Spherix Global Insights

December 06, 2021

EMD Serono’s Mavenclad and Novartis’ Kesimpta Emerging as Growth Brands After Eventful 2021 for the Multiple Sclerosis Market in Canada

The negative CDEC reimbursement recommendation for BMS’ Zeposia highlights the risk (or opportunity) for Janssen’s Ponvory launch, while the advent of generic dimethyl fumarate could dampen uptake of Biogen’s Vumerity

EXTON, Pa., December 6, 2021/PRNewswire – 2021 delivered a number of impactful changes to the multiple sclerosis (MS) market in Canada, including:

  • Novartis’ Kesimpta was approved by Health Canada in January and became commercially available in March
  • Janssen’s Ponvory was approved in April and became commercially available in November
  • Following an October 2020 approval, the CADTH1 CDEC2 recommended against reimbursement of BMS’ Zeposia in June; pCPA3 reimbursement negotiations are not planned
  • Generic versions of Biogen’s Tecfidera launched in early October
  • The pCPA concluded reimbursement negotiations for Novartis’ Mayzent in October

Spherix Global Insights, a leading market intelligence firm specializing in neurology-based research and insights, has been tracking the MS market in Canada through their RealTime Dynamix™: Multiple Sclerosis (Canada) service since 2019.

The most recent wave of research included in the service captured the responses of 47 MS specialists and neurologists in October and early November. Insights uncovered shifts in physicians’ perceptions and self-reported prescribing patterns across disease-modifying therapy (DMT) brands (and implications within drug classes) driven by these market events. Below are a few of these key insights:

  • Moderate-efficacy oral DMTs

Physicians are most likely to report Tecfidera [dimethyl fumarate (DMF)] and Sanofi Genzyme’s Aubagio as their preferred DMTs for relapsing remitting MS (RRMS). This preference is easily seen in the strong reliance on these brands for first-line RRMS prescribing, especially among patients presenting without concerning prognostic profiles.

In the United States, Biogen’s Vumerity preceded generic DMF availability. The dynamics in Canada will unfold quite differently, as generics entered the market while Vumerity is still under Health Canada review. Robbed of the opportunity to convert patients from Tecfidera to Vumerity ahead of generics, the dominance of the first-to-market fumarate will likely be greatly eroded by the time Biogen’s next-generation agent is approved and launched (let alone given recommendation for reimbursement).

Regardless, nearly two-thirds of physicians agree that it would be beneficial for their patients to have access to another fumarate agent, and most believe that Vumerity would provide a better gastrointestinal tolerability profile compared to Tecfidera.

If approved, will a better tolerability profile be enough to earn Vumerity a reimbursement recommendation from the CDEC in light of the cost savings provided by generic DMF?

  • S1P receptor modulators

Use of the third-to-market S1P agent, Zeposia, appears to already be hindered by the negative CDEC reimbursement decision. This pattern is especially stark on recent new prescription volume, where Zeposia had no reported use, and physicians anticipate minimal further uptake of the brand over the next six months.

In comparison, the outlook is much more positive for Novartis’ Mayzent. With pCPA negotiations now complete and the drug having broad market access, the brand’s preferred status for active secondary progressive MS (SPMS) will drive its continued growth trajectory into the new year.

With a seven-month lag between approval and commercial availability, aided awareness of Ponvory’s approval for RRMS is low among physicians, and anticipated timeline to trial is muted.  Nevertheless, with physicians estimating a healthy candidate pool for Ponvory, Janssen could succeed where BMS has not, especially if effective in differentiating from other S1Ps on ease of onboarding, fatigue data, and use of Aubagio as an active control. However, Ponvory’s success will ultimately hinge on the CDEC reimbursement recommendation.

  • Mavenclad and the anti-CD20 monoclonal antibodies

While the platform oral DMTs continue to do very well in Canada, the market is clearly moving towards high-efficacy oral DMTs and anti-CD20 monoclonal antibodies. New prescription share patterns suggest that Genentech’s Ocrevus, Kesimpta, and EMD Serono’s Mavenclad will experience some of the strongest near-term growth.

Four years after approval, the consistent gains across assessed metrics for Mavenclad are especially remarkable and showcase its position as the most prescribed high-efficacy oral brand.  Impressive physician satisfaction and a high grant rate following patient requests/inquiries for Mavenclad suggest that EMD Serono’s momentum with this brand will likely be enduring.

Kesimpta’s notable uptake in the first six months of availability (and prior to pCPA reimbursement being finalized) has cemented the brand as a serious player in the market. With few physicians believing that the use of alternative anti-CD20 agents is a barrier to Kesimpta use, continued Kesimpta uptake coupled with anticipated stable Ocrevus share suggest that the anti-CD20 class will become increasingly dominant in the coming year. The possibility of a 2023 approval of TG Therapeutics’ ublituximab for RMS (assuming positive reimbursement decisions), would only add fuel to this fire.

 Interested in gaining access to the data behind these expert insights, along with custom analyses tailored towards your brand? Learn more below.

 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.

The Q4 2021 report is the sixth semiannual edition included in the RealTime Dynamix™: Multiple Sclerosis (Canada) service. Parallel services are available for the US (quarterly) and EU (semiannual) MS markets. Learn more about our services here.

References:

  1. Canadian Agency for Drugs and Technologies in Health (CADTH)
  2. Canadian Drug Expert Committee (CDEC)
  3. pan-Canadian Pharmaceutical Alliance (pCPA)