The European Society for Medical Oncology (ESMO) provided feedback to a public consultation launched by the EUnetHTA 21 consortium on two of its draft deliverables - D6.2.1 and D6.4.1 - which respectively cover (1) a briefing document template for parallel EMA/EUnetHTA 21 Joint Scientific Consultations (JSCs) and (2) external guidance with the European Medicines Agency (EMA). In its response, ESMO highlighted the need for consultations concerning new methods for rare molecular entities as well as the importance of considering relevant endpoints addressing the potential impact on patients.
The European Union (EU) adopted a new Regulation on Health Technology Assessment (HTA) in 2021. Set to enter into application in January 2025, this new EU legislation establishes permanent EU structures for collaboration on HTA as well as EU-level processes for assessing new health technologies, including Joint Clinical Assessments (JCAs) and Joint Scientific Consultations (JSCs). This with the goal to provide a sustainable framework for EU-wide cooperation whilst reducing duplication of work for HTA authorities in the EU Member States.
The EUnetHTA 21 consortium was established in September 2021 to support the development of guidance documents that will help steer the joint work and processes under the HTA Regulation. Most draft deliverables of EUnetHTA 21 are being put forward for feedback from the public.
ESMO provided input to two of the most recent draft deliverables of EUnetHTA 21:
- D6.2.1 Briefing Document Template - Parallel EMA/EUnetHTA 21 Joint Scientific Consultation
- D6.4.1 Guidance on Parallel EMA/EUnetHTA 21 Joint Scientific Consultation
It its feedback, ESMO underlined the importance of facilitating consultations and interaction concerning new methods for rare molecular entities, which hold great potential to support the development of more effective therapies for patients with cancer. Moreover, as to the number of health technologies to be selected for JSCs, it was suggested to consider a pre-defined number of slots for rare disease therapies as a way to foment development in this field.
ESMO also recommended providing a checklist with the evaluable points for selection, as well as including quality of life as a mandatory endpoint, especially for metastatic diseases.
Given the importance of the HTA Regulation for access to cancer medicines, ESMO will continue to monitor the preparations for the implementation of this new legislation, whilst addressing the needs of cancer patients and oncology professionals.