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

Estimating the Impact of Delayed Access to Oncology Drugs on Patient Outcomes in Canada IntroductionNew 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.MethodsInformation 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]).ResultsRegulatory 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).ConclusionChanges to Canada’s prescription drug pricing processes may prolong reviews. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Oncology and Therapy Springer Journals

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

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References (94)

Publisher
Springer Journals
Copyright
Copyright © The Author(s) 2022
ISSN
2366-1070
eISSN
2366-1089
DOI
10.1007/s40487-022-00187-3
Publisher site
See Article on Publisher Site

Abstract

IntroductionNew 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.MethodsInformation 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]).ResultsRegulatory 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).ConclusionChanges to Canada’s prescription drug pricing processes may prolong reviews.

Journal

Oncology and Therapy – Springer Journals

Published: Jun 1, 2022

Keywords: NSCLC; Targeted therapies; HTA; CADTH; Reimbursement; Canada; Patient access; QALY; Quality of life

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