Roche Gains Important MS Approval — and Takes Unprecedented Pricing Steps

On March 29, the US Food and Drug Administration approved Roche’s Ocrevus (ocrelizumab) for the treatment of either relapsing multiple sclerosis (MS), or primary progressive MS (PPMS).  The approval was particularly noteworthy as Ocrevus is the first therapeutic approved for the treatment of PPMS, a form of the disease that accounts for 10-15% of MS patients and causes a steady worsening of symptoms with no relapses or remissions.

 

Ocrevus is a humanized anti-CD20 antibody, similar to Roche/Genentech’s chimeric antibody Rituxan (rituximab). Both antibodies target the CD20 receptor on mature B-cells, killing those cells but leaving B-cell precursors unaffected; Ocrevus binds to an epitope that overlaps with that targeted by Rituxan. Rituxan is approved for the treatment of several autoimmune diseases, as well as the treatment of various blood cell cancers. While the potential of an anti-CD20 to treat MS was originally discovered by University of California, San Francisco investigator Dr. Stephen Hauser, who was studying Rituxan, Roche chose to develop a distinct, newer antibody for MS, citing potentially greater safety but also clearly choosing to develop a new chemical entity over a much older drug that would soon be facing biosimilar competition.

 

Data supporting the Ocrevus approval included that from two Roche-funded studies in 1,656 patients with relapsing MS, where the drug was shown to cut the annualized relapse rate in half and to lessen the formation of new brain lesions by over 94% compared to an older MS drug, Rebif (interferon-beta-1a). In patients with PPMS, those treated with Ocrevus were 25% less likely to have their disability worsen over 12 weeks of treatment compared to placebo — a modest benefit, but still significant given the lack of approved therapies for this form of the disease. The FDA approval was granted with the requirement that Roche conduct several Phase IV studies, mostly directed to look at particular long-term safety issues including the risks that Ocrevus treatment could cause cancer or progressive multifocal leukoencephalopathy (PML) — a rare, typically fatal viral infection secondary to JC virus that can occur in immunocompromised individuals. Both risks have been reported in a small number of Rituxan-treated patients, and the original identification of the serious risk of PML removed Tysabri, a Biogen MS treatment, from the market for some time.

 

On Ocrevus’ approval, Roche took the step of setting the new drug’s list price at $65,000 per year — a 25% discount to that of Rebif (priced as much as $86,000 per year), which Ocrevus had outperformed in two of the studies leading to approval. Most experts have applauded the move, saying that, while still expensive, this prices Roche’s superior drug very comparably to other approved MS therapies, thus raising expectations for Roche’s new drug to become a market disruptor and gain significant shares of the MS market. However, at least one MS expert (and former Genentech employee) has pointed out that Rituxan may work equally well and is currently priced at under $10,000 per year when her institution uses it to treat MS patients beyond the label.

 

An April 4 report from MedCity News suggests Roche’s pricing move may reflect the start of a trend toward lower drug pricing. The author notes that Teva has priced its new deuterated Huntington’s Disease therapy, Austedo (deutrabenazine) at around $60,000, while an older (non-deuterated) version of the drug, Xenazine (tetrabenazine) is priced at $152,000 and a similar generic version at $96,000. Similarly, Regeneron’s Dupixent (dupilumab) for the treatment of moderate to severe eczema has been priced at $37,000 versus $50,000 for older drugs.

 

Are companies truly rethinking their pricing strategies, in light of public and Congressional negative attention to pricing matters? Or are these exceptions to the usual push for higher prices?

 

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