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

Part of: Special Collection - Methods

Published online by Cambridge University Press:  12 July 2022

Veronika Dóczy Open the ORCID record for Veronika Dóczy [Opens in a new window] ,
Barbara Wernerné Sódar ,
Áron Hölgyesi ,
Gergő Merész  and
Péter Gaál
Veronika Dóczy*
Affiliation:
Department of Health Technology Assessment, National Institute of Pharmacy and Nutrition, Budapest, Hungary
Barbara Wernerné Sódar
Affiliation:
Department of Health Technology Assessment, National Institute of Pharmacy and Nutrition, Budapest, Hungary
Áron Hölgyesi
Affiliation:
Department of Health Technology Assessment, National Institute of Pharmacy and Nutrition, Budapest, Hungary Doctoral School of Molecular Medicine, Semmelweis University, Budapest, Hungary
Gergő Merész
Affiliation:
Department of Health Technology Assessment, National Institute of Pharmacy and Nutrition, Budapest, Hungary Doctoral School of Mental Health Sciences, Semmelweis University, Budapest, Hungary
Péter Gaál
Affiliation:
Faculty of Health and Public Administration, Health Services Management Training Centre, Semmelweis University, Budapest, Hungary Faculty of Technical and Human Sciences, Department of Applied Social Sciences, Sapientia Hungarian University of Transylvania, Targu Mures, Romania
*
* Author for correspondence: Veronika Dóczy, E-mail: [email protected]
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Abstract

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.

Keywords

Technology assessmentHealth (MeSH Unique ID: D013673)Medical oncology (MeSH Unique ID: D008495)Comparative effectiveness research (MeSH Unique ID: D057186)Outcome assessmenthealth care (MeSH Unique ID: D017063)Decision makingorganizational (MeSH Unique ID: D003659)
Type
Method
Information
International Journal of Technology Assessment in Health Care , Volume 38 , Issue 1 , 2022 , e58
Copyright
© The Author(s), 2022. Published by Cambridge University Press

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Footnotes

The authors thank Professor Nathan Cherny and Mrs. Nicola Jane Latino and all the experts at ESMO-MCBS helpdesk for their quick responses and irreplaceable support, all stakeholders who provided feedback and thus improved the framework, Ms. Szilvia Szabó and all other clinical assessors of NIPN for their tireless help with the retrospective testing, the Department of Pharmacovigilance at NIPN for their useful contribution, and Ms. Antonia Bosworth Smith and Mr. Kenneth Paul White for their contribution to language editing.

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