Spherix Global Insights

February 12, 2019

Spherix Global Insights’ Recent Multiple Sclerosis Chart Audit Shows That the Current First-Line Opportunity for High-Efficacy Disease-Modifying Therapies, Including Genentech’s Ocrevus and Biogen’s Tysabri, May Be Limited By A Small Unfavorable Prognosis Segment Size

Conversely, new start shares for Teva’s Copaxone, Biogen’s Tecfidera, Genzyme’s Aubagio, and EMD Serono’s Rebif are buoyed by preferential prescribing among the high volume of patients presenting with a favorable long-term prognosis at the time of therapy initiation

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EXTON, Pa., February 12, 2019 ―With increasing focus on the early implementation of high-efficacy disease-modifying therapies (DMTs) for the treatment of multiple sclerosis (MS), US neurologists (n=213) estimate that one-third of their MS patients who started on their first-line DMT in the past year should have been offered a high-efficacy DMT based upon concerning risk factors for an unfavorable long-term prognosis. However, according to Spherix Global Insights’ recently published RealWorld Dynamix™: DMT New Starts in Multiple Sclerosis (US) audit, less than one in five new start audit patients (n=1,059) started on their first DMT no more than three months prior presented with an unfavorable long-term prognosis, suggesting that neurologists are overestimating the prevalence of such patients in their clinical practices. As a result, the first-line opportunity for high-efficacy DMTs may be more limited than current market valuations.

The monoclonal antibody DMTs, specifically Biogen’s Tysabri, Genentech’s Ocrevus and off label Rituxan, and Genzyme’s Lemtrada, are considered high-efficacy DMTs for first-line use by the majority of the US neurologists collaborating in the audit. Prognostic profile assessment at the time of therapy initiation has a significant impact on first-line DMT brand selection, with almost half of patients with an unfavorable prognostic profile starting therapy with a high-efficacy DMT, specifically Ocrevus or Tysabri. Indeed, more than half of Ocrevus-treated new start patients had an unfavorable prognostic profile ─ higher than that of any other DMT. Accordingly, Ocrevus captured only one-sixth the number of patients with a favorable (as opposed to unfavorable) prognostic profiles, yielding a low first-line share among this highly prevalent subgroup. Instead, patients presenting with favorable prognosis are significantly more likely to be started on standard- or moderate-efficacy DMTs, with Teva’s Copaxone, Biogen’s Tecfidera, Genzyme’s Aubagio, and EMD Serono’s Rebif significantly more likely to have been selected first line for these patients. Interestingly, Biogen’s Avonex, Mylan’s generic glatiramer acetate, and Novartis’ Gilenya shares did not differ based upon prognosis – suggesting other factors, such as MS subtype, market access, or dosing profile preference, were more influential in the first-line selection of these agents.

Patients diagnosed with active secondary progressive MS (SPMS) waited, on average, over a year and a half from MS diagnosis before starting their first DMT ─ potentially contributing to their transition to the progressive form of the disease and a less favorable prognostic profile. The most common reason for SPMS patients not initiating DMT therapy within the first three months of diagnosis was patient request for delay. Active SPMS patients were also significantly less likely to have initiated neurologists’ top recommended DMT (frequently Ocrevus, generic glatiramer acetate, or Gilenya) compared to patients diagnosed with relapsing-remitting MS (RRMS) or primary progressive MS (PPMS). In addition, new start active SPMS patients are viewed as less likely to have a positive mental attitude, to be less informed about DMTs and their options, and to be less compliant with medical instruction compared to RRMS patients. Finally, patient request for a specific agent was significantly more influential in active SPMS compared to RRMS or PPMS patients’ first-line brand selection, consistent with the relatively low acceptance rate of neurologists’ recommended therapy. Taken together, these audit data suggest that patients who do not begin DMT therapy until after reaching a secondarily progressive state may be having issues with diagnosis acceptance and the need for more high-efficacy (and thus riskier) DMTs to slow disability progression.

Currently, there are three agents in late-stage clinical development for the treatment of PPMS ─ MedDay Pharmaceuticals’ Qizenday (MD-1003), AB Science’s masitinib, and MediciNova’s ibudilast. If the current first-line DMTs are not successful, each of these agents are considered potential first-switch options for at least two-thirds of PPMS audit patients. However, compared to PPMS, SPMS actually offers a greater second-line switch candidate pool based upon greater willingness to switch to the agents (72-82% of SPMS patients among neurologists at least moderately familiar with the agents) as well as the higher number of DMT-treated SPMS patients. Among the three pipeline therapies, Qizenday may be competing most directly with Novartis’ Mayzent (siponimod), under review for a first-in-market SPMS approval, for second-line SPMS opportunities based upon similarities in potential candidates’ age, diagnosis, and current disability status. Spherix Global Insights will analyze current switch patterns among marketed DMTs and reasons for brand selection, as well as potential second or later switch opportunities for these DMTs in development, in the upcoming RealWorld Dynamix: DMT Switching in MS (US) patient audit.

RealWorld Dynamix™: DMT New Starts in Multiple Sclerosis (US) blends attitudinal and demographic physician survey data with previously treatment-naive patient record data to uncover how practice type and setting and certain beliefs influence the treatment pathway and to understand how marketed DMTs are being used by physicians and for what patient types. The report also captures physician’s perspectives about products in development and the impact they will have on the current treatment paradigm among new start patients.  Parallel audits include the fourth annual RealWorld Dynamix™: DMT Switching in Multiple Sclerosis (US), publishing in April 2019, and the second annual RealWorld Dynamix™: Progressive Forms of Multiple Sclerosis (US), publishing in November 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.

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

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