Spherix Global Insights

October 20, 2021

Bristol Myers Squibb’s Zeposia Launch Trajectories Diverge in Germany and the UK Following Negative NICE Decision; Janssen’s Ponvory Could Likewise Stumble

If reimbursement hurdles can be overcome, Zeposia may be well positioned for more favorable early line use and less within-S1P class competition in the UK versus in Germany

EXTON, Pa., October 20, 2021 /PRNewswire/ — Following the May 2020 European Medicines Agency (EMA) approval of Bristol Myers Squibb’s Zeposia and the May 2021 approval of Janssen’s Ponvory, there are now four S1P receptor modulators (including Novartis’ Gilenya and Mayzent) available on the European multiple sclerosis (MS) market. The Medicines and Healthcare products Regulatory Agency (MHRA) approval of Ponvory in August 2021 created a similar competitive landscape in the United Kingdom (UK).

While all four S1P agents are reimbursed (at least to some extent) in Germany, the National Institute for Health and Care Excellence (NICE) has since recommended against the reimbursement of Zeposia (final) and Ponvory (preliminary), leaving only Gilenya for relapsing-remitting MS (RRMS) and Mayzent for secondary progressive MS (SPMS) currently reimbursed by the National Health Service (NHS).

In the most recent semiannual report included in Spherix’s RealTime Dynamix™: Multiple Sclerosis (EU) service, data collected from 248 MS specialists and general neurologists in France, Germany, Italy, Spain, and the UK between August 6th and September 12th reveal the impact of these different reimbursement environments on the new S1P entrants.

The final NICE decision announced in May 2021 not to reimburse Zeposia appears to have stifled uptake of the brand in the UK compared to prescribing patterns observed in Germany. While physicians in Germany and the UK report similar shares for Gilenya, Mayzent, and Ponvory, Zeposia shares are noticeably lower in the UK. Suggesting that the difference between these two regions will only amplify, stated new Zeposia prescription volume in the past month grew by 63% in Germany compared to Q1 data and contracted by the same percentage in the UK.

Not surprisingly, anticipated efficacy is the most influential driver of Zeposia initiations, with German prescribers especially motivated by a belief in positive outcomes with such treatment. UK prescribers, on the other hand, are equally likely to be influenced by safety and tolerability expectations when deciding to prescribe the Bristol Myers Squibb (BMS) agent.

The emphasis on efficacy may risk relegating Zeposia to more of a later line disease-modifying therapy (DMT) for RRMS in Germany. Indeed, prescribers estimate that substantially more of their current Zeposia-treated patients were prescribed the therapy after two or more prior DMT failures compared to prescribers in the UK.

Based upon the opportunity cost to competitor analysis, Zeposia prescribing patterns in Germany will most likely mirror those of Gilenya, indicated for patients with high disease activity despite treatment with at least one DMT. In comparison, UK prescribing seems to be much more varied, with the brand competing with earlier-line therapies, such as platform oral DMTs (i.e., Sanofi’s Aubagio and Biogen’s Tecfidera) and Roche’s Ocrevus.

However, without a positive opinion from NICE, the future success of Zeposia in England and Wales is at risk. The current UK prescriber base is dwarfed by the almost ubiquitous base in Germany. Among the remaining non-prescribers, more than one in six do not believe that they will ever prescribe the brand – up from 0% six months ago.

The most common primary barriers to prescribing (or prescribing more) Zeposia are no or limited access/availability and lack of familiarity/experience. In comparison, barriers to Zeposia uptake in Germany spoke to the continued reliance on the first-in-class S1P agent, Gilenya, with many neurologists selecting patient reluctance or use of an alternative S1P receptor modulator as their primary barriers.

Patient-level data collected in June 2021 as part of Spherix’s RealWorld Dynamix: DMT Switching in MS (EU) corroborate the trends observed in the semiannual physician survey. Zeposia’s share of recent switches was especially high among the 255 charts reviewed by German neurologists. Whereas dosing profile was typically most influential in the selection of the other oral DMTs, the promise of a highly effective option was key in the majority of Zeposia selection cases. If Zeposia had not been available for the recent switch, the vast majority of these patients would have instead been switched to Gilenya, stressing the within-S1P class competition introduced by the new agents.

So what of Ponvory – the fourth-to-market S1P receptor modulator? An early read on Ponvory’s introduction to the German and UK markets from Spherix data suggest important distinctions from patterns observed during the first wave of Zeposia tracking in Q3 2020. However, with NICE firing the first warning shot over Janssen’s bow earlier this month with a preliminary decision against recommending reimbursement for relapsing forms of MS, the brand could find itself on similarly divergent trajectories over the next 12 months.

To help answer these and other questions, Spherix will continue to track adoption of Zeposia, Ponvory, and other recent or future launches (i.e., Novartis’ Kesimpta, Biogen’s Vumerity, TG Therapeutics’ ublituximab) through both physician-reported and patient-level data in the EU. With data captured at a consistent cadence since  2017, launch performance can be benchmarked back to the relative successes of prior launches, including Ocrevus, Mayzent, and Merck KGaA’s Mavenclad.

About RealTime Dynamix™
RealTime Dynamix™ is an independent service providing strategic guidance through quarterly or semiannual reports, which include market trending and a fresh infusion of event-driven and variable content with each wave. The reports provide an unbiased view of the competitive landscape within rapidly evolving specialty markets, fueled by robust HCP primary research and our in-house team of experts.

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.

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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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