ArticleBMJ open2015
Health Canada's use of its priority review process for new drugs: a cohort study.
Article in BMJ open, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 17 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
17 citing papers in PubMed.
- Assessing the Opportunity for an Accelerated Access Pathway for Health Canada Priority Review Drugs: A Comparative Analysis with Ontario's FAST Pilot Program.Current oncology (Toronto, Ont.) · 2026Article
- Fear of missing out: Drug availability in the United States vs Canada.Journal of managed care & specialty pharmacy · 2024Article
- Development Time and Patent Extension for Prescription Drugs in Canada: A Cohort Study.International journal of health policy and management · 2021Article
- Time to market for drugs approved in Canada between 2014 and 2018: an observational study.BMJ open · 2021Observational
- Health Canada's Proposal to Accelerate New Drug Reviews.Healthcare policy = Politiques de sante · 2020Article
- Commentary: Expedited Regulatory Review of Low-Value Drugs.Healthcare policy = Politiques de sante · 2020Article
- Truth and direct-to-consumer advertising in Canada of DUKORAL for traveler's diarrhea prevention.Canadian family physician Medecin de famille canadien · 2019Review
- Article
- Health Canada's use of expedited review pathways and therapeutic innovation, 1995-2016: cross-sectional analysis.BMJ open · 2018Article
- Determinants of new drugs prescription in the Swiss healthcare market.BMC health services research · 2018Article
- A real world example of coverage with evidence development in Australia - ipilimumab for the treatment of metastatic melanoma.Journal of pharmaceutical policy and practice · 2018Article
- Priority reviews: innovation and safety.CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne · 2017Article
- How Safe and Innovative Are First-in-Class Drugs Approved by Health Canada: A Cohort Study.Healthcare policy = Politiques de sante · 2016Article
- A Better Prescription: Advice for a National Strategy on Pharmaceutical Policy in Canada.Healthcare policy = Politiques de sante · 2016Article
- Trends in utilization of FDA expedited drug development and approval programs, 1987-2014: cohort study.BMJ (Clinical research ed.) · 2015Article
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Corrections and comments
- Erratum issued
Authors and funding
1 author.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesPriority reviews of new drug applications are resource intensive and drugs approved through this process have a greater likelihood of acquiring a serious safety warning compared to drugs approved through the standard process. Therefore, when Health Canada uses priority reviews, it is important that it accurately identifies products that represent a significant therapeutic advance. The purpose of this study is to compare Health Canada's use of priority reviews to therapeutic ratings from two independent organisations, the Patented Medicine Prices Review Board (PMPRB) and the French drug bulletin Prescrire International, over the period 1 January 1997-31 December 2012.
designCohort study. DATA SOURCES: Annual reports of the Therapeutic Products Directorate, and the Biologics and Genetic Therapies Directorate; evaluations of therapeutic innovation from PMPRB and Prescrire International; WHO Collaborating Centre for Drug Statistics Methodology.
interventionsAssessments by PMPRB and Prescrire International treated as a gold standard for postmarket therapeutic value. PRIMARY AND SECONDARY OUTCOME MEASURES: Drug-by-drug comparison between the review status from Health Canada and the therapeutic status from PMPRB/Prescrire using κ values, and positive and negative predictive values. Analysis of the per cent of all new drug applications put into the priority review category over the 16-year period.
resultsHealth Canada approved 426 new drugs, and 345 were evaluated by PMPRB and/or Prescrire. 91 had a priority review and 52 were assessed as innovative (p=0.0003). Agreement between Health Canada and PMPRB/Prescrire was only fair (κ=0.330). The positive predictive value for Health Canada's review assignments was 36.3% and the negative predictive value was 92.5%.
conclusionsHealth Canada's assignment of a priority approval to a new drug submission is only a fair predictor of the drug's therapeutic value once it is marketed. Health Canada should review its criteria for using priority reviews.
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