OBJECTIVES: In areas of unmet clinical need, it may be possible to gain regulatory approval of a new treatment using data from a planned interim analysis; however, reimbursement using interim data may be more complex, given the lack of information on long-term benefits. METHODS: A protocol of an oncology trial with a planned interim analysis was reviewed in order to determine whether the results would provide sufficient information to support reimbursement. The review results raised considerations that trialists may consider when planning an interim analysis to support both regulatory approval and reimbursement. RESULTS: If reimbursement is sought based on the results from the interim analysis, long-term survival needs to be estimated using statistical extrapolation due to low numbers of events at the time of the interim analysis. Review of long-term oncology survival curves indicate that direct extrapolation of interim data is dependent on the length of follow-up, hence an external reference for long-term survival would be required. Given favourable interim results, this clinical trial protocol enabled patients who progressed on the comparator arm to cross-over to receive the new treatment. The ‘best’ estimate of overall survival would therefore occur at interim rather than final analysis with the hypothesis test for overall survival at the final analysis comparing delayed treatment with the new drug versus continual treatment. CONCLUSIONS:The main purpose of interim analyses is to provide access to effective treatments in a timely manner. In many countries, access to effective treatments occurs not at the point of regulatory approval, but at the point of reimbursement. Pertinent questions for interim analyses for reimbursement include 1) whether interim analyses be performed at all; 2) whether interim analyses be performed at later timepoints to provide data on long-term benefits; 3) whether statistical methods provide sufficient certainty for interim data to inform reimbursement decisions.