OBJECTIVES: With the emergence of digital health therapeutics (DHTs) there has been a growing awareness of the impact of the patient's experience on health technologies, reflected in new health technology assessment (HTA) criteria. This research aims to gain insights into how HTA authorities consider patient-related insights for drugs vs. DHTs and whether the new HTA framework for DHTs will impact the assessment of drugs moving forward.

METHODS: A total of 9 innovative drugs approved via accelerated pathway in Europe between 2018 and 2022 were identified from the European Medicines Agency database. HTA evaluations for the selected drugs were retrieved from HTA agencies in 3 countries (i.e., UK, France and Germany). Subsequently, DHTs reimbursed in these countries up to 2022 were identified, and their HTA evaluations were analysed. Narratives on patient-related insights, including Patient Related Outcomes (PROs), for both drugs and DHTs were analysed.

RESULTS: Overall, 10/20 HTA reports for innovative drugs included patient groups/experts consulted during the appraisal and 16/20 HTAs included Quality of Life (QoL)/PRO data. In the rationale for the decision, a total of 17/20 HTAs included QoL or other patient-centric claims, including 13 QoL arguments and 9 other patient-centric arguments. Conversely, all HTA evaluations for digital therapeutics (42/42) included assessment of patient-related insights, including a mix of DHT functionality (41/42), good data practices (41/42), PRO/QoL (34/42), health literacy (6/42), improvement of productivity and daily functioning (4/42).

CONCLUSIONS: While QoL/PRO remain important outcomes in the assessment of novel technologies, DHTs are shifting the HTA paradigm leading to the incorporation of new patient-related insights that place patients’ ability to use and understand technologies in direct relationship with clinical outcomes at the centre of the HTA. With the expansion of the DHTs, the HTA framework will continue to evolve, possibly reshaping how traditional drugs are being assessed.