12 January 2025 - The Countdown runs
Pharmaceuticals and medical devices - the countdown runs! January 12, 2025, the era of national product assessments ends and the application of the EU HTA Regulation begins.
Major challenges ahead:
The regulation initially applies to pharmaceuticals with new active substances for the treatment of cancer (including orphans drugs with this indication) and advanced therapy medicinal products (ATMPs) from marketing authorization applications submitted after 12.01.2025.
It also applies to selected medical devices in risk classes IIb or III. Pharmaceuticals with new active substances for rare diseases (orphan drugs) will follow in January 2028 and all other centrally authorized medicinal products with new active substances in January 2030.
As EU HTA stakeholder, the IGES Institute and companies of the IGES Group have been intensively involved in the discussions and consultations of EUnetHTA21 and have prepared for the application of the regulation.
How is your preparation going? The challenges are obvious, here some general considerations:
The naming as "Regulation ... ... on health technology assessment..." is somewhat misleading. This name suggests that a full HTA procedure is being created at EU level. In essence, however, "only" a joint clinical assessment is being created.
The decisive conclusions on added benefit, eligibility for reimbursement and pricing remain a national decision-making competence; the results of the joint clinical assessment at EU level have to be given "due consideration", but are not binding for EU/EEA member states.
This results in a complex combination of procedures consisting of central assessment elements based on the requirements of all member states and following national decisions.
For companies, an integrated concept of EU dossier and national supplementary submissions is necessary, as it is foreseeable that many countries will always request certain additional data, for example when countries regularly request a health economic model for national assessments.
National evaluation procedures follow, because centrally submitted and evaluated evidence and nationally submitted data/models must be brought together and only then decisions on market access or price negotiations at national level.
The companies of the IGES Group, with their many years of experience in HTA procedures in EU countries, support pharmaceutical companies, manufacturers of medical devices and other stakeholders in the implementation of the EU HTA Regulation.