A Comparison of Pharmaceutical Reimbursement Agencies' Processes and Methods in France and Scotland

Abstract

<jats:p><jats:bold>Objectives:</jats:bold>Pharmaceutical reimbursement agencies’ processes and methods of appraisal vary across countries. The objective of this study was to examine the contribution of formal health economic analysis in a process using such analysis in Scotland in comparison to a process not routinely using such analysis in France.</jats:p><jats:p><jats:bold>Methods:</jats:bold>A framework for classifying reimbursement systems was used to analyze the two systems. A typology of recommendation was defined and a qualitative analysis of decisions on a sample of medicines appraised by both reimbursement agencies was conducted. Reasons for differences in recommendations were analyzed and case studies selected to illustrate the common reasons.</jats:p><jats:p><jats:bold>Results:</jats:bold>Thirty-nine common medicines appraised by both agencies were identified between 2005 and 2010, treating a variety of diseases for which the Scottish Medicines Consortium tended to provide more restrictive, or did not recommend, listing. Similarities in clinical evidence submitted to the respective reimbursement committees were observed. Differences in recommendation can be explained by a combination of the manufacturer's freedom to set price and the incentives provided by the consideration of health economic analysis and quality of life, alongside differences in relevant comparators, relevant outcomes, treatment guidelines, and the propensity to use network meta-analysis, in decision making.</jats:p><jats:p><jats:bold>Conclusions:</jats:bold>This study provides some explanations and hypotheses for the differences observed in recommendations for a selected sample of medicines with regards to differences in appraisal processes and methods adopted. Further research using larger datasets may allow stakeholders to assess the impact of such differences on the efficient use of health resources.</jats:p>

A Comparison of Reimbursement Recommendations by European HTA Agencies: Is There Opportunity for Further Alignment?

“…The comparisons of eight European HTA agencies in this study, build on previous research by Nicod and Kanavos (2012) and Bending et al (2012). Nicod and Kanavos evaluated HTA recommendations from Australia, Canada, England, Scotland, and Sweden with a particular focus on therapeutic areas and identified significant variation between national recommendations.…”

A comparative analysis of coverage decisions for outpatient pharmaceuticals: Evidence from Denmark, Norway and Sweden

“…HTA methodologies have been implemented in many ways across OECD countries. Studies of HTA processes and outcomes have revealed differences in the way costs and benefits are accounted for in the assessments [9], differences in the scope and timeliness of appraisals [10] and the contextual factors impacting the role of HTA in http://dx.doi.org/10.1016/j.healthpol.2014.12.013 0168-8510/© 2015 Elsevier Ireland Ltd. All rights reserved. The drug must: (1) be safe and efficacious, (2) have a well-defined indication, (3) have a price which is reasonable given the therapeutic value.…”

Early Benefit Assessment of Pharmaceuticals in Germany

“…One study has shown that all substances evaluated by HAS between 2005 and 2010 have entered subsequent price negotiations. 33 In countries that base their decisions on cost-effectiveness information, such as the UK 34 and Australia, 35 coverage decisions are frequently made for specific patient subgroups, particularly those that show favorable cost-effectiveness. Although IQWiG and the FJC evaluate patient subgroup sizes, we did not find any significant associations between patient subgroup size and the rating decisions made by the FJC at patient subgroup level.…”