HTA

SMA Europe is member of the Health Technology Assessment Stakeholder Network. (For further information please see here.)

This network was set up by the European Commission to ease the involvement of a diverse array of stakeholders in the formulation of policies concerning HTAs within the European Union (EU). Health Technology Assessment (HTA) is a multidisciplinary approach used to compare a new technology with an existing one to assess if it is more, equally or less effective. The HTA Network aims to foster dialogue among organisations interested in EU cooperation on HTA and the Member States Coordination Group on HTA, thereby promoting inclusiveness and transparency in this field throughout the European Union.

HTA is a multidisciplinary method assessing medical, social, economic, and ethical factors to guide national authorities in determining which healthcare practices and technologies should be prioritized. Although HTA is a globally acknowledged practice utilized around the world, its processes vary across EU member states. With the aim of making HTA processes easier and more efficient across the European Union (EU), Joint Clinical Assessments (JCAs) have been introduced.

For further information on JCAs, SMA Europe invites viewing its SMAcademy webinar titled “Understanding the new EU Joint Clinical Assessment and its possible implications”, held in January 2025.

Together with 33 non-for-profit organisations, SMA Europe signed a call to action in July 2024 to highlight the challenges in the JCA process for Advanced Therapy Medicinal Products (ATMPs).

As the new EU Joint Clinical Assessment (JCA) can become an additional barrier to patient access to transformative advanced therapies if the HTA Coordination Group does not modernise its approach to evaluating these medicines, the 33 non-for profit organisations urged all those involved in the JCA to recognize and use all types of available clinical evidence, including single-arm trials and real-world evidence, in the assessment of ATMPs, which include cell and gene therapies. The signatories of the Call to Action are working together to bring these issues to the attention of the European Commission, the Coordination Group and members at the national level, to ensure that the voices of patients and all stakeholders in the ATMP ecosystem are heard, and, more importantly, acted upon.