For Commissioner Vytenis Andriukaitis, the input from patients, health professionals and industry in the HTA discussion is essential:
We now have an opportunity to establish a mechanism that ensures that HTA is used to its maximum potential throughout the EU. I believe that joint assessments would not only help patients to have access to the most effective health technologies, but would also contribute to the sustainability of health systems. The broad involvement of stakeholders also ensures quality and predictability. Moreover, I believe that our proposal would bring more transparency in the HTA processes in the EU.
At the conference, together with the European Parliament's rapporteur, Soledad Cabezón Ruiz, Clemens Auer of the Austrian Health Ministry, and EESC rapporteur Dimitris Dimitriadis, the participants gave recommendations on three major topics:
- Engaging with patients and clinicians on HTA. Transparent and systematic engagement with stakeholders is needed, both on product-specific reports and on a broader strategic level. The involvement of patients and health professionals in the joint clinical assessment guarantees that the reports consider patient-relevant endpoints. Appropriate resources such as training are needed to enable their contributions.
- Generating evidence that meets the needs of patients and health system decision makers. A higher involvement of stakeholders will generate the relevant evidence that meets the needs of the health system decision-makers (including regulators, HTA and payer bodies) and that is also relevant for patients. The issue of transparency is key for the success and acceptance of the exercise.
- Managing uncertainty in the post-launch phase. Post-launch evidence is a key component of the re-assessment of health technologies. Registries and real world data form an important part of the body of evidence on the effectiveness and efficacy of medical devices. The EU’s Digital Single Market offers numerous opportunities for interoperable ICT solutions, common standards, data security and digital competences.
The stakeholders input will feed in the work of the current cooperation and in developing of the future approach post-2020.
See the recording of the meeting.