ESMO-Magnitude of Clinical Benefit Scale version 1.1

Cherny, Nathan I.; Dafni, Urania; Bogaerts, Jan; Latino, Nicola Jane; Pentheroudakis, G.; Douillard, Jean Yves; Tabernero, Josep; Zielinski, Christoph; Piccart, Martine; Vries, Elisabeth G.E. de

doi:10.1093/annonc/mdx310

Cited by 499 publications

(483 citation statements)

References 47 publications

Supporting

Mentioning

451

Contrasting

Unclassified

Order By: Relevance

“…It would also allow other cancer medicines to be considered for inclusion on the World Health Organization Model Lists of Essential Medicines. Table describes some methods to help reduce cancer medicine prices …”

Section: Approaches To Decreasing Cancer Medicine Costsmentioning

confidence: 99%

Enhancing global access to cancer medicines

Cortés

Peréz-García

Llombart-Cussac

et al. 2020

CA A Cancer J Clinicians

143

108

View full text Add to dashboard Cite

Globally, cancer is the second leading cause of death, with numbers greatly exceeding those for human immunodeficiency virus/acquired immunodeficiency syndrome, tuberculosis, and malaria combined. Limited access to timely diagnosis, to affordable, effective treatment, and to high‐quality care are just some of the factors that lead to disparities in cancer survival between countries and within countries. In this article, the authors consider various factors that prevent access to cancer medicines (particularly access to essential cancer medicines). Even if an essential cancer medicine is included on a national medicines list, cost might preclude its use, it might be prescribed or used inappropriately, weak infrastructure might prevent it being accessed by those who could benefit, or quality might not be guaranteed. Potential strategies to address the access problems are discussed, including universal health coverage for essential cancer medicines, fairer methods for pricing cancer medicines, reducing development costs, optimizing regulation, and improving reliability in the global supply chain. Optimizing schedules for cancer therapy could reduce not only costs, but also adverse events, and improve access. More and better biomarkers are required to target patients who are most likely to benefit from cancer medicines. The optimum use of cancer medicines depends on the effective delivery of several services allied to oncology (including laboratory, imaging, surgery, and radiotherapy). Investment is necessary in all aspects of cancer care, from these supportive services to technologies, and the training of health care workers and other staff.

show abstract

Section: Approaches To Decreasing Cancer Medicine Costsmentioning

confidence: 99%

Enhancing global access to cancer medicines

Cortés

Peréz-García

Llombart-Cussac

et al. 2020

CA A Cancer J Clinicians

143

108

View full text Add to dashboard Cite

show abstract

“…The combined influence of these 4 criteria on pCODR funding recommendations further indicates the impact of quality of evidence on funding recommendations. In recent years, an increasing number of drugs have been granted regulatory approval on the basis of data from studies lacking a comparator arm, typically within the setting of uncommon malignancies or molecular subtypes of certain cancers . The SOE modifier provides a formal approach with which to assess single‐arm and early‐phase studies while acknowledging the limitations of the data.…”

Section: Discussionmentioning

confidence: 99%

“…Economically diverse countries face inconsistencies in access that have motivated major oncology societies to develop standardized tools for value assessment . The American Society of Clinical Oncology's (ASCO) framework evaluates new cancer drugs at the individual patient level to inform overall value for clinical decision making.…”

Section: Introductionmentioning

confidence: 99%

Value assessment of oncology drugs using a weighted criterion‐based approach

Ezeife¹,

Dionne²,

Fares

et al. 2019

Cancer

View full text Add to dashboard Cite

Background Globally, the rising cost of anticancer therapy has motivated efforts to quantify the overall value of new cancer treatments. Multicriteria decision analysis offers a novel approach to incorporate multiple criteria and perspectives into value assessment. Methods The authors recruited a diverse, multistakeholder group who identified and weighted key criteria to establish the drug assessment framework (DAF). Construct validity assessed the degree to which DAF scores were associated with past pan‐Canadian Oncology Drug Review (pCODR) funding recommendations and European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO‐MCBS; version 1.1) scores. Results The final DAF included 10 criteria: overall survival, progression‐free survival, response rate, quality of life, toxicity, unmet need, equity, feasibility, disease severity, and caregiver well‐being. The first 5 clinical benefit criteria represent approximately 64% of the total weight. DAF scores ranged from 0 to 300, reflecting both the expected impact of the drug and the quality of supporting evidence. When the DAF was applied to the last 60 drugs (with reviewers blinded) reviewed by pCODR (2015‐2018), those drugs with positive pCODR funding recommendations were found to have higher DAF scores compared with drugs not recommended (103 vs 63; Student t test P = .0007). DAF clinical benefit criteria mildly correlated with ESMO‐MCBS scores (correlation coefficient, 0.33; 95% CI, 0.009‐0.59). Sensitivity analyses that varied the criteria scores did not change the results. Conclusions Using a structured and explicit approach, a criterion‐based valuation framework was designed to provide a transparent and consistent method with which to value and prioritize cancer drugs to facilitate the delivery of affordable cancer care.

show abstract

“…The framework is restricted to the evaluation of treatments which had been studied head-to-head in prospective randomised clinical trials [22]. For Europe, the European Society for Medical (ESMO) in 2015 published the first version of the Magnitude of Clinical Benefit Scale (ESMO-MCBS [23]) which was updated in 2017 [24]. The goal formulated with the publication of the first version of the ESMO-MCBS was to provide a “…structured and consistent approach to derive a relative ranking of the magnitude of clinically meaningful benefit that can be expected from a new anti-cancer treatment”.…”

Section: Assessing Benefit and Value Of Cancer Drugs - The Role Of Onmentioning

confidence: 99%

“…In the second version PCR is accepted. As rationale for this decision the authors refer to FDA- and EMA-decisions on approval of a new drug based on this criterion [24]. However, the debate whether this surrogate is linked to a clinical benefit is ongoing.…”

Section: Determining the Clinical Benefit Of New Cancer Drugs - The Ementioning

confidence: 99%

Value and Values in Cancer Care. Assessing the Benefit of Treatment in Patients with Advanced Cancer

Schildmann¹

2019

Oncol Res Treat

View full text Add to dashboard Cite

In recent years, the term “value-based healthcare” has been increasingly used in debates about costs and outcomes of health interventions in cancer care. This paper distinguishes 2 meanings of the term “value” and explores the relevance of both meanings of the word for assessing the “value” of cancer drugs. At the focus of the analysis are value judgments which form an integral part of the assessment of benefit of cancer drugs. The review concludes with a reflection on individual competences and systemic factors which are relevant to decision making about the value of treatment in situations of non-curative cancer.

show abstract

ESMO-Magnitude of Clinical Benefit Scale version 1.1

Abstract: ESMO-MCBS v1.1 incorporates 10 revisions and will allow for scoring of single-arm studies. Scoring remains very stable; revisions in v1.1 alter the scores of only 12 out of 118 comparative studies and facilitate scoring for single-arm studies.

Cited by 499 publications

References 47 publications

Enhancing global access to cancer medicines

Enhancing global access to cancer medicines

Value assessment of oncology drugs using a weighted criterion‐based approach

Value and Values in Cancer Care. Assessing the Benefit of Treatment in Patients with Advanced Cancer

Contact Info

Product

Resources

About