ESMO-MCBS - A well-validated tool to assess clinical benefits of novel anti-cancer treatments in real-world practice

04 Oct 2021

The value of a new therapeutic strategy is determined by the magnitude of its clinical benefit balanced against cost.1 Assessment of anti-cancer treatments has become increasingly vital amid the rapid growth of innovative anti-cancer drugs and technologies, which provide small incremental benefits within the cost-constrained healthcare systems.1,2 However, overestimating the benefits from a new approach could be harmful as it may confound public policy decision making, undermine the credibility of oncology research and put patients in danger with unexpected adverse effects and substantial personal costs.1,2 To evaluate novel anti-cancer interventions in a more precise way, the European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS) v1.0 was rolled out in 2015 as a well-validated tool to stratify the magnitude of clinical benefits for new oncological treatments.1

Dr. Barbara Kiesewetter, a member of ESMO-MCBS working group and a medical oncologist at the Medical University of Vienna, shared some insights and experience of applying ESMO-MCBS in real-world practice at the ESMO Congress 2021.2 Dr. Kiesewetter elaborated that the aims of developing ESMO-MCBS are to identify treatments that can significantly improve the duration of survival and quality-of-life (QoL) of cancer patients, as well as accelerate reimbursement evaluation and decrease treatment standard disparities across Europe.2 The ESMO-MCBS is publicly accessible from the ESMO homepage and user friendly to qualified clinicians.2,3 In the ESMO-MCBS, form 1 and form 2 with grades ranging from C to A and 1 to 5 are developed for the curative and palliative settings separately, in which, grades A and B as well as 4 and 5 represent a high level of clinical benefits.1,2

Dr. Kiesewetter and her team conducted a field testing to assess the clinical applicability and feasibility of ESMO-MCBS v1.0 in the tertiary referral center of the Medical University of Vienna.2,3 A 3-step approach with 2 analyses focusing on common and rare tumor entities was designed for this study.2,3 The 3 steps included (1) systematic collection of data on regimens in daily use, (2) analysis and scoring of data with the ESMO-MCBS and (3) interpretation of results in terms of clinical feasibility, plausibility and applicability by programme directorships.2,3 This pivotal trial supported the ESMO-MCBS as a reliable and reproducible tool for first-line standards in daily clinical practice.2,3

The ESMO-MCBS is developed as a dynamic tool which can be revised on a regular basis pending the real-world experiences and feedback from physicians, pharmaceutical industry and patient advocates.1,2,4 The upgraded version of ESMO-MCBS was published in 2017 with 9 amendments, adding form 3 which is specially for scoring of single-arm studies.1,2,4 The scoring of the ESMO-MCBS v1.1 remains very stable for the most parts and is being used in the daily clinical routine in the Medical University of Vienna.2,4 Furthermore, Dr. Kiesewetter emphasized that the provision of MCBS scorecards was a really important step forward to enable the use of ESMO-MCBS in daily clinical practice,2,5 saying that “The scorecards are available online in the ESMO-MCBS website for the treating physicians, which present scores for all EMA and also the US Food and Drug Administration (FDA) approved drugs.” She highlighted the high accessibility and simple operation of the ESMO-MCBS v1.1 when it came to real-time application.2 Apart from scorecards, the ESMO guidelines are also frequently modified to provide explicit ESMO-MCBS scores for users.2  

In Dr. Kiesewetter’s opinion, the combination of scorecards and the ESMO guidelines allows more communication, not only among experts when encountering decision-making difficulties on novel anti-cancer therapies, but also between physicians and patients when explaining the rationale behind every treatment option.2 She further asserted that the ESMO-MCBS v1.1 was a supportive tool manipulated by the immuno-oncology multidisciplinary tumor boards in the Medical University of Vienna to discuss and determine the off-label use of compounds and particularly immunotherapies in the relapsed or refractory setting.2 Additionally, the ESMO-MCBS v1.1 has been used in Vienna Cancer Center to evaluate reimbursement processes for the healthcare network of Vienna for oncological drugs, constituting one indicating factor that decides whether the drug should be implemented in clinical routine and defines the thresholds in particular cases according to the ESMO recommendations, of which only treatments with grades A and B as well as 4 and 5 are corresponding to notable clinical benefits.2,6

Overall, the ESMO-MCBS is an ever-improving tool to evaluate the clinical benefits of novel anti-cancer treatments, and is highly applicable to real-world clinical practice at the local and national levels.4 The recent 2 papers about the applications of ESMO-MCBS v1.1 to assess immunotherapy in metastatic solid tumors and EMA-approved solid tumor drugs in the Austrian healthcare setting have also proven that the ESMO-MCBS is an efficacious health-economic instrument in analyzing cost-effectiveness of immune checkpoint inhibitors and identifying the actual value of cancer medicines in case of uncertain patient benefits.2,7,8 Taking into consideration of the feedback, critiques and suggestions from end-users of the ESMO-MCB v1.1, a working group is developing and, hopefully, will introduce the ESMO-MCBS v2.0 in the next year.2,4 The upcoming version will contain fine adjustment on toxicity and QoL, current reported outcomes from patients and a new tool for hematologic malignancies, which will cover a wider range of oncological treatments and produce more well-rounded evaluation.2

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