NICE reconsiders and agrees to back Roche’s Ocrevus in relapsing multiple sclerosis—with strings attached

In April, England’s cost watchdog decided Roche’s multiple sclerosis star Ocrevus wasn’t cost-effective enough to win reimbursement backing in relapsing forms of the disease. But on Friday, the agency overturned that ruling.

The National Institute for Health and Care Excellence (NICE) is now endorsing (PDF) the drug for NHS coverage in relapsing-remitting MS. The twist? It can only be recommended in people with active disease—therefore excluding those recovery periods in between flare-ups—if Lemtrada (alemtuzumab) is found unsuitable.

Phase 3 data has already proved Ocrevus outperformed Merck KGaA’s stalwart Rebif in relapsing MS. Besides, patients who switched from Rebif to Ocrevus enjoyed a reduction in relapse frequency of about 50% in the first year and 60% in the second year, results from extension studies unveiled a few days ago showed. However, NICE had previously rejected it, citing no evidence directly comparing Ocrevus with other older treatments.

That has not changed in the new decision. But this time, NICE says indirect analyses comparing Ocrevus with other drugs, including Sanofi’s Aubagio, Biogen’s Tecfidera and Teva’s Copaxone, suggest that Ocrevus “slows disease progression in the total relapsing-remitting multiple sclerosis population compared with some treatments but not others.”

The agency also pointed to patients’ need for less frequent dosing or monitoring as a factor that influenced its decision. After the first dose, given in two separate infusions 2 weeks apart, Ocrevus is administered once every 6 months with fewer adverse effects compared with some other treatments.

Like many other drugs, Roche couldn’t have won over NICE without making price cuts. The company has offered a confidential discount to NHS organizations based on its £4,790-per-300-mg-vial list price.

RELATED: Roche's Ocrevus is one of the best MS launches ever, but Tecentriq in I-O? Not so much

More than 100,000 people live with MS in the U.K., and more than 8 out of every 10 of them are diagnosed with the relapsing-remitting type, according to the NHS. Though RRMS represents the majority of patients, Roche’s work with NICE is not done yet.

Ocrevus got European approval in January for both relapsing forms of MS and primary progressive MS. It is still waiting for NICE’s decision on the latter form, where it will likely encounter less resistance as the first medicine approved for PPMS. Just last week, Roche released new long-term data showing the drug can delay these patients’ need for a wheelchair by seven years.

Industry watchers have predicted big sales for Ocrevus, and it hasn’t disappointed them so far. For the first quarter, the MS injection, only approved by the FDA in March 2017, delivered CHF 479 million ($484 million) to Roche’s top line. That’s compared to $506 million in quarterly sales Tecfidera got for Biogen at about the same point after its launch.