Assessment & Approval

Health technology assessment awareness

Health technology assessment (HTA) bodies are responsible for evaluating new health technologies to support reimbursement decision-making in Europe. As data from DCTs may be used for clinical or economic evaluation (for reimbursement purpose), it is important to investigate the opportunities and challenges for DCT approaches from an HTA perspective.

Recommendations

Increase HTA bodies awareness on DCT approaches

This could be achieved through trainings and stakeholder engagement to help HTA assessors in their appraisal of study results that used DCT approaches.

Engage with HTA bodies early

As the EMA-HTAb Joint Scientific Assessment (JSA) is expected to play an important role in the future evaluation of trials for reimbursement, early engagement with HTA bodies is recommended to support decision-making and ensure acceptability of data generated through innovative approaches.

How Trials@Home reached these recommendations

We conducted semi-structured interviews with 25 European representatives from European HTA bodies.

Their experience in assessing DCTs was limited, however they believed DCTs could provide a better reflection of the real world and reduce recall bias while also expressing concerns about data quality.