Abstract
Background: Influx of innovative therapies and dramatic rise in prices have been prompting value-driven decision-making. Both the American Society of Clinical Oncology (ASCO) and the European Society for Medical Oncology (ESMO) have independently proposed value assessment frameworks. Objectives: To comprehensively examine the value of nivolumab and pembrolizumab by two value assessment frameworks with a cohort of published randomized controlled trials and offer insight into the association between these two frameworks. Methods: Trials were identified with a cutoff date of Nov 30th, 2019. Receiver operating characteristic curves were generated to establish the predictive value of ASCO-VF score to meet ESMO-MCBS grade and discriminate the agreement of these two value assessment tools. Spearman correlation was used to assess the association between monthly cost and ASCO-VF score/ESMO-MCBS grade. Results: 19 randomized controlled trials were eligible. seven (36.8%) trials were of treatment included nivolumab while 12 (63.2%) pembrolizumab. 8 (42.1%) of the trials were of treatments for non-small-cell lung cancer, 5 (26.3%) for melanoma, 2 (10.5%) were for head and neck squamous cell carcinoma, 2 (10.5%) for gastric or gastro-oesophageal junction cancer and 1 (5.3%) for urothelial cancer and renal-cell carcinoma respectively. ASCO scores ranged from 7 to 94.7 with median 40.90. 11 (57.9%) trials met the ESMO criteria for meaningful value achieved. Of 14 trials not meeting the ASCO cutoff score, only 8 did not meet the meaningful ESMO criteria. Agreement between these two frameworks thresholds was only fair (κ = 0.412, P＜0.05). A negative correlation was noted between increment monthly cost and value assessment results. Conclusion: There is only fair correlation between ASCO and ESMO value assessment frameworks. Not all treatment with nivolumab and pembrolizumab meet valuable thresholds.
Highlights
Influx of innovative therapies, the targeted drugs and immunotherapies have marked major therapeutic advances in oncology
19 randomized controlled trials were eligible. seven (36.8%) trials were of treatment included nivolumab while 12 (63.2%) pembrolizumab. 8 (42.1%) of the trials were of treatments for non-small-cell lung cancer, 5 (26.3%) for melanoma, 2 (10.5%) were for head and neck squamous cell carcinoma, 2 (10.5%) for gastric or gastro-oesophageal junction cancer and 1 (5.3%) for urothelial cancer and renal-cell carcinoma respectively
Only a few reports have focused on application of two prominent tools-American Society of Clinical Oncology (ASCO) Value Framework (ASCO-VF), or the European Society for Medical Oncology (ESMO) Magnitude of Clinical Benefit Scale (ESMO-MCBS), or both according to a contemporary cohort of randomized controlled trials (RCTs) to assess the value of anticancer drugs, suggesting that not all approved drugs were significantly associated with meaningful value and exploring the extent of concordance or discordance between these two respective frameworks (Del Paggio et al, 2017; Foote et al, 2017; Vivot et al, 2017; Djatche et al, 2018)
Summary
The targeted drugs and immunotherapies have marked major therapeutic advances in oncology. To facilitate value-driven decision-making, an evolving field from the perspective of stakeholders—physicians, patients, health care insurers, etc., including the American Society of Clinical Oncology (ASCO) (Schnipper et al, 2015; Schnipper et al, 2016) and the European Society for Medical Oncology (ESMO) (Cherny et al, 2015; Cherny et al, 2017) have independently proposed frameworks as unbiased tools for systematic assessment of value of anticancer drugs, justifiably evaluating high quality therapies affordable for various cancer disease states. Influx of innovative therapies and dramatic rise in prices have been prompting value-driven decision-making. Both the American Society of Clinical Oncology (ASCO) and the European Society for Medical Oncology (ESMO) have independently proposed value assessment frameworks
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