Building a Real World Data Network to Support Access to Oncology Medicines in France: the Personalised Reimbursement Models Initiative.

 Oncology medicines reimbursed in France have a fixed price whereas the benefits vary across patient groups.  Pricing models aligned to the clinical benefit open an interesting concept, but they need to be supported by reliable and standardised metrics aligned with health authorities ‘expectation.  The Personalised Reimbursement Models (PRM) project is a global Roche project inspired by the Italian pricing system.  In France, the PRM approach aims to establish an infrastructure to collect routinely existing data in order to be used as input for pricing models.  A pilot phase has been achieved in 2014 to validate the feasibility of the of the project. Pilot phase  All metastatic breast cancer (mBC) patients at 14 pilot centres recorded in the Electronic Pharmacy Record (EPR) system with at least one trastuzumab claim between January 2011 to October 2014 that were not enrolled in a clinical trial were selected (Figure 1).  Data related to demographics, disease description, drug usage and clinical outcomes were collected in the EPR (Figure 2). These data were controlled, cleaned and centralised in an anonymous and secure way through an accredited hosting provider.  Patients were followed from the index date (first Trastuzumab claim) until six months after last date any drug prescription recorded in the EPR (Figure 1).