Italian and Spanish neurologists’ recent embrace of Merck KGaA’s Mavenclad, combined with a shift from Sanofi’s Lemtrada in the UK to Mavenclad, has helped boost share of the high-efficacy oral therapy, according to the 5th wave of the twice-yearly Spherix Global Insights report

 EXTON, Pa., October 7, 2019 ― Expanded access to Merck KGaA’s Mavenclad and Roche’s Ocrevus in Europe has significantly shifted neurologists’ reported disease-modifying therapy (DMT) treatment patterns among multiple sclerosis (MS) patients. Data from 250 EU neurologists surveyed in August for the Q3 wave of the Spherix’s RealTime Dynamix™: Multiple Sclerosis (EU) service confirm that almost all neurologists in the five included European countries now have access to both brands, with the exception of Mavenclad in France where reimbursement was not recommended in a September 2018 SMR opinion of insufficient medical benefit. Consistent with the improved market access, the brands have experienced significant increases in physician-reported share over the past six months, with especially strong uptake of Mavenclad in Italy and Spain. Conversely, Teva’s Copaxone and Biogen’s Tysabri and Avonex have all experienced significant share declines. Novartis’ Gilenya, a high-efficacy oral DMT, is also showing signs of pressure, as reported share has been slowly, but consistently, declining.

In this final comprehensive assessment of the 2018 Ocrevus approval and subsequent EU launches, Spherix found that Ocrevus’ opportunity among patients with relapsing forms of MS (RMS) appears to be growing, even as the brand is pushed back later in the treatment algorithm. Neurologists in France and the UK are more likely to prescribe Ocrevus to patients with relapsing-remitting MS (RRMS) than primary-progressive MS (PPMS). In fact, almost half of UK neurologists select Ocrevus as one of their most preferred DMTs for the treatment of RRMS and a similar percentage of EU neurologists select the brand as a preferred DMT for active secondary progressive MS (SPMS). In addition, neurologists estimate that a significantly higher number of their RRMS and active SPMS patients are appropriate candidates for Ocrevus compared to a year ago, suggesting a shift towards greater competitive pressure on established anti-inflammatory DMTs.

Even as comfort using Ocrevus first line for RMS has increased significantly since EMA approval, first-line RRMS use among Ocrevus-treated patients has been consistently declining and is now half of what was first reported in Q1 2018. Prescriber base expansion among Italian and Spanish neurologists, who prescribe the agent as a second or later switch for the majority of RRMS patients, is likely influencing overall EU Ocrevus use patterns. Accordingly, Roche’s DMT is perceived to be competing most strongly with Tysabri for new RRMS opportunities, consistent with Ocrevus being perceived to have comparative advantages on PML risk, patient convenience, and long-term safety profile. Ocrevus’ slip back in the treatment algorithm should help blunt erosion by the brand on the typical first-line DMTs, especially those that dominated recent initiations among RRMS patients with favorable prognostic profiles (i.e., injectable DMTs, Sanofi’s Aubagio, and Biogen’s Tecfidera).

Use of Sanofi’s Lemtrada is currently restricted while a Pharmacovigilance Risk Assessment Committee (PRAC) review is ongoing to further examine reports of immune-mediated conditions and cardiovascular issues ― an event with high aided awareness among EU neurologists. As a result of Lemtrada’s use being limited to second or later switches among active RRMS patients (as well as competitive pressure from Mavenclad and Ocrevus uptake), neurologists are likely to have perceived a decline in their recent use and see this pattern continuing through at least the end of the year. Once a preferred DMT, neurologists in the UK now report an especially substantial loss in Lemtrada share over the past year. Lemtrada loss has benefited Mavenclad, also considered an induction therapy when used first line, as well as Ocrevus and Sanofi’s own Aubagio. However, Lemtrada may be able to persevere during this period of uncertainty, as the brand is the second most preferred DMT in the UK for patients with rapid disability progression independent of relapse activity (PIRA) and for patients with an active lifestyle who want to minimize office visits.

Lemtrada’s categorization as a shrinking brand by EU neurologists appears to be related more to decreased first-line use as an induction therapy than by discontinuations among patients being treated with Lemtrada. In the first annual RealWorld Dynamix: DMT Switching in Multiple Sclerosis (EU), Spherix evaluated recent DMT switching patterns approximately two months after the initiation of the Lemtrada PRAC review.  Only 11 of the 1,266 EU patients, captured in the Spherix audit, had recently switched from Lemtrada with those patients typically moving to Ocrevus or Tysabri due to, not unsurprisingly, safety concerns.  Instead, Lemtrada continued to benefit from later line switching dynamics with most patients transitioning from Gilenya, Tecfidera, or Copaxone. Spherix will assess year-over-year shifts in EU switching patterns as part of their comprehensive 2020 MS service covering the US, EU and Canada markets.

About RealTime Dynamix™
RealTime Dynamix™: Multiple Sclerosis (EU) is an independent service providing strategic guidance through rapid and comprehensive twice-yearly reports, which include market trending, launch tracking, and a fresh infusion of unique content with each wave. The 6th wave of research will publish in April 2020.

About RealWorld Dynamix™
RealWorld Dynamix™: DMT Switching in Multiple Sclerosis (EU) is an independent, data-driven service unmasking real patient management patterns through annual reports based on chart audits of ~1,250 patients switched to a new 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. First published a few months ago, the second annual report will publish in July 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.

Spherix was recently recognized by Philadelphia Business Journal as a 2019 Soaring 76 recipient for the fastest growing companies in the Greater Philadelphia area and by The Philadelphia Inquirer as an Entrepreneurs’ Forum 2019 Philadelphia 100® Winner for the fastest growing privately-held companies in the Greater Philadelphia area.

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]
www.spherixglobalinsights.com

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