How to design the cost‐effectiveness appraisal process of new healthcare technologies to maximise population health: A conceptual framework

Johannesen, Kasper; Claxton, Karl; Sculpher, Mark; Wailoo, Allan

doi:10.1002/hec.3561

Cited by 6 publications

(9 citation statements)

References 30 publications

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“…Its application was previously described in the context of deriving a conceptual framework for the design of the cost-effectiveness appraisal process of new technologies. 21 While it could always have been applied to negotiations between payers/decision makers, this article adds to the growing literature that the assessment of cost-effectiveness itself is affected by strategies adopted. Hence, companies now have additional considerations when devising reimbursement strategies.…”

Section: Discussionmentioning

confidence: 99%

The Interaction between Price Negotiations and Heterogeneity: Implications for Economic Evaluations

et al. 2020

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Economic evaluation is an important element of the decision making process for the reimbursement of drugs. Heterogeneity can be considered an explained variation in clinical or economic outcomes based on the clinical and sociodemographic characteristics of patients. However, to our knowledge, the relationship between price negotiations and population heterogeneity has not been considered in the literature to date. If a company offers a conditional discount that is dependent on obtaining reimbursement in 2 subgroups or indications, an interaction is generated between groups that should be accounted for in economic evaluations. Critically, where the drug has 2 indications but is only cost-effective in 1 indication at the full price (herein “indication 1”), the cost savings realized from implementation of the discount in indication 1 can be used to offset the incremental cost of extending reimbursement to indication 2 at the discounted price. This reduces the incremental cost-effectiveness ratio and increases the probability of positive reimbursement compared to a stratified approach. Given the additional complexity that this introduces, we introduce a framework deemed the “hybrid approach” to guide the economic assessment. We present 2 worked examples. We show that failure to account for the interaction can lead to inaccurate conclusions regarding a drug’s cost effectiveness and that adoption of strategic behavior could theoretically increase the reimbursement price of drugs. By adopting this framework, cost-effective interventions are identified that may have been previously misclassified as not being cost-effective and vice versa. Recognition of the interaction in the literature by pharmaceutical companies may influence the forms of discounts offered to decision makers. Therefore, we expect this research to have far-reaching effects on medical decision making.

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Section: Discussionmentioning

confidence: 99%

The Interaction between Price Negotiations and Heterogeneity: Implications for Economic Evaluations

et al. 2020

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“…Wherever they were delivered, a variety of quality issues and weak compliance with the established requirements was found in the HEEs submitted to several reimbursement or HTA bodies in Canada (British Columbia), Australia, the Netherlands, Belgium, and France (38–42). For these reasons, the critical assessment of HEEs by internal reviewers, which goes beyond the simple application of a checklist, remains a crucial step in many countries (e.g., Australia and England) (39;43), with different levels of accuracy based on a context-specific trade-off between scientific rigor and available resources (44). Whenever possible, companies' models should be requested and analyzed using different assumptions or inputs, because industry-sponsored studies are likely to overestimate cost-effectiveness (44;45).…”

Section: Discussionmentioning

confidence: 99%

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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“…The drug performance information for each criterion included the clinical trial literature on the five targeted therapies [34–48], the clinical treatment guide for colon and rectal cancer from the National Comprehensive Cancer Network (NCCN) [4, 5], targeted therapy instruction leaflets, 2013 and 2014 Taiwan cancer registration reports [34], the top ten drug price reference countries’ insurance drug prices for the current targeted therapies[34–40], US FDA [41] and TFDA drug permit search websites [42], the Taiwan National Health Insurance reimbursement policy [49], health technology assessment report search websites [43], etc. The assessment criteria performance matrix is shown in Table 1.…”

Section: Methodsmentioning

confidence: 99%

“… References : Clinical Trials [34–48]; clinical treatment guidelines [4, 5]; International pharmaceutical prices [34–40]; Taiwan cancer registration reports [34]; US FDA website [41] and Taiwan FDA websites [42], Taiwan National Health Insurance reimbursement policy [49], health technology assessment report [43]…”

Section: Methodsmentioning

confidence: 99%

Comprehensive value assessment of drugs using a multi-criteria decision analysis: An example of targeted therapies for metastatic colorectal cancer treatment

Hsu

Lin

et al. 2019

PLoS ONE

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ObjectiveThis study is aimed toward establishing a decision-making model with multiple criteria for appraisal and reimbursement to compare the attitudes of different stakeholders toward various dimensions and criteria and to evaluate the five targeted therapies (bevacizumab, cetuximab, panitumumab, aflibercept, and regorafenib) for metastatic colorectal cancer.MethodThis study is a multi-criteria decision analysis (MCDA) using a model that includes three dimensions and nine criteria. Both the overall and individual scores of the respective targeted therapies in different dimensions and criteria were calculated. A sensitivity analysis was carried out in order to evaluate the robustness of the research results. An interview-based questionnaire survey was applied to obtain the performance information for the targeted therapies and the weights of the dimensions and criteria.ResultsOverall, the clinical dimension had the highest weight, followed by the economic dimension, and finally, the social dimension. In the clinical dimension, the “comparative efficacy” criterion had the highest weight; in the economic dimension, the “cost-effectiveness” criterion” was given the greatest importance; in the social dimension, the “social concern and patient needs” criterion was given more emphasis. The overall values ranked from high to low as follows: cetuximab (overall score 3.3666), bevacizumab (3.3043), panitumumab (3.2030), aflibercept (2.8923) and regorafenib (2.8366).ConclusionsA comprehensive value assessment system combining “multi-dimensional criteria,” “multi-perspectives,” and an “integrative assessment” is necessary to evaluate the value of medicines. The results showed not only the order of weights of different dimensions or criteria, but also the rankings of the value of the targeted therapies.

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How to design the cost‐effectiveness appraisal process of new healthcare technologies to maximise population health: A conceptual framework

Cited by 6 publications

References 30 publications

The Interaction between Price Negotiations and Heterogeneity: Implications for Economic Evaluations

The Interaction between Price Negotiations and Heterogeneity: Implications for Economic Evaluations

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

Comprehensive value assessment of drugs using a multi-criteria decision analysis: An example of targeted therapies for metastatic colorectal cancer treatment

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