Estimating the Impact of Delayed Access to Oncology Drugs on Patient Outcomes in Canada

Abstract

Introduction New requirements in Canada’s pricing processes for patented drugs may exacerbate delays in regulatory and reimbursement reviews. This study seeks to better understand the impact of any additional delays on non-small cell lung cancer (NSCLC) patients by measuring the following: (a) durations and outcomes of regulatory and reimbursement reviews of NSCLC drugs in Canada and reference countries; (b) delays in Canada’s reviews of three NSCLC drugs (nivolumab, afatinib, and pemetrexed [NAP]); and (c) estimating clinical, patient, and economic impacts of delays in Canada’s reviews on access to NAP. Methods Information from the Context Matters database and the literature (2005–2020) was used to evaluate the durations and outcomes of reimbursement reviews of NSCLC drugs in Canada and comparator countries. Public information was used to assess delays in Canada’s reviews of NAP. Empirical modeling with data from the literature and the Southern Alberta Lung Cancer database was used to estimate the impact of delays in Canada’s NAP reviews on patients (i.e., as losses in person-years of life and quality-adjusted life-years [QALYs]). Results Regulatory and reimbursement reviews in countries of interest take 12–18 months. In Canada, reviews of NSCLC drugs took 216 days (median), with a 24% rejection rate (mean = 19%). Delays in NAP reviews ranged from 5 to 94 days at Health Canada, 0–80 days at CADTH/pCODR, and 12–797 days in Canadian provinces. These delays may have affected 6400 patients, who lost up to 1740 person-years of life and 1122 QALYs (valued at CA$112 million). Conclusion Changes to Canada’s prescription drug pricing processes may prolong reviews. Supplementary Information The online version contains supplementary material available at 10.1007/s40487-022-00187-3.

Impact of Systemic Delays for Patient Access to Oncology Drugs on Clinical, Economic, and Quality of Life Outcomes in Canada: A Call to Action

“…Of those, 96 were excluded. Snowballing methods yielded two additional records, and therefore, four unique records were included in the TLR [ 13 , 14 , 15 , 16 ]. The study selection process is depicted in the PRISMA flow chart ( Figure 1 ).…”

“…The four articles reporting systemic delays were a retrospective cohort study [ 15 ], a public data analysis [ 13 , 14 ] and an analysis of literature and empirical modelling [ 16 ]. Multiple types of cancer were assessed in most studies [ 15 ], while the study by Vanderpuye-Orgle only assessed non-small cell lung cancer (NSCLC) [ 16 ]. Two studies were from Canada [ 13 , 14 ], while the other two studies were from multiple countries [ 15 , 16 ].…”

“…Multiple types of cancer were assessed in most studies [ 15 ], while the study by Vanderpuye-Orgle only assessed non-small cell lung cancer (NSCLC) [ 16 ]. Two studies were from Canada [ 13 , 14 ], while the other two studies were from multiple countries [ 15 , 16 ]. Also, even though the data were heterogeneous, the great majority of studies reported the impact of delayed access to treatment on clinical outcomes, more specifically live years lost ( n = 2), life years saved ( n = 1), OS ( n = 1), and PFS ( n = 1).…”

“…It is conceivable that delays associated with the lengthy drug approval and reimbursement processes will have an even greater impact. This was specifically analyzed in the four articles included in this review [ 13 , 14 , 15 , 16 ].…”

Disparity in public funding of systemic therapy for metastatic renal cell carcinoma within Canada

“…32 Another recent study evaluating the impact of delays in Canada's regulatory and reimbursement reviews of medications for lung cancer revealed a significant decrease in person-years of life, qualityadjusted life-years and productivity losses. 33 How the inequities identified in the present study affect regional differences in survival with mRCC is beyond the scope of this paper but does raise an important question for future studies.…”