Applying the ESMO-Magnitude of Clinical Benefit Scale in real life

Correspondence to Dr Fortunato Ciardiello; Fortunato.CIARDIELLO@ unina2.it Our level of understanding of the biology of cancer at this point in time is amazing and continues to increase. Each year we know more and more about the fundamental mechanisms of tumour growth and progression of the disease. Thanks to this improved knowledge we are able to evaluate new drugs that in some instances are very effective. We even have biomarkers that define a population of patients that may benefit more from the treatment. In some other patients we don’t have such biomarkers and the benefit is only incremental. This does not mean that the treatment is not good, but the maximum effect can be considered very modest. The European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS) offers an opportunity to grade the effect of these new drugs in each tumour and even in each indication. The tool enables us to gather important information on the real impact of any drug in the different settings in which a drug may be approved. Using data from phase III clinical trials or meta-analyses, the tool uses a rational, structured and consistent approach to derive a relative ranking of the magnitude of benefit than can be anticipated from any new treatment. As the authors of the paper in Annals of Oncology in May 2015 concluded, “the ESMO-MCBS is an important first step to the major ongoing task of evaluating value in cancer care which is essential for appropriate uses of limited public and personal resources for affordable cancer care”. Most countries determine reimbursement by considering the global effect of one particular drug in all the different tumour types and all the different indications in which the drug is approved. The ESMO-MCBS provides real, important information on each of the indications that a drug may have in terms of efficacy and always looks for the primary endpoint which in most patients is survival, progression free survival, or disease free survival. It also balances this information with the safety profile of the drug and the quality of life data we have from clinical trials. The tool is currently applicable over a full range of solid tumours. ESMO’s aim is to use this scale for grading any new anti-cancer drug that is approved by the European Medicines Agency (EMA) after 1 January 2016. This information will be published in ESMO Open and drugs with the highest scores will be incorporated into ESMO Clinical Practice Guidelines. The American Society of Clinical Oncology (ASCO) is developing a framework for evaluating value in oncology through its Value in Cancer Care Task Force. While their work takes the cost of a drug into consideration, the ESMO-MCBS focuses on the magnitude of clinical benefit. Nevertheless, even though the cost-factor is not implemented in the scale, the ESMO-MCBS might also support decision-making within socioeconomic contexts. The paper published in the current issue of ESMO Open by Kiesewetter et al describes the first real life assessment of the ESMO-MCBS within a big comprehensive cancer centre. Medical University Vienna is one of the biggest and most important centres in Europe, and physicians in the Clinical Division of Oncology have applied the methodology to their daily clinical practice in treating patients. The authors have evaluated, in an independent way, how the decisions the physicians take in Vienna correlate with the recommendations of the ESMO-MCBS. And actually they correlate very well. Interestingly, they have looked at different tumour types, namely metastatic/advanced breast cancer, lung cancer, colorectal cancer, gastric and oesophageal cancer, renal cell cancer, and prostate cancer. Most of the decisions made by the physicians in Vienna to treat patients were those that had the best recommendation in the ESMO-MCBS. This exercise validates the use of the scale, since the decisions that were