Evicenter
P&T meetings

Lirafugratinib (Lyrfigtu)

Previously treated FGFR2 fusion or rearrangement-positive cholangiocarcinoma

Also known as RLY-4008
Regulatory submission
NDA submitted January 2026
Last updated
158 sources

Executive summary

Budget impact of Lirafugratinib

1 evidence topic · 14 sources

Summary: price, comparator costs, and budget impact inputs

No wholesale acquisition cost or average sales price for lirafugratinib had been published as of September 2026, and no budget impact model, cost-effectiveness analysis, or health technology assessment of lirafugratinib was identified. Elevar Therapeutics expects the product to be available in the United States by the fourth quarter of 2026.

Comparator prices are partly public. An average monthly United States price of $44,000 has been reported for futibatinib. Canada's Drug Agency estimated that pemigatinib costs $15,499 per 28 days, projected a 3-year budget impact of $63,606,331, and estimated incremental cost-effectiveness ratios of $252,718 and $261,226 per quality-adjusted life-year relative to active symptom control alone and mFOLFOX plus active symptom control. In England, NICE reports list prices of £7,159.04 for a pack of 14 pemigatinib 13.5 mg tablets (an annual cost of £124,430) and £2,386.33 per pack of futibatinib, each supplied to the NHS at a confidential discount. NICE recommended pemigatinib as a life-extending treatment at the end of life, with committee-preferred incremental cost-effectiveness ratios between £45,051 and £45,808 per quality-adjusted life-year compared with mFOLFOX plus active symptom control, and recommended futibatinib as an alternative to pemigatinib after a cost comparison found similar costs.

The inputs a payer model would use are available in part: about 8,000 people in the United States are diagnosed with bile duct cancer each year, FGFR2 fusions or rearrangements occur in 10% to 16% of intrahepatic cholangiocarcinomas, and 46% of 413 participants with advanced biliary tract cancer in one United States claims cohort received second-line treatment. Relay Therapeutics estimated that FGFR2-mediated cancers of all tumor types affect approximately 11,000 late-line patients annually in the United States. Mean all-cause health care costs during second-line therapy for advanced biliary tract cancer were $22,617 per patient per month.

Three features of lirafugratinib bear on its budget effect. Treatment continues until disease progression or unacceptable toxicity, and median progression-free survival in the pivotal cohort was 11.3 months. Ophthalmological examination with optical coherence tomography is required every 2 months for the first 13 months and every 4 months thereafter. Eligibility depends on FGFR2 testing, for which the Canadian agency estimated a cost of $38,000 to identify a single patient eligible for pemigatinib; NICE estimated that adding FGFR2 as a target to the NHS panel test would cost an additional £34, or £340 for each additional person identified who is FGFR2-positive.