PT - JOURNAL ARTICLE AU - Joel Lexchin TI - Time to potential for listing of new drugs on public and private formularies in Canada: a cross-sectional study AID - 10.9778/cmajo.20220063 DP - 2022 Oct 01 TA - CMAJ Open PG - E993--E999 VI - 10 IP - 4 4099 - http://www.cmajopen.ca/content/10/4/E993.short 4100 - http://www.cmajopen.ca/content/10/4/E993.full SO - CMAJ2022 Oct 01; 10 AB - Background: Information about the timing involved in various stages of making new drugs available to Canadians is important for understanding how a national pharmacare plan will affect timely access to new drugs. I explored the timing of the various steps between receiving a Notice of Compliance and a decision by the pan-Canadian Pharmaceutical Alliance (pCPA).Methods: I gathered data from various databases (Canadian and other) about new drugs approved between 2011 and 2020, including generic names, date of application for approval (New Drug Submission [NDS]), date of Notice of Compliance, date of marketing, dates when a submission was made to the Canadian Agency for Drugs and Technologies in Health (CADTH) and the pCPA, and when these agencies made a decision.Results: Marketing dates were available for 301 of the 337 new drugs approved. The median time from NDS to marketing was less than the time to a positive pCPA decision for all years between 2011 and 2020. There was no significant change in the difference between the 2 periods over time (p = 0.2). Additional therapeutic value did not make a difference in the delay (p = 0.3) and companies did not take full advantage of the opportunity to file early submissions with CADTH.Interpretation: The delay between when drugs could be listed on private compared with public formularies was at least 1 year. If a national pharmacare plan is instituted, one of the priorities should be to concentrate on consolidating and working to shorten the CADTH and pCPA processes.