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Table 2 Comparison of five major value frameworks regarding the use of toxicity and adverse event approaches

From: Do current approaches to assessing therapy related adverse events align with the needs of long-term cancer patients and survivors?

Framework

Objective

Efficacy & safety data sources

Scoring/output

Efficacy/safety-related input data

ASCO

Inform joint decision making by patients and clinicians

Clinical trials

• Generates a single composite scored called the ‘Net Health Benefit’ (NHB)

• Uses different algorithms for advanced disease vs adjuvant setting

• Uses AE data drawn from clinical trials.

• Can incorporate adjustments for QoL, treatment-free interval, improvement in cancer symptoms. Can score for disease free survival (cure) or progression free survival.

ESMO

Inform public policy, clinical guidelines, and direct clinical care

Clinical trials

• Semi-quantitative process results in assignment of letter score (A–C) for adjuvant setting

• Semi-quantitative process results in assignment of number score (1–5) for advanced disease

• Can score for disease free survival (cure) or progression free survival.

• “Toxicity” and QoL rating incorporated.

NCCN

Inform joint decision making by patients and clinicians

Clinical trial and expert opinion

• Assigns a series of Evidence Block Scores (5-point high score, 1-point low score) categories such as toxicity, efficacy, cost, etc.

• Incorporates a range of both qualitative and quantitative inputs that are qualitatively synthesized via expert panels.

ICER

Provide synthesis for use by policymakers and payers/formularies

Clinical trials, econometric studies

• Compares standard intervention and new treatment relative to short term costs and longer-term healthcare system burdens and benefits.

• Includes quality-adjusted life year scoring factors.

• Serious AEs are factored into scoring

• Ability to work while on therapy factored into scoring

DrugAbacus

Provide pricing data for use by policymakers and payers

Drug safety /efficacy data as provided to FDA

• Factors benefits and burdens of treatment into a new “price” based on Abacus algorithm relative to industry-specified price.

• Scores improved survival rate

• Serious AEs (e.g., grade 3 or greater) incorporated into scoring

• The probability that a patient discontinues treatment because of toxicity is considered in scoring

• Treatment novelty, R&D cost, health burden and treatment duration

  1. Table 2 was modified from tables previously published in Chandra et al. (2016), Cohen, Anderson, & Neumann (2017), and Schnipper & Bastian (2016). AE, adverse event; ASCO, American Society of Clinical Oncology; DFS, disease-free survival; ESMO, European Society for Medical Oncology; FDA, U.S. Food and Drug Administration; ICER, Institute for Clinical and Economic Review; NCCN, National Comprehensive Cancer Network; NHB, net health benefit; PFS, progression-free survival; QALY, quality-adjusted life-year; QoL, quality of life; R&D, research and development. See Definition section for explanation of terms
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Cardio-Oncology

ISSN: 2057-3804

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