HTA Programme Research
HTA Programme Research: Selecting criteria and identifying goals
Systematic comparison of regulatory and reimbursement processes across multiple countries
Systematic process maps for the path a medicine takes from regulatory review to reimbursement will be produced for key countries and will contain a hierarchy of information from agencies involved to key gateways and key activities. The maps will be used to facilitate comparison between the complex appraisal and reimbursement systems used by different countries and hence help to improve transparency. In addition, the maps will be used as starting points for the identification of comparable milestones for benchmarking.
Benchmarking companies
Pilot study
A pilot study is proposed for 2011 to define and test metrics to be provided by company participants in order to enable the relative benchmarking of resource use, decision making and time to outcome from regulatory approval to reimbursement in selected countries.
The details of the study, milestones and the cohort of compounds will be determined in the Industry Discussion Meeting in March, where the process maps and a draft methodology will be presented by CIRS for discussion. Data collection and analysis is envisaged for May-September. Results will be reported to pilot study participants as company-specific trend analyses in comparison to anonymous peer group averages with a high-level discussion of the results to be held at the “Enabling Process Transparency” Workshop.
Benchmarking agencies
Retrospective feasibility study
A feasibility study of internal review milestones from within HTA and decision making agencies will be initiated for the purpose of enabling these agencies to review their processes and timelines against peer agencies. The feasibility study will involve the retrospective analysis of a small group of predefined compounds that were assessed in 2009-2010 by all agencies included in the study. This study will follow the established methodology of the CIRS Regulatory Agency Benchmarking Database and if successful, will be moved to a pilot study phase in 2012.