ICER on MS drugs: TG's ublituximab not cost effective at the same price as Roche's ocrelizimab

17 Oct 2022
endpts.com
AntibodyCollaborateAcquisition
Drug pricing watchdog ICER keeps its eye on what price point a drug is best suited for based on clinical benefit — and the group’s newest draft report takes a closer look at MS treatments compared to a new one awaiting the FDA’s final say. The watchdog focused on TG Therapeutics’ new, potential blockbuster ublituximab, which is pending FDA review, and compared it to other classes of disease-modifying therapies (DMTs, as ICER calls them) that are currently on the market. As for whether or not the drug would be cost effective if approved, the group gave ublituximab a placeholder price of $71,187 in wholesale acquisition cost, or $55,081 a year. That price is the same as Roche’s Ocrevus (ocrelizimab). Other drug prices ICER compared included natalizumab (Tysabri) at over $100,000 a year, Novartis’ Kesimpta (ofatumumab) at over $80,000 a year and dropping to $71,000 in years two and after, and then dimethyl fumarate, the generic form of Biogen’s Tecfidera, coming in at under $3,000 per year. “At its placeholder price, ublituximab did not meet typical thresholds for cost effectiveness when compared to the market-leading oral, in large part due to differences in net price,” the report added. TG did not immediately respond to a request for comment. The cost-effectiveness group also rated clinical evidence for the antibody against three different classes of drugs: S1P receptor modulators such as Gilenya and Zeposia, fumarates such as dimethyl fumarate, and monoclonal antibodies such as Tysabri and Ocrevus. For relapsed-remitting MS, the evidence of ublituximab compared to other monoclonal antibodies such as natalizumab, ofatumumab, ocrelizumab and rituximab was considered insufficient — partially because of the target population and data limitations. The report noted, “We found insufficient evidence to differentiate the net health benefit of ublituximab compared with other monoclonal antibodies.” Switching to oral therapies, the reviewers had some certainty that ublituximab was at least comparable or better in terms of reductions in annualized relapse rate and confirmed disability progression among fumarates, fingolimod, ozanimod and ponesimod. The final two drugs examined in the report, teriflunomide and siponimod, also had their own unique response compared to TG’s antibody. The reviewers said that ublituximab had a small net benefit over teriflunomide, but they could not rate siponimod due to differences in trial populations — leaving the only “superior” review of TG’s antibody as compared to placebo/no therapy. The drug currently has a PDUFA date of Dec. 28 in MS, after it was punted by three months, as it was one of the components in TG’s proposed blood cancer combo U2. TG pulled the BLA and NDA for the combo after a Phase III readout that favored the control arm over the drug.
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