future model ending up at level 3.

After all, there is one European currency, one bank, one constitution, one Foreign Minister, one licencing authority, one horizon scanning center and increasingly central public health drives. If this project has not all been about harmonization and standardization, then what has it been about? One could definitely see the Commission eventually wanting this and everyone was being far too polite with each other! So all the talk was of a new phase the EUnetHTA Collaboration - and that its activities will be used to inform, not mandate, the content of national/regional/institutional HTA reports.

Winding down the conference, a representative from the EC again stressed that it was each member states responsibility for public health, but went on to describe a proposed new directive which talks about cross-border healthcare. And the Commission is very keen that member states facilitate the development and functioning of a sustainable HTA network. To that end, the Commission is to adopt measures for the establishment and management of such a network and determine the information to be exchanged, notably in the area of new drugs. And again, we note that he emphasised that the development stage of EUnetHTA was now concluded and that this would be the very last time that the EU would fund such a project. It is now time for a permanent and sustainable network to come into existence, he said, although stressing the ball was now very much in the hands of member states.

So, there will now be a transition period until the Directive is transposed into member states within 1-2 years. What happens longer term will depend on the Council of Ministers, the EU Parliament and the pending implementation of the new Directive in 2010. So do we have some kind of EuroNICE or not? Is this truly the moment of truth?

The different funding mechanisms and structures across EU-27 probably preclude an EMEA-like organization for health technology appraisal (what NICE does). But for the first process of assessment and the collection of one EU evidence package by one EU HTA Agency feeding into 27 separate appraisals - - well maybe. Although a European Collaboration HTA Network has now been established, many tensions clearly still are unresolved and the whole project will now go into temporary stasis. However,although HTA centralization is happening very slowly, it is happening and some kind of EuroAssess organisation (but not a EuroNICE!) would seem to be inevitable over the longer term.

The huge number of organizations and people involved around the world also is important to note, as we begin to see a more global network in HTA. But also note, at the conference, a representative of the European Federation of Pharmaceutical Industries and Associations (EFPIA) wanted much higher standards with regard to HTA quality assurance, particularly if one HTA was indeed going to be used across Europe in different countries. Not surprisingly, some tensions remain here too then with regard to the pharma industry! Please see www.eunethta.net for much more detail on all the work programs and conference slides.

Finally, just a few thoughts on recent developments at NICE (as it massively expands in 2009). Technology producers have complained for years about the need for more constructive dialogue and collaboration between the industry and NICE. Note, therefore, that much earlier engagement will be possible beginning in April this year when NICE will launch a not-for profit, fee-for-service scientific advice service(based on a successful pilot with one major pharmaco). The service includes fielding questions from the company to NICE, followed by face to face meetings with external specialists and then a written advice report. This would be for products at phase II/phase III.

So what advice will be offered? Well in response to a briefing book (containing the planned clinical trial program), companies would receive product specific guidance on relevant trial design, use of comparators, outcome data requirements and relevance, as well as economic modeling requirements. But companies would still have to design the trials.

Another moment of truth? Hitherto, it has been really difficult to interact directly with pricing and reimbursement agencies early in the product development cycle. So such early engagement would be most welcome, as it would surely lead to a better understanding between NICE and the industry.

For more details, please see www.nice.org.uk. For sure, HTA certainly continues to be a very fast moving area!

Fatima Moncrieff 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 Services and aims to support organizations in steering the right strategic course through a rapidly changing and turbulent healthcare environment.