Personalized Reimbursement Model (PRM) program: A real-world data platform of cancer drugs use to improve and personalize drug pricing and reimbursement in France
Pierre-Alexandre Squara,Vinh-PhucLuu,David Pérol, Bruno Coudert, Valérie Machuron, Camille Bachot,Laurence Samelson,Virginie Florentin,Jean-Marc Pinguet, Béchir Ben HadjYahia
Abstract
This article provides an overview of the Personalized Reimbursement Model (PRM) program in France, highlighting its methodology, limitations, achievements, and future prospects. The PRM program utilizes real-world data on the usage of cancer drugs to enhance and individualize drug pricing and reimbursement in the country.
Materials and Methods
The PRM platform collects Electronic Pharmacy Records (EPR) data from various medical centers in France known as PRM centers. These data are used to create retrospective cohorts of patients who have received injectable cancer drugs within a hospital setting. For this analysis, data were extracted on January 1st, 2020, specifically focusing on breast cancer (BC) patients who were treated with trastuzumab, trastuzumabemtansin, or pertuzumab since January 1st, 2011, and lung cancer (LC) patients who received bevacizumab or atezolizumab since January 1st, 2015. These data allowed for the reconstruction of the patients' history of injectable cancer drug usage, starting from the date of diagnosis until December 30th, 2019. This dataset was then utilized for assessment and analysis purposes.
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.
Discussion
As of January 1st, 2020, PRM platform enabled capturing RWD from EPR systems among 123 public and non-public French medical centers covering more than a third of BC and LC patients in-hospital therapeutic management in France. PRM database is populated with 30,730 BC or LC patients EPRs data, filled in by physicians in their routine practice for cancer drug prescription, and reviewed by pharmacists for cancer drug dispensation, which enables having a high completeness and correctness for patients characteristics, diagnostic and treatment related data. Moreover, effective data management algorithms improve data quality for disease stage and treatment line. Patient in-hospital injectable cancer drugs history is linked to patient characteristics, diagnostic, disease stage and treatment line, over time. This enabled the computation of RWE of trastuzumab, trastuzumabemtansin, pertuzumab, bevacizumab or atezolizumab use, based on: 1/ target population and patient profiles that are likely to be treated in real-world setting, 2/ off-label use and compliance with guidelines, 3/ treatment indication, especially for label extension and combinations with other treatments, 4/ involvement in clinical trials or in early access programs (ATU) and 5/ benefit of the drug based on proxy indicators such as the number of drug injections or treatment duration. Equitable distribution of BC and LC patients treated in PRM centers, by medical center category and geographic location, ensures the representativeness of the RWE at national level. Data extractions have been honed for several years and are increasingly automated avoiding time lag between data capture and their availability for analyses. Furthermore, PRM data extractions are also available on demand, providing up-to date RWE for timeliness health care decision making across the product life cycle. Data collection requires neither additional workload by healthcare professionals nor clinical monitors hiring, thus ensuring the sustainability of data capture within the PRM program.
Conclusions
PRM Platform enabled building a national database generating on demand Real-World Evidence based on hospitals Electronics Pharmacy Records. This enabled the first performance-based risk-sharing arrangements based on PRM data, between the CEPS and Roche, for atezolizumab cancer immunotherapy in metastatic NSCLC indication. PRM program envisions expanding by collaborating with other healthcare system stakeholders in order to improve integration of RWE at all stages of the product life cycle, which could improve patient access to innovative cancer drugs while ensuring the health care system sustainability.
Acknowledgments
Brice Hyaumet, Joël Da Costa and David Pau, provided statistical support. NasséraChalabi, Manoel Moreau, Dorothée Camus, Christophe Fleury, KarineLaizet, Fanny Zinger, Alice Herreye, Andréa-Pierre Galasso, DelphineCozzone, Emmanuelle Cauchard, FrédéricChassagnol, RémyChoquet, BelguendouzBendahmane, MichaëlLukasiewicz contributed to enrich this article.
Citation: Squara P-A, Luu V-P, Pérol D, Coudert B, Machuron V, Bachot C, et al. (2022) Personalized Reimbursement Model (PRM) program: A real-world data platform of cancer drugs use to improve and personalize drug pricing and reimbursement in France. PLoS ONE 17(4): e0267242. https://doi.org/10.1371/journal.pone.0267242
Editor: Wen-Wei Sung, Chung Shan Medical University, TAIWAN
Received: February 24, 2021; Accepted: April 5, 2022; Published: April 19, 2022
Copyright: © 2022 Squara et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Data Availability: As per local regulation, Roche France SAS (the data controller) has no access to patient individual data. Data is collected, hosted and managed by an independent third party, Advanced Schema (contact@advanced-schema.com; 19 rue Galilée 7511 Paris). Only aggregated data is shared with Roche France SAS in compliance with local regulation. However the individual data may be shared by Advanced Schema with the authorization of Roche France SAS and the French health authorities.
Funding: PA. Squara was employed by Roche France SAS. VP. Luu is employed by Roche France SAS. D. Pérol received grants and non-financial support from Roche France SAS during the conduct of the study; personal fees from Roche France SAS, Pierre Fabre, Novartis, Bristol-Myers Squibb Co., Eli-Lilly, Ipsen, Takeda and MSD outside the submitted work; personal fees and non-financial support from AstraZeneca; and grants from MSD Avenir and Roche France SAS outside the submitted work. B. Coudert received fees from Roche France SAS during the conduct of the study and personal fees from Roche France SAS, Bristol-Myers Squibb Co. and AstraZeneca outside the submitted work. V. Machuron is employed by Roche France SAS. C. Bachot is employed by Roche France SAS. L. Samelson is employed by Roche France SAS. V. Florentin is employed by Roche France SAS. JM. Pinguet is employed by Roche France SAS. B. Ben HadjYahia is employed by Roche France SAS. This study was designed and conducted by Roche France SAS in collaboration with the French oncology healthcare ecosystem. This does not alter our adherence to PLOS ONE policies.
Competing interests: I have read the journal’s policy and the authors of this manuscript have the following competing interests: PA. Squara was employed by Roche France SAS. VP. Luu is employed by Roche France SAS. D. Pérol received grants and non-financial support from Roche France SAS during the conduct of the study; personal fees from Roche France SAS, Pierre Fabre, Novartis, Bristol-Myers Squibb Co., Eli-Lilly, Ipsen, Takeda and MSD outside the submitted work; personal fees and non-financial support from AstraZeneca; and grants from MSD Avenir and Roche France SAS outside the submitted work. B. Coudert received fees from Roche France SAS during the conduct of the study and personal fees from Roche France SAS, Bristol-Myers Squibb Co. and AstraZeneca outside the submitted work. V. Machuron is employed by Roche France SAS. C. Bachot is employed by Roche France SAS. L. Samelson is employed by Roche France SAS. V. Florentin is employed by Roche France SAS. JM. Pinguet is employed by Roche France SAS. B. Ben HadjYahia is employed by Roche France SAS.
https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0267242#ack
