24 January 2019
The introduction of biosimilars has been one of the biggest milestones in autoimmune treatment since the advent of biologics themselves.
Despite all the anticipation in the lead-up to biosimilar introduction, an air of uncertainty still lingers around the true impact these new players have had – and are expected to have – on the autoimmune market. With each day that passes, the market has new learnings to teach us about biosimilars if we watch and listen closely. Navigating this ever-changing market landscape has not been an easy task for these new entrants, nor for those players who are already well-entrenched. Biosimilars, still in their relative infancy, are definitely stirring the pot.
So what has happened in the market since their arrival? Since 2015, we’ve seen growing use of biosimilars to treat autoimmune diseases such as rheumatoid arthritis (RA) and ulcerative colitis (UC) and, more recently, in the treatment of certain cancers. Overall, biosimilars’ market penetration is forecast to reach up to 50% by 2020, with potential savings to health systems exceeding €50 billion over the next five years.
Looking more closely, however, we can see that certain commonly-held beliefs about, or expectations of, biosimilars are not in fact the case. To counter these myths, we have drawn on data from Ipsos’ Autoimmune Therapy Monitors*, Autoimmune Biosimilar Impact Study* and Global Oncology Monitor* in the EU5.
Although bio-originators and biosimilars in the EU5 have the same INN (International Non-proprietary Name), the doctors in Ipsos’ Autoimmune Therapy Monitor still appeared mindful of the definition, “similar but not identical to”.
When asked about anti-TNF molecules and the specific efficacy and safety attributes influencing treatment choice, fewer of the participating doctors connected the same positive attributes with biosimilar versions that they associated with the originators. For example, when considering Enbrel (etanercept) versus the biosimilar etanercept brands for RA, 77% of our sampled rheumatologists associated Enbrel with “Well tolerated”, versus 61% association for biosimilar etanercept.
Despite biosimilar versions of branded biologics being more entrenched in Crohn’s disease (CD) and ulcerative colitis (UC), the gastroenterologists in Ipsos’ study exhibited similar disparities in perception. 73% of participating doctors in the IBD Therapy Monitor associate branded Remicade (infliximab) with “Ability to provide mucosal healing” in Crohn’s disease. Only 59% associated biosimilar versions of infliximab with the same attribute. Unlike the rheumatologists, however, gastroenterologists hold similar levels of association with “Well tolerated” and “Good side effect profile” (45% and 30%, respectively, for both Remicade and its biosimilar versions). Clearly, proof of concept is essential to win over these specialties and personal experience with biosimilars may be necessary to close the perceptual gap that still exists.
Ipsos’ Therapy Monitor data show that biosimilars have certainly intensified competition within the advanced therapy space. However, our latest data (Q3 2018) suggest that their introduction into the market has not yet caused the biologic-treated patient population to swell – showing no significant increase in the biologic-treated population in RA, ankylosing spondylitis, psoriatic arthritis, CD, UC or psoriasis since the launch of the first immunology biosimilars in the EU5 in February 2015.
It is important to note that biosimilars have gained traction in many indications, particularly in certain countries like the UK and Germany. For instance, our RA Therapy Monitor shows that biosimilars account for 18% of the patients who are prescribed a biosimilar/novel oral systemic market in our EU5 sample. This figure does not even take into account the launch of biosimilar adalimumab in mid-October 2018, which is expected to have a big impact. However, at this time, our data show that biosimilars are escalating competition within a confined patient population and that cost-savings from biosimilars have not yet translated into increased penetration.
In the US alone, it has been estimated that biosimilars will reduce direct spending on biologic drugs by $54 billion from 2017 to 2026 – or, about 3 percent of total estimated biologic spending over the same period. Indeed, Ipsos’ IBD Therapy Monitor highlights that 23% of biosimilar patients were prescribed the product for cost/formulary reasons. Because of these cost savings, many believe that cost – and only cost – is the consideration when choosing a biosimilar versus an originator.
Of course, cost savings are critical, but there are additional considerations valued by both doctors and payers. In addition to the obligatory characteristics of an advanced therapy treatment (efficacy, safety, etc.) many biosimilar manufacturers are offering added-value services in order to compete with the marketing might of originator companies. These include patient support programs/physician value-adds, offering knowledge through sales reps/MSLs, hosting conferences/workshops, and more.
Doctors’ satisfaction with these services appears to be high. 69% of the gastroenterologists that took part in Ipsos’ Q4 2017 Biosimilar Impact Study provided a rating of 5, 6 or 7 for satisfaction on a 7-point scale for sales reps’ knowledge.
In a healthcare environment that is becoming increasingly patient centric, one might assume that a patient having an informed discussion with their consultant will always be clinically advantageous. This is certainly an approach many European countries appear to adopt when switching patients from an originator product to a biosimilar equivalent. The aim is no doubt to ensure patient comfort, understanding and compliance. However, Ipsos’ data suggest that this may have unwillingly introduced a counter effect.
34% of European RA patients treated by the doctors in our sample with a biosimilar version of etanercept discontinued their therapy between Q1–Q3 2018 because of side-effects to the product. One might consider this a likely reason for quitting any brand of targeted therapy – but approximately one third of this number (12%) of patients treated with the originator drug, Enbrel, discontinued therapy for the same reason. This may indicate that the extra level of patient engagement and education could have inadvertently introduced a nocebo effect.
Examining another originator product for RA, MabThera, when asked, “What drives your treatment choice when you prescribe a targeted therapy for your RA patients?”, 61% of our sampled doctors in Q3 2018 stated favorable patient-reported outcomes. However, only 47% cited this as a reason for issuing a prescription for the biosimilar equivalent. How this dynamic will evolve over time remains to be seen, but the premise that an informed patient will always lead to clinical advantages does warrant exploration.
In 2017, we saw the approval of two rituximab biosimilars – Truxima® and Rixathon® – which are approved for non-Hodgkin lymphoma (NHL), chronic lymphocytic leukemia (CLL) and RA.
Earlier this year, Ipsos assessed the prescribing of biosimilar rituximab by oncologists (for NHL) versus rheumatologists (for RA) in the EU5. Findings showed that the penetration of biosimilar rituximab within the rituximab molecule for the treatment of NHL has outpaced that within RA, coupled with a greater incidence of non-medical switching. Whilst the difference in chronicity of the two conditions dictates different treatment paradigms, further research may lend credence to the possibility that oncologists have adopted this biosimilar more quickly than rheumatologists.
Even within the same specialism, Ipsos’ data show differences in biosimilar adoption by indication. For instance, in RA, biosimilar etanercept’s share within the overall etanercept molecule (56%) is greater than that seen in PsA (37%) and AS (32%). This is in spite of the fact that we collected data from the same rheumatologists treating across these indications. This undoubtedly highlights a disparity in uptake of biosimilars across indications.
With something as game-changing as the advent of biosimilars, it is no surprise that many expectations were held about their perceived impact, the market’s acceptance of them, and their power to change the treatment paradigm. The myths outlined in this article highlight the importance of pharma companies keeping their finger on the pulse in order to accurately assess the continued impact of biosimilars in intensifying, multi-stakeholder treatment environments.
*About the research
Drug treatment patterns were investigated using EU5 data from the Ipsos Global Autoimmune Therapy Monitors (RA and IBD) and Ipsos Global Oncology Monitor©, which are proprietary syndicated patient record databases. Specifically, doctors reported on their drug-treated patients seen in consultation during the study period. The Ipsos Biosimilar Impact Study was also used, which incorporates research among doctors and payers. Dates and sample sizes are given below, and all research was conducted online. All results cited were tested for significance using Pearson’s chi-squared test; all results were significant at a threshold level of p<0.05.Print
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