Budget impact modelIn development
Overview
Estimates the change in a United States health plan's spending on treatment of previously treated FGFR2 fusion or rearrangement-positive cholangiocarcinoma when lirafugratinib (Lyrfigtu) becomes available.
- Perspective
- United States health plan as third-party payer; patient cost sharing, rebates, and discounts are not deducted
- Time horizon
- 3 years, undiscounted
- Price basis
- Wholesale acquisition cost for oral agents as of 1 October 2026; Medicare payment limits for infused drugs (October 2026) and Medicare fee schedule amounts for services (calendar year 2026); the lirafugratinib price is a placeholder because no price had been published
- Inputs checked
- 2026-10-01
Every field can be changed, and the results recalculate as it is. A field is marked with the basis of its value, which links to the quote, data row, or assumption behind it. PMPM is the cost per member per month.
Target population
| Step | Input | People |
|---|---|---|
| Plan members | Assumption | 1,000,000 |
| Newly diagnosed with intrahepatic cholangiocarcinoma each year | per 100,000Quoted source | 19.9 |
| Unresectable, locally advanced or metastatic, at diagnosis or after recurrence | %Quoted source | 17.7 |
| Tumor molecular profiling performed | %Quoted source | 11.4 |
| FGFR2 fusion or rearrangement found | %Quoted source | 1.48 |
| Receives second-line or later systemic therapy | %Quoted source | 0.99 |
Treatment costs
| Input | Lirafugratinib (Lyrfigtu) | Pemigatinib (Pemazyre) | Futibatinib (Lytgobi) | Chemotherapy (FOLFOX) |
|---|---|---|---|---|
| Drug cost per cycle or pack | USDAssumption | USDPublished data | USDPublished data | USDPublished data |
| Days covered by a cycle or pack | daysQuoted source | daysQuoted source | daysQuoted source | daysQuoted source |
| Dose intensity | %Assumption | %Assumption | %Assumption | %Assumption |
| Administration cost per cycle | Not applicable | Not applicable | Not applicable | USDPublished data |
| Median time on treatment | monthsQuoted source | monthsQuoted source | monthsQuoted source | monthsQuoted source |
| Maximum time on treatment | Not applicable | Not applicable | Not applicable | monthsQuoted source |
| Adverse event cost per patient starting | USDQuoted source | USDQuoted source | USDQuoted source | USDQuoted source |
Monitoring
| Treatment | Item | Schedule | Cost per occurrence |
|---|---|---|---|
| Lirafugratinib (Lyrfigtu) | Ophthalmological examination with optical coherence tomography | Before treatment, every 2 months to month 13, then every 4 months Quoted source | USDPublished data |
| Lirafugratinib (Lyrfigtu) | Serum phosphate | Every month Assumption | USDPublished data |
| Pemigatinib (Pemazyre) | Ophthalmological examination with optical coherence tomography | Before treatment, every 2 months to month 6, then every 3 months Quoted source | USDPublished data |
| Pemigatinib (Pemazyre) | Serum phosphate | Every month Assumption | USDPublished data |
| Futibatinib (Lytgobi) | Ophthalmological examination with optical coherence tomography | Before treatment, every 2 months to month 6, then every 3 months Quoted source | USDPublished data |
| Futibatinib (Lytgobi) | Serum phosphate | Every month Assumption | USDPublished data |
Cost per patient starting treatment
| Result | Lirafugratinib (Lyrfigtu) | Pemigatinib (Pemazyre) | Futibatinib (Lytgobi) | Chemotherapy (FOLFOX) |
|---|---|---|---|---|
| Drug and administration cost per month on treatment | $29,318 | $30,578 | $28,058 | $952 |
| Mean months on treatment | 13.6 | 10.4 | 13.1 | 2.7 |
| Drug acquisition, full course | $397,594 | $317,627 | $368,364 | $381 |
| Administration, full course | $0 | $0 | $0 | $2,177 |
| Monitoring, full course | $1,101 | $885 | $1,051 | $0 |
| Adverse event management, full course | $834 | $644 | $254 | $4,113 |
| Total cost of a full course | $399,530 | $319,156 | $369,669 | $6,670 |
Results
Budget impact by year
| Result | Year 1 | Year 2 | Year 3 | 3-year total |
|---|---|---|---|---|
| Patients starting Lirafugratinib (Lyrfigtu) | 0.10 | 0.20 | 0.30 | 0.59 |
| Total cost without Lirafugratinib (Lyrfigtu) | $102,980 | $212,077 | $251,982 | $567,039 |
| Total cost with Lirafugratinib (Lyrfigtu) | $103,595 | $214,995 | $258,525 | $577,116 |
| Budget impact | +$615 | +$2,918 | +$6,543 | +$10,077 |
| Cost per member per month without Lirafugratinib (Lyrfigtu) | $0.0086 | $0.0177 | $0.0210 | $0.0158 |
| Cost per member per month with Lirafugratinib (Lyrfigtu) | $0.0086 | $0.0179 | $0.0215 | $0.0160 |
| Budget impact per member per month (PMPM) | $0.000051 | $0.00024 | $0.00055 | $0.00028 |
| Budget impact per member per year | $0.00062 | $0.0029 | $0.0065 | $0.0101 |
Year 1
Year 2
Year 3
- Without Lirafugratinib (Lyrfigtu)
- With Lirafugratinib (Lyrfigtu)
Budget impact by cost category
| Cost category | Year 1 | Year 2 | Year 3 | 3-year total |
|---|---|---|---|---|
| Drug acquisition | +$571 | +$2,822 | +$6,395 | +$9,788 |
| Administration | $0 | $0 | $0 | $0 |
| Monitoring | +$3 | +$15 | +$26 | +$45 |
| Adverse event management | +$41 | +$81 | +$122 | +$244 |
Patients starting treatment and treatment cost, by treatment
| Treatment | Mix | Year 1 starts | Year 2 starts | Year 3 starts | Year 1 cost | Year 2 cost | Year 3 cost |
|---|---|---|---|---|---|---|---|
| Lirafugratinib (Lyrfigtu) | Without | 0.00 | 0.00 | 0.00 | $0 | $0 | $0 |
| With | 0.10 | 0.20 | 0.30 | $13,333 | $41,985 | $76,953 | |
| Pemigatinib (Pemazyre) | Without | 0.34 | 0.34 | 0.34 | $44,538 | $88,645 | $102,535 |
| With | 0.30 | 0.26 | 0.21 | $39,003 | $72,093 | $73,112 | |
| Futibatinib (Lytgobi) | Without | 0.45 | 0.45 | 0.45 | $57,211 | $122,116 | $148,132 |
| With | 0.39 | 0.34 | 0.28 | $50,028 | $99,602 | $107,145 | |
| Chemotherapy (FOLFOX) | Without | 0.20 | 0.20 | 0.20 | $1,232 | $1,316 | $1,316 |
| With | 0.20 | 0.20 | 0.20 | $1,232 | $1,316 | $1,316 |
Sensitivity analysis
One-way sensitivity analysis of the 3-year budget impact
Each input is set to its low and its high value in turn, with every other value as entered above. The 12 inputs that move the result most are shown; the vertical line marks the current result, +$10,077.
Scenario analyses
| Scenario | Year 1 | Year 2 | Year 3 | 3-year total | PMPM |
|---|---|---|---|---|---|
| Values as entered above | +$615 | +$2,918 | +$6,543 | +$10,077 | $0.00028 |
| Lirafugratinib priced at parity with PemazyreThe lirafugratinib carton costs $28,129.33, the wholesale acquisition cost of pemigatinib per 28 days. | +$1,183 | +$4,709 | +$9,828 | +$15,720 | $0.00044 |
| Lirafugratinib priced at parity with LytgobiThe lirafugratinib carton costs $25,811.36, the derived wholesale acquisition cost of futibatinib per 28 days. | +$48 | +$1,128 | +$3,257 | +$4,433 | $0.00012 |
| Lirafugratinib priced at the median recent launch priceThe lirafugratinib carton costs $32,194.40, the median launch wholesale acquisition cost per 28 days of 8 oral targeted oncology products introduced in 2024 and 2025. | +$3,172 | +$10,990 | +$21,352 | +$35,514 | $0.00099 |
| Lower uptakeLirafugratinib reaches 5%, 10%, and 15% of eligible patients in years 1 to 3, drawn from pemigatinib and futibatinib in proportion to their shares. | +$306 | +$1,467 | +$3,280 | +$5,053 | $0.00014 |
| Higher uptakeLirafugratinib reaches 32%, 40%, and 40% of eligible patients, which is 40%, 50%, and 50% of the FGFR inhibitor class, the uptake NICE assumed for futibatinib against pemigatinib. | +$1,968 | +$7,865 | +$13,469 | +$23,302 | $0.00065 |
| Class expansionLirafugratinib reaches 10%, 20%, and 30% of eligible patients, with half of its share drawn from chemotherapy and half from pemigatinib and futibatinib, so the FGFR inhibitor class grows from 80% to 85%, 90%, and 95%. | +$6,665 | +$21,822 | +$40,790 | +$69,278 | $0.0019 |
| Treatment until progressionMedian time on treatment equals median progression-free survival for the three FGFR inhibitors: 11.3 months for lirafugratinib, 7.0 months for pemigatinib, and 9.0 months for futibatinib. | +$1,270 | +$6,550 | +$15,336 | +$23,156 | $0.00064 |
| Every patient with advanced disease is profiledTumor molecular profiling is performed in 100% of patients with advanced intrahepatic cholangiocarcinoma, as guidelines recommend. | +$957 | +$4,539 | +$10,175 | +$15,671 | $0.00044 |
| Lirafugratinib dose intensity of 85%Cartons of lirafugratinib are dispensed for 85% of the time on treatment, the median relative dose intensity of futibatinib in its pivotal trial. | -$1,364 | -$3,333 | -$4,926 | -$9,623 | -$0.00027 |
Inputs and sources
A value on a quoted source carries the quote as the evidence report holds it, linked to the document it came from. A value on published data names the row of the file it was read from. An assumption is a value no source states.
Plan members
1,000,000Assumption
A hypothetical health plan of 1,000,000 members, the size against which per member per month results are conventionally reported. Every result scales in proportion to plan size.
Annual incidence of intrahepatic cholangiocarcinoma
1.99 per 100,000Range 1.38 per 100,000 to 2.64 per 100,000Quoted source
The incidence of intrahepatic cholangiocarcinoma in the SEER 18 registries in 2017 was 1.99 per 100,000 person-years. The rate counts adults aged 18 years or older, is age-adjusted to the 2000 United States standard population, and is applied here to all plan members: the adult denominator overstates and the 2000 age standard understates the crude rate of a 2026 plan population. FGFR2 fusions were found only in intrahepatic tumors in the series the report holds, so extrahepatic cholangiocarcinoma is not carried through the funnel. Low: 1.38 per 100,000 in 2020 in the SEER 22 registries, which counts microscopically confirmed cases with a cholangiocarcinoma histology code. High: 1.99 x 1.032^9 = 2.64, the 2017 rate extended over the 9 years to 2026 at the annual increase of 3.2% estimated for 1999 to 2013.
“From 2001-2017, CCA, iCCA, and eCCA incidence (per 100 000 person-years) increased 43.8% (3.08 to 4.43), 148.8% (0.80 to 1.99), and 7.5% (2.28 to 2.45), respectively.”
SourceJavle et al. (2022)
“Patients were at least 18 years old at diagnosis and had iCCA (ICD-O-3 topography code C22.1) or eCCA (ICD-O-3 topography codes C24.0, C24.1, and C24.9).”
SourceJavle et al. (2022)
“Incidence rates (per 100 000 person-years [p-y]) were age-adjusted to the US Census bureau’s population for the year 2000.”
SourceJavle et al. (2022)
“In this analysis of 28,918 iCCA patients, the AAIR increased from 0.49 per 100,000 in 2000 to 1.38 in 2020 [annual percent change (APC) 6.94, 95% confidence interval (CI): 6.32 to 7.56], with a notable decline from 2019 to 2020.”
SourceWang et al. (2024b)
“Incidence rates for 2000–2020 were age-standardized to the 2000 US population in 5-year age groups.”
SourceWang et al. (2024b)
“During this period, ICC (eAPC=3.2%/year, P<0.0001) and ECC (1.8%/year, P=0.001) rates steadily increased across sex and racial/ethnic groups.”
SourceVan Dyke et al. (2019)
Unresectable, locally advanced or metastatic disease, at diagnosis or after recurrence
88.9%Range 75% to 94%Quoted source
At 8 United States centers, 543 of 611 patients with intrahepatic cholangiocarcinoma had locally advanced, primary metastatic, or recurrent metastatic disease: 543 / 611 = 88.9%. Low: 75%, the share not eligible for resection at presentation (100% - 25%), which counts no recurrence after resection. High: 75% + 25% x 75% = 93.75%, rounded to 94%, which adds recurrence in up to 75% of resected patients within 5 years.
“543 (88.9%)”
SourceSpencer et al. (2023)
“Most patients with CCA have metastatic or locally advanced (that is, unresectable) disease at presentation, and only ∼25% are eligible for resection”
SourceBanales et al. (2020)
“Despite the importance of surgical resection to overall prognosis, recurrence is common, occurring in up to 75% of patients after hepatectomy at 5 years, highlighting the importance of developing multimodality therapeutic approaches in order to improve the long-term outcomes for this aggressive cancer”
SourceBeal et al. (2021)
Tumor molecular profiling performed
64.3%Range 50.3% to 79.9%Quoted source
Genomic profiling data were available for 349 of 543 patients with advanced intrahepatic cholangiocarcinoma at 8 United States centers: 349 / 543 = 64.3%. A patient whose tumor is not profiled cannot be identified as FGFR2 fusion or rearrangement-positive. Low: 50.3%, the rate in advanced extrahepatic cholangiocarcinoma at the same centers (92 / 183), used for a setting that profiles less often. High: 79.9%, the rate in advanced cholangiocarcinoma in an Italian multicenter cohort, 2017 to 2023. No rate for United States community practice after 2020 was found.
“Genomic profiling data were available for 64.3% (n = 349/543) of patients with advanced ICC and 50.3% (n = 92/183) of patients with advanced ECC (P < .001) (Figure 1).”
SourceSpencer et al. (2023)
“EMP was performed in 79.9% of patients with advanced CCA. The rate of EMP increased significantly over time (2017–2023: +25.8%).”
SourceGenovesi et al. (2026)
FGFR2 fusion or rearrangement found among profiled tumors
13%Range 9% to 16%Quoted source
FGFR2 translocations were found in 12 of 96 intrahepatic cholangiocarcinomas in a United States series: 12 / 96 = 12.5%, reported as 13%, which is also the midpoint of the published range of 10% to 16%. Low: 9%, the frequency in primary tumor biopsies of intrahepatic cholangiocarcinoma in United States commercial profiling and among patients prescreened for the pemigatinib pivotal trial (107 / 1,206). High: 16%, the upper end of the published range.
“Thirteen (10 women, 3 men; 8%) of 156 biliary tumors harbored FGFR2 translocations, including 12 intrahepatic cholangiocarcinomas (12/96; 13%) and 1 intraductal papillary neoplasm of the bile duct.”
SourceGraham et al. (2014)
“FGFR2 fusions and rearrangements are found almost exclusively in intrahepatic cholangiocarcinoma, occurring in 10–16% of patients.”
SourceAbou-Alfa et al. (2020)
“107 (9%) of the 1206 prescreened patients had centrally confirmed FGFR2 fusions or rearrangements.”
SourceAbou-Alfa et al. (2020)
“In Pbx, Mbx, and Lbx, FGFR2 rearrangements were found in 9%, 6%, and 4%, and IDH1 mutations were identified in 16%, 5%, and 9% patients, respectively.”
SourceIsrael et al. (2021)
Receives second-line or later systemic therapy
66.7%Range 30.3% to 73.3%Quoted source
In a United States clinico-genomic database, 50 of 75 patients with advanced cholangiocarcinoma and an FGFR2 fusion or rearrangement received second-line therapy: 50 / 75 = 66.7%. The value covers receipt of first-line therapy and progression to a second line together, measured in profiled FGFR2-positive patients, which is why this step follows profiling and FGFR2 status. Low: 65.9% x 46% = 30.3%, the product of first-line treatment (388 of 589 patients with intrahepatic cholangiocarcinoma at 8 United States centers) and second-line treatment among first-line recipients in United States claims, both measured in patients not selected by FGFR2 status. High: 11 / 15 = 73.3%, patients with FGFR2 fusions evaluable for second-line treatment among those evaluable for first-line treatment at one United States center.
“As of May 2020, 571 patients met the inclusion criteria; 75 patients with FGFR2 fusions/rearrangements (median age 63 years; 64% female; 95% iCCA; 68% stage IV at initial diagnosis), and 496 patients with WT FGFR2 (median age 65 years; 48% female; 74% iCCA; 55% stage IV at initial diagnosis).”
SourceShroff et al. (2022)
“50 patients with FGFR2 fusions/rearrangements (median age 62 years; 70% female; 94% iCCA; 70% stage IV at diagnosis) received second-line therapy.”
SourceShroff et al. (2022)
“This study used the nationwide (US-based) de-identified Flatiron Health-Foundation Medicine clinico-genomic database.”
SourceShroff et al. (2022)
“388/589 (65.9%)”
SourceSpencer et al. (2023)
“Of 413 patients, 84.5% received gemcitabine-based first-line (1L) treatment, 46% received second-line treatment, and 16.5% received third-line (3L) treatment.”
SourceWang et al. (2024a)
“15”
SourceAbou-Alfa et al. (2022)
“11”
SourceAbou-Alfa et al. (2022)
Lirafugratinib, placeholder price of one 28-day carton
$26,970.35Range $25,811.36 to $32,194.40Assumption
No price for lirafugratinib had been published by 1 October 2026, so the value is a placeholder: the mean wholesale acquisition cost per 28 days of the two approved FGFR inhibitors, the class-average method of the ICER reference case applied to list prices. Pemigatinib: $21,097.00 per 21-day bottle x 28 / 21 = $28,129.33. Futibatinib: $6,452.84 per 7-day carton x 4 = $25,811.36. Mean: ($28,129.33 + $25,811.36) / 2 = $26,970.35. Low: $25,811.36, parity with futibatinib. High: $32,194.40, the median launch wholesale acquisition cost per 28 days of 8 oral targeted oncology products introduced in 2024 and 2025. Each package price is converted at an assumed supply of 30 days (Ensacove 60 x 100 mg plus 30 x 25 mg, $20,959.00; Hernexeos; Hyrnuo; Ibtrozi; Revuforj 2 packages, $39,500.00; Voranigo 40 mg; Komzifti) or 28 days (Avmapki Fakzynja Co-Pack), giving $19,561.73, $20,222.54, $22,400.00, $27,522.13, $36,866.67, $37,222.27, $45,266.67, and $48,500.00; the median is ($27,522.13 + $36,866.67) / 2 = $32,194.40. Whether the 5 daily-dose cartons will carry one price is unknown.
“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;”
“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.”
“Lyrfigtu is expected to be available to patients in the U.S. by Q4 2026.”
Table headed WAC Price (14 count bottle), data as of January 1, 2026: PEMAZYRE 13.5 mg Tablet | 50881-0028-01 | $21,097.00 (the 4.5 mg and 9 mg tablets carry the same price)
SourceIncyte Information for Colorado Prescribers of Prescription Drugs, Pemazyre (2026)
Columns Product Name | Manufacturer | NDC | Pkg Size | Package Price | Per Pill, release date October 1, 2026: LYTGOBI 20 MG Daily Dose | Taiho Oncology, Inc. | 64842-0120-06 | 35 | $7,743.41 | $221.24 (the 12 mg and 16 mg daily dose cartons carry the same package price)
SourceTaiho Oncology Information for Vermont Prescribers of Prescription Drugs, Long Form (2026)
Columns Manufacturer Name | NDC Number | Drug Product Description | Date Introduced to Market | WAC at Introduction: Xcovery Holdings, Inc. | 83076110006 | ENSACOVE, 100 MG CAPSULES, 60 CT | 2025-07-15 | 18631.0000
SourceCalifornia HCAI Prescription Drugs Introduced to Market (2025)
Columns Manufacturer Name | NDC Number | Drug Product Description | Date Introduced to Market | WAC at Introduction: Xcovery Holdings, Inc. | 83076102503 | ENSACOVE, 25 MG CAPSULES, 30 CT | 2025-07-15 | 2328.0000
SourceCalifornia HCAI Prescription Drugs Introduced to Market (2025)
Columns Manufacturer Name | NDC Number | Drug Product Description | Date Introduced to Market | WAC at Introduction: Boehringer Ingelheim | 00597925786 | Hernexeos 60mg tablets | 2025-08-08 | 21667.0100
SourceCalifornia HCAI Prescription Drugs Introduced to Market (2025)
Columns Manufacturer Name | NDC Number | Drug Product Description | Date Introduced to Market | WAC at Introduction: Bayer | 50419039701 | HYRNUO 10mg tablets, Bottle of 120 tablets | 2025-12-08 | 24000.0000
SourceCalifornia HCAI Prescription Drugs Introduced to Market (2025)
Columns Manufacturer Name | NDC Number | Drug Product Description | Date Introduced to Market | WAC at Introduction: Nuvation Bio Inc. | 84651020093 | IBTROZI™ (taletrectinib) 90 capsules 200mg | 2025-06-13 | 29488.0000
SourceCalifornia HCAI Prescription Drugs Introduced to Market (2025)
Columns Manufacturer Name | NDC Number | Drug Product Description | Date Introduced to Market | WAC at Introduction: Syndax Pharmaceuticals, Inc. | 73555050100 | REVUFORJ® (revumenib) 110mg tablet Package Quantity 30 | 2024-11-21 | 19750.0000
SourceCalifornia HCAI Prescription Drugs Introduced to Market (2024)
Columns Manufacturer Name | NDC Number | Drug Product Description | Date Introduced to Market | WAC at Introduction: Servier Pharmaceuticals LLC | 72694072840 | VORANIGO® (vorasidenib) 40 mg tablets, 30-count | 2024-08-07 | 39881.0000
SourceCalifornia HCAI Prescription Drugs Introduced to Market (2024)
Columns Manufacturer Name | NDC Number | Drug Product Description | Date Introduced to Market | WAC at Introduction: Kura Oncology, Inc. | 84696020090 | KOMZIFTI (ziftomenib) 200mg capsules, 90 ct bottle | 2025-11-20 | 48500.0000
SourceCalifornia HCAI Prescription Drugs Introduced to Market (2025)
Columns Manufacturer Name | NDC Number | Drug Product Description | Date Introduced to Market | WAC at Introduction: Verastem, Inc. | 71779062301 | Avmapki™ Fakzynja™ Co-Pack (avutometinib 24ct bottle, 0.8 mg capsule + defactinib 42ct bottle, 200 mg tablet) | 2025-05-16 | 48500.0000
SourceCalifornia HCAI Prescription Drugs Introduced to Market (2025)
Lirafugratinib, days supplied by one carton
28 daysQuoted source
The 70 mg daily dose carton holds 2 blister packs, each with twenty-eight 20 mg capsules and fourteen 30 mg capsules: 2 x (28 x 20 mg + 14 x 30 mg) = 2 x 980 mg = 1,960 mg, which is 1,960 / 70 = 28 days at the recommended 70 mg once daily.
“2 blister packs containing twenty-eight 20 mg capsules and fourteen 30 mg capsules each”
SourceElevar Therapeutics LYRFIGTU prescribing information (2026)
“The recommended dosage of LYRFIGTU is 70 mg orally once daily until disease progression or unacceptable toxicity.”
SourceElevar Therapeutics LYRFIGTU prescribing information (2026)
Lirafugratinib, share of cartons dispensed while on treatment
100%Range 85% to 100%Assumption
No relative dose intensity has been reported for lirafugratinib. The base case dispenses one carton per 28 days on treatment: a dose reduction changes the carton, and whether a lower-dose carton costs less is unknown. The Canadian reanalysis of pemigatinib set relative dose intensity to 100% for the same reason. Low: 85%, the median relative dose intensity of futibatinib in its pivotal trial (85.71%), used as an in-class analog for interruptions that delay a refill; dose reductions for adverse reactions occurred in 81% of patients who received lirafugratinib. High: 100%, the base case.
“CDA-AMC conducted a reanalysis that included: increasing pemigatinib uptake, changing the relative dose intensity to 100%, using the growth rate associated with intrahepatic CCA, removing market shares for clinical trials, assuming 85% of patients were diagnosed and unresectable and using component mFOLFOX prices sourced from DeltaPA.”
SourceCDA-AMC pemigatinib reimbursement recommendation (2025)
“Median relative dose intensity was 85.71%.”
“Dose reductions due to an adverse reaction occurred in 81% of patients who received LYRFIGTU.”
SourceElevar Therapeutics LYRFIGTU prescribing information (2026)
Lirafugratinib, median time on treatment
9.4 monthsRange 6.2 months to 11.3 monthsQuoted source
Median duration of treatment in the pivotal cohort (FGFR inhibitor-naive, chemotherapy-pretreated, N=114) was 41 weeks: 41 x 7 = 287 days, and 287 / 30.4375 = 9.4 months. Low: 27 weeks in the FGFR inhibitor-pretreated cohort, 27 x 7 / 30.4375 = 6.2 months. High: 11.3 months, the median progression-free survival, which is the duration if every patient is treated until progression.
Lirafugratinib, adverse event cost per patient starting
$834.33Range $90.64 to $4,537.06Quoted source
Expected cost per patient starting treatment: the share of patients with each grade 3 or higher event multiplied by a unit cost in 2026 US dollars, applied once at the start of treatment. Events are the clinical adverse reactions of grade 3 or higher reported in 5% or more of patients for any treatment; laboratory shifts in sodium and events the disease produces in every arm (infection, abdominal pain, hemorrhage) are left out unless reported as treatment-related. Unit costs are inflated with the medical care Consumer Price Index (January to August 2026 mean 592.435 divided by the mean of the cost year). Base unit costs: palmar-plantar erythrodysesthesia $1,316 x 592.435 / 525.276 = $1,484; stomatitis $1,687 x 1.1279 = $1,903; rash $1,370 x 1.1279 = $1,545; fatigue $416 x 1.1279 = $469 (90-day claims cost per patient with the event, 2015 to 2021 claims, no cost year stated, 2021 assumed); arthralgia $6,513 x 592.435 / 518.875 = $7,436 (hospitalization, 2020 US dollars); nail toxicity and hypophosphatemia $135.61 each, one office visit (CPT 99214: 4.06 relative value units x $33.4009), a proxy because no United States unit cost was found. Lirafugratinib (grade 3 or 4, N=116): palmar-plantar erythrodysesthesia 33% x $1,484 = $489.72; stomatitis 12% x $1,903 = $228.36; nail toxicity 12% x $135.61 = $16.27; rash 5% x $1,545 = $77.25; fatigue 3.4% x $469 = $15.95; phosphate decreased 5% x $135.61 = $6.78. Total $834.33. Low: outpatient costs for every event: palmar-plantar erythrodysesthesia $134.48 x 592.435 / 435.292 = $183 (2014 US dollars); stomatitis, rash, and arthralgia $135.61 (one office visit); nail toxicity $57.12 x 592.435 / 563.841 = $60 (topical treatment, 2024 US dollars); fatigue and hypophosphatemia $0. High: a hospitalization for every event (2020 US dollars x 592.435 / 518.875): palmar-plantar erythrodysesthesia and rash $6,480, $7,399 in 2026; stomatitis $8,930, $10,196; fatigue $7,979, $9,110; nail toxicity at the rash claims cost of $1,545; arthralgia and hypophosphatemia as in the base case. Low total: 33% x $183 + 12% x $135.61 + 12% x $60 + 5% x $135.61 = $60.39 + $16.27 + $7.20 + $6.78 = $90.64. High total: 33% x $7,399 + 12% x $10,196 + 12% x $1,545 + 5% x $7,399 + 3.4% x $9,110 + $6.78 = $2,441.67 + $1,223.52 + $185.40 + $369.95 + $309.74 + $6.78 = $4,537.06.
“33”
SourceElevar Therapeutics LYRFIGTU prescribing information (2026)
“12”
SourceElevar Therapeutics LYRFIGTU prescribing information (2026)
“5”
SourceElevar Therapeutics LYRFIGTU prescribing information (2026)
“3.4”
SourceElevar Therapeutics LYRFIGTU prescribing information (2026)
“$1,316”
SourceYorio et al. (2024)
“$1,687”
SourceYorio et al. (2024)
“$416”
SourceYorio et al. (2024)
“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).”
SourceYorio et al. (2024)
“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.”
SourceYorio et al. (2024)
“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.”
SourceSpira et al. (2026)
“134.48”
SourceGoldstein et al. (2015)
“Fatigue was assumed to have no specific medical management.”
SourceGoldstein et al. (2015)
“$6480”
SourceMcGregor et al. (2023)
“$8930”
SourceMcGregor et al. (2023)
“$7979”
SourceMcGregor et al. (2023)
“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.”
SourceMcGregor et al. (2023)
“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.”
SourceMcGregor et al. (2023)
File PPRRVU2026_Oct_nonQPP.csv, row as displayed (HCPCS, modifier, description, status, work RVU, non-facility practice expense RVU, facility practice expense RVU, malpractice RVU, non-facility total, facility total, ..., conversion factor): 99214,,Office o/p est mod 30 min,A,,1.92,2.00,,0.47,,0.14,4.06,2.53,0,XXX,0.00,0.00,0.00,0,0,0,0,0,9,,33.4009,09,0,99,0.00,0.00,0.00
SourceCMS 2026 National Physician Fee Schedule Relative Value File, October release (2026)
Table 1, adverse event costs in the United States, US dollars per unit: Onycholysis | 57.120 | 45.696 | 68.544 | Gamma
Series CUUR0000SAM (medical care, United States city average, not seasonally adjusted, 1982-84=100), monthly values January to August 2026: 590.169, 592.593, 592.286, 591.661, 593.239, 592.750, 593.781, 593.003 (mean 592.435); mean of the 12 monthly values of 2012: 414.924; 2014: 435.292; 2015: 446.752; 2020: 518.875; 2021: 525.276; 2024: 563.841
SourceBureau of Labor Statistics Consumer Price Index, medical care (2026)
Pemigatinib, wholesale acquisition cost of one 14-tablet bottle
$21,097Range $18,744.25 to $21,940.88Published data
The manufacturer's state price disclosure lists a wholesale acquisition cost of $21,097.00 per bottle of 14 tablets for each strength (4.5 mg, 9 mg, 13.5 mg), as of 1 January 2026; the California filing records the same amount after an increase of $811.00 on that date. One bottle supplies one 21-day cycle, and a dose reduction keeps 14 tablets per cycle at the same price. Low: $18,744.25, the Federal Supply Schedule price of the 13.5 mg bottle, used as a discounted price. High: $21,097.00 x 1.04 = $21,940.88, one further increase of 4%, the size of the January 2026 increase ($811.00 / $20,286.00).
Table headed WAC Price (14 count bottle), data as of January 1, 2026: PEMAZYRE 13.5 mg Tablet | 50881-0028-01 | $21,097.00 (the 4.5 mg and 9 mg tablets carry the same price)
SourceIncyte Information for Colorado Prescribers of Prescription Drugs, Pemazyre (2026)
Rx0000160,Incyte Corporation,04/29/2026,50881002801,Pemazyre (pemigatinib) 13.5 mg tablet 14 count bottle,Brand,FDA,01/01/2026,811.00,21097.00,08/30/2040,Single Source Drug
SourceCalifornia HCAI Prescription Drug Wholesale Acquisition Cost Increases (2026)
50881-0028-01 | 14 | 36F79720D0189 | Incyte Cor | PEMIGATINIB 13.5MG TAB | PEMAZYRE 13.5MG TAB | $18,744.25 | $0.00 | $13,566.17
SourceVA National Acquisition Center pharmaceutical catalog (2026)
“in bottles of 14 with child-resistant closure”
Pemigatinib, days in one treatment cycle
21 daysQuoted source
The recommended dosage is 13.5 mg once daily for 14 days followed by 7 days off, in 21-day cycles, so one bottle of 14 tablets covers 21 days.
Pemigatinib, share of bottles dispensed while on treatment
100%Assumption
One bottle is dispensed per 21-day cycle on treatment. The bottle price is the same for the 4.5 mg, 9 mg, and 13.5 mg tablets, so a dose reduction does not lower the cost of a cycle, and the Canadian reanalysis set relative dose intensity to 100%.
“CDA-AMC conducted a reanalysis that included: increasing pemigatinib uptake, changing the relative dose intensity to 100%, using the growth rate associated with intrahepatic CCA, removing market shares for clinical trials, assuming 85% of patients were diagnosed and unresectable and using component mFOLFOX prices sourced from DeltaPA.”
SourceCDA-AMC pemigatinib reimbursement recommendation (2025)
Pemigatinib, median time on treatment
7.2 monthsRange 2.8 months to 7.4 monthsQuoted source
Median time on treatment with pemigatinib in the FGFR2 fusion or rearrangement cohort of its pivotal trial was 7.2 months, as summarized in the NICE appraisal of futibatinib. Low: 2.8 months, the median real-world time to discontinuation among 93 patients starting pemigatinib in 2023 or later in United States electronic medical records and claims. High: 7.4 months, the median duration of therapy in a United States chart review of 120 patients.
“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.”
“median rwTTD was similar in both futibatinib and pemigatinib patients (2.8 vs. 2.8 months)”
SourceMahipal et al. (2026)
“Among all patients, the median DOT with pemigatinib was 7.4 months (95% CI: 6.2-8.8).”
SourceSaverno et al. (2025)
Pemigatinib, adverse event cost per patient starting
$643.78Range $23.68 to $1,745.32Quoted source
Expected cost per patient starting treatment: the share of patients with each grade 3 or higher event multiplied by a unit cost in 2026 US dollars, applied once at the start of treatment. Events are the clinical adverse reactions of grade 3 or higher reported in 5% or more of patients for any treatment; laboratory shifts in sodium and events the disease produces in every arm (infection, abdominal pain, hemorrhage) are left out unless reported as treatment-related. Unit costs are inflated with the medical care Consumer Price Index (January to August 2026 mean 592.435 divided by the mean of the cost year). Base unit costs: palmar-plantar erythrodysesthesia $1,316 x 592.435 / 525.276 = $1,484; stomatitis $1,687 x 1.1279 = $1,903; rash $1,370 x 1.1279 = $1,545; fatigue $416 x 1.1279 = $469 (90-day claims cost per patient with the event, 2015 to 2021 claims, no cost year stated, 2021 assumed); arthralgia $6,513 x 592.435 / 518.875 = $7,436 (hospitalization, 2020 US dollars); nail toxicity and hypophosphatemia $135.61 each, one office visit (CPT 99214: 4.06 relative value units x $33.4009), a proxy because no United States unit cost was found. Pemigatinib (grades 3 or 4, N=146): palmar-plantar erythrodysesthesia 4.1% x $1,484 = $60.84; stomatitis 5% x $1,903 = $95.15; nail toxicity 2.1% x $135.61 = $2.85; fatigue 4.8% x $469 = $22.51; hypophosphatemia 12% x $135.61 = $16.27; arthralgia 6% x $7,436 = $446.16. Total $643.78. Low: outpatient costs for every event: palmar-plantar erythrodysesthesia $134.48 x 592.435 / 435.292 = $183 (2014 US dollars); stomatitis, rash, and arthralgia $135.61 (one office visit); nail toxicity $57.12 x 592.435 / 563.841 = $60 (topical treatment, 2024 US dollars); fatigue and hypophosphatemia $0. High: a hospitalization for every event (2020 US dollars x 592.435 / 518.875): palmar-plantar erythrodysesthesia and rash $6,480, $7,399 in 2026; stomatitis $8,930, $10,196; fatigue $7,979, $9,110; nail toxicity at the rash claims cost of $1,545; arthralgia and hypophosphatemia as in the base case. Low total: 4.1% x $183 + 5% x $135.61 + 2.1% x $60 + 6% x $135.61 = $7.50 + $6.78 + $1.26 + $8.14 = $23.68. High total: 4.1% x $7,399 + 5% x $10,196 + 2.1% x $1,545 + 4.8% x $9,110 + $16.27 + $446.16 = $303.36 + $509.80 + $32.45 + $437.28 + $16.27 + $446.16 = $1,745.32.
“4.1”
“5”
“2.1”
“4.8”
“12”
“6”
“$1,316”
SourceYorio et al. (2024)
“$1,687”
SourceYorio et al. (2024)
“$416”
SourceYorio et al. (2024)
“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).”
SourceYorio et al. (2024)
“$6513”
SourceMcGregor et al. (2023)
“134.48”
SourceGoldstein et al. (2015)
“$6480”
SourceMcGregor et al. (2023)
“$8930”
SourceMcGregor et al. (2023)
“$7979”
SourceMcGregor et al. (2023)
File PPRRVU2026_Oct_nonQPP.csv, row as displayed (HCPCS, modifier, description, status, work RVU, non-facility practice expense RVU, facility practice expense RVU, malpractice RVU, non-facility total, facility total, ..., conversion factor): 99214,,Office o/p est mod 30 min,A,,1.92,2.00,,0.47,,0.14,4.06,2.53,0,XXX,0.00,0.00,0.00,0,0,0,0,0,9,,33.4009,09,0,99,0.00,0.00,0.00
SourceCMS 2026 National Physician Fee Schedule Relative Value File, October release (2026)
Table 1, adverse event costs in the United States, US dollars per unit: Onycholysis | 57.120 | 45.696 | 68.544 | Gamma
Series CUUR0000SAM (medical care, United States city average, not seasonally adjusted, 1982-84=100), monthly values January to August 2026: 590.169, 592.593, 592.286, 591.661, 593.239, 592.750, 593.781, 593.003 (mean 592.435); mean of the 12 monthly values of 2012: 414.924; 2014: 435.292; 2015: 446.752; 2020: 518.875; 2021: 525.276; 2024: 563.841
SourceBureau of Labor Statistics Consumer Price Index, medical care (2026)
Futibatinib, wholesale acquisition cost of one 7-day carton
$6,452.84Range $6,083 to $7,743.41Published data
No published wholesale acquisition cost was found, so the value is derived from the published average wholesale price: $7,743.41 per carton / 1.2 = $6,452.84. The ratio of 1.2 between average wholesale price and wholesale acquisition cost holds for pemigatinib ($25,316.40 / $21,097.00) and for futibatinib at launch ($7,002.00 / $5,835.00). The 12 mg, 16 mg, and 20 mg daily dose cartons carry the same price, so a dose reduction does not lower the cost of a carton. Low: $7,299.60 / 1.2 = $6,083.00, the average wholesale price published on 1 January 2025. High: $7,743.41, the average wholesale price itself.
Columns Product Name | Manufacturer | NDC | Pkg Size | Package Price | Per Pill, release date October 1, 2026: LYTGOBI 20 MG Daily Dose | Taiho Oncology, Inc. | 64842-0120-06 | 35 | $7,743.41 | $221.24 (the 12 mg and 16 mg daily dose cartons carry the same package price)
SourceTaiho Oncology Information for Vermont Prescribers of Prescription Drugs, Long Form (2026)
Columns Product | Strength | Dosage Form | Manufacturer | NDC | Package Size | AWP per package | AWP per unit, data source First Data Bank July 07, 2026: PEMAZYRE | 4.5 mg | TABLET | INCYTE CORPORAT | 50881-0026-01 | 14 | $25,316.40 | $1,808.31
SourceIncyte Information for Vermont Prescribers of Prescription Drugs, Pemazyre (2026)
Columns Manufacturer Name | NDC Number | Drug Product Description | Date Introduced to Market | WAC at Introduction: Taiho Oncology, Inc. | 64842012006 | Lytgobi tablets, 20MG (5 tablets); 4MG 35 tablet count DosePak | 2023-02-10 | 5835.0000
SourceCalifornia HCAI Prescription Drugs Introduced to Market (2023)
Columns Product Name | Manufacturer | NDC | Pkg Size | Package Price | Per Pill, release date January 1, 2025: LYTGOBI 20 MG Daily Dose | Taiho Oncology, Inc. | 64842012006 | 35 | $7,299.60 | $208.97
SourceTaiho Oncology Information for Vermont Prescribers of Prescription Drugs, Long Form (2025)
Futibatinib, days supplied by one carton
7 daysQuoted source
Each carton holds one blister card with a 7-day supply (35 tablets of 4 mg for the 20 mg daily dose), so 4 cartons cover 28 days.
Futibatinib, share of cartons dispensed while on treatment
100%Assumption
One carton is dispensed per 7 days on treatment. The carton price is the same for the 12 mg, 16 mg, and 20 mg daily doses, so a dose reduction does not lower the cost of a carton; the median relative dose intensity of 85.71% in the pivotal trial is therefore not applied to cost.
“Median relative dose intensity was 85.71%.”
“CDA-AMC conducted a reanalysis that included: increasing pemigatinib uptake, changing the relative dose intensity to 100%, using the growth rate associated with intrahepatic CCA, removing market shares for clinical trials, assuming 85% of patients were diagnosed and unresectable and using component mFOLFOX prices sourced from DeltaPA.”
SourceCDA-AMC pemigatinib reimbursement recommendation (2025)
Futibatinib, median time on treatment
9.1 monthsRange 2.8 months to 9.1 monthsQuoted source
Median time on treatment with futibatinib in its pivotal trial was 9.1 months, as summarized in the NICE appraisal. Low: 2.8 months, the median real-world time to discontinuation among 122 patients starting futibatinib in 2023 or later in United States electronic medical records and claims. High: 9.1 months, the base case; no longer duration is reported, and the median progression-free survival is 9.0 months.
“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.”
“median rwTTD was similar in both futibatinib and pemigatinib patients (2.8 vs. 2.8 months)”
SourceMahipal et al. (2026)
“At a median follow-up of 17.1 months, the median progression-free survival was 9.0 months and overall survival was 21.7 months.”
SourceGoyal et al. (2023)
Futibatinib, adverse event cost per patient starting
$254.12Range $18.25 to $1,759.59Quoted source
Expected cost per patient starting treatment: the share of patients with each grade 3 or higher event multiplied by a unit cost in 2026 US dollars, applied once at the start of treatment. Events are the clinical adverse reactions of grade 3 or higher reported in 5% or more of patients for any treatment; laboratory shifts in sodium and events the disease produces in every arm (infection, abdominal pain, hemorrhage) are left out unless reported as treatment-related. Unit costs are inflated with the medical care Consumer Price Index (January to August 2026 mean 592.435 divided by the mean of the cost year). Base unit costs: palmar-plantar erythrodysesthesia $1,316 x 592.435 / 525.276 = $1,484; stomatitis $1,687 x 1.1279 = $1,903; rash $1,370 x 1.1279 = $1,545; fatigue $416 x 1.1279 = $469 (90-day claims cost per patient with the event, 2015 to 2021 claims, no cost year stated, 2021 assumed); arthralgia $6,513 x 592.435 / 518.875 = $7,436 (hospitalization, 2020 US dollars); nail toxicity and hypophosphatemia $135.61 each, one office visit (CPT 99214: 4.06 relative value units x $33.4009), a proxy because no United States unit cost was found. Futibatinib (grade 3, N=103): palmar-plantar erythrodysesthesia 4.9% x $1,484 = $72.72; stomatitis 6% x $1,903 = $114.18; nail toxicity 1.9% x $135.61 = $2.58; fatigue 8% x $469 = $37.52; phosphate decreased (grades 3 or 4) 20% x $135.61 = $27.12. Total $254.12. Low: outpatient costs for every event: palmar-plantar erythrodysesthesia $134.48 x 592.435 / 435.292 = $183 (2014 US dollars); stomatitis, rash, and arthralgia $135.61 (one office visit); nail toxicity $57.12 x 592.435 / 563.841 = $60 (topical treatment, 2024 US dollars); fatigue and hypophosphatemia $0. High: a hospitalization for every event (2020 US dollars x 592.435 / 518.875): palmar-plantar erythrodysesthesia and rash $6,480, $7,399 in 2026; stomatitis $8,930, $10,196; fatigue $7,979, $9,110; nail toxicity at the rash claims cost of $1,545; arthralgia and hypophosphatemia as in the base case. Low total: 4.9% x $183 + 6% x $135.61 + 1.9% x $60 = $8.97 + $8.14 + $1.14 = $18.25. High total: 4.9% x $7,399 + 6% x $10,196 + 1.9% x $1,545 + 8% x $9,110 + $27.12 = $362.55 + $611.76 + $29.36 + $728.80 + $27.12 = $1,759.59.
“4.9”
“6”
“1.9”
“8”
“20”
“$1,316”
SourceYorio et al. (2024)
“$1,687”
SourceYorio et al. (2024)
“$416”
SourceYorio et al. (2024)
“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).”
SourceYorio et al. (2024)
“134.48”
SourceGoldstein et al. (2015)
“$6480”
SourceMcGregor et al. (2023)
“$8930”
SourceMcGregor et al. (2023)
“$7979”
SourceMcGregor et al. (2023)
File PPRRVU2026_Oct_nonQPP.csv, row as displayed (HCPCS, modifier, description, status, work RVU, non-facility practice expense RVU, facility practice expense RVU, malpractice RVU, non-facility total, facility total, ..., conversion factor): 99214,,Office o/p est mod 30 min,A,,1.92,2.00,,0.47,,0.14,4.06,2.53,0,XXX,0.00,0.00,0.00,0,0,0,0,0,9,,33.4009,09,0,99,0.00,0.00,0.00
SourceCMS 2026 National Physician Fee Schedule Relative Value File, October release (2026)
Table 1, adverse event costs in the United States, US dollars per unit: Onycholysis | 57.120 | 45.696 | 68.544 | Gamma
Series CUUR0000SAM (medical care, United States city average, not seasonally adjusted, 1982-84=100), monthly values January to August 2026: 590.169, 592.593, 592.286, 591.661, 593.239, 592.750, 593.781, 593.003 (mean 592.435); mean of the 12 monthly values of 2012: 414.924; 2014: 435.292; 2015: 446.752; 2020: 518.875; 2021: 525.276; 2024: 563.841
SourceBureau of Labor Statistics Consumer Price Index, medical care (2026)
FOLFOX, drug cost of one 14-day cycle
$65.18Range $57.76 to $75.15Published data
Doses of the ABC-06 regimen at a body surface area of 1.8 m2 (an assumption), costed at the October 2026 Medicare payment limits for the amount administered. Oxaliplatin 85 mg/m2 x 1.8 = 153 mg = 306 units of 0.5 mg x $0.087 = $26.62; folinic acid 350 mg = 350 units of 1 mg x $0.054 = $18.90; fluorouracil bolus 400 mg/m2 x 1.8 = 720 mg and infusion 2,400 mg/m2 x 1.8 = 4,320 mg, together 504 units of 10 mg x $0.039 = $19.66. Total $65.18. Low: $57.76, the same doses at the July 2026 payment limits (oxaliplatin 306 x $0.055 = $16.83; leucovorin 350 mg / 50 mg x $2.932 = $20.52; fluorouracil 5,040 mg / 500 mg x $2.024 = $20.40). High: $75.15, whole vials billed with the discarded amount at the October 2026 limits (oxaliplatin 200 mg = 400 units x $0.087 = $34.80; leucovorin 350 mg, $18.90; fluorouracil 5,500 mg = 550 units x $0.039 = $21.45).
“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.”
SourceLamarca et al. (2021)
File section 508 version of October 2026 Medicare Part B Payment Limit File 091626.csv, columns HCPCS Code, Short Description, HCPCS Code Dosage, Payment Limit: J9263,Oxaliplatin,0.5 MG,0.087
SourceCMS October 2026 Medicare Part B Payment Limit File (2026)
File section 508 version of October 2026 Medicare Part B Payment Limit File 091626.csv, columns HCPCS Code, Short Description, HCPCS Code Dosage, Payment Limit: J0643,Inj leucovorin calcium 1 mg,1 MG,0.054
SourceCMS October 2026 Medicare Part B Payment Limit File (2026)
File section 508 version of October 2026 Medicare Part B Payment Limit File 091626.csv, columns HCPCS Code, Short Description, HCPCS Code Dosage, Payment Limit: J9192,"Inj, fluorouracil, 10 mg",10 MG,0.039
SourceCMS October 2026 Medicare Part B Payment Limit File (2026)
File section 508 version of July 2026 Medicare Part B Payment Limit File updated 082026.csv, columns HCPCS Code, Short Description, HCPCS Code Dosage, Payment Limit: J9263,Oxaliplatin,0.5 MG,0.055
SourceCMS July 2026 Medicare Part B Payment Limit File (2026)
File section 508 version of July 2026 Medicare Part B Payment Limit File updated 082026.csv, columns HCPCS Code, Short Description, HCPCS Code Dosage, Payment Limit: J0640,Leucovorin calcium injection,50 MG,2.932
SourceCMS July 2026 Medicare Part B Payment Limit File (2026)
File section 508 version of July 2026 Medicare Part B Payment Limit File updated 082026.csv, columns HCPCS Code, Short Description, HCPCS Code Dosage, Payment Limit: J9190,Fluorouracil injection,500 MG,2.024
SourceCMS July 2026 Medicare Part B Payment Limit File (2026)
FOLFOX, days in one treatment cycle
14 daysQuoted source
FOLFOX was given every 2 weeks in ABC-06, so one cycle covers 14 days.
FOLFOX, share of the planned dose given
100%Range 78% to 100%Assumption
The base case costs every cycle at the full planned dose. No relative dose intensity was reported in ABC-06. Low: 78%, the relative dose intensity for FOLFOX that a NICE committee accepted in an appraisal of a second-line comparator. High: 100%, the base case. The model applies this value to the drug cost alone.
FOLFOX, administration cost of one cycle
$372.76Range $372.76 to $822.04Published data
National non-facility payment under the 2026 Medicare Physician Fee Schedule, total non-facility relative value units x the conversion factor of $33.4009: chemotherapy infusion, first hour (96413) 3.99 x 33.4009 = $133.27; additional hour (96415) 0.85 x 33.4009 = $28.39; concurrent infusion of folinic acid (96368) 0.62 x 33.4009 = $20.71; push of an additional drug for the fluorouracil bolus (96411) 1.71 x 33.4009 = $57.12; prolonged infusion with a pump (96416) 3.99 x 33.4009 = $133.27. Sum $372.76. The coding follows the ABC-06 schedule and is an assumption. Low: $372.76, the base case; no lower sourced amount was found. High: $822.04, the hospital outpatient payment rates of October 2026 for 96413 ($337.46), 96415 ($73.56), 96411 ($73.56), and 96416 ($337.46), where the concurrent infusion and the generic drugs are packaged.
File PPRRVU2026_Oct_nonQPP.csv, row as displayed (HCPCS, modifier, description, status, work RVU, non-facility practice expense RVU, facility practice expense RVU, malpractice RVU, non-facility total, facility total, ..., conversion factor): 96413,,Chemo iv infusion 1 hr,A,,0.28,3.64,,3.64,NA,0.07,3.99,3.99,5,XXX,0.00,0.00,0.00,0,0,0,0,0,9,,33.4009,09,0,99,0.00,0.00,0.00
SourceCMS 2026 National Physician Fee Schedule Relative Value File, October release (2026)
File PPRRVU2026_Oct_nonQPP.csv, row as displayed (HCPCS, modifier, description, status, work RVU, non-facility practice expense RVU, facility practice expense RVU, malpractice RVU, non-facility total, facility total, ..., conversion factor): 96415,,Chemo iv infusion addl hr,A,,0.19,0.64,,0.64,NA,0.02,0.85,0.85,5,ZZZ,0.00,0.00,0.00,0,0,0,0,0,9,,33.4009,09,0,99,0.00,0.00,0.00
SourceCMS 2026 National Physician Fee Schedule Relative Value File, October release (2026)
File PPRRVU2026_Oct_nonQPP.csv, row as displayed (HCPCS, modifier, description, status, work RVU, non-facility practice expense RVU, facility practice expense RVU, malpractice RVU, non-facility total, facility total, ..., conversion factor): 96368,,Ther/diag concurrent inf,A,,0.17,0.44,,0.44,NA,0.01,0.62,0.62,5,ZZZ,0.00,0.00,0.00,0,0,0,0,0,9,,33.4009,09,0,99,0.00,0.00,0.00
SourceCMS 2026 National Physician Fee Schedule Relative Value File, October release (2026)
File PPRRVU2026_Oct_nonQPP.csv, row as displayed (HCPCS, modifier, description, status, work RVU, non-facility practice expense RVU, facility practice expense RVU, malpractice RVU, non-facility total, facility total, ..., conversion factor): 96411,,Chemo iv push addl drug,A,,0.20,1.48,,1.48,NA,0.03,1.71,1.71,5,ZZZ,0.00,0.00,0.00,0,0,0,0,0,9,,33.4009,09,0,99,0.00,0.00,0.00
SourceCMS 2026 National Physician Fee Schedule Relative Value File, October release (2026)
File PPRRVU2026_Oct_nonQPP.csv, row as displayed (HCPCS, modifier, description, status, work RVU, non-facility practice expense RVU, facility practice expense RVU, malpractice RVU, non-facility total, facility total, ..., conversion factor): 96416,,Chemo prolong infuse w/pump,A,,0.21,3.71,,3.71,NA,0.07,3.99,3.99,5,XXX,0.00,0.00,0.00,0,0,0,0,0,9,,33.4009,09,0,99,0.00,0.00,0.00
SourceCMS 2026 National Physician Fee Schedule Relative Value File, October release (2026)
File 508-compliant-version-2026_October_Web_Addendum_B.09.28.26.csv, columns HCPCS Code, Short Descriptor, Status Indicator, APC, Relative Weight, Payment Rate: 96413,Chemo iv infusion 1 hr,S,5694,3.6915,$337.46
SourceCMS Hospital Outpatient Prospective Payment System Addendum B, October 2026 (2026)
File 508-compliant-version-2026_October_Web_Addendum_B.09.28.26.csv, columns HCPCS Code, Short Descriptor, Status Indicator, APC, Relative Weight, Payment Rate: 96415,Chemo iv infusion addl hr,S,5692,0.8047,$73.56
SourceCMS Hospital Outpatient Prospective Payment System Addendum B, October 2026 (2026)
File 508-compliant-version-2026_October_Web_Addendum_B.09.28.26.csv, columns HCPCS Code, Short Descriptor, Status Indicator, APC, Relative Weight, Payment Rate: 96411,Chemo iv push addl drug,S,5692,0.8047,$73.56
SourceCMS Hospital Outpatient Prospective Payment System Addendum B, October 2026 (2026)
File 508-compliant-version-2026_October_Web_Addendum_B.09.28.26.csv, columns HCPCS Code, Short Descriptor, Status Indicator, APC, Relative Weight, Payment Rate: 96416,Chemo prolong infuse w/pump,S,5694,3.6915,$337.46
SourceCMS Hospital Outpatient Prospective Payment System Addendum B, October 2026 (2026)
“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.”
SourceLamarca et al. (2021)
FOLFOX, median time on treatment
2.3 monthsRange 0.9 months to 2.8 monthsQuoted source
The median number of cycles received in ABC-06 was 5, with a median of 70 days between the first and last doses: 5 x 14 = 70 days, and 70 / 30.4375 = 2.3 months. Low and high: the interquartile range of 2 to 6 cycles, 2 x 14 / 30.4375 = 0.9 months and 6 x 14 / 30.4375 = 2.8 months.
FOLFOX, maximum duration
5.5 monthsQuoted source
FOLFOX was given for a maximum of 12 cycles in ABC-06: 12 x 14 = 168 days, and 168 / 30.4375 = 5.5 months.
FOLFOX, adverse event cost per patient starting
$4,112.53Range $813.21 to $7,669.73Quoted source
Expected cost per patient starting treatment: the share of the 81 patients assigned to FOLFOX in ABC-06 with each chemotherapy-related grade 3 to 5 event, multiplied by a unit cost in 2026 US dollars (medical care Consumer Price Index, January to August 2026 mean 592.435 divided by the mean of the cost year), applied once at the start of treatment. Fatigue or lethargy 9 / 81 x $469 ($416 x 592.435 / 525.276) = $52.11; neutropenia (8 + 2) / 81 x $7,056 ($5,321 in 2015 US dollars x 592.435 / 446.752) = $871.11; febrile neutropenia (1 + 1) / 81 x $35,367 ($24,770 per hospitalization in 2012 US dollars x 592.435 / 414.924) = $873.26; infection (6 + 1 + 1) / 81 x $23,450 ($17,230 per hospitalization for cellulitis in 2014 US dollars x 592.435 / 435.292, a site-specific proxy) = $2,316.05. Total $4,112.53. Low: outpatient management of neutropenia ($2,087.69 x 1.3610 = $2,841) and infection ($112.65 x 1.3610 = $153), the lower published hospitalization cost for febrile neutropenia ($12,689 x 1.4278 = $18,118), and no cost for fatigue: 10 / 81 x $2,841 + 8 / 81 x $153 + 2 / 81 x $18,118 = $350.74 + $15.11 + $447.36 = $813.21. High: severe-event costs of $17,181 for neutropenia and $21,929 for pneumonia in 2015 US dollars (x 1.3261 = $22,784 and $29,080), a hospitalization for fatigue ($7,979 x 1.1418 = $9,110), and the upper published cost for febrile neutropenia ($27,587 x 1.4278 = $39,389): 10 / 81 x $22,784 + 9 / 81 x $9,110 + 8 / 81 x $29,080 + 2 / 81 x $39,389 = $2,812.84 + $1,012.22 + $2,872.10 + $972.57 = $7,669.73.
“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”
SourceLamarca et al. (2021)
“9 (11%)”
SourceLamarca et al. (2021)
“8 (10%)”
SourceLamarca et al. (2021)
“2 (2%)”
SourceLamarca et al. (2021)
“6 (7%)”
SourceLamarca et al. (2021)
“1 (1%)”
SourceLamarca et al. (2021)
“$416”
SourceYorio et al. (2024)
“5,321.00”
SourceXie et al. (2025)
“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.”
SourceTai et al. (2017)
“All costs are in 2012 US dollars.”
SourceTai et al. (2017)
“ranged from $12,689 to $27,587”
SourceTai et al. (2017)
“17,230”
SourceBilir et al. (2016)
“2087.69”
SourceBilir et al. (2016)
“112.65”
SourceBilir et al. (2016)
“$7979”
SourceMcGregor et al. (2023)
Figure 4 (incremental cost of severe adverse events per treatment episode, 2015 US dollars), values printed in the figure: Neutropenia $17,181; Pneumonitis/pneumonia $21,929
SourceWong et al. (2018)
Series CUUR0000SAM (medical care, United States city average, not seasonally adjusted, 1982-84=100), monthly values January to August 2026: 590.169, 592.593, 592.286, 591.661, 593.239, 592.750, 593.781, 593.003 (mean 592.435); mean of the 12 monthly values of 2012: 414.924; 2014: 435.292; 2015: 446.752; 2020: 518.875; 2021: 525.276; 2024: 563.841
SourceBureau of Labor Statistics Consumer Price Index, medical care (2026)
Ophthalmological examination with optical coherence tomography, cost of one visit
$159.99Range $123.25 to $182.37Published data
National non-facility payment under the 2026 Medicare Physician Fee Schedule, total non-facility relative value units x the conversion factor of $33.4009: comprehensive ophthalmological examination, established patient (92014) 3.81 x 33.4009 = $127.26, plus retinal optical coherence tomography (92134) 0.98 x 33.4009 = $32.73. Sum $159.99. Billing both codes at one visit is an assumption. The examination before treatment is costed at the same amount, although a new-patient examination (92004) pays $149.64. Low: $123.25, an intermediate examination (92012) 2.71 x 33.4009 = $90.52 plus $32.73. High: $182.37, a new-patient examination (92004) 4.48 x 33.4009 = $149.64 plus $32.73 at every visit.
File PPRRVU2026_Oct_nonQPP.csv, row as displayed (HCPCS, modifier, description, status, work RVU, non-facility practice expense RVU, facility practice expense RVU, malpractice RVU, non-facility total, facility total, ..., conversion factor): 92014,,Compre oph exam est pt 1/>,A,,1.42,2.35,,0.40,,0.04,3.81,1.86,0,XXX,0.00,0.00,0.00,0,2,0,0,0,9,,33.4009,09,0,99,0.00,0.00,0.00
SourceCMS 2026 National Physician Fee Schedule Relative Value File, October release (2026)
File PPRRVU2026_Oct_nonQPP.csv, row as displayed (HCPCS, modifier, description, status, work RVU, non-facility practice expense RVU, facility practice expense RVU, malpractice RVU, non-facility total, facility total, ..., conversion factor): 92134,,Cptrz oph dx img pst sgm rta,A,,0.31,0.65,,0.65,NA,0.02,0.98,0.98,1,XXX,0.00,0.00,0.00,7,2,0,0,0,9,,33.4009,09,0,99,1.97,1.97,0.05
SourceCMS 2026 National Physician Fee Schedule Relative Value File, October release (2026)
File PPRRVU2026_Oct_nonQPP.csv, row as displayed (HCPCS, modifier, description, status, work RVU, non-facility practice expense RVU, facility practice expense RVU, malpractice RVU, non-facility total, facility total, ..., conversion factor): 92012,,Intrm oph exam est patient,A,,0.92,1.76,,0.29,,0.03,2.71,1.24,0,XXX,0.00,0.00,0.00,0,2,0,0,0,9,,33.4009,09,0,99,0.00,0.00,0.00
SourceCMS 2026 National Physician Fee Schedule Relative Value File, October release (2026)
File PPRRVU2026_Oct_nonQPP.csv, row as displayed (HCPCS, modifier, description, status, work RVU, non-facility practice expense RVU, facility practice expense RVU, malpractice RVU, non-facility total, facility total, ..., conversion factor): 92004,,Compre oph exam new pt 1/>,A,,1.82,2.62,,0.47,,0.04,4.48,2.33,0,XXX,0.00,0.00,0.00,0,2,0,0,0,9,,33.4009,09,0,99,0.00,0.00,0.00
SourceCMS 2026 National Physician Fee Schedule Relative Value File, October release (2026)
Serum phosphate test, cost of one test
$4.74Range $4.74 to $14.08Published data
The 2026 Medicare Clinical Laboratory Fee Schedule rate for assay of phosphorus (84100) is $4.74. The blood draw is assumed to be shared with the routine tests of an oncology visit. Low: $4.74, the base case. High: $4.74 + $9.34 = $14.08, which adds a venipuncture (36415) for a test drawn alone.
File PUF_CLFS_CY2026_Q4V1.csv, columns YEAR, HCPCS, MOD, EFF_DATE, INDICATOR, RATE, SHORTDESC: 2026,84100,,20260101,N,00004.74,Assay of phosphorus
SourceCMS Clinical Laboratory Fee Schedule, 2026 fourth quarter (2026)
File PUF_CLFS_CY2026_Q4V1.csv, columns YEAR, HCPCS, MOD, EFF_DATE, INDICATOR, RATE, SHORTDESC: 2026,36415,,20260101,N,00009.34,Coll venous bld venipuncture
SourceCMS Clinical Laboratory Fee Schedule, 2026 fourth quarter (2026)
Ophthalmological examination with optical coherence tomography schedule, Lirafugratinib (Lyrfigtu)
Before treatment, every 2 months to month 13, then every 4 monthsQuoted source
The label requires an examination before the first dose, every 2 months for the first 13 months, and every 4 months afterwards. Intervals are read as calendar months since the start of treatment. Unscheduled examinations for visual symptoms are not counted.
Serum phosphate schedule, Lirafugratinib (Lyrfigtu)
Every monthAssumption
The label calls for monitoring of serum phosphate and states no frequency. One test per month on treatment is assumed for each FGFR inhibitor, close to the schedule of the futibatinib pivotal trial after the first cycle (day 1 of each 21-day cycle). The additional tests of the first cycle and the weekly tests during phosphate-lowering therapy are not counted.
Ophthalmological examination with optical coherence tomography schedule, Pemigatinib (Pemazyre)
Before treatment, every 2 months to month 6, then every 3 monthsQuoted source
The label requires an examination before the first dose, every 2 months for the first 6 months, and every 3 months afterwards. Intervals are read as calendar months since the start of treatment. Unscheduled examinations for visual symptoms are not counted.
Serum phosphate schedule, Pemigatinib (Pemazyre)
Every monthAssumption
The label calls for monitoring of serum phosphate and states no frequency. One test per month on treatment is assumed for each FGFR inhibitor, close to the schedule of the futibatinib pivotal trial after the first cycle (day 1 of each 21-day cycle). The additional tests of the first cycle and the weekly tests during phosphate-lowering therapy are not counted.
“Monitor for hyperphosphatemia and initiate a low phosphate diet when serum phosphate level is > 5.5 mg/dL. For serum phosphate levels > 7 mg/dL, initiate phosphate lowering therapy and withhold, reduce the dose, or permanently discontinue PEMAZYRE based on duration and severity of hyperphosphatemia”
“Serum phosphate levels were measured on days 1, 4, 8, and 15 of cycle 1 and on day 1 of every cycle thereafter.”
SourceGoyal et al. (2023)
Ophthalmological examination with optical coherence tomography schedule, Futibatinib (Lytgobi)
Before treatment, every 2 months to month 6, then every 3 monthsQuoted source
The label requires an examination before the first dose, every 2 months for the first 6 months, and every 3 months afterwards. Intervals are read as calendar months since the start of treatment. Unscheduled examinations for visual symptoms are not counted.
Serum phosphate schedule, Futibatinib (Lytgobi)
Every monthAssumption
The label calls for monitoring of serum phosphate and states no frequency. One test per month on treatment is assumed for each FGFR inhibitor, close to the schedule of the futibatinib pivotal trial after the first cycle (day 1 of each 21-day cycle). The additional tests of the first cycle and the weekly tests during phosphate-lowering therapy are not counted.
“Monitor for hyperphosphatemia throughout treatment. Initiate a low phosphate diet and phosphate lowering therapy when serum phosphate level is ≥5.5 mg/dL. For serum phosphate levels >7 mg/dL, initiate or intensify phosphate lowering therapy and dose reduce, withhold, or permanently discontinue LYTGOBI based on duration and severity of hyperphosphatemia”
“Serum phosphate levels were measured on days 1, 4, 8, and 15 of cycle 1 and on day 1 of every cycle thereafter.”
SourceGoyal et al. (2023)
Methods and limitations
Methods
- The model follows the structure of the ISPOR budget impact analysis good practice report (Sullivan et al., 2014): an eligible population, a treatment mix without and with the new product, the cost of each mix in each year, and the difference between the two.
- The eligible population is incidence-based. Plan members are multiplied in turn by the annual incidence of intrahepatic cholangiocarcinoma, the share with unresectable, locally advanced or metastatic disease, the share whose tumor is profiled, the share with an FGFR2 fusion or rearrangement, and the share who receive second-line or later systemic therapy. The same number of patients becomes eligible in each of the 3 years.
- Profiling and FGFR2 status come before the treatment-line step because the only United States estimates of second-line treatment in FGFR2-positive patients were measured in patients already profiled, and they are about twice the rate in patients not selected by FGFR2 status (66.7% against 65.9% x 46% = 30.3%).
- Two treatment mixes are compared: pemigatinib, futibatinib, and chemotherapy (FOLFOX) without lirafugratinib, and the same treatments with lirafugratinib taking a share that rises over 3 years. Chemotherapy takes whatever share the FGFR inhibitors leave, so each year totals 100%.
- Four cost categories are counted: drug acquisition, administration of FOLFOX, monitoring (ophthalmological examination with optical coherence tomography, and serum phosphate), and management of grade 3 or higher adverse events.
- Costs fall in the calendar year in which they are incurred. Patients start treatment evenly through each year and leave it along an exponential curve fitted to the median time on treatment, so a course that runs past the end of a year is paid for in the next one; FOLFOX stops at 12 cycles.
- Costs are not discounted and prices are not inflated over the 3 years.
- Oral agents are costed at wholesale acquisition cost as of 1 October 2026 without rebates; FOLFOX, administration, examinations, and laboratory tests are costed at Medicare payment amounts for 2026. The lirafugratinib price is a placeholder.
- Uncertainty is shown by a one-way sensitivity analysis over every input with a low and a high value, and by 9 scenarios on price, uptake, the source of the lirafugratinib share, time on treatment, profiling, and dose intensity.
Limitations
- No price for lirafugratinib had been published by 1 October 2026. The base case uses a placeholder, the mean list price of the two approved FGFR inhibitors, and the result changes almost in proportion to it. Whether the cartons for reduced doses will cost less is unknown; dose reductions occurred in 81% of patients in the pivotal cohort.
- No United States data on the division of second-line treatment between FGFR inhibitors and chemotherapy in this population were found. Every market share is an assumption, including the uptake of lirafugratinib.
- The funnel ends in patients who receive second-line or later systemic therapy, so patients given best supportive care alone are outside the eligible population and the model does not show a change in how many patients are treated. All chemotherapy is costed as FOLFOX; other regimens and clinical trial treatment are not costed separately.
- Time on treatment comes from single-arm trials. The lirafugratinib median of 41 weeks was reported while some patients were still on treatment, and a single exponential curve fits the labeled exposure (73% at 6 months, 37% beyond 12 months) only approximately. One United States dataset reported a median time to discontinuation of 2.8 months for both approved FGFR inhibitors, which the low bounds carry.
- The shares with advanced disease and with tumor profiling come from 8 academic centers and from diagnoses since 2009. No rate for community practice after 2020 was found. The incidence rate is for adults, age-adjusted to the 2000 standard population, and dates from 2017.
- The model counts FGFR inhibitor-naive patients becoming eligible each year. The label does not exclude patients previously treated with an FGFR inhibitor, and the existing pool of such patients at launch is not counted; its size is unknown.
- Rebates, discounts, and patient cost sharing are not deducted. The futibatinib wholesale acquisition cost is derived from its published average wholesale price divided by 1.2. A commercial plan's payment rates for services differ from the Medicare amounts used.
- Costs left out: phosphate binders (at most about $137 per treated patient, for futibatinib), diagnostic testing (the same in both mixes), disease management, end-of-life care, and any treatment after the modeled line.
- Adverse event costs rest on unit costs from other cancers, on proxies where no United States cost exists (nail toxicity, hypophosphatemia), and on an assumed cost year for one claims study. Two unit costs in the high bound for FOLFOX are values printed in a figure and one in the low bounds comes from a preprint. Adverse event rates come from separate single-arm trials and are not adjusted for differences between their populations.
- No published United States budget impact model or per member per month benchmark for an FGFR inhibitor in cholangiocarcinoma was found. The base case of 0.99 eligible patients per 1,000,000 members per year compares with 0.62 and 0.89 per 1,000,000 population in the two NICE resource impact assessments and 3.77 per 1,000,000 in the sponsor's Canadian budget impact analysis of pemigatinib.
- With about 1 eligible patient per 1,000,000 members per year, a plan of this size will see whole patients in some years and none in others; the results are expected values.