Uptake of Merck KGaA's Mavenclad in the European Multiple Sclerosis Market Currently Stalled Due to Restrictive Guidelines and Pending Additional Country-Level Approvals

EXTON, Pa., March 27, 2018 /PRNewswire/ -- With an additional six months on the multiple sclerosis (MS) market in the EU, Merck KGaA's Mavenclad trial and uptake has appeared to stall ahead of additional country-level launches. Neurologists surveyed in Q3 2017 anticipated a 45% prescriber base and 2.5% share of disease-modifying therapy (DMT)-treated patients by this time, but actual Mavenclad use reported by EU neurologists (n=262) has not changed over the past six months. Even in the UK, where Mavenclad received NICE recommendation within record time, use remains low due to limited access, restrictive guidelines, and a resulting lack of prescriber base growth.

Mavenclad, primarily prescribed to relapsing-remitting MS (RRMS) patients, is competing with Novartis' Gilenya and monoclonal antibody (mAb) DMTs, such as Roche's Ocrevus, Sanofi's Lemtrada, and Biogen's Tysabri, for patients. It is interesting to note that, potentially in anticipation of the March market withdrawal of Biogen's Zinbryta, some current Mavenclad-treated patients were switched from Zinbryta, especially in Germany where neurologists are more likely to see Mavenclad displacing Zinbryta than other DMTs. Although Mavenclad's once-yearly short course dosing profile makes it competitive with Gilenya on the convenient dosing frequency attribute, the newest entrant lags the other oral DMTs on compelling brand section attributes. With most recent details conveying a dosing convenience message, Merck KGaA would benefit from continuing to emphasize this clinical differentiator during physician and patient communications along with efficacy, lack of known PML risk, and Mavenclad's favorable tolerability profile to compete with oral and mAb DMTs for the highly active relapsing MS (RMS) patients.

Ocrevus, approved in January 2018 for RMS and first-in-market early primary progressive MS (PPMS), has experienced a vastly different initial EU launch due to broad use across the five EU countries even in advance of national pricing and reimbursement decisions in many counties. One month post-launch, the Ocrevus prescriber base and self-reported share has surpassed that of Mavenclad. Compared to neurologists in Germany and the UK, neurologists in Italy and Spain report a greater Ocrevus trial rate, share, and patient volume per neurologist supported by the availability of local compassionate use programs in response to the high unmet need in PPMS. Neurologists in the UK, with the lowest current prescriber base and most limited access, are pessimistic about payer restrictions for Ocrevus, perhaps in reaction to the recent NICE draft guidance for routine funding for Novartis' Extavia which may be putting other DMTs, such as the interferons and Teva's Copaxone, at risk for reimbursement. Indeed, while current access through non-formulary channels will be beneficial for increasing neurologists' familiarity and comfort with Ocrevus, transitioning these patients from the compassionate use programs to country-level health plans may present a discontinuation pressure point due to potentially restrictive guidelines and out-of-pocket cost for patients. In contrast to the early US launch, only about one-third of Ocrevus-treated patients in the EU are diagnosed with RRMS (compared to 54% one month post-launch in the US). Slower uptake within RRMS, the MS subtype with the largest number of patients, may suppress Ocrevus maximal share especially with EU neurologists' lower expectations of regulatory authorities finding added benefit in RMS compared to PPMS.

In the EU, Novartis is positioned to challenge Biogen for the MS market leadership position based upon current manufacturer support perceptions and an appealing MS pipeline. While more than two out of five neurologists currently select Biogen as the manufacturer offering the best overall support to their clinical practice, Novartis is a close second and both companies are frequently selected for best overall support to patients. Novartis has carved out their current position with just two marketed DMTs (Extavia and Gilenya) and two late-stage DMTs in the pipeline: siponimod, a next-gen S1P receptor modulator filing in Q3 2018 for the first broad SPMS label, and ofatumumab, a human anti-CD20 therapy that will be the only subcutaneous mAb DMT following the recent withdrawal of Zinbryta. With the majority of neurologists selecting one of these two Novartis products as the pipeline DMT they are most interested in having available, successful launches over the next three years could shift the competitive dynamic in favor of Novartis.

RealTime Dynamix™: Multiple Sclerosis (EU) is an independent report series published on a biannual basis that provides rapid response trending on the key issues affecting the MS market based upon surveys fielded in France, Germany, Italy, Spain, and the United Kingdom. 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 EU research will be published in October 2018.

RealTime Dynamix™: Multiple Sclerosis (US), an independent report series published on a quarterly basis, will next be published in June 2018.

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