Changing from a biologic to a biosimilar can create insecurity among patients with RA.
Stakeholders are seeking to ease patient fears and concerns about being switched from a biologic to a biosimilar to treat rheumatoid arthritis (RA).
The Danish Rheumatism Association launched a national plan in August 2015 and implemented through 2016. It was created to ensure patients received independent information about biosimilars and involved close monitoring of prescriptions to provide reassurance about their safety.
After the biosimilar for Remicade was approved in Denmark, the national council for the use of expensive hospital medicines recommended hospitals use the biosimilar infliximab to treat both treatment-naïve patients and those already undergoing Remicade therapy.
The introduction of biosimilars allows the health care system to save money without compromising health and safety. However, the lack of knowledge, understanding, and misinformation surrounding biosimilars caused significant concern among patients.
Initially, the Danish Rheumatism Association conducted a small study that examined the shift from biologics to biosimilars in different regions. The results showed that patients were notified about the change in their treatment, but did not receive information about the new biosimilars from their physicians.
Although nearly all patients receiving a biologic are registered in a national database, it is not registered at a batch-level, making it more difficult to monitor safety.
“In order to change this situation, we started a dialogue with politicians and the authorities on a national level and hospital administrations on a regional level,” said Lene Mandrup Thomsen, Danish Rheumatism Association. “The purpose was 3-fold: to improve the registration of biologics and biosimilars on a batch-level, the provision of more independent patient information, and the involvement of patients in the decision-making process.”
The plan consisted of 4 parts: monitoring the safety and efficacy of biologics and biosimilars on a batch level; information campaign targeting health professionals and patients; digital solutions to aid easy reporting of adverse events from patients and health professionals; and a focus on monitoring patient safety by the authorities.
Additionally, representatives from the Danish Rheumatism Association were invited by hospitals to participate in a working group aimed at including the patient perspective in future national recommendations regarding the use of biologics and biosimilars.
The results of the initiative were presented at the Annual European Congress of Rheumatology.