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Analysis of health economics assessment reports for pharmaceuticals in France - understanding the underlying philosophy of CEESP assessment.

ABSTRACT: Background: Despite the guidelines for Economic and Public Health Assessment Committee (CEESP) submission having been available for nearly six years, the dossiers submitted continue to deviate from them, potentially impacting product prices. Objective: to review the reports published by CEESP, analyse deviations from the guidelines, and discuss their implications for the pricing and reimbursement process. Study design: CEESP reports published until January 2017 were reviewed, and deviations from the guidelines were extracted. The frequency of deviations was described by type of methodological concern (minor, important or major). Results: In 19 reports, we identified 243 methodological concerns, most often concerning modelling, measurement and valuation of health states and results presentation and sensitivity analyses; nearly 63% were minor, 33% were important and 4.5% were major. All reports included minor methodological concerns, and 17 (89%) included at least one important and/or major methodological concern. Global major methodological concerns completely invalidated the analysis in seven dossiers (37%). Conclusion: The CEESP submission dossiers fail to adhere to the guidelines, potentially invalidating the health economics analysis and resulting in pricing negotiations. As these negotiations tend to be unfavourable for the manufacturer, the industry should strive to improve the quality of the analyses submitted to CEESP.

SUBMITTER: Toumi M

PROVIDER: S-EPMC5533125 | biostudies-literature | 2017

REPOSITORIES: biostudies-literature

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Analysis of health economics assessment reports for pharmaceuticals in France - understanding the underlying philosophy of CEESP assessment.

Toumi Mondher M Motrunich Anastasiia A Millier Aurélie A Rémuzat Cécile C Chouaid Christos C Falissard Bruno B Aballéa Samuel S

Journal of market access & health policy 20170716 1

Background: Despite the guidelines for Economic and Public Health Assessment Committee (CEESP) submission having been available for nearly six years, the dossiers submitted continue to deviate from them, potentially impacting product prices. Objective: to review the reports published by CEESP, analyse deviations from the guidelines, and discuss their implications for the pricing and reimbursement process. Study design: CEESP reports published until January 2017 were reviewed ...[more]

PMID: 28804600

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Project description:Introduction: Economic topics appear in the medical studies curriculum at different times. Despite socio-political relevance, there is hardly any information about the degree of understanding that medical students have of "economics in medicine". The present study addresses the questions: What understanding of "economics in medicine" do medical students have before the start of the Practical Year? To what extent is economic teaching content understood as "economization" from outside the profession? Method: Magdeburg medical students in the 5th year of study, who participated in preparatory seminars for the Practical Year (PY) in 2014 and 2015 (60 participants each), assessed the relevance of various seminar topics four months prior to the start of the semester. On the basis of a three-stage qualitative-reconstructive partial evaluation, students' economic understanding is explored through secondary analysis: deductive derivation of the analysis units; integrative basic method ("segmentation", "micro-linguistic detailed analysis", "central theme"); development of a theoretical model by placing the central themes in context following Grounded Theory. Results: Based on the theory, 19 free-text answers with economic reference were identified from the total of all free-text answers. Each answer was assigned to at least one of a total of six themes of the students' understanding of economics: de-professionalizing economization, deciding and working economically, ambivalent requirements for efficiency and equity, the doctor as an entrepreneur, economics as relevant learning content, PY as a conflict-laden setting for economized working and learning. The theoretical model contains social, praxeological and professional references, which can themselves be ambivalent and conflicting. Conclusion: Despite their critical attitude, the surveyed medical students are neither hostile to economics nor do they regard economics in medicine as a taboo subject. Economic learning content is recognized as relevant. Educational formats that tackle the tension between patient and system orientation in a problem-oriented manner can be a productive setting for economic reflection.

Project description:BACKGROUND: Many countries conduct Health Impact Assessment (HIA) of their projects and policies to predict their positive and negative health impacts. In recent years many guides have been developed to inform HIA practice, largely reflecting local developments in HIA. These guides have often been designed for specific contexts and specific need, making the choice between guides difficult. The objective of the current study is to identify underlying principles in order to guide HIA practice in Iran. METHODS: This study was conducted in three stages: 1) Studies comparing HIA guidelines were reviewed to identify criteria used for comparison seeking emphasized principles. 2) The HIA characteristics extracted from published papers were categorized in order to determine the principles that could guide HIA practice. 3) Finally, these principles were agreed by experts using nominal group technique. RESULTS: The review of the studies comparing HIA guides demonstrated there are no clear comparison criteria for reviewing HIA guides and no study mentioned HIA principles. Investigating the HIA principles from peer-reviewed papers, we found 14 issues. These were, considering of general features in planning and conducting HIAs such as HIA stream, level, timing and type, considering of the wider socio-political and economic context, considering of economic, technical and legal aspects of HIA and capacities for HIA, rationality and comprehensiveness, using appropriate evidence, elaborating on HIA relation to other forms of Impact Assessment, considering of equity, and encouraging intersectoral and interdisciplinary cooperation, involvement of stakeholders and transparency as underlying principles to guide HIA practice. The results emphasize how critical these technical as well as tactical considerations are in the early scoping step of an HIA which plans the conduct of the HIA in reponse to local contextual issues. CONCLUSION: Determining the principles of HIA from peer-reviewed papers provides an opportunity for guiding HIA practice comprehensively. It seems to be feasible to develop a universal guide that covers all principles required.

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Analysis of health economics assessment reports for pharmaceuticals in France - understanding the underlying philosophy of CEESP assessment.

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Analysis of health economics assessment reports for pharmaceuticals in France - understanding the underlying philosophy of CEESP assessment.

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