Recent Chart Audit of New Start Multiple Sclerosis Patients Confirms Dominance of the Oral Class, including Biogen's Tecfidera, for First-Line Treatment But Finds Monoclonal Antibody Therapies, such as Genentech's Ocrevus, Emerging as Legitimate Competitors
Teva's Copaxone remains the brand share leader among new start patients year-over-year, although neurologists are beginning to write prescriptions for Mylan's generic glatiramer acetate and Sandoz's Glatopa independent of direct payer influence, according to a recently published independent audit from Spherix Global Insights
EXTON, Pa., July 23, 2018 /PRNewswire/ -- The oral disease-modifying therapies (DMTs) dominate the first-line position among multiple sclerosis (MS) patients recently started on their first DMT, with one in five oral DMT starts driven primarily by the preference for an oral formulation, according to the second annual edition of Spherix Global Insights' new start patient chart audit (n=1,033). However, even with two-thirds of collaborating US neurologists (n=274) agreeing that they have started using oral DMTs more frequently as first-line agents over the past year, the new start oral DMT class share, including Genzyme's Aubagio, Novartis' Gilenya, and Biogen's Tecfidera, has remained stable with the prior audit. Instead, it is the monoclonal antibody (mAb) DMT class that has enjoyed the greatest gain in share, with Genentech's Ocrevus solely responsible for the almost doubling in new start business volume.
In keeping with Ocrevus' first-in-market unrestricted primary progressive MS (PPMS) label, the mAb DMT class has experienced the largest gain among PPMS patients where neurologists tend to underestimate first-line use of the infusion therapies. With an additional 30% of mAb DMT-treated new start patients initiated on Biogen's Tysabri and a promising mAb DMT pipeline (i.e., Novartis' ofatumumab, TG Therapeutics' ublituximab), the mAb DMT class as a whole should be viewed as an emergent first-line competitor for newly diagnosed patients presenting with progressing disability where the neurologists' desire for a high efficacy agent will direct brand selection.
Regardless of the focus on the "newer" DMTs, the traditional first-line agents, specifically the injectable interferon and glatiramer acetate (GA) agent classes, remain highly relevant as together they represented half of all recent new starts. While the interferon class share has decreased substantially over the prior year, driven by a significant decrease in Biogen's Avonex new starts, Teva's Copaxone remains the new start brand share leader ─ granted at a significantly diminished prominence. Even as the overall GA agent class share has remained flat, the recent availability of Mylan's generic GA agents has put significant pressure on Copaxone first-line share – consistent with generic competitive pressure being predominantly confined within the GA agent class. Indeed, one-third of patients started on one of the generic GA agents were initially written a Copaxone prescription, with the brand-to-generic switch triggered by pharmacy-level pressure in three out of five cases. However, with most first-line generic GA prescriptions being written unprompted by the neurologists, we anticipate exponential generic erosion of the brand over the next year, especially with the availability of Glatopa 40mg and aggressive generic price cuts.
With mounting evidence supporting the need for a more urgent approach to MS management to ensure optimal long-term outcomes, the gross underestimation of neurologists' self-reported time from diagnosis to DMT initiation compared to real world clinical cases confirms there is still much to do by neurologists, patients, and payers to secure prompt treatment upon diagnosis. While neurologists believe that half of their relapsing remitting MS patients are immediately started on a DMT at the time of diagnosis, audit data show that only 17% are actually initiated at that point in the patient journey, with the vast majority instead initiated on their first DMT at some later visit up to three months postdiagnosis.
Patient resistance and diagnosis by a different neurologist are the most common reasons for DMT initiation delays of four months or more. Within the GA agent class, insurance issues played a role in almost one-third of delays - more so than other classes - reflecting the impact that generic-related payer negotiations can have on optimizing treatment timelines. The probable delay of generic oral agent entry to the market, as a result of the recent Patent Trial and Appeal Board decision to uphold the dosage patent for Gilenya, should keep access-related obstacles secondary to hurdles addressable by improved patient education regarding the benefits of early treatment.
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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