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While FDA just approved the first drug for primary progressive multiple sclerosis (PPMS), the drug’s price tag is controversial.
While FDA recently approved the first drug for primary progressive multiple sclerosis (PPMS), the drug’s price tag is controversial.
For patients without health insurance, the new drug ocrelizumab (Ocrevus, Genentech) will cost $65,000 a year. However, a competing multiple sclerosis (MS) drug, Rebif (EMD Serono), costs around $86,000 a year. “Pricing Ocrevus 25 percent less than the comparator in our trials is an important first step,” Genentech said in a statement.
Ocrevus is an intravenous infusion given by a healthcare professional.
“The FDA’s approval of Ocrevus is the beginning of a new era for the MS community and represents a significant scientific advance with this first-in-class B cell targeted therapy,” said Sandra Horning, MD, chief medical officer and head of Global Product Development for Genentech. “Until now, no FDA-approved treatment has been available to the primary progressive MS community, and some people with relapsing forms of MS continue to experience disease activity and disability progression despite available therapies. We believe Ocrevus, given every six months, has the potential to change the disease course for people with MS, and we are committed to helping those who can benefit gain access to our medicine.”
PPMS is characterized by steadily worsening function from the onset of symptoms, often without early relapses or remissions. The U.S. Centers for Disease Control and Prevention estimates that around 15% of patients with MS have PPMS.
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The efficacy of Ocrevus for the treatment of relapsing forms of MS was shown in two clinical trials in 1,656 participants treated for 96 weeks. Both studies compared Ocrevus to Rebif (interferon beta-1a). In both studies, the patients receiving Ocrevus had reduced relapse rates and reduced worsening of disability compared to Rebif.
In a study of PPMS in 732 participants treated for at least 120 weeks, those receiving Ocrevus showed a longer time to the worsening of disability compared to placebo.
FDA granted breakthrough therapy designation, priority review and fast track designation to Ocrevus.
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