Health Canada's use of expedited review pathways and therapeutic innovation, 1995-2016: cross-sectional analysis

BMJ Open
Joel Lexchin

Abstract

This study examines the use of expedited approval pathways by Health Canada over the period 1995 to 2016 inclusive and the relationship between the use of these pathways and the therapeutic gain offered by new products. Cross-sectional study. Therapeutic Products Directorate, Biologics and Genetic Therapies Directorate, Notice of Compliance database, Notice of Compliance with conditions web site, Patented Medicine Prices Review Board, La revue Prescrire, WHO Anatomical Therapeutic Chemical classification system. Percent of new drugs evaluated by Health Canada that went through an expedited pathway between 1995 and 2016 inclusive. Kappa values comparing the review status with assessments of therapeutic value for individual drugs. Of 623 drugs approved by Health Canada between 1995 and 2016, 438 (70.3%) drugs went through the standard pathway and 185 (29.7%) an expedited pathway. Therapeutic evaluations were available for 509 drugs. Health Canada used an expedited approval pathway for 159 of the 509 drugs, whereas only 55 were judged to be therapeutically innovative. Forty-two of the 55 therapeutically innovative drugs received an expedited review and 13 received a standard review. The Kappa value for the entire period for all 50...Continue Reading

References

May 1, 2007·Healthcare Policy = Politiques De Santé·Joel Lexchin
Jul 10, 2014·Clinical Pharmacology and Therapeutics·L G BairdG Hirsch
Sep 25, 2015·BMJ : British Medical Journal·Aaron S KesselheimJonathan J Darrow
Sep 21, 2018·Therapeutic Innovation & Regulatory Science·Neil McAuslaneStuart Walker

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Citations

Apr 28, 2020·JAMA Network Open·Joel Lexchin
Sep 27, 2020·Social Science & Medicine·Donald W Light, Joel R Lexchin
Nov 17, 2020·Frontiers in Public Health·Nigel S B Rawson
Dec 24, 2020·Clinical Therapeutics·Winona Rei BolislisThomas C Kühler
Apr 29, 2021·Journal of Managed Care & Specialty Pharmacy·Jonathan J Darrow

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