Mandatory or voluntary? A sticking point for European HTA

The long road to unified European Health Technology Assessment (HTA) is continuing. It has become clear that the mandatory – or not – nature of  European Joint Clinical Assessments (JCAs) is a sticking point. Leela Barham takes a look at progress and ways forward for this tricky issue.

The ambitions for a European JCA – not a full HTA but rather focusing on the first four domains of EUnetHTAs core model, including identification of a health problem and current technology, the examination of the technical characteristics of the technology, its relative safety, and its relative clinical effectiveness – is the culmination of years of work to explore how member states in the European Union could make the most of the plethora of work done to assess new technologies. A proposal for a Regulation on HTA to formalise sharing of JCAs, particularly through ensuring JCAs are taken into account and member states don’t do the work again, was tabled in January 2018. At the heart of the proposals is the idea of doing it once, and doing it well.

The proposed Regulation has been making its way through the EU legal machine. The initial Regulation has been subject to much debate and hundreds of proposed amendments, not all of which have been taken forward. By October 2018, the Parliament held a first reading and adopted text that includes 199 amendments. As summarised by a Presidency note to the Council, the text adopted is not a legislative resolution, so there is still the option of agreement at first reading.

The note also stresses the main concern of those member states who have raised issues – including the Czech Republic, France, Poland and Germany, who together could block the Regulation – is how JCAs will influence national decisions. National decisions are where the rubber hits the road; it’s where member states make decisions on whether to reimburse, and if so, at what price. That is a national competency in law. It’s also why one of the amendments adopted makes it clear the JCA does not cover cost and economic evaluation of a technology, its ethical, organisational, social and legal aspects.

The proposals are still under development. It seems that the way to overcome concerns about subsidiarity and ensure that member states still get to decide how to spend their funds is by allowing for what are described as complementary national clinical assessments and to allow for adaptation of European JCAs.

The trouble is that bringing back the option for a national clinical assessment, on the face of it, sounds like the kind of duplication that a European JCA is trying to avoid in the first place. Of course, it’s the detail that matters. Where the complementary national clinical assessment considers, for example, a comparator that isn’t in the European JCA that makes far more sense. It should just be clearer whether this type of issue comes up with new provisions in the draft Regulation for setting out the content of the JCA in terms of interventions, comparators, patient population and patient-relevant health outcomes.

There is also a reality check needed; in practice there is already a great deal of use of HTA from other jurisdictions. Based on 2017 work, 26 HTA agencies in Europe use HTA from other organisations for horizon scanning, 30 agencies draw on the work of other agencies for topic selection, 48 for the assessment details such as scope, reports, evidence submissions etc. and 40 draw on HTA advice and the subsequent decision-making. This means that sharing is already done, and may even be seen as routine given the number of agencies that do it.

Of course, the use of others’ HTAs is completely voluntary and agencies will be deciding from which agencies and from which bits they want to draw on. It’s not clear just which agencies are more or less referenced by others, and it’s not clear on what basis other HTA agencies’ assessments are chosen from the 2017 work; maybe it’s pragmatic reasons such as availability in English, timeliness of reports, or views on the quality of the HTA done. All of this is very different to the mandatory proposals for using European JCAs, and all of this does not deal with the duplication of effort that the proposal for a European HTA wants to address.

Leaving things as they are might raise some uncomfortable questions about the millions spent on efforts to collaborate on HTA across Europe. Amendment 16 points out that even with EUnetHTA Joint Actions “the production of output has been inefficient.” It goes further and says that, “use of results of the joint actions, including their joint clinical assessments, at member-state level has remained low, meaning that the duplication on the same health technology by HTA authorities and bodies in different member states within identical or similar timeframes has not been sufficiently addressed”. The status quo is therefore not seen as good enough to allow it to continue; hence the interest in making use of JCAs mandatory.

The amendments made to the original draft of the Regulation for European HTA result in what could be described as a quasi-mandatory status for European JCAs; a kind of pick and mix. The idea being that there could be “special circumstances” where the European JCA “does not cover all necessary aspects” that a member state could then either change or do their own assessment for, but otherwise they really should use the European JCA. The discussions on this idea are not yet finished.

Much will depend on finessing the words to ensure that the Regulation can really manage the balance of independence at the state level for pricing and reimbursement, whilst still having a European JCA that is used by member states. Those with expertise in the complexities of HTA across Europe, such as Finn Boerlum Kristensen, Secretariat Director and Chairman of the Executive Committee of the EUnetHTA network from 2006 to 2016, believe it is possible to reach a constructive result on what mandatory use would mean in practice.

Leela Barham is an independent health economist and policy expert who has worked with all stakeholders across the health care system, both in the UK and internationally, working on the economics of the pharmaceutical industry.

Contact Leela on leels@btinternet.com