Cost-utility of lifileucel in patients with advanced melanoma after progression on immune checkpoint inhibitors And targeted therapies: a middle-income economy setting.

Publication date: Jul 18, 2025

Autologous tumour-infiltrating lymphocyte (TIL) therapy for treatment-resistant advanced melanoma was recently granted marketing authorization. This study aimed to compare the cost-effectiveness of TIL therapy for metastatic or unresectable malignant melanoma with current treatment options, including chemotherapy and triple therapy involving a B-Raf inhibitor, mitogen-activated protein kinase inhibitor and PD-1 blocker. This study used a modelling approach that involved the construction and simulation of a partitioned survival model. The target population consisted of patients with treatment-resistant advanced melanoma in Montenegro, a small, middle-income economy. The study showed that a 1-time therapy with modified lymphocytes derived from the melanoma-infiltrated tissue (lifileucel) is not a cost-effective treatment option for advanced melanoma resistant to targeted and immunotherapy when compared to chemotherapy or triple therapy. The incremental net monetary benefit was -417 270. 26 +/- 3748. 33 EUR and -368 813. 66 +/- 4220. 11 EUR, respectively. The incremental cost-effectiveness ratio was 550 276. 80 +/- 1 134 093. 26 EUR (95% confidence interval) and 675 364. 93 +/- 1 181 289. 48 EUR (95% confidence interval), respectively, which is much above the highest acceptable cost-effectiveness threshold for Montenegro of 86 382. 00 EUR per quality-adjusted life year. The sensitivity analysis did not alter this conclusion, which could be clearly confirmed by clinical or prospective cohort studies involving 75-100 patients per arm, requiring an investment of 45-50 million euros. The treatment of therapy-resistant advanced melanoma using TILs (lifileucel) is currently not cost-effective in small, middle-income economies and is unlikely to become so in the near future.

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