Some German Physicians and Patients Reluctant to Accept Infliximab Biosimilars

The European Medicines Agency (EMA) approved marketing of 2 infliximab biosimilars (Inflectra and Remsima) in 2013, and both products were launched in major European markets, including Germany, in February 2015. By 2014, Germany was said to be leading the way in its fast uptake of biosimilars and had the highest use of biosimilars in Europe, with around 50% volume uptake.

Germany prevents pharmacists from automatically substituting originators with biosimilars, but the nation does have recommended biosimilar prescribing quotas. Despite these quotas, only a quarter of German rheumatologists said they felt pressure from healthcare authorities to switch patients to biosimilar therapies, and less than a third were aware that the 2 licensed infliximab biosimilars were approved for all indications of the originator.

In 2017, prescriptions for biosimilars account for fewer than 10% of total biologic therapy prescriptions in Germany, and more than 95% of rheumatologists would choose to prescribe the originator over its biosimilar as the first- or second-line therapy if they were unrestricted, according to a recent German study published in Patient Preference and Adherence.

What motivates rheumatologists to prescribe infliximab biosimilars, and do their preferences match actual prescribing of infliximab biosimilars? What is the level of understanding and acceptance among rheumatology patients for treatment with infliximab originators versus biosimilars of infliximab? John Waller, PhD, and colleagues sought answers to these questions, asking rheumatologists and their patients with rheumatoid arthritis (RA), ankylosing spondyloarthritis (AS), or psoriatic arthritis (PA), questions about their attitudes toward, and practices related to, innovator and biosimilar infliximab. The study was funded by Merck.

The study was conducted between December 2015 and March 2016, using the Adelphi Real World Disease Specific Programmes methodology, which seeks to provide real-world data from clinical practice in chronic disease management. Fifty rheumatologists and 261 of their patients participated in the study. The physicians provided data on their prescribing behavior and attitudes toward biosimilars via an online survey, and recruited the next 8 consecutive consulting patients, aged 18 and over, with a confirmed diagnosis of RA (n = 133), AS (n= 63), or PA (n = 65), who were being treated with an originator or a biosimilar. Patients were invited to complete online forms containing detailed questions on demographics, current conditions, level of satisfaction with current treatment, and perspectives and opinions on using biologic therapies, including originators and biosimilars.

Based on prescribing behavior and attitudes towards biosimilars, physicians were divided into 3 groups:

• Investigative (primarily concerned with symptom improvement and disease modification)
• Conservative (primarily concerned with safety)
• Other (primarily concerned with other factors, such as cost)

Patients were divided into 4 groups:

• BioSN: patient receiving an infliximab biosimilar, previously biologic naïve (n = 88)
• BioSE: patient receiving an infliximab biosimilar, previously treated with the originator (n = 86)
• BioOA: patient receiving the infliximab originator, initiated after February 2015 (n = 40)
• BioOB: patient receiving the infliximab originator, initiated before January 2015 (n = 47)

The data found that patients showed some reluctance to accept biosimilars, and a small proportion of patients were unhappy when switched to a biosimilar. Satisfaction with treatment was highest in patients who started treatment with an originator prior to biosimilar availability. Patients’ concerns with starting treatment with an originator or biosimilar included the following:

• Not knowing enough about the drug (25%-41%)
• Potential side effects (26%-32%)
• Potential long-term problems (19%-30%)

When asked about their preferences for prescribing (assuming unrestricted circumstances), more than 95% of rheumatologists said that they would prefer to prescribe an originator to a biosimilar as either the first-line therapy or the second-line therapy. This number decreased to 80% to 92% when considering third-line therapy. Further, cost and desire for experience were key factors driving physicians to prescribe biosimilars.

The researchers conclude that patients’ reluctance to accept biosimilars shows a need for patient education, especially for those who are unsure about biosimilars—education would allow patient engagement in decision making. Their reluctance also highlights the importance of patient and physician communication. “There remains a need for further research into nonclinical switching and the long-term impact of prescribing biosimilars,” the authors said.