Irrespective of Celgene’s recent receipt of a refusal-to-file letter for ozanimod, neurologists are eagerly awaiting a secondary progressive multiple sclerosis indication for Novartis’ siponimod, but are more divided on the value EMD Serono’s Mavenclad will bring to their practices, according to a new report from Spherix Global Insights
EXTON, Pa., March 13, 2018 /PRNewswire/ — The primary progressive multiple sclerosis (PPMS) treatment rate reported by US neurologists (n=101) has increased significantly compared the period prior to Genentech’s Ocrevus launch. With almost one-third of Ocrevus-treated PPMS patients on the disease-modifying therapy (DMT) first line, Ocrevus has clearly been a driver of expanding the treated PPMS patient pool. However, upon closer inspection, the reported PPMS treatment rate does not differ between Ocrevus prescribers and nonprescribers, suggesting that Ocrevus alone is not driving this uptake. Indeed, since launch, there has been a consistent decline in the percent of Ocrevus nonprescribers comfortable using Ocrevus first line in PPMS patients, representing a major hurdle for initial Ocrevus trial. Instead, Ocrevus nonprescribers may be increasing their prescribing of off label DMTs -potentially due to perceptions of greater familiarity and less payer restriction for DMTs, like Genentech’s off label Rituxan, when prescribed for PPMS. Regardless of DMT choice, Ocrevus prescribers and nonprescribers do not differ in their reported satisfactory response rate for their DMT-treated PPMS patients.
Ten months post-launch, active secondary progressive multiple sclerosis (SPMS) represents the greatest growth subtype for Ocrevus with almost as many Ocrevus-treated patients now diagnosed with active SPMS as with PPMS. The high anticipated use in active SPMS aligns with the relapsing MS (RMS) positioning recalled during recent Ocrevus’ details targeting highly active patients who have been refractory to previous therapies. Indeed, Ocrevus prescribers and nonprescribers do not differ in their active SPMS candidate shares for the brand implying a predominantly later line RMS positioning for the foreseeable future. However, less than a third of SPMS-experienced Ocrevus prescribers report being extremely satisfied with Ocrevus in this MS subtype (fewer than in other MS subtypes and fewer than previous quarters) which may foreshadow a slowing in active SPMS patient volume uptake per prescriber, especially considering future competition from Novartis’ siponimod in SPMS.
The recent refusal-to-file (RTF) for Celgene’s ozanimod NDA opens the door for two pipeline DMTs to potentially launch on the market prior to the now delayed ozanimod: siponimod with its novel SPMS indication and EMD Serono’s Mavenclad (cladribine) which will have post-marketing data at launch related to its August 2017 EU approval. While unaided awareness of both DMTs has increased substantially over the past quarter, interest in siponimod has been trending up driven by favorable safety/tolerability and efficacy perceptions as well as a desire for a “better Gilenya” and a potential SPMS label which could cover both active and not active forms. With more neurologists reporting that they would consider a DMT switch based upon new MRI activity alone than on secondary neurodegeneration alone, the manufacturer of the first DMT to get a label that includes not active, yet progressing, SPMS will need to convince neurologists (and patients) reluctant to switch (or start) a “stable” patient to a new DMT specifically targeting the silent disability accumulation.
For Mavenclad, neurologists are more divided on their interest in the DMT. According to Dr. Robert Naismith, a recognized MS expert and advisor to Spherix Global Insights, “Mavenclad offers a high efficacy, infrequently dosed oral therapy with induction potential, but safety/tolerability concerns may be a barrier to use. It remains to be seen where Mavenclad will be used in the treatment algorithm as US neurologists tend to be more conservative than their EU counterparts.” With slightly more neurologists agreeing with an induction over escalation approach preference in the current quarter, a convenient selective immune reconstituting therapy (SIRT) like Mavenclad could compete with the infusion monoclonal antibody DMTs for patients with highly active MS especially if post-marketing data from Europe supports its safety profile.
RealTime Dynamix™: Multiple Sclerosis (US) is an independent report series published on a quarterly basis. The series provides a close-quarters analysis of key performance metrics, focusing on brand gains and losses, industry contact rates, familiarity and adoption rates of recently launched products and awareness of products in development. Product perceptions, disease awareness and attitudes, practice management and other topics are rotated throughout the year to provide an ongoing probe of the crucial drivers of change. The next wave of research will be published in June 2018.
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.
All company, brand or product names in this document are trademarks of their respective holders.
To view media coverage of this release, click here.