Fig 1.
Current recommendations for the 1L treatment of la/mUC.
1L, first-line; AFU, French Urological Association; CR, complete response; DDMVAC: dose-dense methotrexate, vinblastine, doxorubicin, and cisplatin; EAU, European Association of Urology; EMA, European Medicines Agency; ESMO, European Society for Medical Oncology; FDA, US Food and Drug Administration; GFR, glomerular filtration rate; la/mUC, locally advanced or metastatic urothelial carcinoma; MCBS, Magnitude of Clinical Benefit Scale; NCCN, National Comprehensive Cancer Network; PD-L1, programmed death-ligand 1; PS, performance status; PR, partial response; SD, stable disease. a Maintenance therapy with avelumab only if there is no progression with 1L platinum-containing chemotherapy. bCreatinine clearance grade 2 and New York Heart Association class III heart failure. c Rechallenge with platinum-based chemotherapy may be considered if progression occurred 12 months after the end of previous platinum-based chemotherapy or 12 months after the end of previous platinum-based chemotherapy and avelumab maintenance therapy. d This should be assessed within 10 weeks of completion of chemotherapy. e ESMO-MCBS v1.1120 was used to calculate scores for new therapies and indications approved by the EMA or the FDA. The scores have been calculated by the ESMO-MCBS Working Group and validated by the ESMO Guidelines Committee (https://www.esmo.org/guidelines/esmo-mcbs/scale-evaluation-forms-v1.0-v1.1/scale-evaluationforms-v1.1). f Fit patient: creatinine clearance ≥60 mL/min and PS <2. g Unfit patient: creatinine clearance <60 mL/min and PS≥2. h Patients experience no progression after 1L chemotherapy (stable or responsive disease). Maintenance avelumab has shown a benefit in overall survival (pending availability of the molecule).
Table 1.
Patient characteristics from the JAVELIN Bladder 100 study and the retrospective chart review study.
Fig 2.
Schematic diagram of model utilized in the cost-effectiveness analysis.
BSC, best supportive care; IO, immuno-oncotherapy; Tx, treatment.
Fig 3.
Area under the curve model developed for the cost-effectiveness analysis.
OS, overall survival; PPS, post-progression survival; PFS, progression-free survival.
Fig 4.
OS KM curves followed by log-normal extrapolation beyond KM curves for both arms (reference analysis).
1LM, first-line maintenance; BSC, best supportive care; KM, Kaplan-Meier; OS, overall survival.
Fig 5.
PFS KM curves followed by Weibull and log-normal extrapolations for avelumab plus BSC and BSC alone, respectively (reference analysis).
1LM, first-line maintenance; BSC, best supportive care; KM, Kaplan-Meier; PFS, progression-free survival.
Fig 6.
TTD KM curves followed by generalized gamma and log-logistic extrapolations for avelumab plus BSC and BSC alone, respectively (reference analysis).
1LM, first-line maintenance; BSC, best supportive care; KM, Kaplan-Meier; TTD, time to treatment discontinuation.
Table 2.
Summary of costs included in the model for each cost category and by treatment arm.
Table 3.
Distribution of post-progression treatments in JAVELIN Bladder 100 compared with the cost-effectiveness model.
Table 4.
Summary of utility data for avelumab plus BSC and BSC alone considered for the reference analysis.
Table 5.
Disutilities associated with adverse events of treatments studied for efficiency analysis in the reference analysis.
Table 6.
Discounted results of the reference analysis (ICER).
Fig 7.
Tornado diagram for the one-way sensitivity analysis.
1LM, first-line maintenance, AE, adverse event; BSC, best supportive care; ICER, incremental cost-effectiveness ratio; IO, immuno-oncotherapy; KM, Kaplan-Meier; OS, overall survival; pop2, population 2; QALY, quality-adjusted life-year; sub, subsequent; TTD, time to treatment discontinuation; Tx, treatment.
Fig 8.
Scatterplot of the probabilistic sensitivity analysis comparing avelumab plus BSC versus BSC alone.
BSC, best supportive care.
Fig 9.
Acceptability curve of cost-effectiveness for the reference analysis.
1LM, first-line maintenance; BSC, best supportive care.