Applied Clinical Trials
Discussions on collaborative health technology assessment have been so intense over the last year that it might be thought that Brussels is the hub for HTA action. Peter O'Donnell writes how there is plenty going on elsewhere in Europe.
The European Union discussions on collaborative health technology assessment have been so intense over the last year or so that it might be thought that Brussels is where all the HTA action is. Until now, anyway, because since the collapse in December of Austria's gallant bid to move the discussions forward on the bid for European collaboration, Brussels has gone very quiet on the subject. Romania, which took over the EU presidency from Austria in January, has very low ambitions for advancing the talks among member states. And meanwhile, Soledad Cabezón, the Spanish socialist who piloted the complex legislation through the European Parliament, has announced that she is standing down as MEP at the upcoming elections in May.
But there is plenty going on elsewhere. An international consortium tasked with finding a common definition of HTA has just published its suggestion and is seeking comments on it until the end of April. This is a rather longer definition than the EU is proposing in its legislation: "multidisciplinary", "explicit and scientifically robust methods", assessing value "at different points in the lifecycle", "comparative", "systematic", "transparent", "multiple stakeholders" are all in there. So too are "clinical effectiveness and safety, costs and economic implications, wider implications for the patient and caregivers, and any ethical, social, cultural, or legal issues, as well as organisational and environmental aspects." The whole thing can be seen on https://htai.org/blog/2019/03/20/open-consultation-updated-definition-of-hta/ and comments can be sent to HTAdefinition@ihe.ca by April 30.
Up at the northern tip of Europe, the first HTA pilots are in progress within the Nordic co-operation between the authorities in Norway, Finland, and Sweden. This mechanism, initiated a year ago, claims that it will speed up evaluations and generate uniform reports while making applications smoother for companies. Roche has volunteered its Tecentriq for one of these pilots.
In Amsterdam, right in the heart of Europe - even more so since the European Medicines Agency has now opened up for business there - the European technical collaboration on HTA, EUnetHTA, is holding its annual conference in early April. This is going to focus on what constitutes unmet medical need, on questions of uptake of joint assessments, and on links between HTA and patients, payers, and healthcare providers.
HTAi, the international association for HTA, has also offered an interesting glimpse of the future in the announcement of its upcoming conference in June. It is going to plunge headfirst into the question of whether joint international assessments are a good or bad thing. On the one hand, it suggests, agreement on standards for study methodology and HTA evaluation can promote consistency, irrespective of the context. But on the other hand, the requirements on issues such as subgroups or comparators are heavily context-dependent, because they are defined differently from place to place. So, the proponents of one-size-fits-all approaches to ensure quality of trials and assessment run into opposition from those who fear that the usefulness of HTA to the national or regional or local setting will get lost if assessments are done at a higher level.
This dilemma reflects closely the issue that is paralyzing the EU's bid for cooperation. Consensus on the merits of joint discussion does not imply consensus on the subsequent application of the outcome of any such discussion, so any attempt to enforce cooperation is seen as over-reach.
Maybe Brussels needs to cast its eyes widely to see how the dilemma is being approached elsewhere in the world.
Peter O'Donnell is a freelance journalist who specializes in European health affairs and is based in Brussels, Belgium