Factors Delaying the Public Listing of New Drugs in Canada
Author(s)
Etienne Gaudette, PhD1, Shirin Rizzardo, PharmD1, Kevin Pothier, BSc Pharm.1, Mina Tadrous, PhD2;
1Patented Medicine Prices Review Board, Ottawa, ON, Canada, 2University of Toronto, Toronto, ON, Canada
1Patented Medicine Prices Review Board, Ottawa, ON, Canada, 2University of Toronto, Toronto, ON, Canada
Presentation Documents
OBJECTIVES: Canada’s decentralized public payer structure has been criticized for contributing to long delays in the public listing of new drugs. This research aimed to identify the main factors contributing to delays during the listing process.
METHODS: A cohort study approach was used to examine the prescription drugs with a first Canadian public listing between 2018 and 2023. Time-to-listing components, timeline exceptions, reimbursement recommendations, and negotiation results were documented using the Canadian Institute for Health Information’s Formulary Coverage tool, Health Canada’s Notice of Compliance (NOC) database, the Canadian Drug Agency (CDA) Reimbursement Review reports, and the pan-Canadian Pharmaceutical Alliance’s Brand Name Drug Negotiation Status website. We compiled summary measures of time-to-listing and used linear regression models to identify factors contributing to delays.
RESULTS: From 2018 to 2023, N=160 new drugs were added to Canadian public formularies and were included in the analysis. The average time from Health Canada approval to first public listing was 906 days (2.5 years), with a standard deviation of 640 days (1.8 years). Factors associated with the longest delays were drugs without a submission to the CDA (average delay of 629 days, N=10 drugs), with unsuccessful price negotiations (587 days, N=19), with CDA submissions made after the approval (467 days, N=71), and with “do not list” recommendations from the CDA (278 days, N=19). The N=92 drugs impacted by one or more of these factors had an average time-to-listing of 1,194 days (3.3 years, SD 1.9 years) compared to 517 days (1.4 years, SD 0.6 years) for the N=68 drugs not affected by these factors.
CONCLUSIONS: Adding new drugs to public formularies takes over 2 years on average in Canada. Important factors delaying time-to-listing include manufacturer decisions about CDA submissions, unsuccessful price negotiations, and drugs with unproven cost-effectiveness that receive a negative recommendation from the CDA.
METHODS: A cohort study approach was used to examine the prescription drugs with a first Canadian public listing between 2018 and 2023. Time-to-listing components, timeline exceptions, reimbursement recommendations, and negotiation results were documented using the Canadian Institute for Health Information’s Formulary Coverage tool, Health Canada’s Notice of Compliance (NOC) database, the Canadian Drug Agency (CDA) Reimbursement Review reports, and the pan-Canadian Pharmaceutical Alliance’s Brand Name Drug Negotiation Status website. We compiled summary measures of time-to-listing and used linear regression models to identify factors contributing to delays.
RESULTS: From 2018 to 2023, N=160 new drugs were added to Canadian public formularies and were included in the analysis. The average time from Health Canada approval to first public listing was 906 days (2.5 years), with a standard deviation of 640 days (1.8 years). Factors associated with the longest delays were drugs without a submission to the CDA (average delay of 629 days, N=10 drugs), with unsuccessful price negotiations (587 days, N=19), with CDA submissions made after the approval (467 days, N=71), and with “do not list” recommendations from the CDA (278 days, N=19). The N=92 drugs impacted by one or more of these factors had an average time-to-listing of 1,194 days (3.3 years, SD 1.9 years) compared to 517 days (1.4 years, SD 0.6 years) for the N=68 drugs not affected by these factors.
CONCLUSIONS: Adding new drugs to public formularies takes over 2 years on average in Canada. Important factors delaying time-to-listing include manufacturer decisions about CDA submissions, unsuccessful price negotiations, and drugs with unproven cost-effectiveness that receive a negative recommendation from the CDA.
Conference/Value in Health Info
2025-05, ISPOR 2025, Montréal, Quebec, CA
Value in Health, Volume 28, Issue S1
Code
HPR144
Topic
Health Policy & Regulatory
Topic Subcategory
Approval & Labeling, Insurance Systems & National Health Care, Reimbursement & Access Policy
Disease
No Additional Disease & Conditions/Specialized Treatment Areas