Assessing the benefit of cancer drugs approved by the European Medicines Agency using the European Society for Medical Oncology Magnitude of Clinical Benefit Scale over time

Thomson, Sasha; Witzke, Noah; Gyawali, Bishal; Santos, Seanthel Delos; Udayakumar, Suji; Cardone, Claudia; Cheung, Matthew C.; Chan, Kelvin K.

doi:10.1016/j.ejca.2021.03.044

Cited by 5 publications

(4 citation statements)

References 21 publications

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“…Despite the decrease in scores, when the other value framework was used for respective agent, changes in scores were not observed.The proportion of clinical trials that exhibited a score change over time differed between the two frameworks used. In our analysis, only one-third of the included trials showed an ESMO-MCBS score change, which was similar to the findings ofThomson et al's (2021) study based on the European Medicine Agency's approval data. In contrast, two-thirds (68%) of the trials showed an ASCO-VF NHB score change, which is similar to the findings of Delos Santos et al's (2021) study based on the Food and Drug…”

supporting

confidence: 89%

“…In our analysis, only one-third of the included trials showed an ESMO-MCBS score change, which was similar to the findings of Thomson et al . ’s ( 2021 ) study based on the European Medicine Agency’s approval data. In contrast, two-thirds (68%) of the trials showed an ASCO-VF NHB score change, which is similar to the findings of Delos Santos et al .…”

Section: Discussionmentioning

confidence: 99%

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Evaluation of changes in the clinical benefits of oncology drugs over time following reimbursement using the ASCO-VF and the ESMO-MCBS

Yoon,

Na,

Lee

et al. 2024

J Cancer Res Clin Oncol

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Purpose This study aims to estimate changes in the value of oncology drugs over time from initial data of the reimbursement decisions to subsequent publications in Korea, using two value frameworks. Methods We retrieved primary publications assessed for reimbursement between 2007 and July 2021 from the decision documents of Health Insurance Review and Assessment and subsequent publications made available following reimbursement decision from ClinicalTrials.Gov and PubMed databases. Changes in the clinical benefit scores were assessed using the American Society of Clinical Oncology Value Framework (ASCO-VF) and the European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS). A paired t test was performed to test whether there was a difference in the scores between primary and subsequent publications. Results Of 73 anticancer product/indication pairs, 45 (61.6%) had subsequent publications, of which 62.5% were released within 1 year of reimbursement decision. The mean ESMO-MCBS and ASCO-VF Net Health Benefit scores increased from primary to subsequent publications, although the differences were not significant. The mean ASCO-VF bonus score significantly increased from 15.91 to 19.09 (p = 0.05). The ESMO-MCBS and bonus scores increased by 0.25 and 0.21, respectively, and the bonus score had a greater impact on the ESMO-MCBS score than the preliminary score did. Conclusion The value of drugs demonstrated in subsequent publications varies considerably among oncology drugs, depending on uncertainty associated with the initial evidence and the availability of updated evidence. As decision-making in the face of uncertainty becomes more prevalent, the value frameworks can serve as simple screening tools for re-evaluation in these cases.

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supporting

confidence: 89%

Section: Discussionmentioning

confidence: 99%

Evaluation of changes in the clinical benefits of oncology drugs over time following reimbursement using the ASCO-VF and the ESMO-MCBS

Yoon,

Na,

Lee

et al. 2024

J Cancer Res Clin Oncol

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“…The ESMO-MCBS has been widely recognised as the most robustly validated tool for the evaluation of the magnitude of clinical benefit reported in studies for the treatment of solid tumours in adults. It has been used to benchmark the benefit of approved treatments [33][34][35][36], it is widely applied in HTA process [37][38][39], it is used to screen candidate medication for the WHO essential medicines list [40,41], it is used in the ESMO guidelines [42], it facilitates teaching of a structured approach to study evaluation and it has been implemented in clinical routine at many oncological centres across Europe.…”

Section: Discussionmentioning

confidence: 99%

ESMO-Magnitude of Clinical Benefit Scale for haematological malignancies (ESMO-MCBS:H) version 1.0

et al. 2023

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“…Finally, clinical relevance should also be recognized. Previous studies have shown that many drugs with OS or QoL data offer non-substantial clinical benefits according to value frameworks established by EMSO and ASCO, where outcomes such as progression-free survival, OS, and QoL are regarded [ 61 , 70 – 72 ]. In our review, only one trial reported a clinically relevant improvement in QoL compared to the alternative for the reimbursed indication [ 49 ].…”

Section: Discussionmentioning

confidence: 99%

Cancer Drugs Reimbursed with Limited Evidence on Overall Survival and Quality of Life: Do Follow-Up Studies Confirm Patient Benefits?

Chauca Strand,

Johansson,

Jakobsson

et al. 2023

Clin Drug Investig

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Background and Objective Cancer drug costs have increased considerably within healthcare systems, but many drugs lack quality-of-life (QoL) and overall survival (OS) data at the time of reimbursement approval. This study aimed to review the extent of subsequent literature documenting improvements in OS and QoL for cancer drug indications where no such evidence existed at the time of reimbursement approval. Methods Drug indications with claims of added therapeutical value but a lack of evidence on OS and QoL that were reimbursed between 2010 and 2020 in Sweden were included for review. Searches were conducted in PubMed and ClinicalTrial.gov for randomized controlled trials examining OS and QoL. Results Of the 22 included drug indications, seven were found to have at least one trial with conclusive evidence of improvements in OS or QoL after a mean follow-up of 6.6 years. The remaining 15 drug indications either lacked subsequent randomized controlled trial data on OS or QoL ( n = 6) or showed no statistically significant improvements ( n = 9). Only one drug demonstrated evidence of improvement in both OS and QoL for its indication. Conclusions A considerable share of reimbursed cancer drug indications continue to lack evidence of improvement in both OS and QoL. With limited healthcare resources and an increasing cancer burden, third-party payers have strong incentives to require additional post-reimbursement data to confirm any improvements in OS and QoL. Supplementary Information The online version contains supplementary material available at 10.1007/s40261-023-01285-4.

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Assessing the benefit of cancer drugs approved by the European Medicines Agency using the European Society for Medical Oncology Magnitude of Clinical Benefit Scale over time

Cited by 5 publications

References 21 publications

Evaluation of changes in the clinical benefits of oncology drugs over time following reimbursement using the ASCO-VF and the ESMO-MCBS

Evaluation of changes in the clinical benefits of oncology drugs over time following reimbursement using the ASCO-VF and the ESMO-MCBS

ESMO-Magnitude of Clinical Benefit Scale for haematological malignancies (ESMO-MCBS:H) version 1.0

Cancer Drugs Reimbursed with Limited Evidence on Overall Survival and Quality of Life: Do Follow-Up Studies Confirm Patient Benefits?

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