Summary: available economic evidence and the comparator precedent

No cost-effectiveness analysis, budget impact model, or health technology assessment of zilurgisertib has been published. The National Institute for Health and Care Research Innovation Observatory briefing of July 2025 recorded the cost as not yet known and identified no relevant NICE guidance. Mirum states that FOP affects approximately 300 people in the United States and 900 worldwide. No U.S. price has been announced; a Citizens analyst quoted by Reuters estimated an annual cost of about $750,000 and peak worldwide sales of roughly $150 million.

The only economic evaluation in the FOP population located for this report is the 2023 Canadian review of palovarotene. CADTH's reanalysis estimated an incremental cost of $19,020,252 and 1.46 incremental QALYs versus standard of care alone, an ICER of $13,055,900 per QALY gained (Canadian dollars), with drug acquisition representing 99% of total predicted costs; a price reduction of more than 99% would be needed to reach $50,000 per QALY. The committee recommended reimbursement on condition of a price reduction and prescribing by an FOP expert, and CADTH estimated a 3-year public drug plan budget impact of $14,336,341. In England, the NICE highly specialised technologies evaluation of palovarotene was suspended in March 2023 after the negative CHMP opinion and discontinued in January 2025. Sections 4.2.1 through 4.2.7 report the palovarotene budget impact analysis as the closest available precedent; its inputs describe the Canadian population, price, and dosing of palovarotene.

United Kingdom horizon scanning of zilurgisertib

“Estimated Cost The cost of zilurgisertib is not yet known.” (opens the source at this quote in a new tab)
“NICE Guidance No relevant guidance identified.” (opens the source at this quote in a new tab)
“There is currently no treatment option recommended by the National Institute for Health and Care Excellence (NICE) for FOP.” (opens the source at this quote in a new tab)

Analyst sales forecast for zilurgisertib

“Citizens analyst Jonathan Wolleben estimates Atebrioz could cost about $750,000 annually and generate roughly $150 million in peak worldwide sales.” (opens the source at this quote in a new tab)

Canadian reimbursement recommendation for the comparator palovarotene

“CADTH recommends that Sohonos be reimbursed by public drug plans to reduce the formation of heterotopic ossification (HO) in adults and children aged 8 years and above for females and 10 years and above for males with fibrodysplasia ossificans progressiva (FOP), if certain conditions are met.” (opens the source at this quote in a new tab)
“Sohonos should only be reimbursed if prescribed by an expert in the diagnosis and management of FOP and if the cost of Sohonos is reduced.” (opens the source at this quote in a new tab)
“Based on CADTH’s assessment of the health economic evidence, Sohonos does not represent good value to the health care system at the public list price. A price reduction is therefore required.” (opens the source at this quote in a new tab)

Cost-effectiveness of the comparator palovarotene in the Canadian review

“In the sponsor’s base-case analysis, palovarotene plus SoC was associated with an estimated cost of $16,629,383 and 44.03 QALYs over the 80-year horizon, resulting in an ICER of $2,979,324 per QALY gained (incremental costs = $16,471,773; incremental QALYs = 5.53) compared to SoC alone (Table 3).” (opens the source at this quote in a new tab)
“Based on CADTH’s reanalysis, palovarotene plus SoC is more costly (incremental costs = $19,020,252) and more effective (incremental QALYs = 1.46) compared with SoC, resulting in an incremental cost-effectiveness ratio (ICER) of $13,055,900 per QALY gained.” (opens the source at this quote in a new tab)
“The results of CADTH’s reanalyses are driven by palovarotene drug acquisition costs, which represent 99% of the total predicted costs of care.” (opens the source at this quote in a new tab)
“Based on CADTH’s reanalysis, for palovarotene to be considered cost-effective compared to SoC alone at a WTP threshold of $50,000 per QALY, the price of palovarotene would need to be less than $3.24 per mg (e.g., $16.21 per 5 mg tablet), reflecting a price reduction of more than 99%.” (opens the source at this quote in a new tab)

NICE evaluation of the comparator palovarotene

“Please note that following on from information provided to NICE by the company in January 2023, the appraisal was suspended from NICE’s work programme. As no further information has been received from the company the topic has been discontinued” (opens the source at this quote in a new tab)
“The company have advised that the European Medicines Agency Committee for Medicinal Products (CHMP) have issued a negative opinion for Palovarotene to reduce the formation of heterotopic ossification associated with fibrodysplasia ossificans progressiva. Therefore, NICE has decided to suspend this evaluation from its work program until further information is available.” (opens the source at this quote in a new tab)

Atebrioz (zilurgisertib)

Modeling overview