INTRODUCTION: The Canadian reimbursement process for therapies is lengthy and each step can cause delay. With the introduction of new requirements in PMPRB there may be additional delays and so it is important to understand how reimbursement review times ultimately impact patient outcomes.

OBJECTIVES: To compare the number, duration, and outcome of reimbursement reviews for lung cancer drugs in Canada versus other comparable countries; and to estimate the effect on patients, of delays in access to the lung cancer therapies nivolumab, afatinib and pemetrexed (NAP).

METHODS: Submissions for lung cancer drugs to CADTH/pCODR, NICE, HAS, and SMC were reviewed, and the number, duration and outcome of reviews were recorded and assessed for time trends. To define delays, the duration of reviews for NAP by CADTH/pCODR and Canadian provinces were assessed using internal benchmarks. The Southern Alberta Lung Cancer database was used to estimate the number of lung cancer patients that could be affected by delayed access to NAP. Data from phase III clinical trials and the literature were used to estimate the economic value of potential years of life lost (PYLL) and quality-adjusted life-years (QALYs) attributable to a one-day delay in access to NAP.

RESULTS: 101 applications for new lung cancer drugs were made to CADTH/pCODR, NICE, SMC, and HAS between 2012 and 2019. Median rejection rates/days of review were 26%/213, 6%/329, 17%/87 and 14%/unknown at CADTH/pCODR, NICE, SMC and HAS, respectively. Delays in NAP reviews ranged from 17-182 days and 0-797 days at CADTH/pCODR, and Canadian provinces respectively. Delay in access to NAP by one day could affect 6350 Canadian patients and may lead to 1681 PYLL and 1082 QALYs lost (valued at $108.2million CAD).

CONCLUSIONS: Avoidable delays exist in the Canadian reimbursement process, and these could have significant impacts on the lives of lung cancer patients.