Edging Through Europe's HTA Jungle

April 20, 2015

Reflector is Pharm Exec's Brussels correspondent.

Reflector edges through the complex terrain that is health technology assessment in Europe.

Reflector edges through the complex terrain that is health technology assessment in Europe.

“Tell me what your drug is worth and I’ll tell you what you can charge” used to be to approach that pricing and reimbursement authorities took when a company came onto the market with a new medicine. It was rarely an easy exchange, but it was relatively direct. Not any more. The rise of health technology assessment (HTA) has brought new layers and new players into the process. The intention - getting better value for money - is legitimate and laudable. But in practice, HTA is turning what was already tough terrain into a tangle of new complexities.

Naturally, nothing in Europe is ever simple. Companies have always had to negotiate their prices with the pricing authority in each of the European Union (EU) countries. But now they are also obliged to pre-negotiate with the multiplicity of different organs and organizations that advise the authorities. And because there is still no real Europe-level agreement on how to conduct HTA, each of these advisory bodies has been developing its own approaches to evaluating drugs - often reaching strikingly different conclusions and delivering equally divergent advice.

The obvious answer is to see where common ground can be found among these bodies - and that is just what has been going on in Europe for a decade now, ever since the European Commission (EC) and Council of Ministers targeted HTA as “a political priority” in 2004. But it is slow work. The latest in a long line of worthy but limited efforts will shortly see the light of day in the form of a reflection paper on “Reuse of joint work in national HTA activities". This has been in gestation since last autumn, in a French-led working group with a mandate to explore how to "facilitate take-up and reuse at national level of HTA production, including information and joint assessments".

EU insiders were recently given a glimpse of the group’s work-in-progress, to see how it was advancing and how national or regional HTA authorities could support its reuse in their own activities. The outline that was presented suggests very reasonably that partial replacements for national assessment s could include joint assessments reports, rapid relative effectiveness assessments, and full or comprehensive HTAs - making use of submission templates and methodological standards and coordinated generation of additional evidence.

But the way the draft tries to set out why and how common work should be used immediately demonstrates the delicacy of the exercise; it says more about the obstacles than the objectives, and more about the process than the content. "Recommendations shall not interfere with member states’ competence in deciding on the implementation of the conclusions of HTAs and shall not harmonize any laws or regulations of the member states,” it states, adding that the recommendations “shall fully respect the responsibility of member states for the organization and delivery of health services and medical care”. Thus the group pre-emptively deflects any suggestions that it is deploying its tanks on the wrong lawns. And in case that isn't clear enough, it repeats the need to "respect national responsibilities of member states and their HTA bodies to define their national/regional legal framework and working practices for implementing HTA, and exclude aspects related to pricing and reimbursement issues".

This hasn't gone down too well with some of the constituencies that have seen the outline. Industry, in particular, was hoping for something more operationally useful, more detailed. The European Federation of Pharmaceutical Industries and Associations (EFPIA) has itself been exploring options for making some use of joint HTA work with its own member associations. On the basis of the limited experience so far, the overwhelming industry conclusion is that generalizations are not enough. Any examination of what might be a useful replacement for part of a national HTA will have to be specific about what it replaces in which country's individual system, and about what complementary measures might be needed in each case to fit into the idiosyncracies of each country's way of going about HTA.

In other words, flailing at the challenges with broad concepts is not going to cut a path through the undergrowth. The different and divergent national approaches to HTA already constitute something of a jungle, so adding new lianas is going to make things more difficult, not easier. Something more precise, more surgical, with sharper edges and closer attention to the real conditions on the ground will be needed.

The game isn't over yet. The working group is still working on its draft, which should appear in finished form later this year, and may prompt a welcome for its content rather than just for its intentions. And despite all the evident difficulties, there is high-level support for pushing ahead with HTA. The European Medicines Agency (EMA) - one of the most energetic forces in European health policy, despite its strictly limited remit - has been brokering intensive dialogue between HTA bodies, regulators and companies, and most conspicuously in the context of its high-profile adaptive pathways project to bring drug development procedures into the 21st century. And faithful to its remit under the legislation that provided the first firm base for HTA in Europe - the 2011 cross-border patients directive - the EC is committed to helping the HTA process move forward.

Ladislav Miko, the Commission's acting director general for health, recently confirmed that the Commission plans to launch a new joint project on HTA in 2016. He noted that the EC is "actively engaged in strengthening cooperation with HTA bodies and other key players in the debate to facilitate access to innovative medicines". The synergies that can be created "are in the best interest of European patients", he said, and "that is also why we have invited the EMA to be part of the HTA network".

Bringing EMA closer into the process could bring that sharper edge to the discussions, because - even in its current leaderless state after Guido Rasi was unceremoniously removed from his post - it can offer an unrivalled corps of focused expertise to the issue.  It also, however, brings a new challenge. If member states are resistant to aligning their HTA systems in a way that makes Europe look more of a jardin anglais than a jungle, and are cautious of any attempts by the HTA network to usurp their authority by offering to trim the excessive growth, how will they feel if an EMA bulldozer comes charging through to drive a highway across their private, if unkempt, domains?


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