Atebrioz (zilurgisertib)

At approval, no wholesale acquisition cost (WAC), list price, or average sales price (ASP) had been announced for Atebrioz; Mirum Pharmaceuticals plans to announce the price at the U.S. launch, expected in October 2026. A Citizens analyst quoted by Reuters estimated an annual cost of about $750,000. The manufacturer states that eligible patients may pay as little as $0 per month through its Mirum Access Plus program. For the two other FDA-approved FOP therapies, Ipsen set an average U.S. list price for Sohonos (palovarotene) of $624,000 per year at its 2023 approval, and Regeneron stated an average annual U.S. list price for Pasatru (garetosmab-grts) of about $1.4 million, ranging from $693,000 to $2.1 million by dose and body weight.

No budget impact model, cost-effectiveness analysis, or health technology assessment of zilurgisertib has been published, and the United Kingdom horizon-scanning briefing of July 2025 recorded its cost as not yet known. The only budget impact analysis in FOP identified for this report is the 2023 Canadian review of palovarotene. For palovarotene, the sponsor estimated a 3-year budget impact of $10,429,302 and CADTH estimated $14,336,341 (Canadian dollars), based on approximately 19 patients with FOP in Canada; CADTH's reanalysis estimated an incremental cost-effectiveness ratio of $13,055,900 per QALY gained for palovarotene and stated that a price reduction of more than 99% would be required for palovarotene to be cost-effective at $50,000 per QALY.