ESMO provided feedback to the public consultation on the draft Implementing Act for JCAs of Medicinal Products. The ESMO response - accessible here - highlights the importance of:
- Using the ESMO-Magnitude of Clinical Benefit Scale (ESMO-MCBS) as a supportive tool for the new joint HTA processes to signal new compounds with a large magnitude of benefit that should require immediate attention from health authorities for accelerated review and coverage-reimbursement decisions to prompt patient access;
- Using the ESMO Clinical Practice Guidelines as a benchmark ensuring that patients receive appropriate treatment and care;
- Involving medical oncologists in a consultative role in JCAs of antineoplastic therapies;
- Providing additional information on the steps to be taken in cases where the outcomes of JCAs diverge substantially from the conclusions of the benefit/risk evaluations done by the European Medicines Agency (EMA) in relation to marketing authorisations;
- Addressing patient reported outcome data (including quality of life assessment) and the statistical analysis plan as part of the information retrieval process (Point 4.2.1. of Annex I);
- Providing information on context and country-specific treatment alternatives, including medicines that are already available for the concerned indication, as part of the overview of the medical condition (Point 2.1. of Annex II);
- Addressing primary, secondary and exploratory endpoints as part of the information on the study design (Point 4.2.1. of Annex II);
- Providing further clarity on the composition and ways of working of the JCA Subgroup.
The European Union’s (EU) HTA Regulation was adopted in December 2021 and is set to enter into application in January 2025. This Regulation provides a permanent framework for collaboration on HTA at the EU level, with a key novelty being the introduction of JCAs which are assessments of clinical aspects of novel medicines that can be considered for use in HTA at the national level. JCAs will start with cancer medicines and advanced therapies as from January 2025.
As part of the preparations for the entry into application of the HTA Regulation, the European Commission published the draft of the Implementing Act for JCAs of medicinal products in March 2024. Amongst other things, this act sets out procedural rules and timelines for JCAs and provides the format and templates of the submission dossier and the JCA report.
Experts from ESMO’s Public Policy Committee, Cancer Medicines Committee, and ESMO-MCBS Working Group have reviewed the draft Implementing Act and provided their feedback and comments, reflected in the consultation response submitted by the Society.
ESMO stands ready to collaborate with all stakeholders, including the EU institutions and the Member State Coordination Group on HTA, on the development of the Implementing Act and the preparations for the implementation of the HTA Regulation.
For further information, please contact: publicpolicy@esmo.org