Background During the past ten years, treatments with biologics have proven added value for several inflammatory illnesses, such as rheumatoid arthritis, spondyloarthritis and juvenile arthritis. In 2015, the first biosimilars for infliximab were introduced in the Netherlands. They were welcomed for their financial benefits, but also some questions arose. The Dutch Arthritis Foundation was frequently asked to comment or advise on biosimilars. Yet, we found that clear and unbiased patient information was scarcely available, that opinions differed regarding switching existing patients, and lastly, that there were no recommendations available on switching practices, studies and monitoring.
Objectives As several patents for widely-used biologics will expire the coming years, it was important to approach this development carefully and realistically. We wished to develop patient information and a view on biosimilars that would fit both new patients and existing arthritis patients. And it was clear to us that patients who worried about switching to biosimilars, wished for unbiased and reliable answers. Therefore, we contacted the Dutch Society for Rheumatology (NVR), who were updating their recommendations on biological treatments, and started working closely together with patient organisations, dealing with the same information challenges. And lastly, considering all the strong (financial) opinions around biosimilars, we wanted to raise awareness for the more practical issues and questions, arthritis patients had shared with us.
Methods The Dutch Medicine Evaluation Board (MEB) published its stance in April 2015, permitting the exchange between biological medicines. However, the conditions for switching patients were interpreted differently, as we experienced in panel discussions and workshops with prescribing doctors, pharmacists, pharmaceutical companies and health insurers. Therefore, as patient organisations, we jointly asked MEB for guidance regarding patient information. In July 2015, MEB organised a meeting on biosimilars in the fields of IBD and arthritis, in which we expressed our concerns and asked for careful monitoring of patients and traceability of treatments. After this meeting, MEB started developing a patient information leaflet, involving several patient organisations. We analysed and collected all questions from arthritis patients on biosimilars and switching, and sent those to MEB.
Results While biosimilars were being prescribed and administered, there was hardly any practical information available to patients in 2015, or patient organisations. Most information focused on the biochemistry and interchangeability of biosimilars, but did not answer practical questions on switching conditions, long-term (side) effects or health insurance issues. The MEB patient information leaflet will be ready in January 2016. And we will update our information for arthritis patients afterwards, closely cooperating with NVR.
Conclusions It is interesting and important to learn from the introduction of infliximab biosimilars and the current switching studies. Also to prepare for the near future when biosimilars will be introduced for biological treatments that patients administer themselves. Patients ask for practical information instead of lessons in biochemistry. With suitable patient information, we can try to avoid concerns or prevent that adherence issues arise if medicines look slightly differently, or if the administration and packaging work slightly differently.
Disclosure of Interest None declared
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