The French Transitional Coverage Pathway (PECT) for Innovative Therapeutic Medical Devices: A Four-Year Retrospective Analysis
Author(s)
Ouassim Naiet el Gaied, PharmD., DELPHINE CHAVADE, MSc, PharmD, de Sauvebeuf Côme, PharmD..
Biodimed Conseils, Paris, France.
Biodimed Conseils, Paris, France.
OBJECTIVES: France introduced the Prise En Charge Transitoire (PECT) in 2021 to enable early coverage of innovative therapeutic medical devices (MDs) while collecting missing data for permanent listing. Four years after its implementation, an analysis is needed to assess its application and alignment with initial objectives.
METHODS: This study analyzes all available public data on devices assessed by the HAS (French HTA body) for PECT listing, their associated procedure code creation and coverage decisions, either transitional or permanent via MD reimbursement list (LPPR).
RESULTS: Of 13 MDs assessed, 7 received unfavorable PECT opinions. The most frequent reasons were “insufficient clinical added value” (n=6) and “uncertain benefit-risk profile” (n=6). Of the 6 MDs approved by HAS, only 4 received effective PECT listing. Two remain pending after 30 and 36 months. Reasons could be either missing procedure codes (CCAM) or failed pricing negotiation. As 2 PECT-listed devices requiring procedure creation had the fastest listings (3 and 6 vs. 11 and 13 months), CCAM code creation is unlikely to be incriminated. Among PECT-listed MDs, 2 received favorable LPPR opinions from HAS, without confirmation of the high added value expected at PECT (ASA III/IV and III). This was primarily due to the lack of relevant comparative evidence, notably caused by delays in completing an RCT anticipated by HAS following PECT assessment. Another MD was delisted following unfavourable clinical outcomes. These suggest that the high added value expected at PECT entry isn’t consistently confirmed in later evaluations. No MD has yet transitioned to LPPR listing. Meanwhile, PECT coverage continues, with durations ranging from 17 to 34 months, exceeding the initial 12-month target, and raising questions about efficiency.
CONCLUSIONS: PECT facilitates early access to promising MDs, but faces delays, prolonged coverage, and unconfirmed added value. This highlights the need for better integration and clearer exit strategies to meet initial objectives.
METHODS: This study analyzes all available public data on devices assessed by the HAS (French HTA body) for PECT listing, their associated procedure code creation and coverage decisions, either transitional or permanent via MD reimbursement list (LPPR).
RESULTS: Of 13 MDs assessed, 7 received unfavorable PECT opinions. The most frequent reasons were “insufficient clinical added value” (n=6) and “uncertain benefit-risk profile” (n=6). Of the 6 MDs approved by HAS, only 4 received effective PECT listing. Two remain pending after 30 and 36 months. Reasons could be either missing procedure codes (CCAM) or failed pricing negotiation. As 2 PECT-listed devices requiring procedure creation had the fastest listings (3 and 6 vs. 11 and 13 months), CCAM code creation is unlikely to be incriminated. Among PECT-listed MDs, 2 received favorable LPPR opinions from HAS, without confirmation of the high added value expected at PECT (ASA III/IV and III). This was primarily due to the lack of relevant comparative evidence, notably caused by delays in completing an RCT anticipated by HAS following PECT assessment. Another MD was delisted following unfavourable clinical outcomes. These suggest that the high added value expected at PECT entry isn’t consistently confirmed in later evaluations. No MD has yet transitioned to LPPR listing. Meanwhile, PECT coverage continues, with durations ranging from 17 to 34 months, exceeding the initial 12-month target, and raising questions about efficiency.
CONCLUSIONS: PECT facilitates early access to promising MDs, but faces delays, prolonged coverage, and unconfirmed added value. This highlights the need for better integration and clearer exit strategies to meet initial objectives.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
HPR201
Topic
Health Policy & Regulatory, Health Technology Assessment
Topic Subcategory
Coverage with Evidence Development & Adaptive Pathways
Disease
No Additional Disease & Conditions/Specialized Treatment Areas