TG Therapeutics’ Briumvi (ublituximab) was approved by the FDA at the end of December 2022 for the treatment of relapsing forms of multiple sclerosis (MS). In January, it became commercially available.

Briumvi joins Genentech’s Ocrevus (ocrelizumab) and Novartis’ Kesimpta (ofatumumab) as the third anti-CD20 monoclonal antibody approved to treat relapsing MS. According to TG Therapeutics, Briumvi is more potent than other therapies in its class, which allows for a shorter infusion time than Ocrevus (1 hour versus 2 to 3.5 hours). Kesimpta is dosed as a subcutaneous injection.

Recently, TG Therapeutics announced that it plans to make Briumvi the most accessible therapy in its class by pricing it at $59,000 per year. This is the lowest price of any brand-name therapy currently approved to treat MS.

Even so, based on this year’s Final Evidence Report from the Institute for Clinical and Economic Review (ICER), this price is not low enough. In a panel vote, ICER found no net health benefit of Briumvi compared with other monoclonal antibodies prescribed to treat relapsing forms of MS. The list included Rituxan (rituximab), which is not currently FDA-approved to treat MS but is used off-label. The panelists found adequate clinical evidence showing a net health benefit of Briumvi over certain oral treatments, including fumarates and Novartis’ Gilenya (fingolimod).

However, ICER calculates that Briumvi, along with other monoclonal antibodies that treat MS, would have to be priced between $16,500 and $34,900 per year to achieve common thresholds for cost-effectiveness. For TG Therapeutics, this would mean discounting the treatment by at least 59% of its current price.

Currently, the company offers a patient support program to help patients in the United States gain access to Briumvi. For patients with commercial insurance, the program assists with copays. Patients without insurance coverage or those who are covered by government-funded programs, such as Medicaid or Medicare, may be able to obtain the treatment free of charge if they meet certain financial qualifications.