Improving access to innovative cancer treatments through robust Health Technology Assessment processes
Following regulatory approval of new treatments, many countries evaluate the benefits, added value and cost-effectiveness of these treatments through a Health Technology Assessment (HTA) process - comparing them with other health technologies. The outcome of this process usually informs decisions on the reimbursement of the new treatment.
In the European Union (EU), cooperation on HTA has previously been taking place through the EU funded EUnetHTA Joint Actions. The 3rd and last EUnetHTA Join Action concluded in 2021.
A new EU Regulation on HTA, which was adopted in December 2021 and will replace the previous project-based cooperation, is to establish a permanent EU framework for joint work and collaboration on HTA. The new legislation aims to improve access to innovative treatments by creating EU-level processes for assessing new health technologies (scientific/clinical aspects) through Joint Clinical Assessments (JCAs) and Joint Scientific Consultations (JSCs). These aim to provide robust assessment reports for the consideration of the EU Member States whilst reducing duplication of work for HTA authorities in EU countries. The Regulation will enter into application in January 2025.
ESMO welcomed the adoption of the HTA Regulation as it has the potential to significantly improve patient access to new cancer treatments. ESMO was active during the political negotiations on the Regulation and successfully campaigned for the joint work - most notably JCAs and JSCs - to commence with new cancer treatments, effective from the entry into application of the legislation.
ESMO also provides feedback to public consultations on the Implementing Acts for the HTA Regulation (in total 6 are to be adopted by the end of 2024), and previously submitted input to consultations on the draft deliverables of the now concluded EUnetHTA 21 consortium. Both the EU Implementing Acts and the EUnetHTA 21 deliverables fulfil important roles in supporting preparations for the entry into application of the HTA Regulation.
ESMO is also raising awareness of the ESMO-Magnitude of Clinical Benefit Scale (ESMO-MCBS), a comprehensive tool that aims to facilitate improved decision-making as to the value of anti-cancer therapies, promote the accessibility of these therapies and reduce inequity of access to high-value cancer treatments. The ESMO-MCBS is a validated and reproducible scale that is applicable across the full range of solid tumours and, since 2023, also in haematological malignancies (ESMO-MCBS:H). It is a dynamic tool, and its criteria are revised on a regular basis to address the rapidly-evolving landscape of new treatment development and regulatory decisions.
Given its value for supporting the prioritisation of medicines for evaluation, ESMO considers that it would be of benefit for patients with cancer if the ESMO-MCBS is used 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.
What is more, the ESMO Clinical Practice Guidelines, developed and reviewed by leading experts and based on the findings of evidence-based medicine, provide medical oncologists with a set of recommendations for optimal patient care. ESMO considers that the Clinical Practice Guidelines can be used as a benchmark ensuring that patients receive appropriate treatment and care.
As EU institutions and Member States are preparing the implementation of the HTA Regulation, ESMO is committed to supporting the eventual uptake and use of JCA and JSC reports at the national level (the use of these reports is not obligatory in the current legislation). Moreover, ESMO stands ready to support the new joint assessment processes, including through its expertise and dedicated tools such as the ESMO-MCBS - which is currently being used as part of HTA in many countries - and the ESMO Scale for Clinical Actionability of molecular Targets (ESCAT).
For further information, please contact: publicpolicy@esmo.org