OBJECTIVES: Oncology medicines reimbursed in France have one fixed price whereas benefits vary across patient groups. Herceptin®, anti-HER2 targeted therapy, obtained reimbursement successively for metastatic breast cancer (2002), adjuvant setting (2006) and neo-adjuvant setting (2012). Consequently, its price decreased regularly on a volume based agreement ignoring the scaling of patients clinical benefit. The Personalised Reimbursement Models (PRM) project is an infrastructure validated by the French National Data Privacy Committee to collect real life data of HER2+ breast cancer (BC) patients receiving Roche targeted therapies since January 2011. The French PRM database has been active since 2015. It provides fully available datasets extracted from chemotherapy prescriptions, which gives the opportunity of modeling reimbursement agreements for Roche BC drugs next indications.

METHODS: BC patients at 105 centers recorded in the Electronic Pharmacy Record system with at least one HER2 targeted Roche therapy administration since January 2011. PRM scenarios have been simulated to reflect the impact of price rebate of trastuzumab regarding its indications.

RESULTS: From >18,000 HER2+BC patient files extracted, 13,535 patients from 97 centers were analyzed, accounting for around 45% of all 2011-2016 French HER2+BC. 7,658 patients had at least one prescription for 2015 or 2016 and at least one treatment line initiation for 5,347 of them within this period (respectively 3,728 (64%) / 2,128 (36%) early / advanced treatments). 49,372 trastuzumab injections are recorded in the database for 2016; 31,030 (63%) were related to early treatments and 18,342 (37%) to advanced treatments. According to price decrease over time, PRM agreements could have resulted in 40% price difference for Herceptin between early and metastatic indications.

CONCLUSIONS: PRM database provides a reliable reference basis for substantial and relevant price agreements in HER2+ breast cancer drugs opening innovative pricing solutions based on in real life care practices that could be extended to new therapies in breast cancer