What Impact Will European Commission’s Draft Regulation on HTA Have on Decision Makers in the European Union?

Panel Debates Proposed Europe-Wide Introduction of a Joint Health Technology Assessment

 Barcelona, Spain—12 November 2018—ISPOR, the professional society for health economics and outcomes research, opened ISPOR Europe 2018 this morning with its first plenary, “Joint Assessment of Relative Effectiveness: ‘Trick or Treat’ for Decision Makers in the EU Member States,” a provocative session on the impact of the European Commission’s Draft Regulation on health technology assessment (HTA) for decision makers in the European Union (EU).

Evidence-based health policy and decision making requires more and better clinical evidence on the relative efficacy, effectiveness, and therapeutic benefits of new and existing health technologies. The requirements to develop evidence and transparency of the assessment process, however, are often not aligned in the EU member states. These uneven requirements lead to a number of challenges, including the quality of assessments produced by various HTA bodies, issues around patient access to innovative technologies, and questions of sustainability of the healthcare systems in the EU member states.

The European Commission has drafted regulation on HTA that proposes the introduction of a Europe-wide joint clinical assessment. In this plenary session, a panel of diverse stakeholders addressed the issues, risks, and benefits of joint clinical assessments in Europe. Finn Børlum Kristensen, MD, PhD, University of Southern Denmark, Odense, Denmark moderated the session and set the stage by providing an overview of the issue.

Panelists acknowledged that many benefits could results from joint HTA assessment in Europe.

  • Roman Topór-Mądry, MD, PhD, Agency for Health Technology Assessment at Tariff System, Warsaw, Poland outlined the most pressing issues in this area and identified whether the regulation addressed them. He noted that the draft regulation addressed standardization of the clinical assessment process and common methodologies but did not address the issues of better access to therapies for patients, reasonable pricing, inequality, or improved quality of the evidence.
  • Luciana Ballini, EUnetHTA, Emilia Romagna, Italy stressed that joint decision making needs to be multidisciplinary with a prioritization process for HTA that involves the spectrum of decision makers. She noted that aiming for a seamless flow of information from early dialogue to post-launch evidence generation would be most likely to bring European scientific and technical cooperation on joint clinical assessments to fruition.
  • Menno Aarnout, International Association of Mutual Benefit Societies, Brussels, Belgium offered the perspective of payers on this issue, pointing out that payers need good clinical assessments. He stressed that dialogue between health technology assessors and payers needs to be strengthened as it is “all about trust.”
  • Ansgar Hebborn, PhD, F. Hoffman-La Roche AG, Basel, Switzerland noted that the key is for joint clinical assessment to be conducted properly. He stressed that if it is done properly that greater consistency and predictability can be expected.
  • Nicola Bedlington, European Patients Forum, Brussels, Belgium brought forth the patient perspective. She noted that “joint” is the key word for joint clinical assessment and she believes that the current proposal is somewhat weak on patient engagement.
  • Flora Giorgio, European Commission, Brussels, Belgium outlined key elements of the proposed regulation that include a support framework and procedures for EU cooperation on HTA, well-defined scope, focus on clinical aspects, member states-driven approach, high-quality, timely output, transparency and independence, and a pragmatic phase-in approach.

Additional information on ISPOR Europe 2018 can be found here. Released presentations from the conference can be found here. Interested parties can follow news and developments from the conference on social media using the hashtag #ISPORBarcelona.

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