Presentation (CTI)

OBJECTIVES: PECAN is a temporary reimbursement pathway introduced in France in 2023 to support early market access and evidence generation for innovative digital medical devices. This study aimed to characterize the evidence expectations and decision drivers of PECAN assessments and explore their relationship with subsequent reimbursement evaluations.
METHODS: We reviewed all PECAN opinions published by the French National Authority for Health (HAS) between July 2023 and June 2026 and analyzed the rationale supporting favourable and unfavourable decisions, as well as subsequent assessments for permanent reimbursement (LATM/LPPR).
RESULTS: Thirteen PECAN evaluations were identified (7 telemonitoring solutions [TM], 6 digital therapeutics [DTx]), of which four received a favourable opinion. All favourable decisions concerned TM, whereas all DTx received unfavourable opinions. Favourable outcomes were associated with a clear organisational need, plausible care pathway benefits, and a credible evidence-generation strategy supporting future reimbursement assessment. Unfavourable decisions were mainly driven by insufficient product-specific evidence, methodological weaknesses, lack of demonstrated organisational value, and ongoing studies considered unlikely to generate decision-relevant evidence within PECAN timelines. Among nine products receiving an unfavourable PECAN opinion, six did not subsequently undergo reimbursement assessment. Conversely, all products eventually receiving a favourable reimbursement opinion had previously obtained a favourable PECAN opinion. Among the four products granted a favourable PECAN opinion, three subsequently underwent reimbursement assessment, resulting in two favourable and one unfavourable reimbursement opinions.
CONCLUSIONS: PECAN appears to act as an early signal of reimbursement readiness. Across published decisions, favourable opinions were associated with a clear organisational value proposition and a credible evidence-generation plan. While favourable PECAN opinions were not systematically followed by favourable reimbursement outcomes, all products eventually receiving a favourable reimbursement opinion had previously obtained a favourable PECAN opinion. In contrast, only 2 of 9 products receiving an unfavourable PECAN opinion subsequently underwent reimbursement assessment.