Lirafugratinib (Lyrfigtu)

No budget impact model of lirafugratinib has been published and no price has been announced, so its budget effect cannot be estimated from public evidence. The population inputs a payer would need 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 in approximately 9% of profiled cholangiocarcinomas, 46% of participants with advanced biliary tract cancer in one United States claims cohort initiated second-line therapy, and Relay Therapeutics estimated approximately 11,000 late-line United States patients annually with FGFR2-mediated cancers of any tumour type.

Comparator costs are partly public. A United States retail price of $44,000 per month has been reported for futibatinib, and Canada's Drug Agency estimated pemigatinib at $15,499 per 28 days, with a 3-year public budget impact of $63,606,331 that it considered an underestimate because costs beyond 1 year of treatment were not captured. 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, both supplied at confidential discounts, and assumed the same time on treatment for futibatinib and pemigatinib. Real-world all-cause health care costs among United States participants treated with pemigatinib were $11,139 per patient per month, and all-cause costs during second-line therapy for advanced biliary tract cancer were $22,617 per patient per month.

Three features of lirafugratinib bear on a budget model. Treatment continues until progression and median progression-free survival in the pivotal cohort was 11.3 months, against 7.0 months for pemigatinib and 9.0 months for futibatinib in their pivotal trials, so drug cost per treated patient depends on duration as well as price. Required ophthalmologic examinations with optical coherence tomography occur every 2 months for 13 months and every 4 months thereafter, compared with every 2 months for 6 months and every 3 months thereafter for the comparators. FGFR2 testing costs are material: the Canadian estimate was about $38,000 per eligible patient identified, NICE estimated £340 for each additional FGFR2-positive person identified by adding FGFR2 to the NHS panel test, a Taiwanese model applied a genetic testing fee of NT$30,000, and the lirafugratinib companion diagnostic had not yet been specified in labeling at approval.