ABSTRACT
OBJECTIVE: This article describes the Personalized Reimbursement Model (PRM) program methodology, limitations, achievement and perspectives in using real-world data of cancer drugs use to improve and personalize drug pricing and reimbursement in France. MATERIALS AND METHODS: PRM platform aggregates Electronic Pharmacy Records (EPR) data from French medical centers (PRM centers) to build retrospective cohorts of patients treated with injectable cancer drugs in a hospital setting. Data extracted on January 1st, 2020, from breast cancer (BC) patients who received trastuzumab, trastuzumab emtansin or pertuzumab since January 1st, 2011, and from lung cancer (LC) patients who received bevacizumab or atezolizumab since January 1st, 2015, enabled recovering their injectable cancer drugs history from diagnosis date until December 30th, 2019, and served as dataset for assessment. RESULTS: 123 PRM centers provided data from 30,730 patients (25,660 BC and 5,070 LC patients respectively). Overall, 20,942 (82%) of BC and 4,716 (93%) of LC patients were analyzed. Completion rate was above 98% for patients characteristics, diagnostic and treatment related data. PRM centers cover 48% and 33% of BC and LC patients in-hospital therapeutic management in France, respectively. Distribution of BC and LC patients therapeutic management, by medical center category and geographic location, was similar in PRM centers to all French medical centers, ensuring the representativeness of the PRM platform. CONCLUSION: PRM Platform enabled building a national database generating on demand Real-World Evidence based on EPR. This enabled the first performance-based risk-sharing arrangements based on PRM data, between the CEPS and Roche, for atezolizumab cancer immunotherapy in metastatic non-small cell lung cancer indication.
Subject(s)
Antineoplastic Agents , Breast Neoplasms , Carcinoma, Non-Small-Cell Lung , Lung Neoplasms , Antineoplastic Agents/therapeutic use , Breast Neoplasms/drug therapy , Breast Neoplasms/pathology , Carcinoma, Non-Small-Cell Lung/drug therapy , Drug Costs , Female , France , Humans , Lung Neoplasms/drug therapy , Retrospective Studies , Trastuzumab/therapeutic useABSTRACT
OBJECTIVES: The aim of this study was to describe the characteristics of patients receiving bevacizumab plus first-line metastatic chemotherapy for non-squamous advanced non-small cell lung cancer (aNSCLC), with or without brain metastases, in routine clinical practice. Other objectives were to describe treatment efficacy, modalities of use, and safety. METHODS: For this non-interventional, prospective, national, multicentre study, data were collected every 3 months over 18 months. RESULTS: Of the 407 patients analysed, 84 (21%) with brain metastases at bevacizumab initiation had poorer general health than patients with no brain metastases (Eastern Cooperative Oncology Group [ECOG] performance status score = 2: 16 vs. 11%). All but 2 patients received bevacizumab (7.5 or 15 mg/kg/3 weeks in 99% of patients) in combination with doublet chemotherapy. Median progression-free survival and overall survival did not differ significantly between patients with or without brain metastases (6.5 months, 95% CI 5.7-8.1 vs. 6.9 months, 95% CI 5.9-7.6, p = 0.57; 14.5 months, 95% CI 10.0 vs. 12.5 months, 95% CI 10.1-14.7, p = 0.33). In 30 and 32% of the patients, respectively, at least one serious adverse event was reported, with a causal relationship to bevacizumab in 20 and 21% of the patients. CONCLUSION: This study confirmed in a real-life setting the safety profile and survival benefits of first-line chemotherapy with bevacizumab in aNSCLC patients with brain metastases.
