As our colleagues at DRG Abacus recently discussed, in January 2018, the European Commission (EC) unveiled a proposal to increase health technology assessment (HTA) cooperation among EU member states.
While the EU has had a single centralized market authorization process for new medicines since 2004, HTA has largely remained under the purview of individual member states, with the exception of experimental programs like EUnetHTA. As a result, current market access for novel technologies varies nationally and even regionally across Europe.
The EC believes this lack of centralization has resulted in negative consequences for industry, the EU member states and for patients, due to a lack of predictability and transparency, as well as duplication of work and inefficient use of resources.
The January 2018 legislative proposal of the EC intends to centralize the clinical assessment of new medicines and new medical devices across Europe. However, individual EU countries will continue to be responsible for assessing non-clinical (e.g. economic, social, ethical) aspects of health technology, and making decisions on pricing and reimbursement. The proposal foresees the use common HTA tools, methodologies and procedures across the EU to work together on joint clinical assessment, early dialogue, horizon scanning and continuing voluntary cooperation in areas outside of the current scope.
The proposal establishes a Coordination Group on HTA, composed of representatives from national HTA authorities and bodies, which will be responsible for overseeing the joint work carried out by the different sub-groups of the Coordination Group. Member states’ HTA authorities will then use the assessments conducted at EU-level as part of their national or regional HTA processes, complementing them with their own assessments into the non-clinical aspects, such as economic analyses.
The sought-after benefits of the potential implementation of the EC’s proposal are ambitious, and the EC believes that they will provide great value for patients, EU national authorities, and manufacturers. With the implementation of a single clinical assessment procedure at the EU-level, manufacturers and patients would potentially benefit from greater transparency on the therapeutic added value of new drugs and a faster market access process for innovative products in all EU member states. Manufacturers would no longer have to adapt to different national procedures. National HTA bodies should be able to issue assessments more quickly, and based on more robust evidence, as members from different HTA bodies would potentially contribute to the outcome of the clinical assessment.
As a result, the EU commission foresees that the new proposal would provide for savings and a more efficient use of human and financial resources for both manufacturers and member states. Additionally, a transparent EU-wide HTA system has a clear potential to improve predictability and business planning for manufacturers, and translate into increased investments in R&D activities across Europe, as developers of novel technologies will be guided through the single clinical evaluation process and, therefore, the risk of facing negative decisions should be lowered. At the EU level, the proposal is expected to allow HTA bodies to specialize in different topics (e.g. orphan medicines, medical devices), rather than to keep a general profile of both their tasks and staff. Moreover, the proposal could be beneficial for EU countries with less developed HTA processes.
Additional advantages of the new EU coordination proposal for payers, manufacturers and patients are the inclusion of a framework for the involvement of patients and healthcare professionals in the EU-level HTA process, and safeguard clauses by which member states can (1) refuse to participate in mandatory joint clinical assessments on grounds related to the need to protect public national health and (2) incorporate all sorts of subsequent changes to the proposal.
The new proposal appears to have backing from the pharma industry (European Federation of Pharmaceutical Industries and Associations (EFPIA) and member states manufacturers’ associations), patient groups, healthcare providers, and academics. Indeed, EU cooperation on HTA was supported by 87% of those that took part in the open public consultation launched by the EC from Oct. 21, 2016 until Jan. 13, 2017.
Despite the effusive response from the public, not everyone is as enthusiastic about the prospects of EU-level HTA cooperation. Some member states have even rejected it outright. In Germany, the Statutory Health Insurance Organisation (GKV-Spitzenverband) and the Joint Federal Committee (G-BA) rejected the move towards HTA cooperation, arguing that the German standards regarding the evaluation and assessment of new drugs would be significantly lowered by the single, EU-wide HTA process. However, this was walked back by German industry groups (the Association of Research-Based Pharmaceutical Companies (VFA) and Federal Association of Pharmaceutical Manufacturers (BAH)), who welcomed the legislative proposal, emphasizing the potential of a close cooperation between regulatory and value assessment authorities.
Germany is not the only country that is concerned by these prospects, with other countries – and regions, as in the case of Spain – concerned that the proposal is a step too far, and a non-mandatory assessment that could be adapted locally would be a better option for member states’ specific HTA needs.
The scope and competencies seem to be a particular area of division for European countries, with some preferring much more decentralized approaches, while others favour greater cooperation. Unlike some areas of concern for the EU, the battle lines in this conflict are not as clear, with countries like Greece and Germany both supporting more decentralized approaches (for more info why this may be, see our Country Archetypes). In fact, it seems that Germany is one of the countries most strongly opposed to further cooperation, with the Netherlands at the helm of the pro camp.
Given the fear of many members states and payers that the HTA system will revert to the lowest common denominator and will make untenable compromises, despite all of the potential advantages that would come from a centralized system, the negotiations will be fraught and could take a considerable amount of time in order to win buy-in from all the key stakeholders. After all, those potential advantages could all disappear if the system is poorly designed.
The proposal can be adopted as soon as 2019, if successfully negotiated and approved by European Parliament and Council of Ministers. Assuming it is successfully adopted, the proposal includes a phase-in approach (three years between its adoption and becoming applicable in member states, plus a further three-year transition period) to allow member states’ authorities and industry to fully adapt to the new system. Following the supply chain, R&D and EMA headquarter upheaval caused by Brexit, European market access is in for a tumultuous road ahead, and manufacturers should be prepared for many changes.