The Real Divides on European HTA

The European Union bid to forge closer cooperation among its fifty-plus national and regional health technology assessment bodies still has a long way to go, to judge from early submissions to a massive consultation exercise on the subject.

A questionnaire circulated by EU officials last year has produced widely varying views on everything from what should be coordinated to who should be in charge. And as with all European health issues, the parties in the discussions have such distinct starting points that it is going to be impossible to satisfy everyone.

Take a simple issue such as whether the European Medicines Agency could play a role in any future system. That might seem a logical possibility, particularly given its current engagement in early dialogue to find some common ground among drug sponsors, HTA agencies and regulators. As the R&D-based drug firms' federation EFPIA says, the EMA "is a good model for a successful and scientifically based secretarial/organization support." But GKV, the German health insurance organization, says the agency "is not suited for managing or organizing future European cooperation on HTA." The European Public Health Alliance says giving competence to EMA for HTA would be "counter-productive", creating an "excessive and unchallenged concentration of power." Prescrire, the drug information service, goes even further, alleging that the European Medicines Agency "is not financially independent from pharmaceutical companies" and that its conflict of interest policies are "not sufficiently robust."

Prescrire is also sceptical – in fact down right critical – of early dialogue, which it sees as risking "regulatory capture" by drug firms. "Such opaque initiatives should not be used to build new policies and guidelines," it says. "Our advice to HTA bodies would be to refuse to engage in early trialogues with the EMA and pharmaceutical companies." But GKV believes that cooperation on early dialogue is "useful", and members of the International Society for Pharmacoeconomics and Outcomes Research give it "a favorable response". And for EFPIA early dialogue is helping bridge the gap between agencies' differing clinical evidentiary standards.

Similar divergences are discernible on whether any future system should be mandatory or voluntary, or on whether the EU, member states, or industry should pay for it. But the biggest divide – and one that has received less attention in many of the comments seen so far by this columnist – is over the scope of assessments.

For EFPIA, this is a cardinal issue. It insists on the distinction between relative efficacy and relative effectiveness, and "underlines" that only aspects focused on efficacy rather than on effectiveness "are in scope of European cooperation, while the rest is not." So while more alignment on relative efficacy assessment at time of launch could streamline processes and lead to better decision-making, the differing circumstances across member states impede joint work on a full HTA covering relative effectiveness – and preclude the implications of any such analysis for pricing and reimbursement. Those sensitive issues have to remain a matter for each member state to decide on its own. For the research-based drug industry in Europe (and EFPIA's view is shared by the other principal R&D-based federations, Vaccines Europe and Europabio), "it is not possible to align on full HTA, as this covers context-specific elements which are best dealt with at the national level."

This is likely to become one of the battlegrounds for the future. No one denies the link between HTA and pricing and reimbursement, but how tight that link should be will be at the heart of the arguments this year as the EU prepares an initiative (still very undefined) on HTA cooperation. There are plenty of organizations who favor a tight link, and want to see HTA take on a bigger role as a gatekeeper. But others are conscious of the complexities that will arise if at EU level the scope of HTA cooperation is extended beyond the clinical and into the economic domain.