The Switch from Reference Biologic Medicines to Biosimilars in France: The Perspective of Patients and Prescribers on Barriers and Needs

Cécile Gaujoux-Viala,1,2 Sonia Tropé,3 Anne Buisson,4 Fabienne Lacombe,5 François Bocquet,6,7 Emeric Languérand,8 Laura Cordurié,9 Géraldine Margulies,10 Catherine Le Berre,11 Olivier Vittecoq12 1Inserm, IDESP, University of Montpellier, Montpellier, France; 2Rheumatology Department, CHU of Nîmes, Nîmes, France; 3French National Patient Organization Against Rheumatoid Arthritis (ANDAR), Paris, France; 4AFA Crohn RCH France, Paris, France; 5Association France Spondyloarthrites, Tulle, France; 6Data Factory & Analytics Department, Institut de Cancérologie de l’Ouest, Nantes-Angers, France; 7Law and Social Change Laboratory, Faculty of Law and Political Sciences, Nantes University, Nantes, France; 8Psychologist and Psychotherapist Cannes Sainte-Anne Hospital Paris, Paris, France; 9Consultant Access Strategy and Public Affairs Real World Solution, IQVIA France, Courbevoie, France; 10Marketing Biosimilars, Biogen France SAS, Puteaux, France; 11Institut des Maladies de l’Appareil Digestif, Hépato-Gastro-Entérologie et Assistance Nutritionnelle, CHU Nantes, Nantes, France; 12Rheumatology Department, CHU of Rouen, Rouen, FranceCorrespondence: Géraldine Margulies, Biogen France SAS, Tour Légende, 20 Place de la Défense, Puteaux, 92 800, France, Tel +33 1 41 37 95 95, Fax +33 1 41 37 24 00, Email [email protected]: In France, the integration of biosimilars into medical practice in rheumatology and gastroenterology is well established. Despite a high penetration rate in hospitals, the adoption of biosimilars varies depending on the molecules. This adoption differs between new patients, for whom biosimilars are prescribed as initial biologic treatment, and those receiving these medications as part of a treatment switch from reference biologics. The objective of the COMPRENDRE study was to identify and understand the obstacles to switching from reference biologic products to their biosimilars by examining prescription practices and patient decisions. This study proposes recommendations to overcome these barriers.Patients and Methods: A total of twelve rheumatology and gastroenterology prescribers and fourteen patients with rheumatologic and gastrointestinal disorders were interviewed for qualitative insights. Subsequently, one hundred prescribing physicians and one hundred ninety patients responded to a quantitative survey to validate and explore these findings. The study was supervised by a multidisciplinary expert committee.Results: The results from the quantitative and qualitative surveys show similarities in the outcomes. In the qualitative study, 71% (10/14) of patients accepted the switch to a biosimilar. For half of them (7/14), trust in the physician-patient relationship was the main reason for acceptance. Key barriers identified by prescribers included the limited time available during consultations and patient anxiety due to their illness, both of which negatively impacted willingness to switch. In the quantitative study, 89% (89/100) prescribers reported prescribing biosimilars through switching from the reference biologic. However, only 33% (29/89) indicated that they systematically switch eligible patients. Overall, 55% (104/190) of the patients surveyed had never been offered a switch to a biosimilar.Conclusion: Switching from a reference biologic to biosimilars is hampered by several factors, including the lack of systemic proposals in the practice of prescribers as well as the lack of information given to patients.Keywords: biologic, biosimilar, gastroenterology, healthcare professional, patient satisfaction, rheumatology, shared decision making, switch