Comparative Assessment of Clinical Benefit Using the ESMO-Magnitude of Clinical Benefit Scale Version 1.1 and the ASCO Value Framework Net Health Benefit Score

Abstract

PURPOSE To better understand the European Society for Medical Oncology-Magnitude of Clinical Benefit Scale version 1.1 (ESMO-MCBS v1.1) and the ASCO Value Framework Net Health Benefit score version 2 (ASCO-NHB v2), ESMO and ASCO collaborated to evaluate the concordance between the frameworks when used to assess clinical benefit attributable to new therapies. METHODS The 102 randomized controlled trials in the noncurative setting already evaluated in the field testing of ESMO-MCBS v1.1 were scored using ASCO-NHB v2 by its developers. Measures of agreement between the frameworks were calculated and receiver operating characteristic curves used to define thresholds for the ASCO-NHB v2 corresponding to ESMO-MCBS v1.1 categories. Studies with discordant scoring were identified and evaluated to understand the reasons for discordance. RESULTS The correlation of the 102 pairs of scores for studies in the noncurative setting is estimated to be 0.68 (Spearman’s rank correlation coefficient; overall survival, 0.71; progression-free survival, 0.67). Receiver operating characteristic curves identified thresholds for ASCO-NHB v2 for facilitating comparisons with ESMO-MCBS v1.1 categories. After applying pragmatic threshold scores of 40 or less (ASCO-NHB v2) and 2 or less (ESMO-MCBS v1.1) for low benefit and 45 or greater (ASCO-NHB v2) and 4 to 5 (ESMO-MCBS v1.1) for substantial benefit, 37 discordant studies were identified. Major factors that contributed to discordance were different approaches to evaluation of relative and absolute gain for overall survival and progression-free survival, crediting tail of the curve gains, and assessing toxicity. CONCLUSION The agreement between the frameworks was higher than observed in other studies that sought to compare them. The factors that contributed to discordant scores suggest potential approaches to improve convergence between the scales.

New Treatment Options for Advanced Gastroesophageal Tumours: Mature for the Current Practice?

“…Thus, it is important for clinical trials to evaluate the real-life benefit of novel drug regimens, so that the financial toxicity can be related to the benefits for the patient. The ESMO-Magnitude of Clinical Benefit Scale (ESMO-MCSBS) or ASCO Value Framework Net Health Benefit Score are such tools to stratify the magnitude of clinical benefit that can be anticipated from anticancer therapies [94,95]. Clinical benefit scales should be evaluated in further clinical trials and also involved in individual decision making to optimize patient care and minimize financial toxicity without benefit.…”

Value assessment of oncology drugs using a weighted criterion‐based approach

“…Due to individual cognitive biases, decision makers may have different ways of understanding the data and interpreting the scales. Expert training often is required to ensure the appropriate application of value assessment tools, and this issue has been recognized with the ASCO and ESMO value frameworks as well …”

“…Expert training often is required to ensure the appropriate application of value assessment tools, and this issue has been recognized with the ASCO and ESMO value frameworks as well. 34,35 In the current study, a criterion-based valuation framework was designed using multiple perspectives, and the robustness of the tool was demonstrated when compared with past submissions. This derived score represents the overall impact of a new cancer treatment, and the quality of evidence used to generate the score.…”

Anticancer drugs approved by the Food and Drug Administration for gastrointestinal malignancies: Clinical benefit and price considerations

“…Only two out of nine approved indications in CRC (22%) met this modest target in our study. More recently, ASCO has proposed pragmatic threshold scores of 40 or less for low benefit, and 45 or greater for substantial benefit . Only four supporting trials met this threshold.…”

“…ASCO VF has a cumbersome process for scoring toxicity which will limit uptake. More recently, scores of many studies by ASCO VF NHB version 2 have been published, which can serve as a useful reference . Similarly, scores of ESMO MCBS version 1.1 are publicly available through the online score card on the ESMO website (https://www.esmo.org/score/cards).…”