ESMO Director of Public Policy Prof. Jean-Yves Blay spoke at the regional HTA conference ‘From Theory to Practice: Implementing the EU Health Technology Assessment Regulation’, held on 5 November in Paris, and highlighted the value of the ESMO-Magnitude of Clinical Benefit Scale (ESMO-MCBS) for supporting the new processes under the HTA Regulation.
“Given its value for supporting the prioritisation of medicines for evaluation, ESMO believes that it would be of benefit for patients with cancer if the ESMO-MCBS is used as a supportive tool for the new joint HTA processes”, he said. “The ESMO-MCBS can help signal new compounds with a substantial magnitude of clinical benefit that should require immediate attention from health authorities for accelerated review and coverage-reimbursement decisions to prompt patient access”.
The HTA Regulation, set to enter into application in January 2025, puts in place a permanent framework for EU level collaboration on HTA and introduces new EU-wide Joint Clinical Assessments (JCAs) for evaluating scientific/clinical aspects of new medicines. The results of these assessments can be considered by EU Member States in their HTA processes at national level. JCAs will commence with cancer medicines and advanced therapy medicinal products (ATMPs) as from the start of application in January 2025.
In his closing remarks, Prof. Blay highlighted the importance of the HTA Regulation for reducing duplication of work for national HTA authorities: “We would absolutely like to avoid unnecessary duplication and have robust metrics in place that are encouraging and convincing for all the EU Member States”.
The ’From Theory to Practice’ conference in Paris was the last of a total of 7 regional conferences held from 2023-2024 with the aim to inform stakeholders on the implementation of the HTA Regulation. The Paris conference targeted regional stakeholders in both Germany and France.
ESMO stands ready to collaborate with all stakeholders and work towards a robust implementation of the new EU legislation on HTA.