#EAPM - Pulling the #HTA (Health Technology Assessment) strands together

The European Alliance for Personalised Medicine (EAPM) last week (6 June) held a key meeting to discuss the European Commission’s proposed directive on health technology assessment (HTA), writes EAPM Executive Director Denis Horgan.  

A draft report from the European Parliament on the Commission plan was discussed by MEPs the following day, which took into account EAPM’s own conclusions from the day before, culminating in a notable and healthy degree of alignment.  The Commission believes that although member states have been co-operating on HTA for 20 years, now is the time to step up commitments in this area.

There is a need, the Commission, Parliament and EAPM believe, to bring experts together to create scientific reports that are inclusive and more general, in respect of HTA in EU health-care systems.

The Commission stresses that the aim is not to touch member state competence on health care, pricing and reimbursement. This will frankly prove problematic, and is mentioned again below.  At the ENVI committee meeting, rapporteur Soledad Cabezón Ruiz said that the Commission’s initiative could strengthen the EU, adding that health is one of the core values and concerns of European citizens. This is undeniably true, and cited by people across all member states.

At EAPM, we hear this all of the time.  As the rapporteur noted on 7 June, any changes to the HTA system are aimed towards higher quality assessments using independent experts and geared towards firm, evidence-based decisions. Medical devices and higher-risk products should also come under the improved HTA umbrella, she believes.

Cabezón Ruiz added that subsidiarity would also be respected by amendments and that the exclusive competence of the member states will not be jeopardized.  This is a moot point, as currently, member states make decisions on efficacy and value on an individual basis. There is resistance in some quarters where certain countries believe that mandatory joint assessment is over-stepping the mark in the closely guarded health-care sector, in which individual countries have competence.

However, both the Commission and also the European Parliament believe that joint clinical assessment is the way forward. This, so they say, will avoid duplication across EU countries, caused by a lack of clinical evidence and less-than-optimal communication.  The rapporteur was backed by Annie Schreijer-Pierik MEP, who said she believes that future HTA cooperation needs to be obligatory, adding that there is currently no level playing field.  At the same meeting Bolesław G Piecha MEP said that a co-operation framework should be supported in respect of common tests based on common principles. However, he also cautioned that medical procedures are not subject to EU standardization and warned that harmonizing too much HTA could go in the wrong direction.

But Gesine Meissner MEP took the opportunity to emphasize that a future Europe needs to have one, and not 27, HTAs and that this would benefit EU patients. The debate continues, but EAPM is generally in support of the Commission proposal, which leans in the direction of the previously mentioned mandatory use of joint clinical assessment of health technologies at EU level (after a three-year transition period).

At the ENVI meeting Cabezón Ruiz MEP also said that the EU needs to better protect citizens' health, not least through guaranteeing independence and objectivity when it comes to HTA procedures.

Research should also be prioritized, she said, adding that the Commission proposal could help to improve the single market.  EAPM broadly agrees as, within the EU, HTAs are currently fragmented with different systems, different procedures and different requirements regarding the type of clinical evidence. This has generally been bad news for patients in Europe.

During the Alliance’s own earlier meeting, it was decided that several principles need to be established and put in place. These principles will form the basis for future engagement by EAPM on the subject of HTA with the Parliament and member states. The structure of HTA programmes is an important element, and should involve all stakeholders across all disciplines when formulating the way forward, including definitions of questions that HTA should be asking as well as links between the process and emerging technologies.   Essentially, the use of HTA needs to be clearly focused in order to be as precise and informative as possible. That is its necessary role in modern-day health care.

Cost v. access, of course, is key to HTA - although the definition of ‘value’ is controversial when patients are losing out purely on this basis. Prices and availability/access differ widely across the EU, and joint clinical assessment could go some way towards addressing this.  Setting up a joint assessment is likely to be complex and a dedicated body should be put in place to determine the process, again with multi-stakeholder involvement, and this should be separate and independent from the ultimate payers.

Transparency and a balanced approach are also important elements to be taken which is ensured by the Commission providing the secretariat.

At the EAPM meeting, it was acknowledged that many stakeholders have a direct interest in the HTA process, including patients, payers, industry, those working directly in health care, and also the public at large. It’s important to involve these stakeholders from a base level.  When it comes to new technologies and procedures, EAPM (and others) take the view that each and all HTA decision-making processes should be open and freely available to all those potentially affected by the decisions. This is likely to occur much more under joint clinical assessment, even in the context of ‘private’ payers. Those under private plans should still have transparent decision making frameworks on how decisions are made, when these clearly have an impact on them.

At the end of the day, it is all about weighing up the pluses and minuses, the costs and the benefits. And while, as hinted at earlier, the concept of ‘value’ should likely be decided by the consumer, it is impossible to avoid the fact that cost is a significant factor at a time when Europe is dealing with an ageing population and a consequent rise in chronic conditions, in a way that would allow for a sustainable health-care systems. A joint EU-wide HTA system at the very least aims to tackle this head on, should stop wastage (replication) and surely bring about better sharing of knowledge, although fiscal issues per member state will still exist.

If country ‘A’ decides, for example, that a treatment is not worth the money being charged by companies and country ‘B’ decides that it is, there needs to be consensus. This is especially true when cross-border health care often doesn’t work as intended due to different levels of compensation in richer and poorer member states. At the end of the day, an agreed, joint system of governance, process and methods of HTA programmes on an EU-wide basis could certainly improve decisions at both clinical and policy level, so despite that certain reluctance in some member states, EAPM broadly supports the Commission plan.

A new joint clinical assessment system across the continent will have a key part to play in improving the lot of patients and the crux of the matter will be finding the very best way to do this, while persuading the EU’s individual countries to buy into the idea. One of the challenge for health-care systems is to manage medicines access while also delivering on innovation through rational use of resources. We need to get ‘smart’ with the resources that we have, break down silos (individual member state thinking, in this case) and get the balance right. Working together and moving on through consensus is a key (in fact probably the most important) element.

Early dialogue between technology developers, regulators, HTA and, where relevant, pricing bodies should promote innovation and quicker access to medicines at affordable prices, for the benefit of patients everywhere. Discussions and amendments proposals are ongoing but the final Commission directive could go a long way to allowing HTA bodies to catch up with a scientific arena that is moving forward quickly, not least in the sphere of personalised medicine.

Let’s do it together. The Alliance will be engaged and monitoring progress at every turn via several meetings down the line and ongoing discussions with MEPs, member states and Commission on the amendments, and will keep all of its various stakeholders informed on the HTA debate. The next EAPM meeting on this vital topic will take place on 3 July in Strasbourg.

Share this article: