The ESMO-MCBS uses a structured and disciplined approach to deriving estimates of clinically meaningful benefit of cancer medicines from published data and can be used in a range of settings, including:
Grading derived from the ESMO-MCBS provides a backbone for value evaluations of cancer medicines and can help public policy-makers in the advancement of ‘accountability for reasonableness’ in resource allocation deliberations. It is being used as part of HTA processes in a growing number of countries.
- ESMO has developed a methodology template designed to empower health systems globally to make efficient spending decisions allowing comprehensive coverage of cancer services for entire populations. The generalisable model, was originally developed to help the country of Kazakhstan update and rationalise its national list of essential cancer medicines and treatment protocols. The evidence-based methodology for the evaluation of national medication formularies rely on freely accessible, validated tools to help decision-makers maximise the impact of their cancer programmes by investing in care that offers the highest value for money. In a four-phase approach a comprehensive list of all anticancer medicines used in Kazakhstan was created and cross-checked against the WHO Model List of Essential Medicines, therapeutic indications from the European Medicines Agency (EMA) database and, where applicable, scores on the ESMO Magnitude of Clinical Benefit Scale (ESMO-MCBS) were provided. National treatment protocols for different cancer types were equally compared with recommendations from the ESMO Clinical Practice Guidelines. Following an expert review of the findings, a summary report was submitted to the government of Kazakhstan to inform further action.
The data enclosed in ESMO-MCBS scoring can help clinicians weigh the relative merits of competing relevant therapeutic options and may also be of benefit in explaining the relative merit of therapeutic options to patients and their families. This information may be especially helpful when treatments incorporate substantial out-of-pocket costs.
- Since 2019, the WHO Expert Committee on Selection and Use of Medicinesacknowledge the role of the ESMO-MCBS as a screening tool to identify cancer treatments that have potential therapeutic value that warrants full evaluation for the Essential Medicines List (EML) listing. Potential new EML cancer medicines, in general, should have a score on the ESMO-MCBS of A or B in the curative setting and of 4 or 5 in the non-curative setting.
For cancer therapies, the ESMO-MCBS scale provides a clear, well-structured and validated mechanism to indicate the magnitude of clinical benefit, in addition to the level of evidence, that can inform both national and international guidelines.
- Since 2016, where relevant, the ESMO-MCBS scores are incorporated in the ESMO Clinical Practice Guidelines and the Pan-Asian Adapted Guidelines, helping to provide patients with the best care options and setting the highest standards for cancer care.
The ESMO-MCBS may be of use to editors, peer reviewers and commentators in considering the clinical significance of research findings from randomised clinical studies, cohort studies and meta-analyses with statistically significant positive findings.
The ESMO-MCBS is a powerful tool to teach a disciplined and validated approach to data interpretation. It is especially valuable for oncologists in training and for application in journal club discussion.
- The ESMO-MCBS has been presented inside and outside Europe and in educational workshops for stakeholders, patient (advocates), pharma representatives and Health Technology Assessment (HTA) bodies to increase knowledge sharing of the tool. Additionally, it is being used in oncology training programmes and journal club presentations, modelling a structured approach to data interpretation in the evaluation of clinical benefit.
To know more about the Kazakhstan project, check the section ‘Public policy applications’.