Spherix Global Insights

April 29, 2019

Biogen’s Tecfidera Share of the Multiple Sclerosis Switch Segment Continues a Three-Year Downward Trend to the Benefit of Novartis’ Gilenya and Genentech’s Ocrevus

EMD Serono and Novartis will have the greatest opportunity to drive patient switches to Mavenclad and Mayzent, respectively, within the first six months following transition to secondary progressive multiple sclerosis, according to a new audit by Spherix Global Insights

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EXTON, Pa., April 29, 2019 ― According to Spherix’s new RealWorld Dynamix™: DMT Switching in Multiple Sclerosis (US) audit, more than half of multiple sclerosis (MS) patients (n=1,003) recently switched to a new disease-modifying therapy (DMT) were prescribed one of four brands ― Genentech’s Ocrevus, Biogen’s Tecfidera, Novartis’ Gilenya, or Teva’s Copaxone. Among the oral DMTs, Tecfidera just edges out Gilenya to remain the switch share leader, with most Tecfidera-treated patients switching from a first-line injectable DMT due to the desire for an oral therapy. However, new Tecfidera switch business has consistently declined over the past three years, resulting in close to a four percentage point drop in switch share. Conversely, Gilenya switch share increased compared to a year ago, while switch-from share has remained stable, resulting in the brand besting both Tecfidera and Genzyme’s Aubagio for new business won from the switch segment. These switch dynamics stress the importance of new start patients to Tecfidera business ― a segment in which the brand has also experienced a decline in share over the past year, according to the recent RealWorld Dynamix™: DMT New Starts in Multiple Sclerosis (US) audit. Among these treatment-naive patients, Tecfidera lost potential new start share to Gilenya and Aubagio due to expectations of greater efficacy and less safety risk, respectively.

Less than two years after launch, Ocrevus, approved for relapsing-remitting MS (RRMS) and  primary progressive MS (PPMS), is already the switch segment leader. While Ocrevus dominates all other DMTs for PPMS switch share, the brand is also the monoclonal antibody (mAb) class leader among the recently switched RRMS patients. Compared to Genzyme’s Lemtrada, Genentech’s off label Rituxan, and Biogen’s Tysabri, only Ocrevus won more switch share than it lost to alternative DMTs, driven by the brand’s first-in-market PPMS indication and expectations of greater efficacy and less safety risk. Tysabri, on the other hand, could have more than doubled its recent switch share if the agent had competed successfully in all cases (frequently switches to Ocrevus) where it was the alternative therapy. On a patient level, significantly more Ocrevus-switch patients are positive for the anti-John Cunningham (JC) virus antibody compared to Tysabri-switch patients, and more than one-quarter of switches away from Tysabri were due to safety concerns. As such, lingering progressive multifocal leukoencephalopathy (PML) concerns associated with Tysabri will most likely continue to blunt the brand’s competitiveness with Ocrevus.

With the FDA approval of Novartis’ Mayzent and EMD Serono’s Mavenclad last month, the treated secondary progressive MS (SPMS) segment size will grow at the expense of the RRMS segment. Among recently switched patients considered to have active SPMS, almost half had RRMS noted in the chart for payer purposes, reflecting the lack of options specifically approved for active SPMS at the time of chart collection. With the approved labels for both Mayzent and Mavenclad specifically including the treatment of active SPMS, Spherix expects to see greater alignment between diagnoses for payer versus patient management purposes over the next year. Novartis and EMD Serono will have the greatest opportunity to drive switches within the first six months of confirmed transition from RRMS to SPMS, as more than half of SPMS switches occurred within this short time period. Both brands would benefit most from being positioned as high-efficacy oral DMTs to build upon the desire for efficacy that is most influential in the active SPMS switch brand selection and to successfully compete with the segment leader, Ocrevus. Currently, efficacy is a stronger driver in the consideration of Mavenclad as a very likely alternative switch therapy among audited patients compared to Mayzent. “Great efficacy, very easy administration and compliance” was noted as the reason one audit patient, recently switched to Ocrevus, would have been considered a very likely Mavenclad candidate. Fielding four months post-launch, Spherix Global Insights will capture 750 charts of patients diagnosed with SPMS or PPMS in the upcoming RealWorld Dynamix™: Progressive Forms of Multiple Sclerosis (US) patient audit, allowing for greater characterization of Mayzent- and Mavenclad-treated patients and reasons for the selection of the brands.

About RealWorld Dynamix™
RealWorld Dynamix™: DMT Switching in Multiple Sclerosis (US) blends physician self-reported data with actual patient chart records from the same physicians to uncover differences in how physicians report managing their patients and how specific populations are managed differently. It augments claims data by providing the “why” behind the switching behavior and by providing essential details not available in claims data that may be driving the switch, such as MS subtype, payer pressure, co-morbid conditions, or patient requests. Parallel audits include the third annual RealWorld Dynamix™: DMT New Starts in Multiple Sclerosis (US), published in February 2019, and the second annual RealWorld Dynamix™: Progressive Forms of Multiple Sclerosis (US), publishing in November 2019. The inaugural RealWorld Dynamix™: DMT Switching in Multiple Sclerosis (EU) will publish in July 2019.

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.

All company, brand or product names in this document are trademarks of their respective holders.

For more information contact:
Virginia Schobel, Neurology Franchise Head
Email: [email protected]

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