Health is back on the EU legislative agenda. After a leaked draft provoked several stakeholder responses earlier this month, the European Commission published their Proposal on Health Technology Assessment (HTA) on 31st January to address concerns about the degree of variation with which HTA is conducted and applied across Europe.
With the objective of enhancing cooperation and coordination among the member states in measuring the value of innovative drugs and medical devices, the proposal puts forward a number of policy tools to build on previous EU initiatives (e.g. EUNetHTA) and assist member states in achieving a “smooth functioning of the internal market, sustainable health systems, and an ambitious research and innovation agenda.” These tools are all carefully designed to avoid overstepping the European Commission’s competence. However, with the introduction of the word “mandatory” in the use of the joint clinical assessment reports, the next stages of the legislative proposal will undoubtedly re-ignite discussions on where the health competences of the EU should end.
The draft raises the questions: What can be done on EU level; and is this what is really needed to improve the way HTA works in the context of increasing patient access to (complex) medical innovation?
A tool for policymakers
To address these questions, we first need to remind ourselves of the reasons for having HTA systems in the first place. What value is measured and for what reason?
HTA methodologies are used to assess the benefits that new treatment options bring to the health system to support reimbursement decisions. As the cost of care continues to rise due to a combination of an ageing society and medical advances that increasingly transform conditions from acute to chronic, decision makers are increasingly turning to HTA with the aim of containing costs.
HTA is therefore a tool for policymakers to help take and justify difficult resource allocation decisions. These decisions are primarily focused on assessing the relative safety and clinical effectiveness, followed by economic and budgetary considerations. In practice, minimal consideration is given to issues of ethics, equity and feasibility. Efficacy evaluations are for the most part based on clinical trials and the economic considerations are based on health economic modeling. Both sources are not always in line with the real patient experience.
What about the patients?
While patient input is often requested in HTA and value assessment discussions, it is generally felt that their concerns are insufficiently acted on, mainly because current systems are not designed to do so in any meaningful way.
Patient groups (particularly in Europe) have grown more concerned about access to medicines as the limitations of the evidence used for HTA decisions become more apparent, and their influence becomes more widespread in decision-making about coverage for new pharmaceuticals. What about the effects on quality of life, taking into account what is important to patients, their social surroundings and the effects that certain treatments (especially in combination) can have on their day-to-day lives? Current HTA methodologies are not always able to capture and assess more holistic and longer-term aspects of value for health and social care systems.
A national can of worms
While discussions on the use of real world data are taking place, Member States currently do not show much appetite for radical changes to their HTA methodologies for various reasons. In France, HTA reform is high on the agenda but policy-makers avoid an open debate that could lead to an overhaul of the reimbursement system. In Germany, HTA reform is currently not even regarded as a pressing issue, as they are in the middle of a much broader debate on health insurance reform.
Generally, governments are eager to keep discussions on HTA outside the public domain, afraid to open a can of worms by allowing external input into how their health decisions are made.
What can the EU do?
In the explanatory memorandum of the proposal several problems are outlined for which EU action can bring added value:
Problem 1. impeded and distorted market access:
Here it is argued that the EU could play a role in streamlining and harmonizing data and evidence requests to reduce delays and inequalities in patient access to health technologies. However, it is not clear yet how that can be done on EU level. Perhaps the EU can be a platform to discuss and agree on which data and evidence requests should be considered. But these discussions are already difficult between stakeholders working within one health system, let alone 27 different ones.
Problem 2. Duplication of work for national HTA bodies
By encouraging the use of, and adherence to, joint clinical assessments the European Commission aims to reduce duplication and increase predictability. However, it is not clear how introducing a harmonized approach for the clinical domain and national approach for the non-clinical domains is going to address this.
Problem 3. Unsustainability of HTA cooperation
A more secure and long-term approach to providing organizational and financial support indeed seems sensible. Of course, the big question is going to be: How much funding, and who will pay for this? Smaller countries are likely to look towards bigger countries to support these cooperative evaluations. Considering the very cautious approach France has so far taken on the issue, and with Germany even being openly hesitant towards EU interference, securing a decent budget for this will not be an easy task.
A step in the right direction
Of course, no one can or should expect the EU to solve all these problems with this current proposal. Further HTA collaboration on EU level is heading in the right direction, but it is not enough. On national (and in some countries, regional) levels it is surely time for informed discussion on what needs to be done to future-proof European HTA systems in order to be able to assess the right value for patients, practitioners and payers.
With specific regard to registries of real world data, the proposal provides an opportunity to link the EU legislative framework for HTA to that of the EU Digital Single Market and the EU Research agenda. It’s just the start of a very long process, but perhaps a first step in providing the right incentives to unleash the potential of digital health for improving health systems across Europe.
There is also a potential threat of creating an EU legislative framework for HTA based on the least common denominator: budget constraints. Let’s not forget that HTA is automatically related to price and access and that voluntary cooperation on drug pricing is emerging in Europe.
The proposal is a step forward, as it hopefully creates momentum for a wider debate on HTA, what value should be measured and how. Let’s just hope there is enough time left before the end of the current European legislative term to allow for informed discussions that will give us a result that is meaningful and implementable.