The ESMO-Magnitude of Clinical Benefit Scale (ESMO-MCBS) was developed to facilitate improved decision-making regarding the value of anti-cancer therapies, promote the accessibility and reduce iniquity of access to high value cancer treatments.
The ESMO-MCBS was developed to promote the scientific integrity of ESMO and of oncologists and in particular to:
- Reduce bias in data interpretation and analysis and enhance critical appraisal to the evidence
- Reduce hype
- Provide robust validation with strict adherence to standards for “accountability for reasonableness”
- Provide reliable and fair evaluation of benefit to assist in cancer planning, value-based priority-setting and impact-oriented resource allocation decisions
Since value is based on considerations of the magnitude of clinical benefit as well as cost, and given the challenges to understanding the actual magnitude of the clinical benefit, the ESMO-MCBS was developed in 2015 as a validated and reproducible scale that is applicable across the full range of solid tumours and since 2023 in hematological malignancies. The latter has been developed in collaboration with the European Haematological Association (EHA).
It incorporates a structured, rational and valid approach to clinical trial data interpretation and analysis that reduces the tendency to have judgements affected by bias or uninformed and/or idiosyncratic data interpretation that has been developed in accordance with the ethical framework for fair decision-making and public policy standard of “accountability for reasonableness”.
It is a dynamic tool and its criteria are revised on a regular basis, to address the rapid evolving landscape of new drugs development and regulatory decisions. The ESMO-MCBS was revised in 2017 (version 1.1), based on feedback and queries from clinicians, patients, researchers and representatives of the pharmaceutical industry, and a dynamic process of internal peer review.
The ESMO-MCBS is intended to both assist oncologists in explaining the likely benefits of a particular treatment to their patient as well as to aid public health decision makers to prioritise therapies for reimbursement. It is currently incorporated in the ESMO Clinical Practice Guidelines and is being used as part of Health Technology Assessment (HTA) processes in many countries.
The ESMO- MCBS grading highlights those treatments which substantially improve the duration of survival and/or the quality of life (QoL) of patients with cancer and aims to distinguish them from trials demonstrating more limited and sometimes even marginal benefits. The ESMO-MCBS assigns categorical benefit scores to European Medicines Agency (EMA) and US Food and Drugs Administration (since January 2020) approved cancer medicines, based on results from ‘positive’ randomised clinical trials:
- superiority trials that have demonstrated a statistically significant result for the primary endpoint of the study, and/ or secondary in case of overall survival and
- non-inferiority trials, reaching a conclusion of non-inferiority.
The ESMO-MCBS also includes scales to evaluate the benefit of cancer medicines as assessed in single-arm clinical trials.
The scale considers overall survival, progression-free survival, disease free survival, hazard ratio, response rate, quality of life, prognosis of the condition and toxicity. There are 5 evaluation forms depending on the primary endpoint and a form to evaluate ESMO-MCBS score adjustments based on quality of life.
Grading derived from the ESMO-MCBS provides a backbone for value evaluations for cancer medicines. Medicines and therapies that fall into the ESMO-MCBS A and B for curative therapies and 4 and 5 for non-curative therapies should be highlighted for accelerated assessment of value and cost-effectiveness. While a high ESMO-MCBS score does not automatically imply high value (that depends on the price), the scale can be used to frame such considerations and can help public policymakers advance ‘accountability for reasonableness’ in resource allocation deliberations.
The scoring process is reported below: