EU Joint Clinical Assessment – One for All and All for One?

Speaker(s)

Anne Willemsen, MSc, -, Zorginstituut Nederland (ZIN), Diemen, Netherlands, James Ryan, MSc, AstraZeneca, Cambridge, CAM, UK, Kim Helleberg Madsen, MSc, Danish Medicines Agency, Copenhagen, Denmark and Anke van Engen, MSc, IQVIA, Amsterdam, NH, Netherlands

Presentation Documents

ISSUE: EUnetHTA-21’s scoping guideline suggests most new medicines undergoing JCA would have a small number of PICOs. However, analysis in a common oncology indication indicates that the stated method could initially lead to >10 PICOs. Furthermore, the unique needs of a MS for outcomes across all PICOs could lead to more analyses than currently requested across Europe.

The PICOs will determine the size of the evidence to be submitted, assessed and reported. The EU HTA Regulation lays out a tight timeframe to deliver this. It may therefore require prioritization and consolidation in the PICOs, as well as sufficient resources, to ensure that a high quality assessment can be undertaken within the timeframe, without delaying time to patient access decisions at Member State level.

OVERVIEW: (10 min) Anke van Engen will open the discussion on how to ensure a transparent, evidence-based approach to producing common European PICOs. Using a case study she will illustrate how implementation of the scoping process as outlined by EUnetHTA21 could be challenging for both industry and assessors leading to a high number of PICOs, many requiring ITC, and substantial analysis requests.

(10 min) Anne Willemsen will respond based on a survey conducted among MS and will suggest how to bridge the gap between industry and HTA bodies in terms of scoping expectations.

(10 min) James Ryan will outline an industry perspective on the proposed process, methodology and implications for evidence development. He will suggest how comparators and populations can be selected in a predictable, consistent, and transparent manner, to deliver on the original vision of the Regulation.

(10 min) Kim Helleberg Madsen will comment on differences between JCA and local scope and what can be expected in terms of additional analysis requests.

(20 min) Facilitated discussion with the audience with the opportunity to ask questions and propose solutions.

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NOTE: There will be a discussion group on this topic following the session. Join us in the Discussion Lounge in Hall E North from 11:45 - 12:45 in Discussion Group B.

Code

101

Topic

Health Technology Assessment