Merging Regulatory and Reimbursement Needs in Clinical Trials

Mar 1, 2015, 00:00 AM
10.1016/j.jval.2015.02.007
https://www.valueinhealthjournal.com/article/S1098-3015(15)00046-7/fulltext
Section Title : Editorials
Section Order : 25
First Page : 145
The ISPOR Cost-Effectiveness Analysis Alongside Clinical Trials—Good Research Practices II Task Force Report achieves its stated objective, to refresh the 2005 Task Force Report with developments that have taken place over the past 9 years [,]. Certain fundamental components of the original report remain the same (e.g., data should be fully integrated into the trial; incremental analyses should be reported with appropriate measures of uncertainty based on an intention-to-treat analysis). However, the authors conveniently highlight in Table 1 several updates that should improve the quality of the economic evaluations conducted. Despite advances over the past 9 years, there remain areas in which further research and more detailed guidance are needed. Below are just a few areas in which I hope the (future) third Task Force will report that progress has been made.
As noted by the Task Force, early joint advice meetings with both regulatory and HTA agencies are now offered in some jurisdictions. These meetings have the potential for clarifying the issues in a comprehensive manner and ideally leading to greater harmonization of the evidentiary needs of the regulators and reimbursement agencies. With such alignment, the Task Force could emphasize that the choice of relevant patient population, comparator and study endpoints would be most important, in combination with a discussion of how well the sponsor's plan will meet these needs. Thus, earlier and closer alignment of the evidence generation plans for regulatory and reimbursements purposes are needed in the planning process. It is important to recognize that not all clinical trials lend themselves to conducting cost-effectiveness evaluations (either within the study period or thru extrapolation beyond the time horizon of the study). In these cases, clinical trials may still provide an opportunity to collect data that will inform a future cost-effectiveness model. Regardless of the intended purpose of the trial, there must be a shared, early understanding of the research objectives (both clinical and economic) to ensure the design adequately addresses these needs.
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HEOR Topics :
  • Clinical Trials
  • Cost-comparison, Effectiveness, Utility, Benefit Analysis
  • Economic Evaluation
  • Health Policy & Regulatory
  • Reimbursement & Access Policy
  • Study Approaches
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Regions :
  • Global