Assessment of Methodological Quality of Economic Evaluations in Belgian Drug Reimbursement Applications

Simoens, Steven

doi:10.1371/journal.pone.0085411

Cited by 4 publications

(1 citation statement)

References 6 publications

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“…those with more therapeutic value than the existing alternatives. The decision on reimbursement is based on multiple factors, including the therapeutic value of the drug, its price, its importance in clinical practice, its budget impact, and cost-effectiveness [ 14 ].…”

Section: Introductionmentioning

confidence: 99%

Value judgment of health interventions from different perspectives: arguments and criteria

Vermeulen

Krabbe

2018

Cost Eff Resour Alloc

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BackgroundThe healthcare sector is evolving while life expectancy is increasing. These trends put greater pressure on healthcare resources, prompt healthcare reforms, and demand transparent arguments and criteria to assess the overall value of health interventions. There is no consensus on the core criteria by which to value and prioritize interventions, and individual stakeholders might value specific elements differently. The present study is based on a literature review that retrieved the most widely recognized arguments and criteria used in decision-making. The aim was to compile a smaller set of arguments and criteria that would seem most relevant to different stakeholders.MethodsA literature review was performed in Medline and EMBASE. The initial search retrieved over 2000 articles and documents of relevant committees. A selection was made based on their reference to healthcare, policy issues, or social justice. Finally, 84 papers were included. Data extraction took place after appraisal of the articles. A full table was made, including all arguments and criteria found; next, identical or largely overlapping arguments were excluded. The remaining arguments and criteria were assessed for relevance and a reduced set was compiled.ResultsThe final set included 25 arguments and criteria, categorized by type (clinical, social justice, ethical, and policy). For each argument and criterion, relevance to stakeholders was scored on three levels (not, partly, and completely relevant).ConclusionsMany arguments and criteria play a role in making value judgments on health interventions, but not all are relevant to all interventions. Moreover, they may interact with each other. A viable way to deal with interacting and possibly conflicting arguments and criteria might be to arrange public discussions that would evoke different stakeholders’ perspectives.

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Section: Introductionmentioning

confidence: 99%

Value judgment of health interventions from different perspectives: arguments and criteria

Vermeulen

Krabbe

2018

Cost Eff Resour Alloc

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Evaluating the conduct and application of health utility studies: a review of critical appraisal tools and reporting checklists

et al. 2021

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Quality of health economic evaluations submitted to the Italian Medicines Agency: current state and future actions

Carletto

Zanuzzi

Sammarco

et al. 2020

Int J Technol Assess Health Care

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Objectives The purpose of this study was to evaluate the current state of health economic evaluations (HEEs) submitted by pharmaceutical companies to the Italian Medicines Agency (AIFA) as part of their pricing and reimbursement (P&R) dossiers, and to explore potential future actions in order to enhance their quality. Methods All company dossiers submitted from October 2016 to December 2018 were reviewed to select those containing pharmacoeconomic studies. The general characteristics of HEEs were described and their quality assessed based on a checklist adapted from Philips et al. (Review of guidelines for good practice in decision-analytic modelling in health technology assessment. Health Technol Assess. 2004;8: 1–158). Results Of the 299 dossiers submitted to AIFA, 105 included one or more pharmacoeconomic studies, of which fifty-three were cost-effectiveness analyses. Overall, the compliance of the HEEs with the quality checklist was highly variable: some studies reached high methodological standards whereas others had serious flaws (mean 59.22 percent, range 19.35–90.32 percent). The main weaknesses were the unjustified exclusion of relevant alternatives, poor description and justification of model data and assumptions, and insufficient exploration of uncertainty and study validity. Non-homogeneity across studies was found in study perspectives, discount rates, methods for costing, estimating quality-adjusted life-years and conducting sensitivity analyses. Conclusions Based on the results of this study, the recommended actions for increasing the quality of HEEs within reimbursement submissions in Italy are twofold: first, to set methodological standards for conducting and reporting HEEs; second, to strengthen the internal assessment process, also through the acquisition of companies' models and re-evaluation of results. These actions will hopefully provide greater contribution to the evidence-based P&R decision making.

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Assessment of Methodological Quality of Economic Evaluations in Belgian Drug Reimbursement Applications

Cited by 4 publications

References 6 publications

Value judgment of health interventions from different perspectives: arguments and criteria

Value judgment of health interventions from different perspectives: arguments and criteria

Evaluating the conduct and application of health utility studies: a review of critical appraisal tools and reporting checklists

Quality of health economic evaluations submitted to the Italian Medicines Agency: current state and future actions

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