Danish NGO Plays a Key Role in Patient Education on Biosimilars

Denmark is the first nation in Europe—and in the world—to switch all well-treated rheumatoid arthritis patients from reference infliximab (Remicade) to the biosimilar Remsima, and 1 early study suggests that the switch has been successful.

The study, published in Annals of the Rheumatic Diseases, examined the non-medical switch of 802 Danish patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA), and axial spondyloarthritis (AxSpA) from the reference to the biosimilar infliximab. The researchers investigated the patients’ disease activity 3 months prior to and 3 months after the switch and subsequently measured changes over time. The 403 patients with RA, 120 patients with PsA, and 279 with AxSpA had been treated with the reference infliximab for a median duration of 6.8 years (range, 4.3 to 9.5). Follow-up was conducted at 413 days (range, 339 to 442). The researchers found that disease activities were similar 3 months before and after the switch, and concluded that the switch had no negative impact on disease activity.

The results suggest that Denmark could realize a substantial cost savings in the treatment of RA by switching patients to a lower-cost, high-quality biosimilar treatment. Yet, however willing Denmark’s health system may be to make the switch from reference to biosimilar products, Danish patients have been reluctant to switch from more familiar biologics to less expensive biosimilars.

A statement provided by the European League Against Rheumatism (EULAR) says that many patients felt anxious about the national switch to biosimilars and their concerns were exacerbated by several factors:

• Concerns about the safety and efficacy of biosimilars
• Physicians’ discomfort with explaining the principle of biosimilarity to patients
• The varying nature of information on biosimilars posted to Danish health system websites
• The fact that the national database of patients receiving biological treatments did not monitor drugs by batch, leading to concerns about biosimilar monitoring

To address these apprehensions, the Danish Rheumatism Association (DRA), a non-governmental organization with an 80,000-person membership, engaged with politicians, medical authorities, and hospital administrations in a 4-pronged plan, which ran from August 2015 through the end of 2016, and had the following objectives:

• Monitor the safety and efficacy of biologics and biosimilars at a batch level
• Launch an informational campaign designed to educate both health professionals and patients about biosimilar treatments
• Provide digital tools to facilitate both physicians’ and patients’ reporting of adverse effects
• Encourage medical authorities to monitor patient safety

Additionally, representatives from the DRA have participated in working groups in hospitals across the nation’s regions with the objective of including the patient perspective in future national recommendations concerning biological drugs, biosimilars, and switching.

The US healthcare system differs significantly from the government-sponsored Danish system, in which patients could be made to switch treatments unless a medically justified reason prevented treatment with the biosimilar. In the United States, patients may have more say in their own treatment protocols, and may prove reluctant to switch treatments if they do not feel that biosimilars provide as much safety and efficacy as they do affordability. Manufacturers, payers, and other stakeholders seeking to drive biosimilar uptake in the United States may wish to look to the DRA’s example in advocating for and facilitating greater education and safety monitoring as a means of alleviating patient concerns.