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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 report

Modeling overview

24 evidence topics · 23 sources

Summary

No cost-effectiveness analysis, budget impact model, or health technology assessment of lirafugratinib was identified, and no price had been announced as of September 2026. Elevar Therapeutics expects United States availability by the fourth quarter of 2026. Under the December 2024 license, Relay Therapeutics is eligible for up to $75 million in upfront and regulatory milestones, up to $425 million in commercial milestones, and tiered royalties up to the low-teens percentage; by June 30, 2026 Relay had received $5.0 million on execution, $3.7 million on transfer of materials, and $10.0 million in milestone payments, and remained eligible for up to $485.0 million.

Comparator economics come from pemigatinib and futibatinib. Canada's Drug Agency recommended reimbursement of pemigatinib in 2025 on condition of a price reduction, after a 2022 recommendation not to reimburse; its reanalysis estimated incremental cost-effectiveness ratios of $252,718 and $261,226 per quality-adjusted life-year versus active symptom control alone and mFOLFOX plus active symptom control, and price reductions exceeding 95% would be needed to reach $50,000 per quality-adjusted life-year. From a Taiwanese payer perspective, pemigatinib was not cost-effective over 5 years at a hypothesized price (NT$5,814,700 per quality-adjusted life-year versus mFOLFOX), whereas a lifetime analysis using final FIGHT-202 data estimated US$83,475 per quality-adjusted life-year, below the threshold applied. A Greek analysis estimated €69,928 per quality-adjusted life-year versus mFOLFOX plus active symptom control, and a United States conference poster comparing pemigatinib with gemcitabine and cisplatin reported an overall survival-based incremental cost-effectiveness ratio of $183,628. NICE recommended pemigatinib in July 2021 (TA722) as a life-extending treatment at the end of life, on condition of a commercial arrangement; the company's base-case incremental cost-effectiveness ratios, including an updated patient access scheme, were £42,076 and £45,029 per quality-adjusted life-year gained compared with mFOLFOX plus active symptom control and active symptom control alone, the committee-preferred assumptions gave between £45,051 and £45,808 and between £44,354 and £45,010, against an upper limit of £50,000 per quality-adjusted life-year gained for a life-extending treatment at the end of life. NICE recommended futibatinib (TA1005) as an alternative to pemigatinib, which it concluded was the only relevant comparator: matching-adjusted indirect comparison hazard ratios for futibatinib compared with pemigatinib were 0.95 (95% CI 0.72 to 1.21) for overall survival and 1.07 (95% CI 0.86 to 1.30) for progression-free survival, a cost comparison found similar costs, and all incremental cost-effectiveness ratios are confidential because of the confidential pemigatinib discount. A second Taiwanese analysis of a biomarker-driven regimen (pemigatinib for FGFR2 fusion-positive and mFOLFOX for fusion-negative intrahepatic cholangiocarcinoma) against fluorouracil estimated NT$3,411,098 per quality-adjusted life-year, with a probability of cost-effectiveness of 53.2%, and a positive incremental net monetary benefit when the price of pemigatinib was reduced by 40%. No Institute for Clinical and Economic Review assessment was identified. A systematic review of 20 economic studies in biliary tract cancer concluded that most current-price targeted agents were not cost-effective in the jurisdictions studied. Worldwide net revenue of pemigatinib across all indications was $86.7 million in 2025.

Economic model, cost-effectiveness analysis, or health technology assessment of lirafugratinib

No evidence found.

Announced price of lirafugratinib

No evidence found.

Announced United States launch timing for lirafugratinib

“Lyrfigtu is expected to be available to patients in the U.S. by Q4 2026.” (opens the source at this quote in a new tab)

“FDA approval does not guarantee commercial success or any particular level of market adoption, reimbursement, revenue generation, or clinical outcomes in broader patient populations.” (opens the source at this quote in a new tab)

Partnership economics for lirafugratinib: Elevar Therapeutics license terms

“Relay Therapeutics has potential to receive up to $500 million in upfront, regulatory and commercial milestone payments, including $75 million in upfront and regulatory milestones, plus up to double digit royalties on global sales” (opens the source at this quote in a new tab)

“Elevar will assume full responsibility for all further development activities, including submission of the NDAs, all subsequent clinical development, and global commercialization for FGFR2-driven CCA and FGFR2-altered other solid tumors.” (opens the source at this quote in a new tab)

“Relay Therapeutics is eligible to receive up to $75 million in upfront and regulatory milestones, plus up to $425 million in potential commercial milestone payments, as well as tiered royalties up to the low-teens percentage.” (opens the source at this quote in a new tab)

Partnership economics for lirafugratinib: payments received and milestones outstanding

“In December 2024, we and Elevar Therapeutics, Inc., or Elevar, entered into an exclusive global licensing agreement, or the Elevar Agreement, pursuant to which Elevar was granted global development and commercialization rights for lirafugratinib.” (opens the source at this quote in a new tab)

“Under the terms of the Elevar Agreement, we received $5.0 million upon execution, $3.7 million upon transfer of active pharmaceutical ingredient and other materials, and $10.0 million in milestone payments as of June 30, 2026.” (opens the source at this quote in a new tab)

“We are eligible to receive up to $485.0 million in regulatory and commercial milestone payments, as well as tiered royalties.” (opens the source at this quote in a new tab)

“During the six months ended June 30, 2026 the Company recognized $3.4 million of revenue from the Elevar Agreement, specifically upon receipt of certain milestone payments, as well as upon transfer of active pharmaceutical ingredient and other materials.” (opens the source at this quote in a new tab)

“During the year ended December 31, 2025, we recognized $15.4 million of license and other revenue from the Elevar Agreement, specifically in connection with the completion of each of our performance obligations thereunder in 2025, as well as receipt of certain milestone payments.” (opens the source at this quote in a new tab)

“In connection therewith, certain milestone payments and royalties were excluded from the transaction price as of December 31, 2025, because such payments were variable consideration fully constrained.” (opens the source at this quote in a new tab)

Systematic review of published economic evidence in biliary tract cancer

“Twenty studies were included: 13 cost-effectiveness or cost–utility analyses and seven cost-of-illness or resource-use studies.” (opens the source at this quote in a new tab)

“First-line immunotherapy combinations and biomarker-directed targeted therapies frequently produced ICERs above jurisdiction-specific willingness-to-pay thresholds at current prices, often requiring substantial price reductions to approach cost-effectiveness.” (opens the source at this quote in a new tab)

“Real-world studies showed high resource use and costs, particularly with hospitalizations and later treatment lines.” (opens the source at this quote in a new tab)

“A central finding is that most current-price immunotherapies and targeted agents were not cost-effective in the jurisdictions studied.” (opens the source at this quote in a new tab)

Economic evidence specific to the second-line setting in biliary tract cancer

“The second-line economic literature was relatively sparse and concentrated on biomarker-selected therapies rather than on cytotoxic chemotherapy.” (opens the source at this quote in a new tab)

“we did not identify a dedicated peer-reviewed cost-effectiveness analysis of FOLFOX versus active symptom control in BTC” (opens the source at this quote in a new tab)

“Overall, the second-line evidence supports a cautious interpretation: targeted agents may offer clinically relevant options for molecularly selected patients, but at current prices, they have generally not been shown to be cost-effective in the jurisdictions studied.” (opens the source at this quote in a new tab)

Cost-effectiveness analyses of pemigatinib in previously treated intrahepatic cholangiocarcinoma

“Pemigatinib was not cost-effective at the hypothesized price of NT $17,820/13.5 mg.” (opens the source at this quote in a new tab)

“The ICER versus mFOLFOX and 5-FU was NT $3,411,098/QALY” (opens the source at this quote in a new tab)

“ICER vs. mFOLFOX: NT $6,268,528/QALY; vs. 5-FU/LV: NT $5,670,555/QALY” (opens the source at this quote in a new tab)

Net product revenue of pemigatinib, all indications worldwide

“The following table presents our disaggregated revenues for the periods presented (in thousands):” (opens the source at this quote in a new tab)

YearPEMAZYRE revenues, net (USD thousands)
2025“86,727”
2024“81,748”
2023“83,642”

Health technology assessment of pemigatinib in Canada: 2025 reimbursement recommendation

“Canada’s Drug Agency (CDA-AMC) recommends that Pemazyre be reimbursed by public drug plans for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma (CCA) with an FGFR2 fusion or other rearrangement if certain conditions are met.” (opens the source at this quote in a new tab)

“Pemazyre should only be reimbursed if prescribed by clinicians with expertise in managing patients with gastrointestinal malignancies and if the cost of Pemazyre is reduced.” (opens the source at this quote in a new tab)

“Based on the CDA-AMC assessment of the health economic evidence, Pemazyre does not represent good value to the health care system at the public list price. A price reduction is therefore required.” (opens the source at this quote in a new tab)

“The cost-effectiveness of pemigatinib is highly uncertain due to the high degree of uncertainty of the magnitude of clinical benefit of pemigatinib compared with ASC alone and mFOLFOX plus ASC.” (opens the source at this quote in a new tab)

“In 2022, pemigatinib was reviewed by CDA-AMC for the treatment of adult patients with previously treated, unresectable, locally advanced, or metastatic CCA with an FGFR2 fusion or other rearrangement and received a do not reimburse recommendation.” (opens the source at this quote in a new tab)

Health technology assessment of pemigatinib in Canada: 2022 reimbursement recommendation

“The pCODR Expert Review Committee (pERC) recommends that pemigatinib not be reimbursed for the treatment of adults with previously treated, unresectable locally advanced, or metastatic cholangiocarcinoma (CCA) with a FGFR2 fusion or other rearrangement.” (opens the source at this quote in a new tab)

Health technology assessment of pemigatinib in England, as reported by the manufacturer

“In July 2021, the U.K.’s National Institute for Health and Care Excellence (“NICE”) recommended PEMAZYRE for patients with cholangiocarcinoma with an FGFR2 fusion or rearrangement that have progressed after at least one prior line of systemic therapy.” (opens the source at this quote in a new tab)

“NICE’s guidance enables all eligible patients in England and Wales to have access to PEMAZYRE through the National Health Service.” (opens the source at this quote in a new tab)

Health technology assessment of pemigatinib in England: NICE TA722 recommendation

“Pemigatinib is recommended, within its marketing authorisation, as an option for treating locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that has progressed after systemic therapy in adults. It is recommended only if the company provides pemigatinib according to the commercial arrangement.” (opens the source at this quote in a new tab)

“Current treatment for advanced cholangiocarcinoma with an FGFR2 fusion or rearrangement that has progressed after systemic therapy is symptom control, with or without modified folinic acid, 5-fluorouracil and oxaliplatin (mFOLFOX) chemotherapy.” (opens the source at this quote in a new tab)

“Clinical evidence from 1 study suggests that pemigatinib may be more effective than current treatments. This is uncertain because the study did not directly compare pemigatinib with symptom control or mFOLFOX.” (opens the source at this quote in a new tab)

“Pemigatinib meets NICE's criteria for a life-extending treatment at the end of life. The cost-effectiveness estimates are uncertain but are likely to be within the range that NICE considers a cost-effective use of NHS resources. So, pemigatinib is recommended.” (opens the source at this quote in a new tab)

Health technology assessment of pemigatinib in England: comparators and committee-preferred ICERs

“The clinical experts advised that the relevant comparators currently used in routine clinical practice include mFOLFOX+ASC and ASC alone. The committee concluded that these are the most appropriate comparators for this appraisal.” (opens the source at this quote in a new tab)

“It concluded that the matching adjusted indirect comparison suggests pemigatinib was more effective than the comparators, but that this was uncertain.” (opens the source at this quote in a new tab)

“For the short life-expectancy criterion, the company's base-case model estimated a mean undiscounted life expectancy of 8.0 months for mFOLFOX+ASC and 7.3 months for ASC alone. For the life-extension criterion, the company's base-case model estimated an undiscounted mean incremental life expectancy with pemigatinib of 25.6 months compared with mFOLFOX+ASC and 26.4 months compared with ASC alone.” (opens the source at this quote in a new tab)

“For a life-extending treatment at the end of life, the upper limit of the range usually considered to represent a cost-effective use of NHS resources is £50,000 per quality-adjusted life year (QALY) gained. The committee noted that the company's new base-case ICERs for pemigatinib, including an updated patient access scheme, were £42,076 per QALY gained compared with mFOLFOX+ASC, and £45,029 per QALY gained compared with ASC alone.” (opens the source at this quote in a new tab)

“Using these preferred assumptions, the ICER was between £45,051 and £45,808 per QALY gained compared with mFOLFOX+ASC, and between £44,354 and £45,010 per QALY gained compared with ASC alone.” (opens the source at this quote in a new tab)

“Other scenarios, including using the generalised gamma curve to extrapolate long-term survival with pemigatinib, resulted in higher ICERs.” (opens the source at this quote in a new tab)

“It concluded that the cost-effectiveness estimates for pemigatinib suggest it is an acceptable use of NHS resources for a life-extending treatment at the end of life. So pemigatinib was recommended for routine use in the NHS.” (opens the source at this quote in a new tab)

Cost-effectiveness analysis of pemigatinib from the Taiwanese payer perspective, 2020 FIGHT-202 data

“Pemigatinib was not cost-effective compared to mFOLFOX or 5-FU in the base-case analysis.” (opens the source at this quote in a new tab)

“According to the NCCN guidelines, the daily use of pemigatinib 13.5 mg at the hypothesized NHIA price of NT$17,820/13.5 mg was not cost-effective compared to mFOLFOX or 5-FU.” (opens the source at this quote in a new tab)

Cost-effectiveness analysis of pemigatinib from the Taiwanese payer perspective, 2024 FIGHT-202 final data

“In 2023, Taiwan’s National Health Insurance Administration granted provisional payment for pemigatinib for patients with advanced ICC and FGFR2 fusions/rearrangements.” (opens the source at this quote in a new tab)

“Pemigatinib is cost-effective with updated long-term benefits from the pivotal trial in the lifetime simulation for advanced patients with advanced ICC and FGFR2 fusions/rearrangements.” (opens the source at this quote in a new tab)

Cost-effectiveness analysis of a biomarker-driven pemigatinib or mFOLFOX regimen versus fluorouracil from the Taiwanese payer perspective

“Although the new second-line genetic-based and biomarker-driven regimen of pemigatinib/mFOLFOX appears not cost effective for patients with advanced intrahepatic cholangiocarcinoma in the base-case analysis, our analysis suggests it is highly likely to be cost effective in the case of a 40% price reduction on pemigatinib.” (opens the source at this quote in a new tab)

“In Taiwan, only pemigatinib has been approved by the Taiwan FDA for the aforementioned indications but has not been reimbursed by the Taiwan National Health Insurance (NHI) as of November 2022.” (opens the source at this quote in a new tab)

“Currently, mFOLFOX is not reimbursed for patients with ICC in Taiwan; consequently, pemigatinib is compared to the far lower priced chemotherapy 5-FU, making pemigatinib even more unfavorable.” (opens the source at this quote in a new tab)

Cost-effectiveness analysis of pemigatinib from a Greek payer perspective

“Pemigatinib, a therapy covering the unmet medical need of patients with previously treated locally advanced or metastatic CCA with an FGFR2 fusion or rearrangement, was estimated to be cost-effective compared with mFOLFOX+ASC and ASC alone in Greece.” (opens the source at this quote in a new tab)

Cost-effectiveness analysis of pemigatinib from a United States perspective

“Pemigatinib has a higher cost but is also more effective than gemcitabine/cisplatin.” (opens the source at this quote in a new tab)

“The higher cost of pemigatinib is attributed to the direct cost, while the bulk of gemcitabine/cisplatin therapy’s cost is from the treatment of adverse events.” (opens the source at this quote in a new tab)

Health technology assessment of futibatinib in England: NICE TA1005 recommendation

“Futibatinib is recommended, within its marketing authorisation, as an option for treating locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that has progressed after at least 1 line of systemic treatment in adults. Futibatinib is only recommended if the company provides it according to the commercial arrangement.” (opens the source at this quote in a new tab)

“Usual treatment for locally advanced or metastatic cholangiocarcinoma with an FGFR2 fusion or rearrangement that has progressed after systemic treatment is pemigatinib. Futibatinib would be an alternative option to pemigatinib.” (opens the source at this quote in a new tab)

“There are no clinical trials directly comparing futibatinib with pemigatinib. An indirect comparison of futibatinib and pemigatinib suggests that they may have similar effectiveness, but this is uncertain.” (opens the source at this quote in a new tab)

“A cost comparison suggests that futibatinib has similar costs to pemigatinib. So, futibatinib is recommended.” (opens the source at this quote in a new tab)

Health technology assessment of futibatinib in England: comparator, indirect comparison, and cost comparison

“The EAG suggested that mFOLFOX should also be considered as a comparator because it may still be used in this population.” (opens the source at this quote in a new tab)

“But it noted that the company had positioned futibatinib as an alternative to pemigatinib, rather than after pemigatinib, so it could not evaluate futibatinib in this positioning. The committee considered the clinical expert's view that all people with a known FGFR2 alteration would have pemigatinib. It concluded that pemigatinib was the only relevant comparator.” (opens the source at this quote in a new tab)

“MAIC (adjusted) hazard ratios for futibatinib compared with pemigatinib were 0.95 (95% CI 0.72 to 1.21) for overall survival and 1.07 (95% CI 0.86 to 1.30) for progression-free survival.” (opens the source at this quote in a new tab)

“The committee concluded that there was no clear evidence of a difference in efficacy between pemigatinib and futibatinib.” (opens the source at this quote in a new tab)

“The company's resulting QALY weight of 1.2 was validated by the EAG. The committee concluded that the severity weight of 1.2 applied to the QALYs was appropriate.” (opens the source at this quote in a new tab)

“Because pemigatinib has a confidential discount, all ICERs are confidential and cannot be reported here.” (opens the source at this quote in a new tab)

“The committee concluded that the cost for futibatinib was similar to that of pemigatinib. It agreed that the cost-effectiveness estimates for futibatinib were within the range that NICE considers an acceptable use of NHS resources. So, the committee recommended futibatinib as an alternative option to pemigatinib for previously treated locally advanced or metastatic cholangiocarcinoma with FGFR2 fusion or rearrangement.” (opens the source at this quote in a new tab)

Institute for Clinical and Economic Review assessment of FGFR inhibitors in cholangiocarcinoma

No evidence found.

Health technology assessment of zanidatamab, a second-line targeted therapy for advanced biliary tract cancer, in England

“There is enough evidence to show that zanidatamab provides benefits and value for money, so it can be used routinely across the NHS in this population.” (opens the source at this quote in a new tab)

“If further treatment is suitable, people usually have FOLFOX chemotherapy with active symptom control (ASC). If this is not suitable, people usually have ASC only.” (opens the source at this quote in a new tab)

“The committee concluded that FOLFOX plus ASC, or ASC alone, were the relevant comparators for zanidatamab.” (opens the source at this quote in a new tab)

“The committee concluded that an acceptable ICER would be towards the upper end of the range NICE considers a cost-effective use of NHS resources (£25,000 to £35,000 per QALY gained).” (opens the source at this quote in a new tab)

“The committee was satisfied that its preferred assumptions produced an ICER that was within the range that NICE considers to be a cost-effective use of NHS resources.” (opens the source at this quote in a new tab)

Cost-effectiveness analysis of ivosidenib in previously treated IDH1 mutant cholangiocarcinoma from an Italian perspective

“The main reported outcomes are reported in Table 1. Ivosidenib obtained 7962 € per month OS-gained. FOLFOX obtained 7676 € per month OS-gained.” (opens the source at this quote in a new tab)

“Furthermore, let us consider that this price is based on ex-factory costs and that the real, confidential, is based on further discounts (indicative reduction of a further 40%) [15]. It means that ivosidenib could obtained 3185 € per month OS-gained with the normally applied discounts [15] and with a 38 220 € annual perspective, that is well below the cut-off [14].” (opens the source at this quote in a new tab)

“Another limit is related to the consideration of only the costs of drugs (which account for about 55% of total medical expenses).” (opens the source at this quote in a new tab)

Cost-effectiveness analysis of first-line durvalumab added to gemcitabine and cisplatin from a United States payer perspective

“For US payers, the placebo plus chemotherapy group had a total cost of $56,157.05 and a utility of 1.10 QALYs, while the durvalumab plus chemotherapy group had a total cost of $217,069.25, a utility of 1.52 QALYs, resulting in an ICER of $381,864.39/QALY.” (opens the source at this quote in a new tab)

“For US payers, we set the willing to pay (WTP) threshold to $150,000/QALY.” (opens the source at this quote in a new tab)

“Both in China and in the US, durvalumab in combination with chemotherapy is not a cost-effective option for the first-line treatment of BTC compared with chemotherapy.” (opens the source at this quote in a new tab)

Cost-effectiveness analysis of first-line pembrolizumab added to chemotherapy from a United States payer perspective

“In the US, this treatment was not cost-effective, resulting in an improvement in effectiveness of 0.144 QALYs and an increase in overall cost of $141,000 (ICER of $976,925).” (opens the source at this quote in a new tab)

“In the US, the WTP threshold was set at $150,000” (opens the source at this quote in a new tab)