Drug price watchers have not been sympathetic to multiple next-generation sclerosis treatments, even though their developers have offered heaps of evidence to show that the treatments offer clear benefits to patients. patients.
These critics include the British National Institute for Health and Care Excellence (NICE). And now their analysts are questioning the value of the new MS drug Bristol Myers Squibb Zeposia (ozanimod).
NICE issued an introduction to Zeposia, an S1P oral modulator, in a consultation document. Price negotiation between BMS and the UK government is confidential. Nevertheless, the document stated, “the cost-effectiveness estimates for ozanimod compared with other first-line treatments for relapse – eliminate multiple sclerosis beyond what NICE does. often seen as an appropriate use of NHS resources. ”
NICE is now receiving feedback on their Zeposia regulation and may change its recommendation. Bristol Myers said in a statement that he is disappointed in the draft decision, as “we know there is an unmet need” for the UK re-broadcast removing MS patients. The company plans to “provide additional clinical evidence to NICE to help demonstrate the benefits of Zeposia for adults with RRMS.”
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NICE raised a number of obstacles facing its reviewers in determining the cost-effectiveness of Zeposia. For example, the group said, BMS initially prescribed the drug to all patients with multiple relapsing-remitting multiple sclerosis but later blocked the application to take it. into those with active symptoms preferred oral choice.
That limitation worried NICE analysts, who struggled to explain the true number of patients who could be better off taking a pill over injectables. In addition, the committee was concerned that population restriction would exclude comparators that could be used routinely in the NHS, ”the document states. saying.
The group proposed several ways to develop a cost analysis for Zeposia, one of which would include comparisons with second-line treatments such as Lemtrada Sanofi and Ocrevus Roche.
Bristol said patients need easy treatment options now more than ever. “BMS believes it is important to offer patients oral treatment that may reduce the need to be present at a clinical setting for treatment, especially during the routine pandemic,” the company said in its statement.
Zeposia won European approval in May, shortly after the FDA cleared in the U.S. The launch was anything but easy, however, as COVID-19 had stay-at-home restrictions that prompted BMS to delay put on release. And the drug, which carries a list price of $ 86,000 a year, has entered a crowded range that includes Novartis S1P Gilenya and Mayzent modulators.
By the end of the third quarter, Zeposia had raised just $ 3 million in sales. However, CFO David Elkins said during the company’s employment call that BMS was “pleased” with the way doctors treating MS responded to the new option. Activists have estimated the drug could fetch $ 5 billion annually.
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This is far from the first time the high cost of a new MS drug has raised concerns. In 2017, the U.S. Institute for Clinical and Economic Review (ICER) blocked almost all MS drugs on the market, reporting that the cost per year of life had fluctuated with quality (QALY) for all but Lemtrada outweighs their benefits.
NICE has not been as tolerant of high – priced MS drugs, although history shows that BMS can change the body ‘s mind for good.
In 2018, NICE first began blocking at the expense of Ocrevus Roche, but then reversed the decision a few months later. They said the NHS should cover the drug for patients with relapsing MS. There was one caveat, however: NICE affirmed its confirmation to patients with active disease that could not be treated with Lemtrada.
Editor’s note: This story has been updated with comments from Bristol Myers.