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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

Cost assumptions

31 evidence topics · 34 sources

Budget impact model of lirafugratinib: cost assumptions

No evidence found.

Drug acquisition cost of pemigatinib in Canada

“Treatment with Pemazyre is expected to cost, on average, $15,499 per 28 days (assuming 13.5 mg is administered orally once daily for 14 consecutive days followed by 7 days off therapy, in 21-day cycles).” (opens the source at this quote in a new tab)

Drug acquisition cost of pemigatinib in Taiwan

“A 5-year cost-effectiveness analysis (CEA) conducted prior to reimbursement indicated that pemigatinib’s value-based price of NT$8,910 (US$286.04) per 13.5 mg was lower than the NHIA’s listing price of NT$12,500 (US$401.28), suggesting that the current listing price exceeds the estimated value-based price, making pemigatinib not cost-effective compared to systemic therapies with mFOLFOX or 5-FU/LV over 5 years” (opens the source at this quote in a new tab)

“The direct medical costs associated with the PD state primarily consist of supportive care expenses covered by the NHIA, totaling US$15,978 per year” (opens the source at this quote in a new tab)

“These costs are reported in 2023 U.S. dollars (1 USD = 31.35 TWD)” (opens the source at this quote in a new tab)

“The price of pemigatinib 13.5 mg was set at the potentially highest listing price (NT$17,820).” (opens the source at this quote in a new tab)

“The hypothesized medication cost of pemigatinib (NT$6600 × 3 × 0.9 = NT$17,820) was set at the potential highest listing price and assumed to be a uniform distribution” (opens the source at this quote in a new tab)

Drug acquisition cost of pemigatinib and futibatinib in England

“The list price of pemigatinib 13.5 mg tablets is £7,159.04 for a pack of 14 (company submission), which is an annual cost of £124,430. The company has a commercial arrangement. This makes pemigatinib available to the NHS with a discount. The size of the discount is commercial in confidence.” (opens the source at this quote in a new tab)

“The list price of futibatinib is £2,386.33 per pack containing 35, 28 or 21 4-mg tablets (excluding VAT, company submission).” (opens the source at this quote in a new tab)

“The company has a commercial arrangement. This makes futibatinib available to the NHS with a discount. The size of the discount is commercial in confidence.” (opens the source at this quote in a new tab)

Cost inputs and genetic testing fee in the Taiwanese cost-effectiveness analysis of a biomarker-driven pemigatinib regimen

“Genetic testing fees, medication costs for second-line therapy, and other medical expenses were included in the progression-free state; expenditure for supportive care was included in the disease-progressed state.” (opens the source at this quote in a new tab)

“Except for genetic testing (ACTFusion™, NT$30,000 on the date of the new treatment regimen [27]) and the cost of pemigatinib (NT$285,714 per month) set at the market price in 2021 and assumed to be uniform distributions, all other costs were estimated from the National Health Insurance Research Database (NHIRD) and assumed to be gamma distributions.” (opens the source at this quote in a new tab)

“For the progression-free state, the average costs per cycle of medication and other medical expenditures were NT$285,714 and NT$23,949 for pemigatinib users, NT$33,847 and NT$70,389 for mFOLFOX users, and NT$14,600 and NT$70,389 for 5-FU users, respectively. For the disease progression state, the average cost per cycle of supportive care was NT$37,518 for all patients.” (opens the source at this quote in a new tab)

Modelled lifetime cost per patient of pemigatinib and second-line comparators from a Greek payer perspective

“Total lifetime cost per patient with pemigatinib, mFOLFOX+ASC and ASC alone were estimated to be €85,534, €2,537 and €1,010 respectively.” (opens the source at this quote in a new tab)

“Reimbursable direct costs pertaining to drug acquisition, administration, monitoring, adverse events, and end of life were considered in the analysis.” (opens the source at this quote in a new tab)

Real-world United States health care cost per patient per month among patients treated with pemigatinib, claims data 2020 to 2023

“During the follow-up period, mean all-cause health care costs (PPPM) were $11 139, based on 2022 US dollars, with $8889 attributable to CCA-related care.” (opens the source at this quote in a new tab)

“The majority of all-cause health care costs were driven by ambulatory visits ($6464 PPPM) and inpatient stays ($3888 PPPM).” (opens the source at this quote in a new tab)

“During observation, 47.1% of patients discontinued pemigatinib; median [95% confidence interval (CI)] time to discontinuation was 7.0 (6.1-9.7) months.” (opens the source at this quote in a new tab)

United States monthly price of futibatinib, an FGFR inhibitor comparator

“The cost of drugs was obtained from www.pharmacychecker.com using the FDA label to determine the dosage and number of tablets required per day. This methodology excludes any private or governmental insurance coverage, which would cover the entire cost or more likely a fraction of the stated price.” (opens the source at this quote in a new tab)

“The average monthly cost for the treatment of neoplastic diseases was $17,900 with a price of $44,000 for futibatinib (used to treat cholangiocarcinomas with FGFR2 fusions) and minimum of $5100 for binimetinib (melanoma).” (opens the source at this quote in a new tab)

“We retrieved drug prices in November 2023 from www.pharmacychecker.com for the average patient living in the state of North Carolina (ZIP code 28791). These values represent the retail price of a drug at the pharmacy as determined by negotiations between pharmacies and insurers and reflect both wholesale and retail markups.” (opens the source at this quote in a new tab)

“Results from clinical trials do not favor one drug over the other [83]; the difference in pricing is thus unrelated to clinical efficacy.” (opens the source at this quote in a new tab)

“Infigratinib had also been approved for the treatment of this uncommon disorder, but the distribution of this FGFR inhibitor has been discontinued in the United States [84].” (opens the source at this quote in a new tab)

United States drug cost inputs per treatment cycle for regimens used in advanced biliary tract cancer

“Drug costs in the US, $/per cycle” (opens the source at this quote in a new tab)

DrugBaseline cost in the United States, USD per cycle
Gemcitabine“15.06”
Cisplatin“8.72”
Durvalumab“11,730”
Oxaliplatin“26.76”
Calcium folinate“52.48”
Fluorouracil“18.57”
Irinotecan“35.88”
Capecitabine“180.6”
Regorafenib“21,546”
Real-world United States cost per patient per month by line of therapy in advanced biliary tract cancer

“The mean PPPM costs for the overall population were $18,274 for all-cause costs, of which approximately 84% ($15,296) comprised BTC-related costs. The total mean (SD) PPPM all-cause costs by LOT were $19,589 ($22,603) for 1LOT, $22,617 ($19,302) for 2LOT and $33,534 ($40,588) for 3LOT.” (opens the source at this quote in a new tab)

“We found that total all-cause PPPM cost was $19,589 during 1LOT, increasing to $22,617 and $33,534 as the treatment advanced to 2LOT and 3LOT, respectively, with >80% of PPPM costs only related to BTC.” (opens the source at this quote in a new tab)

Real-world United States cost per patient per month after failure of first-line therapy for advanced cholangiocarcinoma

“Total mean per patient per month CCA-related healthcare costs were $7,743, with medical services ($6,685) a larger driver of monthly costs relative to treatment costs ($1,058).” (opens the source at this quote in a new tab)

“The total mean all-cause PPPM healthcare costs were $14,403.” (opens the source at this quote in a new tab)

Real-world United States cost per patient per month among patients treated with pemigatinib

“CUP was associated with significantly higher prevalence of metastatic disease (100.0% vs 63.6%), per patient per month (PPPM) ambulatory HCRU (8.2 vs 5.5), and ambulatory costs ($8584 vs $5308).” (opens the source at this quote in a new tab)

“Medical costs averaged $13 444 vs $9881 PPPM for CUP and non-CUP, respectively” (opens the source at this quote in a new tab)

Modelled lifetime treatment costs per patient in advanced biliary tract cancer from a United States payer perspective

“In China and the US, the cost of pembrolizumab plus chemotherapy was higher than that of chemotherapy alone ($85,480 versus $21,616, $297,282 versus $156,281).” (opens the source at this quote in a new tab)

Administration and monitoring cost assumptions for FOLFOX, the principal second-line chemotherapy comparator

“the committee concluded that the model should include a relative dose intensity of 78% for FOLFOX, and that relative dose intensity should be applied to both treatment acquisition and administration costs.” (opens the source at this quote in a new tab)

“At the second meeting, the company updated its model to include the NHS cost collection reference cost for all ECGs. This was £118. The EAG noted that this may be an overestimate and instead chose to use the cost for directly accessed diagnostic services only (£54).” (opens the source at this quote in a new tab)

Biomarker testing cost assumptions for biomarker-selected second-line comparators

“The clinical experts described that the cancer is screened for different genetic alterations at diagnosis to determine eligibility for targeted second-line treatment.” (opens the source at this quote in a new tab)

“The costs of additional IHC tests were included as part of the company submission.” (opens the source at this quote in a new tab)

“To the present costs we should add the cost of the IDH1 analysis (about 190 € for each patient [18]), that should be performed for all cholangiocarcinoma, with IDH1 mutation in approximately 20% of patients with intrahepatic cholangiocarcinoma [1]” (opens the source at this quote in a new tab)

FGFR2 testing cost and availability assumed in health technology assessments of pemigatinib

“The price reduction is influenced by the cost of testing, which is estimated to be $38,000 to identify a single patient eligible for treatment with pemigatinib.” (opens the source at this quote in a new tab)

“Availability of FGFR2 testing: pERC noted that the pharmacoeconomic reanalysis assumed that FGFR2 testing was not publicly funded without pemigatinib.” (opens the source at this quote in a new tab)

“Feedback from the sponsor indicated that FGFR2 testing is currently available and funded in Alberta and Ontario and may be provided on a case-by-case basis in Nova Scotia and New Brunswick.” (opens the source at this quote in a new tab)

“It was noted by the drug programs that FGFR2 testing is not routinely available nor funded in jurisdictions.” (opens the source at this quote in a new tab)

“The genetic testing fee and price of pemigatinib were set as the market price.” (opens the source at this quote in a new tab)

“The genetic testing fee was set at the market price and assumed to be uniform distribution.” (opens the source at this quote in a new tab)

FGFR2 testing and optical coherence tomography costs in the NICE appraisal of pemigatinib

“The prevalence of FGFR2 fusion or rearrangement is about 10% across all types of cholangiocarcinoma. So, adding FGFR2 as a target would incur an additional cost of £34, which would be applicable if pemigatinib is recommended for routine use in NHS practice. This gives a preferred cost of £340 for each additional person identified who is FGFR2-positive.” (opens the source at this quote in a new tab)

“The committee concluded that the costs of optical coherence tomography should be included in the economic analysis. After consultation, the company included the cost of optical coherence tomography in its analysis.” (opens the source at this quote in a new tab)

Time on treatment assumed in the NICE appraisal of futibatinib

“Respective median progression-free survival and median time on treatment were 8.9 months and 9.1 months for futibatinib and 6.9 months and 7.2 months for pemigatinib.” (opens the source at this quote in a new tab)

“So, the committee concluded that time on treatment should be the same for futibatinib and pemigatinib.” (opens the source at this quote in a new tab)

Placeholder price for a product without a published price in the ICER reference case

“3) If still not available and there are other similar drugs in the class, calculate the average net price across these drugs (using net pricing steps described in the section for branded treatments with a price available that do not require provider administration) and use that average as the placeholder price for the treatment;” (opens the source at this quote in a new tab)

“Regardless of specific approach, the price selected will be a placeholder price and should be identified as such throughout the review with clarifying text and footnotes to respective result displays.” (opens the source at this quote in a new tab)

Package sizes of pemigatinib and futibatinib in the United States labels

“in bottles of 14 with child-resistant closure” (opens the source at this quote in a new tab)

“20 mg daily dose: Each carton contains 1 blister card containing a 7-day supply (35 tablets; 4 mg futibatinib per tablet). [NDC-64842-0120-6]” (opens the source at this quote in a new tab)

Relative dose intensity of futibatinib in the FDA review of the pivotal trial

“Median relative dose intensity was 85.71%.” (opens the source at this quote in a new tab)

Duration of pemigatinib and futibatinib treatment in United States real-world studies

“Among all patients, the median DOT with pemigatinib was 7.4 months (95% CI: 6.2-8.8).” (opens the source at this quote in a new tab)

“median rwTTD was similar in both futibatinib and pemigatinib patients (2.8 vs. 2.8 months)” (opens the source at this quote in a new tab)

FOLFOX regimen, cycle length, and number of cycles received in ABC-06

“Patients allocated to the ASC plus FOLFOX group also received FOLFOX chemotherapy every 2 weeks for a maximum of 12 cycles.” (opens the source at this quote in a new tab)

“Treatment took place over 2 days, and consisted of oxaliplatin 85 mg/m2 (in 250–500 mL of 5% glucose; 2-h intravenous infusion), L-folinic acid 175 mg (or folinic acid 350 mg; 2-h intravenous infusion concurrently with oxaliplatin infusion), and fluorouracil 400 mg/m2 (5–10 min bolus) completed on day 1, and fluorouracil 2400 mg/m2 as continuous intravenous infusion starting on day 1 and finishing on day 2.” (opens the source at this quote in a new tab)

“The median number of FOLFOX cycles received was five (IQR 2–6), with a median interval between the first and last doses received of 70 days (41–111).” (opens the source at this quote in a new tab)

Grade 3 or 4 adverse reactions with pemigatinib in the United States label (N=146)
Adverse reactionAll grades (%)Grades 3 or 4 (%)
Hypophosphatemia“23”“12”
Nail toxicity“43”“2.1”
Palmar-plantar erythrodysesthesia syndrome“15”“4.1”
Stomatitis“35”“5”
Fatigue“42”“4.8”
Arthralgia“25”“6”
Grade 3 adverse reactions and grade 3 or 4 phosphate decrease with futibatinib in the United States label (N=103)
Adverse reactionAll grades (%)Grade 3 (%)
Nail toxicity“47”“1.9”
Palmar-plantar erythrodysesthesia syndrome“21”“4.9”
Stomatitis“30”“6”
Fatigue“37”“8”
Laboratory abnormalityAll grades (%)Grades 3 or 4 (%)
Decreased phosphate“50”“20”
Chemotherapy-related grade 3 to 5 adverse events with FOLFOX in ABC-06 (N=81)

“The most frequently reported grade 3–5 chemotherapy-related adverse events were neutropenia (ten [12%] patients), fatigue or lethargy (nine [11%] patients), and infection (eight [10%] patients” (opens the source at this quote in a new tab)

Chemotherapy-related adverse eventGrade 3Grade 4Grade 5
Fatigue or lethargy“9 (11%)”“0”“0”
Neutropenia“8 (10%)”“2 (2%)”“0”
Infection“6 (7%)”“1 (1%)”“1 (1%)”
Febrile neutropenia“0”“1 (1%)”“1 (1%)”
Site of care assumed for grade 3 or higher adverse events in United States cost models

“However, for certain AEs (eg, dermatologic events and laboratory abnormalities) management was assumed to occur in the outpatient setting only based on clinical expert input indicating that these events, even at Grade ≥3 severity, do not routinely require inpatient admission.” (opens the source at this quote in a new tab)

“As patients with grade 3/4 AEs require hospitalization based on the definitions by Common Terminology Criteria for Adverse Events (CTCAE), the national level of inpatient costs from the HCUP database were used to estimate the unit costs associated with each grade 3/4 AE.” (opens the source at this quote in a new tab)

“All costs were inflated to 2020 US dollars (USD) using an inflation factor of 1.0793 from 2017 USD based on the Consumer Price Index (CPI) for all urban consumers in medical care service.” (opens the source at this quote in a new tab)

United States cost per adverse event from claims of patients treated with VEGFR tyrosine kinase inhibitors, 2015 to 2021

“A sum of all claims associated with the AE diagnosis code during the 90 days following the index AE (including index AE), contributed to cost.” (opens the source at this quote in a new tab)

“The least costly AEs were proteinuria and fatigue, with an average total cost of $76 and $416 respectively over the 90-day timeframe, while the costliest were mucositis ($1687 average), diarrhea ($1371 average), and rash ($1370 average).” (opens the source at this quote in a new tab)

Adverse eventAverage cost per patient with the adverse event
Palmar-plantar erythrodysesthesia or hand-foot skin reaction“$1,316”
Mucositis or stomatitis“$1,687”
Asthenia or fatigue“$416”
United States hospitalization cost per grade 3 or 4 adverse event, 2020 United States dollars
Adverse eventUnit cost
Arthralgia“$6513”
Palmar-plantar erythrodysesthesia syndrome“$6480”
Stomatitis“$8930”
Fatigue“$7979”
United States cost of neutropenia, febrile neutropenia, and infection
Adverse eventCost in the United States, USD
Neutropenia“5,321.00”

“For adults, the mean length of stay for cancer-related neutropenia hospitalizations was 9.6 days, with a mean hospital cost of $24,770 per stay.” (opens the source at this quote in a new tab)

“All costs are in 2012 US dollars.” (opens the source at this quote in a new tab)

“ranged from $12,689 to $27,587” (opens the source at this quote in a new tab)

ResourceCost, 2014 United States dollars
Cellulitis, mean inpatient cost per hospitalization“17,230”
Neutropenia, outpatient management“2087.69”
Infection, outpatient management“112.65”
Outpatient cost of hand-foot syndrome and fatigue in a United States cost-effectiveness analysis, 2014 United States dollars
Adverse eventBaseline cost, USD
Hand-foot syndrome“134.48”

“Fatigue was assumed to have no specific medical management.” (opens the source at this quote in a new tab)

“Only direct medical costs were considered and stated in 2014 US dollars.” (opens the source at this quote in a new tab)

Serum phosphate testing schedule in the pivotal trial of futibatinib

“Serum phosphate levels were measured on days 1, 4, 8, and 15 of cycle 1 and on day 1 of every cycle thereafter.” (opens the source at this quote in a new tab)