OBJECTIVES: Health technology assessments (HTAs) inform reimbursement decisions. International differences in HTA processes lead to international differences in patient access to new treatments. Using HTAs for nivolumab plus chemotherapy in first-line gastric cancer as an example, we quantified the variation in time to patient access and in the evaluation of benefits between different HTA agencies.

METHODS: We compared time to patient access using three measures, time from regulatory approval to reimbursement, time from regulatory approval to HTA submission and time from HTA submission to reimbursement. We compared HTA evaluation of benefits using the incremental QALY (ΔQALY) for the CM-649 trial direct comparison, nivolumab plus fluoropyrimidine and platinum chemotherapy vs fluoropyrimidine and platinum chemotherapy. Comparisons were also made between ΔQALYs submitted vs those accepted for each HTA agency.

RESULTS: Time from regulatory approval to reimbursement varied from 0 to 13 months (n=11). Several countries have yet to reimburse, so the maximum time will be longer. Time from regulatory approval to HTA submission varied from -11 months to +12 months (n=16). Time from HTA submission to reimbursement varied from -9 to +22 months (n=8), with several countries yet to achieve reimbursement. For the HTA agencies for which details of the accepted ΔQALY were available (n=5), submitted ΔQALYs varied from 0.395 to 1.039, while the difference between the submitted and accepted ΔQALYs varied from – 47% to + 8%.

CONCLUSIONS: Considerable variation was observed in time to patient access and evaluation of benefits. Variation in time to patient access was driven by differences in HTA and reimbursement processes. Submitted ΔQALYs varied partly due to differences in patient populations and database locks between submissions, but also due to differences in HTA agencies’ methodological preferences. Variation in submitted vs accepted ΔQALYs were mainly due to differences in the changes HTA agencies made to overall survival extrapolations.