EXTON, Pa., Dec. 10, 2019 /PRNewswire/ -- Biogen's Vumerity (diroximel fumarate), a monomethyl fumarate prodrug, was approved by the FDA on October 30th for the treatment of relapsing forms of multiple sclerosis (MS). Fielded between November 1st and 18th, data from 99 neurologists surveyed for the Q4 wave of the ongoing quarterly report series included in Spherix's RealTime Dynamix™: Multiple Sclerosis (US) service confirm robust opportunity for the newest disease-modifying therapy (DMT) in the relapsing-remitting MS (RRMS) segment. More than half of neurologists are aware that Vumerity demonstrated a significantly improved gastrointestinal (GI) tolerability profile compared to Biogen's own Tecfidera in the EVOLVE-MS-2 trial. While there has been some question about the relatively high adverse event rate for Tecfidera in EVOLVE-MS-2 compared to the brand's larger pivotal trials (DEFINE and CONFIRM), most neurologists believe that Vumerity will offer a clinically superior GI tolerability profile in clinical practice. Indeed, four out of five neurologists believe that Vumerity offers at least some advance over Tecfidera, as well as over future generic dimethyl fumarate agents.
Not surprisingly, Vumerity is expected to compete most directly with Tecfidera once available, offering an alternative for patients at risk of side effects, especially GI issues, or as a switch for Tecfidera-treated patients. Neurologists estimate that, on average, more than one in ten patients discontinue Tecfidera within the first three months of treatment. GI tolerability is the primary driver for the majority of these early discontinuations. Whereas a minority of current Tecfidera-treated patients are expected to be switched to Vumerity, neurologists estimate that Vumerity will be selected over Tecfidera for about half of treatment-naïve patients who are candidates for fumarate. As a viable option for first-line selection and tolerability-related switches among RRMS patients, Vumerity is also anticipated to compete with the other established oral DMTS, Genzyme's Aubagio and Novartis' Gilenya. Thus, a clear opportunity exists for Vumerity to not only improve fumarate persistency, but additionally grow the fumarate class share of DMT-treated patients over the six months post-Vumerity availability, suggesting slow erosion of Tecfidera share.
The greatest potential threats to a successful Vumerity launch will be the characterization of the brand as a "me-too" agent and the impact of pricing on neurologist and payer acceptance. Spherix's Q3 2019 data highlighted Vumerity as the DMT in development that neurologists were least interested in having available for prescribing. Concerns were related to the lack of differentiation with Tecfidera, as noted by neurologists: "Recycled Tecfidera," "Simply a second-generation Tecfidera," and "Too much like Tecfidera. GI side effects with Tecfidera are not that much of an issue." In the weeks following approval, surveyed neurologists encouraged Biogen to stress the clinically relevant benefits over other DMTs (i.e., Tecfidera) as part of a broad physician education and marketing strategy to help support the successful introduction of Vumerity.
Neurologists also specifically advised pricing Vumerity substantially lower than Tecfidera. Announced by Biogen after fielding, Vumerity was instead priced just shy of the lowest cost oral DMT — a strategy that was met with backlash from some in the MS community as a missed opportunity to provide an affordable option ahead of potential generic dimethyl fumarate challengers. At that time, with the list price still an unknown, the majority of neurologists already anticipated payers would be highly restrictive of Vumerity. Now, payers may be especially reluctant to provide favorable coverage of Vumerity, not only because of the looming potential of generics, but also as the high price of the first-gen fumarate, Tecfidera, was specifically called out recently by ICER as not supported by new clinical evidence. Luckily for Biogen's commercialization efforts, only one in four neurologists were aware of the ICER assessment.
Once commercially available, Spherix will be tracking the Vumerity launch metrics over the first 18 months as part of our quarterly report series. A key early launch indicator will be whether the brand has a greater impact among patients initiating their first DMT or among patients switching from an existing therapy. In the current survey, neurologists reported that fewer new start MS patients recently started a glatiramer acetate agent (i.e., Teva's Copaxone) or Gilenya compared to a year ago, with the bulk of share shifting to Aubagio, Novartis' Mayzent, and Roche's Ocrevus. Conversely, neurologist-reported recent switch shares have remained stable across brands, with use of the new high-efficacy DMTs, including EMD Serono's Mavenclad, pulling slightly from Gilenya and Ocrevus. In both patient segments, Tecfidera share has remained flat.
In 2020, Spherix will verify brand share trends, including the impact of Vumerity market entry, as well as drivers of (and obstacles to) brand selection, using our independent patient-level data collected annually on MS patients newly initiated on their first DMT [RealWorld Dynamix™: DMT New Starts in Multiple Sclerosis (US)] and MS patients recently switched to a new DMT [RealWorld Dynamix™: DMT Switching in Multiple Sclerosis (US)]. Of particular interest among patients switched to Vumerity will be the source of business, whether switches are predominantly coming at the expense of Tecfidera or have a broader footprint pulling from the injectable and other oral DMTs. In order to ensure continued growth of Biogen's MS franchise, a sustained synergistic Vumerity effect on fumarate class share within both patient segments will be essential.
About RealTime Dynamix™
RealTime Dynamix™: Multiple Sclerosis (US) is an independent service providing strategic guidance through rapid and comprehensive quarterly reports, which include market trending, launch tracking, and a fresh infusion of unique content with each wave. The 17th wave of research will publish in March 2020.
About RealWorld Dynamix™
RealWorld Dynamix™: DMT New Starts in Multiple Sclerosis (US) is an independent, data-driven service unmasking real patient management patterns through annual reports based on chart audits of ~1,000 patients started on their first DMT within the previous three months. The report uncovers the "why" behind treatment decisions, includes year over year trending to quantify key aspects of market evolution, and integrates specialists' attitudinal & demographic data to highlight differences between stated and actual treatment patterns. The fourth annual report will be publishing in February 2020.
Parallel US services include RealWorld Dynamix™: Progressive Forms of Multiple Sclerosis (US), third annual report publishing in November 2020; RealWorld Dynamix™: DMT Switching in Multiple Sclerosis (US), fifth annual report publishing in April 2020.
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 immunology, nephrology, and neurology markets.
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SOURCE Spherix Global Insights