Health technology assessment

KEY POINTS

Health technology assessment

A health technology assessment (HTA) is an evidence-based scientific process that enables national authorities to assess the relative effectiveness of new or existing health technologies. It focuses in particular on the added value of a health technology compared to other new or existing technologies.

The regulation sets out rules on the use of common methods, procedures and tools for an HTA throughout the EU, specifically:

• a support framework and procedures for cooperation between Member States on health technologies at the EU level;
• common EU rules and methods for joint HTA work, including joint clinical assessments (JCAs);
• a mechanism whereby all information, analysis and evidence required for the JCA of health technologies is submitted by the health technology developer only once at the EU level.

Scope

• The regulation focuses on common scientific and clinical aspects of HTAs.
• Member States’ HTA bodies will conduct JCAs of new medicines and certain high-risk medical devices.
• These bodies will also engage in joint scientific consultations (JSCs) to advise technology developers on clinical study designs that generate appropriate evidence.
• HTA bodies will also conduct joint ‘horizon scanning’ of emerging health technologies with a potentially significant impact on patients, public health and healthcare systems.
• Member States can also engage in further voluntary cooperation activities, such as on health technologies other than medicines and medical devices, or on economic aspects of HTAs.

Coordination group

• The regulation sets up a Member States Coordination Group on HTAs, with members designated by each Member State.
• It will oversee the joint technical work carried out by subgroups of national representatives for specific types of work such as JCAs or JSCs.
• It aims to ensure that the joint work carried out is of the highest quality, meets international standards of evidence-based medicine and is timely. It will operate in an independent, impartial and transparent manner.
• The coordination group reviews and approves joint work (e.g. JCA reports, methodological and other guidance documents).

Member State obligations

• Member States must ‘give due consideration’ to the JCA reports.
• They are required to annex the JCA report to the national HTA report and to report on how each JCA report was given due consideration in the assessment at the national level.

Implementing act concerning joint clinical assessments

An implementing act, Implementing Regulation (EU) 2024/1381, lays down detailed procedural rules for JCAs of medicinal products at the EU level, as regards:

• cooperation, in particular by exchange of information, with the European Medicines Agency on the preparation and update of JCAs of medicinal products;
• interaction, including the timing thereof, with and between the coordination group (see above), its subgroups and health technology developers, patients, clinical experts and other relevant experts during JCAs of medicinal products and their updates;
• general procedural rules on the selection and consultation of stakeholder organisations, patients, clinical experts and other relevant experts in JCAs at the EU level;
• the format and templates for dossiers with information, data, analyses and other evidence to be provided by health technology developers for JCAs;
• the format and templates for JCA reports and summary JCA reports.