Mavenclad, Ocrevus Use Rising in EU as Injectables and Tysabri Decline, Spherix Reports

Prescriptions of two multiple sclerosis (MS) treatments —  Merck KGaA‘s Mavenclad (cladribine) and Roche‘s Ocrevus (ocrelizumab) — have been rising in Europe over the past six months, bolstered by greater market access and compassionate use programs, according to a survey of 250 EU neurologists run by Spherix Global Insights.

In contrast, use of Teva‘s Copaxone (glatiramer acetate; injection), and Biogen‘s Tysabri (natalizumab; infusion) and Avonex (interferon beta-1a; injection) have substantially declined.

The bi-annual report “RealTime Dynamix: Multiple Sclerosis (EU)” confirms that nearly all neurologists in the five European countries surveyed in August — Italy, Spain, France, Germany, and the UK — now have access to both Ocrevus (approved in the EU in January 2018) and Mavenclad (approved there in August 2017).

France is the one exception, a press release summarizing the report noted. Regulatory officials there decided against including Mavenclad as a low-cost treatment under the country’s public health program in 2018, citing insufficient medical benefit.

Doctors in Italy and Spain are particularly reporting a greater use of Mavenclad, the report found, and in the U.K., prescriptions of this oral and short-course therapy are displacing reliance on Sanofi‘s Lemtrada (alemtuzumab), an infusion therapy given in two rounds over two years.

Ocrevus’ use is growing among patients with relapsing forms of MS. Neurologists in France and the U.K. reported being more likely to prescribe this infusion therapy to people with relapsing-remitting MS (RRMS) than to those with primary progressive MS (PPMS). Almost half of the British neurologists choose Ocrevus as one of their most preferred therapies for RRMS, and a similar proportion of neurologists in the EU selected Ocrevus as their treatment of choice for active secondary progressive MS (SPMS).

Use of Ocrevus as a first RRMS treatment has been consistently declining, however, and is now half of what was reported in early 2018, shortly after the medicine was approved by the European Commission.

Spherix analysts attributed the drop in first-line Ocrevus use to a trend among neurologists in Italy and Spain, where the infusion treatment is prescribed as a second or later “switch”  medicine for the majority of their RRMS patients. This trend is likely influencing overall use patterns in Europe, the report said.

Ocrevus also seems to be competing directly with Tysabri, based on the perception among clinicians that Ocrevus carries a lower risk of progressive multifocal leukoencephalopathy or PML, a life-threatening brain infection associated with Tysabri use. They also were reported to see Ocrevus as more convenient infusion therapy (every six months) than Tysabri, in addition to having a better long-term safety profile.

Prescriptions of Copaxone, Tysabri, and Avonex lost significant ground over the last six months, the survey found.

Novartis‘ Gilenya (fingolimod), a high-efficacy oral disease-modifying therapy (DMT) like Mavenclad, is also showing signs of decline, but more slowly.

Lemtrada is currently restricted to second or later “switch” use for active RRMS patients, as the treatment is under a safety review by the European Medicines Agency (EMA). The agency’s Pharmacovigilance Risk Assessment Committee is examining reports of serious side effects that include immune system-mediated complications and heart and blood vessel problems in patients.

Neurologists surveyed reported a perceived decline in Lemtrada use patterns, but this seems more related its a drop as a first-line treatment than to patients stopping the medicine.

A perceived decline was particularly strong among neurologists in the U.K., but among them it remains the second most preferred MS therapy for patients with rapid disability progression independent of relapses, and for those with an active lifestyle who prefer as few office visits as possible.

Switching patterns among DMTs for MS patients was evaluated in a separate  Spherix’s report, an EU neurologist survey and data report conducted about a month after the Lemtrada safety review was announced. It found that very few patients in European countries were moving away from Lemtrada. Only 11 of the 1,266 patients analyzed had switched from the medicine, moving mostly to Ocrevus or Tysabri, due to safety concerns.

Lemtrada also continued to be the choice in later-line treatment switches by patients transitioning from Gilenya, Tecfidera, or Copaxone, the report said.