U.S. drug pricing watchdog Institute for Clinical and Economic Review said Novartis AG's Mayzent may not be cost-effective compared to best supportive care in treating a certain type of multiple sclerosis.
Mayzent, or siponimod, is an investigational drug for treating an aggressive form of multiple sclerosis, an autoimmune disorder characterized by nerve damage in the brain and spine, leading to loss of physical and cognitive function. The medicine is intended to treat patients with secondary progressive multiple sclerosis, or SPMS, which develops from relapsing-remitting sclerosis. In SPMS, the patient's condition gets steadily worse, with the symptoms occurring in the absence of, or independent of, relapses.
In its review, the agency, known as ICER, compared Mayzent to best supportive care as well as to a group of drugs known as beta interferons; Roche Holding AG unit Genentech's ocrelizumab, marketed as Ocrevus; rituximab, also marketed by Genentech as Rituxan; and Biogen Inc.'s natalizumab, sold as Tysabri.
In its March 14 draft evidence report, ICER said Mayzent improved health outcomes of patients compared to the best supportive care, significantly reducing the risk of disability progression with decreased inflammatory disease activity.
However, ICER said it was not able to evaluate the comparative net health benefit of Mayzent to Ocrevus and Tysabri due to the lack of head-to-head data and its inability to indirectly compare the Novartis drug with other MS disease-modifying therapies through network meta-analysis.
Mayzent's cost-effectiveness — assuming the drug will have a price similar to Ocrevus — is estimated to be $826,000 per quality-adjusted life years gained above best supportive care, exceeding the usual threshold for cost effectiveness, ICER noted.
ICER will accept public comments on the draft scoping document until April 10 and will publish an evidence report May 2. The report will be the subject of a May 23 meeting of the Midwest Comparative Effectiveness Public Advisory Council.
Novartis submitted Mayzent's new drug application to the U.S. Food and Drug Administration in October 2018, with the decision expected to be available in March.