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Health Technology Assessment (HTA)

Improving accessibility 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 outcomes of this process usually inform decisions on the reimbursement of the new treatment.

In the European Union (EU), cooperation on HTA has 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, adopted in December 2021 replacing the previous project-based cooperation, establishes 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 a sustainable framework for EU-wide cooperation whilst reducing duplication of work for HTA authorities in the EU Member States. 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 - including JCAs and JSCs - to commence with new cancer treatments, effective from the entry into application of the legislation. ESMO also frequently provides feedback to public consultations of the EUnetHTA 21 consortium, which fulfils an important role in supporting the preparations for the entry into application of the HTA Regulation.

As the 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-Magnitude of Clinical Benefit Scale (ESMO-MCBS) - which is currently being used as part of HTA in many countries – or the ESMO Scale for Clinical Actionability of molecular Targets (ESCAT).

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