Implementation of the EU-Health Technology Assessment Regulation Joint Clinical Assessment

DRA symposium

The EU Health Technology Assessment (HTA) Regulation, formally known as Regulation (EU) 2021/2282, is a significant step towards improving healthcare across Europe. The regulation aims to accelerate patient access to innovative treatments by streamlining the assessment process for new medicines and medical devices. This is achieved by establishing a permanent framework for joint work, the regulation replaces the previous voluntary network, ensuring the long-term sustainability of EU HTA cooperation. One of the key features of the regulation is the introduction of joint clinical assessments (JCAs). These assessments involve a collaborative evaluation of clinical evidence by national HTA bodies across the EU. JCAs aim to streamline the evaluation process, reduce redundancy, and provide a unified basis for national value assessments and price negotiations.

In this symposium key stakeholders will discuss what the European Joint Clinical Assessment mean for the national assessments and how this process will facilitate better access to medicines.

Please register for the symposium here no later than 20 October.

Programme

15:00-15:15 Welcome and opening remarks
Speaker: Christine Hallgreen
MSc, PhD, Associate Professor; CORS, Department of Pharmacy, Faculty of Health and Medical Sciences, University of Copenhagen
Chair: Finn Børlum Kristensen
 MD, PhD, Adjunct Professor in Health Economics and HTA; Faculty of Health Sciences, University of Southern Denmark; Independent consultant, Science & Policy

15:15-16:00

Incl. Q&A

A. Member State HTA Coordination Group (HTACG):
     Short progress status
B. JCA and Danish Medicines Council methodology
Speaker: Linda Aagaard Thomsen
MSc, PhD, Head of Department, Department of Rare Diseases, Danish Medical Council
16:00-16:20 Coffee break

16:20-16:50

Incl. Q&A

Pertinent statistical issues in preparing JCA submissions
Speaker: Anders Gorst-Rasmussen
MSc, PhD; Co-Chair PSI/EFSPI HTA SPIG, Head of Biostatistics HTA, Novo Nordisk

16:50-17:20

Incl. Q&A

Joint Nordic HTA Bodies – recent developments and a view to JCA
Speaker: Karen Kleberg Hansen
MSc, PhD; Department Head, Danish Medical Council
17:20-18:00

Panel discussion on how decision making will be made in a cost effectiveness market
Speakers and patient representatives (TBC), and Peter Hertzman, SmartStep Nordics
18:00-18:30 Closing remarks and farewell drinks

The symposium is organized on behalf of the graduate programme in pharmaceutical sciences, Drug Research Academy, by Associate Professor Christine E. Hallgreen, Copenhagen Centre for Regulatory Science, Department of Pharmacy, Faculty of Health and Medical Sciences, University of Copenhagen.

The symposium is free of charge and open for attendance by all interested parties.

Map showing pavilion building in the University park

Map showing the location of rooms in the pavilion building