NICE deems use of Roche's Ocrevus in primary progressive MS not cost-effective

In a final appraisal determination published Monday, the National Institute for Health and Care Excellence ruled against NHS reimbursement of Roche's Ocrevus (ocrelizumab) for treating patients with early primary progressive multiple sclerosis (PPMS). The regulator noted that while study results show that Ocrevus can slow the worsening of disability in people with the condition, the cost of the drug is not "an acceptable" use of NHS resources.

Ocrevus gained European approval in January for the treatment of both early PPMS and patients with active relapsing forms of MS. Meanwhile, in June, NICE backed use of the humanised monoclonal antibody, which is designed to selectively target CD20-positive B cells, for relapsing-remitting MS.

NICE noted that the list price of Ocrevus is 4790 pounds ($6195) per 300 mg vial, with the drug initially dosed as two 300 mg infusions two weeks apart, with subsequent doses of 600 mg infused every six months. While the agency determined that the use of Ocrevus in relapsing forms of MS is a cost-effective use of NHS resources, use at the same price in PPMS was deemed not to be cost effective, because of less compelling evidence of the drug's benefit in the latter indication.

Roche also noted that the agency could not consider an indication-specific price for using Ocrevus in PPMS, as under Department of Health rules, the drug cannot be offered at different cost than that in relapsing forms of MS. Richard Erwin, general manager of Roche UK, remarked "we ask that NICE are given the flexibility to consider an indication-specific price for [Ocrevus] in PPMS," adding that such a change in stance "could also have huge implications for future access to innovative medicines for people in the UK."

Erwin said "as we have done with other disease areas, want to work together with NICE and NHS England to find a solution so this decision can be overturned." Global sales of Ocrevus reached 1 billion Swiss francs ($1 billion) in the first half of the year.

Commenting on the decision, Genevieve Edwards, director of external affairs at the MS Society, said "right now bureaucracy is standing in the way," adding "we're petitioning NICE, Roche and NHS England to put patients first and agree a deal to make [Ocrevus] available at a price the NHS can afford."

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