EXTON, Pa., March 31, 2021 /PRNewswire/ -- Biogen's Tecfidera, Novartis' Gilenya, and Genentech's Ocrevus have all faced extensive competitive pressure over the past year due to launches of generics and new brands in the US multiple sclerosis (MS) market. Increased competition has led to an active switching dynamic, with patients being led off one disease-modifying therapy (DMT) and started on a new brand in hopes of an improved outcome.
Spherix has been tracking the switch segment of the MS market through their RealWorld Dynamix™: DMT Switching in Multiple Sclerosis (US) service for the last six years. The 2021 audit included in the service captured chart data from 1,117 patients switched to a new DMT within the past three months (provided by 223 neurologists) and found that some established brands are faring better than others.
Driven by an improved gastrointestinal tolerability profile, Biogen's Vumerity is poised to succeed Tecfidera as the most prescribed DMT in the fumarate class among recently switched patients. Indeed, Vumerity is the only fumarate agent that found more patients switching to the brand than away from it. Conversely, when switching occurs, both Tecfidera and dimethyl fumarate generics lose share, while the low volume of switches to offset the switches from Banner Life Sciences' recently launched Bafiertam – resulting in essentially no movement for the agent.
The net loss experienced by Tecfidera in this patient segment is new for the brand, having benefited strongly from switching in each of the previous five years of Spherix tracking. In the long run, continued Tecfidera share decline could have a blowback effect on Vumerity's uptake trajectory, as the follow-on fumarate sources most of its switch share from Tecfidera itself.
Recent switches to next-generation S1P receptor modulators, Novartis' Mayzent and Bristol Myers Squibb's Zeposia, now exceed the number of switches to well-established Gilenya. After five straight years of net share gains in the market, switches away from Gilenya now outnumber the switches to the brand.
However, unlike with the fumarate class, switches within the S1P class are uncommon. Instead, switches to Mayzent and Zeposia often originate from other oral DMTs (most frequently Tecfidera), underscoring that the ease of onboarding and minimal first-dose observation requirements (as opposed to clinical factors) are the primary differentiating factors between agents in the S1P class.
These class switching patterns suggest that Gilenya is unlikely to experience patient attrition due solely to the expansion of the S1P receptor modulator class. With the approval of the fourth-to-market S1P agent, Janssen's Ponvory, on March 19th, Gilenya's staying power will be tested once again.
Within the anti-CD20 monoclonal antibody (mAb) class, recent launches do not appear to be impacting established brands, specifically Ocrevus, to the same extent as seen with the fumarate and S1P receptor modulator classes. Kesimpta, Novartis' subcutaneously-administered anti-CD20 mAb DMT, has already attracted an impressive share of switches due to its mechanistic similarity to Ocrevus, coupled with the option for at-home administration. Yet, Ocrevus share continues to benefit from the net impact of switching dynamics.
While Ocrevus has maintained its class dominance, switch share for the first-to-market anti-CD20 agent has shown some erosion among relapsing-remitting MS (RRMS) patients compared to last year. However, this erosion may be driven by multiple factors, including Kesimpta uptake, expansion of oral high-efficacy DMT options, and COVID-19-related concerns. Indeed, COVID-19 played a role in three out of five recent switches away from Ocrevus – higher than that of any other established oral or mAb DMT.
Ocrevus may be at least somewhat protected from Kesimpta competition due to slower uptake of the Novartis injectable DMT in the first switch RRMS segment and because most switches to these agents are originating from oral DMTs and not within the anti-CD20 or broader mAb DMT classes. That being said, switches from Ocrevus do represent a common source of Kesimpta share – suggesting that competitive pressure on the first-to-market anti-CD20 mAb may just be beginning to heat up.
About RealWorld Dynamix™ RealWorld Dynamix™ is an independent, data-driven service unveiling real patient management patterns through rigorous analysis of large-scale patient chart audits. Insights reveal the "why" behind treatment decisions, include year over year trending to quantify key aspects of market evolution, and integrate specialists' attitudinal & demographic data to highlight differences between stated and actual treatment patterns.
The 2021 audit is the sixth annual edition included in the RealWorld Dynamix™: DMT Switching in Multiple Sclerosis (US) service. Learn more about our services here.
About Spherix Global Insights Spherix Global Insights is a hyper-focused market intelligence firm that leverages our own independent data and expertise to provide strategic guidance, so biopharma stakeholders make decisions with confidence. We specialize in select dermatology, gastroenterology, nephrology, neurology, and rheumatology markets.
All company, brand or product names in this document are trademarks of their respective holders.