Value Frameworks: Adaptation of Korean Versions of Value Frameworks for Oncology

Bae, Green; Bae, Seung Jin; Lee, Donghwan; Han, Juhee; Koo, Dong Hoe; Kim, Do Yeun; Kim, Hee Jun; Oh, Sang-Young; Lee, Hee Yeon; Lee, Jong Hwan; Han, Hye Sook; Ha, Heggtveit; Kang, Jin Hyoung

doi:10.3390/ijerph18063139

Cited by 4 publications

(2 citation statements)

References 28 publications

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“…Using existing frameworks, like ESMO-MCBS, in a national setting is not unique either. In Korea, the American Society of Clinical Oncology and the ESMO-MCBS were adapted to produce a reliable framework (18). In Canada, multicriteria decision analysis methods were applied to the development of a value assessment framework for antineoplastic drugs.…”

Section: Discussionmentioning

confidence: 99%

Development, testing, and implementation of a new procedure to assess the clinical added benefit of pharmaceuticals

Dóczy¹,

Sódar²,

Hölgyesi

et al. 2022

Int J Technol Assess Health Care

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Objectives The reimbursement process for innovative health technologies in Hungary lacks any formalized assessment of clinical added benefit (CAB). The aim of this research is to present the development, retrospective testing, and implementation of a local assessment framework for determining the CAB of cancer treatments at the Department of Health Technology Assessment of the National Institute of Pharmacy and Nutrition in Hungary. Methods The assessment framework was drafted after screening existing methods and a retrospective comparison of local reimbursement dossiers to that of German and French methods. The Magnitude of Clinical Benefit Scale of the European Society for Medical Oncology was chosen to rate the extent of CAB in oncology, as part of a conclusion complemented by the assessment of endpoint relevance and the quality of evidence. Several rounds of retrospective assessments have been conducted involving all clinical assessors, iterated with semistructured discussions to consolidate divergence between assessors. External stakeholders were consulted to provide feedback on the framework. Results Retrospective assessments resulted in average more than 75 percent concordance between assessors on each element of the conclusion. Input from ten stakeholders was also incorporated; stakeholders were generally supportive, and they mostly commented on the concept, the elements of the framework, and its implementation. Conclusions The procedure is suitable for routine use in the decision-making process to describe the CAB of antineoplastic technologies in Hungary. Further extension of the framework is required to cover more disease areas for structured and comparable conclusions on CAB of innovative health technologies.

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Section: Discussionmentioning

confidence: 99%

Development, testing, and implementation of a new procedure to assess the clinical added benefit of pharmaceuticals

Dóczy¹,

Sódar²,

Hölgyesi

et al. 2022

Int J Technol Assess Health Care

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show abstract

“…We were trained for the tools and had applied the tools to more than 10 phase 3 trials for previous study. The inter-rater reliability was achieved [13].…”

Section: Methodsmentioning

confidence: 99%

The value measurement of emerging therapeutics in renal cell carcinoma: ASCO value framework and ESMO-MCBS

Kang

Kim

et al. 2022

BMC Health Serv Res

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Purpose Rapid development of novel therapeutics in renal cell carcinoma (RCC) has led to financial burden for patients and society. Value including clinical benefit, toxicity affecting quality of life and cost-effectiveness are a concern, prompting the need for tools to facilitate value assessment of therapeutics. This study reviews the value assessment tools, and evaluates the value of emerging therapeutics in RCC. Materials and methods Two medical oncologists used American Society of Clinical Oncology value framework (ASCO VF) v2.0 and European Society for Medical Oncology-magnitude of clinical benefit scale (ESMO-MCBS) v1.1 to phase 3 trials evaluating first-line therapy in patients with metastatic RCC. Follow-up (FU) reports and extended survival data were included. Equivocal aspects and limitations of the tools were discussed. Results Six trials (COMPARZ, CheckMate 214, JAVELIN renal 101, Keynote 426, CLEAR, and CheckMate 9ER) were assessed. The control arm was standard-of-care sunitinib in all trials. ASCO VF’s net health benefit, calculated as clinical benefit, toxicity and other bonus point was 11 in pazopanib, 41.9 in nivolumab plus ipilimumab, 22.4 in axitinib plus avelumab, 48.7 in axitinib plus pembrolizumab, 35.2 in lenvatinib plus pembrolizumab, and 50.8 in cabozantinib plus nivolumab. A higher score means a greater treatment benefit. ESMO-MCBS gave grade 5 to nivolumab plus ipilimumab, 4 to pazopanib, lenvatinib plus pembrolizumab and cabozantinib plus nivolumab, 3 to axitinib plus avelumab or pembrolizumab. Both tools had unclear aspects to be applied to clinical practice, and should be more clearly defined, such as endpoint for determining survival benefits or how to standardize quality of life and toxicity. Conclusions ASCO VF and ESMO-MCBS were applied to evaluate the newly emerging drugs in RCC and assessed their value. In-depth discussion by experts in various fields is required for appropriate clinical application in a real-world setting.

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How Do Patients Value the Benefit of Minimally Invasive Surgery in Cancer Treatment?

Kim¹,

Yu²,

Ryu³

et al. 2022

Value in Health

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Value Frameworks: Adaptation of Korean Versions of Value Frameworks for Oncology

Cited by 4 publications

References 28 publications

Development, testing, and implementation of a new procedure to assess the clinical added benefit of pharmaceuticals

Development, testing, and implementation of a new procedure to assess the clinical added benefit of pharmaceuticals

The value measurement of emerging therapeutics in renal cell carcinoma: ASCO value framework and ESMO-MCBS

How Do Patients Value the Benefit of Minimally Invasive Surgery in Cancer Treatment?

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