The multi-sclerosis drug Zeposia was rejected by NICE

Regulators, including the National Institute for Health and Care Excellence (NICE), have questioned the price of the multiple sclerosis drug Zeposia (ozanimod) despite extensive evidence from BMS.
NICE initially rejected the oral S1P regulator Zeposia in a consultation paper.
While pricing negotiations between BMS and the UK government are confidential, according to the consultation document, NICE does not consider the cost-effectiveness of the drug to be within the range of resources acceptable to the NHS compared to other first-line relapsed remission-relieving multiple sclerosis (RRMS) treatments.
NICE cited a number of obstacles faced by its examiners in determining the cost-effectiveness of Zeposia.
For example, the agency said BMS initially offered treatment for the drug to all patients with relapsed remission-relieving multiple sclerosis, but would later limit the scope of patients submitted for review to those with active symptoms who wished to be treated orthopoly.
this additional restriction has puzzled NICE analysts because the new restrictions will make it difficult for them to determine which groups of patients with the drug prefer to take the drug rather than use injection preparations.
, The Nice, said in the document that "the committee is concerned that limiting the number of patients would avoid comparing the drug to other drugs in NHS resources."
the agency has proposed several ways to improve Zeposia's cost analysis, one of which is to compare the drug with second-line drugs such as Sanofi Lemtrada and Roche Ocrevus.
BMS seems intent on avoiding this comparison, responding that patients with multiple sclerosis today need more convenient treatment options than ever before.
"BMS believes that it is important to provide oral treatment to patients, especially during the current new coronary pneumonia pandemic, which reduces the need to go to the hospital for clinical treatment," the company said in a statement.
" it is worth noting that Zeposia is indeed the first and only S1P subject regulator that does not require first dose observation.
Zeposia is an oral drug that only needs to be taken once a day.
last March, the drug was approved by the FDA.
may last year, the European Commission (EC) approved the drug for the treatment of adult patients with active relapsed relapsed multiple sclerosis defined by clinical or imaging characteristics.
The drug was originally developed by Celgene, and Zeposia's approval marks the first FDA-approved application for a new drug (NDA) since BMS acquired the new base, expanding the franchise in immunology.
The U.S. and European Union approvals are based on trial data from SUNBEAM and RADIANCE, the largest, head-to-head, key Phase 3 clinical trials conducted so far in patients with multiple sclerosis, which have recruited more than 2,600 patients in 150 regions in more than 20 countries around the world.
SUNBEAM test results show that Zeposia reduced its annual recurrence rate by 48% in a year compared to Avonex, zeposia also reduced the number of T1-weighted pyration (GdE) brain injuries by a relatively 63%, reducing the number of new or expanded T2 injuries by 4 In the RADIANCE study, Zeposia reduced the annual recurrence rate of patients by 38% over two years, while Zeposia reduced the number of T1-weighted GdE brain injuries by 53% and the number of new or expanded T2 injuries by 42% compared to Avonex.
prices of multiple sclerosis drugs have remained high.
despite Zeposia's annual wholesale purchase price (WAC) of $86,000 a year in the U.S., the price tag is lower than Novarma's $885 million competitor, Mayzent.
price advantage does not appear to reflect sales performance, with Zeposia's sales at just $3 million by the end of the third quarter of 2020.
, BMS Chief Financial Officer David Elkins said on the company's earnings conference call that he was pleased to see feedback from doctors on Zeposia's treatment plan.
BMS is confident that Zeposia will eventually bring in about $5 billion a year.
, NICE is currently receiving extensive feedback on Zeposia's ruling and may eventually change its recommendations.
BMS said in a statement that NICE's draft decision was disappointing because "BMS is aware that there are still unsealed clinical needs in patients with relapsed multiple sclerosis in the UK."
the company plans to provide NICE with other "clinical evidence" of the drug to help demonstrate the therapeutic benefits Zeposia can bring to adult patients with relapsed remission-relieving multiple sclerosis.
" Reference Source: 1.Bristol Myers Squibb's MS newcomer Zeposia gets thumbs-from down England's price police 2.NICE no for BMS' multiple sclerosis drug Zeposia 3.NICE rejects multiple sclerosis drug Zeposia