JCA should not hamper access to transformative ATMPs
The EHC joins a group of patients, clinicians, academic medical centres, and therapeutic developers and manufacturers in signing a call to action for the successful roll-out of the Joint Clinical Assessment (JCA).
With the adoption of the Implementing Act on the JCA for medicinal products and the HTA Coordination Group’s Methodological and Practical Guidelines on direct and indirect comparison, the implementation of the JCA under the EU HTA Regulation is entering a critical phase. The EHC and other signatories are concerned that European patients with few or no treatment alternatives will experience further delays and limitations in access to potentially life-changing medicines. This would defeat the purpose of the EU HTA and JCA which aspire to increase and accelerate patient access.
Therefore, the joint statement urges the members of the HTA Coordination Group and its relevant subgroups, and JCA assessors to recognise all types of available evidence including single-arm trials and RWE, and to use the JCA report to describe, rather than judge, any resulting uncertainty as to the treatments’ benefits, as called for by the HTA Regulation. A significant portion of outstanding uncertainty can be addressed at the national level during the appraisal phase and through the collection of RWE.
In so doing, the Coordination Group can lead the development of a fit-for-purpose JCA system that efficiently addresses the needs of healthcare systems, without obstructing patient access to transformative therapies.