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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

Economic information and modeling reportBudget impact model

Approach and framework

9 evidence topics · 18 sources

Budget impact model of lirafugratinib: approach and framework

No evidence found.

Model structures used in economic evaluations of advanced biliary tract cancer

“The progression-free health state was further divided into on-treatment and off-treatment substates. The EAG agreed that the structure of the economic model was appropriate and consistent with previous NICE evaluations for biliary tract cancer.” (opens the source at this quote in a new tab)

“In comparing medical costs and clinical outcomes between patients with BTC treated with pembrolizumab plus chemotherapy and those treated with chemotherapy, we used a partitioned survival model” (opens the source at this quote in a new tab)

“The health states included in this model were PFS, progressed disease (PD), and death.” (opens the source at this quote in a new tab)

“The model included three health states: PFS, progressive disease (PD) and death.” (opens the source at this quote in a new tab)

Model structures used in economic evaluations of FGFR inhibitors in cholangiocarcinoma

“This study used a 3-state partitioned survival model to analyze the 5 year cost-effectiveness of pemigatinib as a second-line treatment for advanced ICC patients in whom first-line gemcitabine-based chemotherapy failed and to compare the results with those for the mFOLFOX and 5-FU chemotherapy regimens.” (opens the source at this quote in a new tab)

“Overall survival and progression-free survival were estimated from the FIGHT-202 trial (pemigatinib), ABC-06 trial (mFOLFOX), and NIFTY trial (5-FU).” (opens the source at this quote in a new tab)

“We used a three-state partitioned survival model to evaluate the lifetime cost-effectiveness of pemigatinib compared to mFOLFOX or 5-FU/LV, based on data from the updated FIGHT-202, ABC-06, and updated NIFTY pivotal trials.” (opens the source at this quote in a new tab)

“As a result, we reconstructed survival curves from published KM curves and conducted a naïve indirect comparison, assuming comparability across the three trial populations.” (opens the source at this quote in a new tab)

“A partitioned survival model, with five health states, was locally adapted from a Greek payer perspective over a lifetime horizon.” (opens the source at this quote in a new tab)

“A matching-adjusted indirect comparison of pemigatinib and mFOLFOX+ASC was performed.” (opens the source at this quote in a new tab)

Model structure and inputs of the Taiwanese cost-effectiveness analysis of a biomarker-driven pemigatinib regimen

“To better reflect the current circumstances in Taiwan, the intervention regimen was pemigatinib for advanced ICC patients with FGFR2 fusions or rearrangements and mFOLFOX for those without FGFR2 fusions. The comparison regimen was 5-FU systemic therapy, one of the current regimens reimbursed by the NHI (Fig. 1).” (opens the source at this quote in a new tab)

“Patients with advanced intrahepatic cholangiocarcinoma receive genetic testing before starting second-line therapy.” (opens the source at this quote in a new tab)

“Overall and progression-free survival functions of pemigatinib, mFOLFOX, and fluorouracil were estimated from the FIGHT-202, ABC-06, and NIFTY trials, respectively.” (opens the source at this quote in a new tab)

“We decided to proceed with the PSMs on a 1-month cycle and with a follow-up for 5 years.” (opens the source at this quote in a new tab)

“health state utility values for progression-free status and progressed disease were 0.76 and 0.68, respectively, and assumed to be beta distributions.” (opens the source at this quote in a new tab)

“The proportions of adverse events ≥ grade 3 were 56%, 54%, and 18% in the pemigatinib arm, the mFOLFOX arm, and the 5-FU arm, respectively.” (opens the source at this quote in a new tab)

Model structures used in NICE appraisals of FGFR inhibitors in cholangiocarcinoma

“The company's partitioned survival model used parametric survival models to predict outcomes including time-on-treatment, progression-free survival and overall survival.” (opens the source at this quote in a new tab)

“It used a life-time horizon with a cycle length of 1 week. An annual discount rate of 3.5% was applied to costs and outcomes.” (opens the source at this quote in a new tab)

“The model cycle length was 21 days and a lifetime time horizon was used.” (opens the source at this quote in a new tab)

Use of FGFR inhibitors among patients with FGFR2 fusion-positive biliary tract cancer at academic centers

“In contrast, 80 (7.6%) of 1049 patients had a tumor with an FGFR2 fusion, and 64 (80%) were treated with FGFR inhibitors.” (opens the source at this quote in a new tab)

Numbers of patients starting futibatinib and pemigatinib in United States electronic medical records and claims, 2023 or later

“This study included 50 futibatinib and 55 pemigatinib patients.” (opens the source at this quote in a new tab)

“This study included 122 futibatinib (median age: 64 years; female: 58%; White: 66%) and 93 pemigatinib patients (median age: 66 years; female: 61%; White: 69%).” (opens the source at this quote in a new tab)

Uptake of pemigatinib assumed in the Canadian budget impact reanalysis

“In the CADTH reanalysis, the proportion of eligible patients who will use pemigatinib in year 1, 2, and 3 was changed to 80%, 85%, and 90%, respectively.” (opens the source at this quote in a new tab)

Uptake of futibatinib against pemigatinib assumed in the NICE resource impact assessment
YearUptake for futibatinib (%)
Current practice“0”
2024-25“40”
2025-26“50”
2026-27“50”

“The uptake for futibatinib is based on the NHS England expert opinion.” (opens the source at this quote in a new tab)

“The comparator treatment for the eligible population is pemigatinib.” (opens the source at this quote in a new tab)

Market share assumed for later-entrant oral targeted oncology agents in United States budget impact models

“Drug acquisition, molecular testing, treatment monitoring, and adverse event management costs were included to estimate total annual costs and per-member per-month (PMPM) costs in current (without pralsetinib) and potential future market scenarios, where pralsetinib is assumed to split the projected RET inhibitor market share with selpercatinib.” (opens the source at this quote in a new tab)

“With an assumed market share of approximately 6% for enzalutamide in year 1, the budget impact would be $106,074 ($0.009 per member per month [PMPM]). With a 26% enzalutamide share in year 3, the budget impact would be $632,729 ($0.048 PMPM).” (opens the source at this quote in a new tab)

“In the scenario with access to zanubrutinib, it is assumed uptake is 10% in year 1, followed by an increase of 5% in year 2 and year 3” (opens the source at this quote in a new tab)

“Market share for pirtobrutinib was assumed to be 39% in year 1 (year of pirtobrutinib approval) and 50% for years 2-5 (post approval).” (opens the source at this quote in a new tab)