Ocrevus cedes substantial ground to off-label glatiramer acetate agents (particularly generics) in the first-line primary progressive multiple sclerosis subgroup, due to a desire for favorable tolerability and pressure from payers, with little hope of redemption coming from potential first switches among these patients, according to Spherix Global Insights’ most recent patient chart audit

EXTON, Pa., February 11, 2020 ― Overall share of Genentech’s Ocrevus in the new start multiple sclerosis (MS) segment has not changed compared to the prior year. Fielded in December for the fourth year in a row, 199 neurologists provided data from 1,006 charts of MS patients recently prescribed their first disease-modifying therapy (DMT) for Spherix’s RealWorld Dynamix™: DMT New Starts in Multiple Sclerosis (US) service. These patient chart data confirm that Ocrevus share lags that of the first-line segment leaders, specifically Teva’s Copaxone, Biogen’s Tecfidera, Mylan’s generic glatiramer acetate (GA), and Novartis’ Gilenya. However, Ocrevus is unique with a dual indication label for MS, approved for the treatment of both relapsing forms of MS (RMS) and primary progressive MS (PPMS). So, when analyzed at a MS subtype level (which cannot be done with traditional claims data) and compared to the same time last year, Spherix found opposing trends emerging for the brand, with first-line Ocrevus share almost doubled among relapsing-remitting MS (RRMS) patients, yet plummeted by half among PPMS patients.

Neurologists are now significantly more likely to agree that they are comfortable prescribing Ocrevus as a first-line DMT for RMS patients compared to respondents from the 2018 audit, suggesting the shift towards Ocrevus use earlier in the RMS treatment algorithm will continue to progress. To quantify the potential impact of this shift in perception, the 58% of contributing neurologists who agree with the statement prescribed Ocrevus to ten times as many of their recent new start RMS patients compared to those few who disagree with being comfortable with first-line Ocrevus use.  Among RRMS patients, Ocrevus is most successful in competing with Tecfidera, Gilenya, and Biogen’s Tysabri for new start business. Indeed, both Tecfidera and Tysabri have seen consistent erosion of first-line RRMS share over the last few years. This erosion is most likely fueled, in part, by the high rate at which Ocrevus is co-presented as a viable option during the first-line discussions involving Tecfidera or, especially, Tysabri. Gilenya share has remained resilient to date, aided by a perception of a once-daily oral therapy offering a balanced efficacy and tolerability profile.

While the majority of neurologists continue to believe that they have used oral DMTs more frequently as first-line therapy over the past year, the oral DMT class share has actually remained flat since Spherix first fielded the audit in 2016, impeded by declining Tecfidera share and stable Gilenya share in the influential new start RRMS segment. The recent introduction of two new high-efficacy oral DMT options, Novartis’ Mayzent and EMD Serono’s Mavenclad (generally recommended for patients who have failed one prior DMT), as well as incremental gains by Sanofi Genzyme’s Aubagio, have made up for the majority of the lost Tecfidera share. Tecfidera may offer a cautionary tale to the oral DMTs poised to enter the fray, including Biogen’s Vumerity, Bristol Myers Squibb (BMS)/Celgene’s ozanimod, and Janssen’s ponesimod, that just offering an oral dosing profile, the most influential driver of Tecfidera first-line selections, may not be enough to pay the cost of entry in an increasingly crowded market.

Ocrevus remains the segment leader among new start PPMS patients, a subgroup that represents a larger proportion of the overall segment compared to three years ago due to Ocrevus’ first-in-market PPMS label and revisions to the McDonald diagnostic criteria. That being said, share of the brand has decreased significantly compared to the previous two years, with greater use of off-label GA agents in its place. A similar pattern was observed in the recent RealWorld Dynamix™: Progressive Forms of Multiple Sclerosis (US) chart audit, where the GA agent class was prescribed to twice as many PPMS patients on their first DMT compared to Ocrevus. PPMS patients were more likely to have recently been initiated on a first-line GA agent when tolerability, long-term safety, ease of therapy initiation, low cost to patient, and/or payer coverage preferentially drove the brand selection. In fact, step therapy mandate was behind one-third of the PPMS cases where a generic GA agent was prescribed first line.

Spherix’s independent patient-level data suggests that Genentech’s past dominance in PPMS may be under threat by pressure to try a generic GA first and “fail.” To add insult to injury, neurologists anticipate switching 75% of current generic GA-treated PPMS patients to Copaxone if they have a nonoptimal response, minimizing Ocrevus’ potential for sizeable second-line PPMS share. Currently in the field, Spherix will confirm recent PPMS switching patterns in the upcoming RealWorld Dynamix™: DMT Switching in MS (US) chart audit.

This shifting new start landscape may strengthen the commercial opportunity for late-stage pipeline agents in development for PPMS, specifically MedDay Pharmaceuticals’ Qizenday (MD-1003), AB Science’s masitinib, and Mapi/Mylan’s GA Depot. Indeed, new start patients who were identified as very likely candidates for first-line Qizenday or masitinib (had they been available at the time of the recent therapy initiation) are significantly more likely to be diagnosed with PPMS compared to patients considered not appropriate candidates. Conversely, MS subtype does not impact first-line candidacy for GA Depot, a once-monthly GA injection in development for RMS and PPMS. However, if the GA agent class continues to erode Ocrevus share in new start PPMS patients and Mapi is successful in their PPMS clinical development program, Mylan will have a sizeable commercial advantage at launch over competitors as the only GA agent approved for PPMS.

About RealWorld Dynamix™
RealWorld Dynamix™: DMT New Starts in Multiple Sclerosis (US) is an independent, data-driven service unmasking real patient management patterns through annual reports based on chart audits of ~1,000 patients started on their first DMT within the previous three months. The report uncovers the “why” behind treatment decisions, includes year over year trending to quantify key aspects of market evolution, and integrates specialists’ attitudinal & demographic data to highlight differences between stated and actual treatment patterns. The fourth annual report published in February 2020.

Parallel US services include RealWorld Dynamix™: DMT Switching in Multiple Sclerosis (US), fifth annual report publishing in April 2020; RealWorld Dynamix™: Progressive Forms of Multiple Sclerosis (US), third annual report publishing in November 2020.

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.

All company, brand or product names in this document are trademarks of their respective holders.

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

To view media coverage on this release, click here.