Bristol Myers Squibb's MS newcomer Zeposia gets the thumbs-down from England's price police

Zeposia
NICE's analysts struggled to define the exact population of MS patients who might prefer BMS's oral medicine over lower-cost injectable options.(Bristol Myers Squibb)

Drug-pricing watchdogs haven’t been kind to next-generation multiple sclerosis treatments, even though their developers have been offering piles of evidence to show the treatments offer clear benefits to patients.

Britain's National Institute for Health and Care Excellence (NICE) is among those critics. And now its analysts are casting doubt on the value of Bristol Myers Squibb’s new MS drug Zeposia (ozanimod).

NICE issued a preliminary rejection of Zeposia, an oral S1P modulator, in a consultation document. Pricing negotiations between BMS and the U.K. government are confidential. Nevertheless, the document said, “the cost-effectiveness estimates for ozanimod compared with other first-line treatments for relapsing–remitting multiple sclerosis were outside what NICE normally considers an acceptable use of NHS resources.”

NICE is now taking feedback on its Zeposia ruling and could change its recommendation. Bristol Myers said in a statement that it's disappointed in the draft decision, because "we know an unmet need still exists" for U.K. relapsing remitting MS patients. The company plans to offer NICE additional "clinical evidence to help demonstrate the benefit Zeposia can provide to adults with RRMS."

RELATED: Bristol Myers Squibb execs tout progress on Zeposia, Reblozyl and Onureg launches

NICE cited several obstacles its reviewers faced in determining Zeposia's cost-effectiveness. For example, the agency said, BMS originally submitted the drug for all patients with relapsing–remitting multiple sclerosis but later limited the submission to include those with active symptoms who prefer an oral option.

That restriction confused NICE’s analysts, who struggled to define the exact population of patients who might prefer a pill over injectables. What’s more, the “committee was concerned that restricting the population would exclude potential comparators that are routinely used in the NHS,” the document says.

The agency suggested several methods for improving the cost analysis for Zeposia, one of which would be to include comparisons with second-line treatments such as Sanofi’s Lemtrada and Roche’s Ocrevus.

Bristol said patients need easy treatment options now more than ever. "BMS believes it’s important to offer patients an oral therapy that may reduce the need to attend a clinical setting for treatment, particularly during the current pandemic," the company said in its statement.

Zeposia won European approval in May, shortly after the FDA cleared it in the U.S. The launch was anything but easy, though, given COVID-19 stay-at-home restrictions that prompted BMS to delay the rollout. And the drug, which carries a list price of $86,000 a year, entered a crowded field that included Novartis S1P modulators Gilenya and Mayzent.

By the end of the third quarter, Zeposia had brought in just $3 million in sales. Still, CFO David Elkins said during the company's earnings call that BMS was “pleased” with how doctors who treat MS were responding to the new option. Executives have estimated the drug could eventually bring in $5 billion a year.

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

This is far from the first time the high cost of a new MS drug has raised concerns. In 2017, the Institute for Clinical and Economic Review (ICER) in the U.S. balked at just about every MS drug on the market, declaring that the cost per additional quality-adjusted life-year (QALY) for all of them except Lemtrada outweighed their benefits.

NICE hasn’t been all that tolerant of high-priced MS drugs either, though history indicates BMS could very well change the agency’s mind.

In 2018, NICE initially balked at the cost of Roche’s Ocrevus, but then reversed its decision a few months later. It said the NHS should cover the drug for patients with relapsing-remitting MS. There was one hitch, however: NICE limited its endorsement to patients with active disease who couldn’t be treated with Lemtrada.

Editor's note: This story was updated with comments from Bristol Myers.