Session (CTI)

ISSUE: The HTA Regulation (HTAR) came into effect on January 2025 and the first Joint Clinical Assessments (JCA) on medicinal products started. To understand the predictability of the PICOs (Patient Population, Intervention, Comparators and Outcomes) in JCAs, comparison are made between the Outcomes and Comparators requested by six European HTA bodies on 21 oncology/ATMP drugs in a retrospective study. Further, this comparisons looks at the data studied in the trial and compares this to the HTA bodies needs. The panel explores whether there are differences or similarities between the Outcomes and Comparators the HTA bodies assess in their reports. Another question is whether this variation stems from the different approaches they have on a scoping phase. Further, the panel explores whether data studied in the trials reflects relevant questions HTA bodies require information on. After the panel discussion, the audience will understand how each HTA body decides on their Outcomes and Comparators and also how this may impact the predictability of the assessment scope of the JCAs. OVERVIEW: The panel starts with a brief scene-setting presentation with results of the retrospective study in which comparators and outcomes six European HTA bodies on 21 drugs are compared. In a moderated discussion, each panelist reflects on the questions how their HTA body decides on the PICO and how the joint work under the HTAR may impact the availability of data to answer their questions. While each panellist is from an HTA organisation, each organisation has a different approach on conducting a scoping phase prior the assessment or assessing based on what the industry submits for national reimbursement applications. Therefore, this session is very relevant to understand the HTA bodies perspective and needs and will help to understand the expectations for the JCA work. The panel ends with a Q&A with the audience.