Non-Medical Switching: Ready for Prime Time?

There is an accumulating body of evidence supporting the efficacy and safety of biosimilars for the treatment of rheumatologic diseases. Yet there remains a lot of uncertainty when it comes to prescribing these agents. This was exemplified during a satellite symposium Friday morning at EULAR. When asked whether they have used biosimilars in clinical practice, just over half of the audience (53%) answered yes. However, a quarter (25%) said they would not consider switching a patient from an innovator drug to a biosimilar.

An expert panel addressed some of the reasons behind this ongoing reluctance to use biosimilars in clinical practice. Dr. Chris Edwards summarized data from three switching RCTs, including two long-term extension studies and one immunogenicity study. Overall, the data show that switching from innovator etanercept to biosimilar SB4 or from innovator infliximab to SB2 offers comparable efficacy and safety as continuing the innovator drugs. An immunogenicity study in IBD showed that anti-drug antibodies to infliximab are cross-reactive, further supporting the similarity of these drugs.

Dr. Merete Lund Hetland presented recent findings from the nationwide DANBIO registry, which is tracking the outcomes of patients who underwent a mandated non-medical switch from innovator infliximab to CT-P13 and from innovator etanercept to SB4. The data for infliximab switchers were recently published by Glintborg et al in the Annals of Rheumatic Diseases, and data for etanercept switchers were presented as a poster at EULAR (Glintborg et al, #FRI0190). In total, 2350 patients with RA, PsA or axial SpA were switched to biosimilars, and disease activity and flare rates were comparable during follow-up versus historical controls.

Dr. Lars Erik Kristensen addressed the 'nocebo' effect (or "talking a drug down") and the less tangible factors that can influence outcomes of non-medical switching that are not captured in clinical trials and registry data. These subjective factors include patient and health care provider convictions about treatment, communications between patients and health care providers, and psychological factors. Dr. Kristensen called out the 'elephant' in the room: non-medical switching is largely driven by economic factors. "Nobody is talking about it but we all know it's the reason. We need to address it so it's not a big taboo."

Dr. Edwards and Dr. Maria Cuadrado shared their own experience with non-medical switching from the perspective of two different rheumatology clinics in the United Kingdom. Both described successful switching of patients to biosimilars using a uniform process that was customized to their clinic. Common elements included a detailed patient information letter, making a face-to-face visit or telephone consultation available for patients with concerns, applying an earlier follow-up after the switch (i.e. at 3 months), and giving patients the option to switch back to the originator biologic if they were unhappy with the outcome of the switch. The potential cost savings to the health care system were impactful to both patients and to clinicians, particularly since cost savings were funneled back to the rheumatology department via a "gain sharing model" that ultimately allows more patients to be treated with biologics.

Dr. Cuadrado directly addressed the criticism that long-term data on switching to biosimilars is lacking by arguing that the same was the case when TNFi's were first introduced. "All medicines have some risks. We use anti-TNFs because we have seen them improve the lives of our patients." Why should this not apply to biosimilars?

Dr. Edwards acknowledged that there remain some unanswered questions. For instance, data on reverse switching and cross-switching between biosimilars is lacking. This underscores the importance of collecting real-world data and for sharing with the wider rheumatology community through publication and discussion at meetings such as EULAR.

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