Written by Priyanka Kiritharan, Analyst
Contact: [email protected]
Taking effect from January 2025, all advanced therapeutic medicines (ATMPs) and oncology drugs will be mandated to undergo a joint clinical assessment (JCA) at an EU level. Several activities are set to take place between now and then, in preparation for the implementation of EUnetHTA [1]:
- Member States must nominate representatives to support the development of methodological and procedural guidance, for JCA and the identification of emerging HTAs
- Complex IT platform required by the new system is in development
- Support and training will be provided to national and regional authorities and other stakeholders over the next two years
- A call for applications for the stakeholder network, who will be involved in JCAs, was addressed to eligible candidates on 12 December 2022, for which the deadline is 17 February 2023
It will be mandatory for manufacturers to participate in JCAs, however it will not be compulsory for individual Member States to adopt the joint report. Therefore, Member States have the right to conduct economic assessments to make pricing and reimbursement decisions on ATMPs. This gives rise to uncertainties regarding the homogenous alignment amongst all Member States to reach price and access decisions, which drive equitable access across Europe [2].
The overarching aim of EUnetHTA assessments is to harmonise and improve efficient patient access to innovative therapies in Europe. However, there has been some recent criticism from leading pharma associations (VFA and BPI) in Germany relating to the trajectory of EUnetHTA assessments. The general consensus of the VFA and BPI are that [3]:
- The ‘merging of national practices’ does not ensure that administrative burden will be reduced, without an ‘alignment with common EU methods and information requirements and a harmonised HTA criteria’
- According to the VFA and BPI, EUnetHTA has not met the requirements of the HTA regulation to adapt methods for ATMPs and therefore poses a huge risk for potential ATMPs to fail assessments, counteracting the aim of EUnetHTA
- National authorities may be limited to requesting additional information or clinical evidence from the manufacturer which is not included in the JCA. The VFA and BPI are calling for additional scoping meetings to strengthen the involvement of companies within the joint-HTA process
Despite several comments and concerns from stakeholders, there has been minimal changes to the EUnetHTA21 deliverables. The concerns raised by German pharma associations mirror the views shared at EUCOPE and EFPIA in October 2022 [4]. It is a concern that views on the way ahead are being ignored. Without more meaningful collaboration between manufacturers, HTA agencies, patient organisations, clinicians and other stakeholders, the consequence will be a joint system that is fragmented and misaligned. This has the potential to delay the HTA process, ultimately impacting timely access of ATMPs to patients. We hope that in the coming months, EUnetHTA will seek to act on the repetitive concerns raised by multiple associations.
References:
[2] https://partners4access.com/blogs/european-hta-regulation-how-will-it-work-in-practice/
