The European Society for Medical Oncology (ESMO) responded to the EUnetHTA 21 public consultation on its draft deliverable D4.4 on ‘Endpoints’.
The EUnetHTA 21 consortium, established after the completion of EUnetHTA Joint Action 3, supports the development of guidance documents in view of the coming into application of the EU Health Technology Assessment (HTA) Regulation in January 2025. In this regard, various public consultations are underway to collect feedback from stakeholders on the draft deliverables that the consortium is preparing.
In its response, ESMO highlighted that endpoints in Joint Clinical Assessments (JCAs) that are to be carried out under the HTA Regulation should be patient-centred, i.e. mortality and Patient-Reported Outcome Measures (PROMs) such as quality of life. Only in settings where such endpoints cannot be measured, and provided that there is surrogacy validation, surrogate endpoints can be used.
ESMO also underlined that, for cancer medicines, the ESMO-Magnitude of Clinical Benefit Scale (ESMO-MCBS), when used from the outset of JCAs, may be instrumental in prioritizing medicines and helping to avoid possible duplication of efforts.
The ESMO-MCBS is a tool, created by ESMO, that helps to assess the value of cancer care and prioritize medicines, and also addresses the challenges of the appropriate use of limited resources to deliver cost-effective and affordable cancer care. The ESMO-MCBS is currently being used as part of HTA processes by authorities, regions and oncology societies in various countries across the world - including Australia, Austria, Brazil, Germany, Israel, Singapore, Slovakia, South-Africa and Spain - to assess cancer medicines. The ESMO-MCBS plays a key role to support sustainability in oncology and ensure that optimal care becomes accessible to everyone, everywhere.
For further information, please contact: publicpolicy@esmo.org