• Warning to Eli Lilly’s Olumiant (baricitinib): Entrenched First-to-Market Rheumatoid Arthritis Products are Tough to Unseat

    • May 10, 2018
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    According to Spherix Global Insights’ second quarter update of RealTime Dynamix™: Rheumatoid Arthritis (US), at just under one-year post-launch, less than half of US rheumatologists (n=100) have experience prescribing Kevzara to their RA patients. While the percent of respondents prescribing Kevzara in more than five patients has slowly increased and future estimates reveal overall growth of both the user- and patient-base, these projections are not overly robust, and not all current users anticipate new Kevzara initiations over the next three months.

    Though Kevzara users report steady improvements in the ease and speed of managed care approvals since launching, insurance and cost issues are cited as the greatest barriers for increased use. Furthermore, Kevzara uptake continues to be hampered by existing satisfaction with other treatments, largely Actemra, and US rheumatologists are left begging the question, “Why should I use it instead of Actemra?” Indeed, despite a perceived cost advantage, differentiated and more flexible dosing options, and being fully humanized, Kevzara still greatly lags behind Actemra on a host of metrics and, overall, has had minimal impact on Roche/Genentech’s first-to-market IL-6 inhibitor.

    Kevzara representative contact rates have remained relatively stable over the prior two quarters, with less than half of the respondents reporting a Kevzara call in the past month, a figure lower than what is reported for Actemra. With recent representative contact being significantly associated with Kevzara use, it is worrisome that only 15% of rheumatologists report promotion for Kevzara has increased over the past six months, making it tough to move the needle. 

    Should Eli Lilly’s Olumiant (baricitinib) finally gain US FDA approval in the coming weeks, it will be critical to come out of the gates with a clear differentiator from Pfizer’s Xeljanz, a brand that will likely enjoy many of the same first-to-market benefits as Actemra. Indeed, the majority of surveyed physicians identified Xeljanz’s length of time on the market and well understood safety profile, as well as their general comfort prescribing the agent, as the leading challenges for new JAKs entering the space.

    When queried specifically on what a new JAK could bring to market to overthrow Xeljanz, outside of a better cost/access position, improved safety and side effects were the second most frequently cited attribute; however, Olumiant may enter the market with somewhat of a “dark cloud” of potential safety issues.  Indeed, Lilly’s JAK has been associated with venous thromboembolic events (VTEs), an issue raised in FDA documents released prior to last month’s FDA advisory panel vote that resulted in a recommendation against the 4mg approval, largely due to safety issues (though the 2mg dose was recommended for approval).  Furthermore, Xeljanz seems to be largely in the clear for being associated with VTEs as only 15% of rheumatologists agree that if the JAK inhibitors in development are linked to such events, that Xeljanz may also pose a similar risk.  Despite the challenges Olumiant will likely encounter if and when it enters the US RA market, the agent is projected to capture a fair amount of biologic/JAK share within the first six months of launching; however, Xeljanz is not the only brand projected to feel an impact from the likely new entrant.  

    The next wave of this study, RealTime Dynamix™ Rheumatoid Arthritis (US), will field in July and will continue to track the launch of Kevzara, as well as the potential introduction of Olumiant to the US RA market.  A parallel study tracking the evolution of the European RA market will publish at the end of May 2018.

    About Spherix Global Insights
    Spherix Global Insights is an independent business intelligence and market research company, specializing in renal, autoimmune, neurologic and rare disease markets. Our aim is to apply our commercial experience and unique relationships within core specialty markets to translate data into insight, enabling our clients to make smarter business decisions.


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