Factors Influencing Delays in Patient Access to New Medicines in Canada: A Retrospective Study of Reimbursement Processes in Public Drug Plans

Abstract

Individuals who rely on public health payers to access new medicines can access fewer innovative medicines and must wait longer in Canada compared to major markets around the world. New medicines/indications approved by Health Canada and reviewed for eligibility for reimbursement by the Common Drug Review or the pan-Canadian Oncology Drug Review (CDR/pCODR) from the beginning of 2012 through to the end of December 2016 were analyzed, with data taken from the relevant bodies’ websites and collected by IQVIA. This analysis investigated individual review segments – Notice of Compliance (NOC) to Health Technology Assessment (HTA) submission, HTA review time, pan-Canadian Pharmaceutical Alliance (pCPA) negotiation time, and public reimbursement decision time, and analyzed the trends of each over time and contributions to overall time to listing decisions. Average overall timelines for public reimbursement after NOC were long and most of this time is taken up by HTA and pCPA processes, at 236 and 273 days, respectively. This study confirms that Canadian public reimbursement delays from 2013-2014 to 2015-2016 lengthened from NOC to listing (Quebec + 53%, first provincial listing + 38%, and country-wide listing + 22%), reaching 499, 505, and 571 days, respectively. Over the same period, time from NOC to completion of HTA has increased by 33%, and time from post-HTA to first provincial listing by 44%. The pCPA process appears to be the main contributor to this increasing time trend, and although some provinces could be listing more quickly post-pCPA, they appear to be listing fewer products. Reasons for large delays in time to listing include the many-layered sequential process of reviews conducted before public drug plans decide whether to provide access to new innovative medicines. Although there has been some headway made in certain parts of the review processes (e.g., pre-NOC HTA), total time to listing continues to increase, seemingly due to the pCPA process and other additional review processes by drug plans. More clarity in the pCPA and provincial decision-making processes and better coordination between HTA, pCPA, and provincial decision-making processes is needed to increase predictability in the processes and reduce timelines for Canadian patients and manufacturers.

Pan-Canadian Pharmaceutical Alliance (pCPA): Timelines Analysis and Policy Implications

“…Alternatively, provinces/territories may negotiate collectively if the pCPA becomes involved and decides that joint pan-Canadian negotiations for the drug will occur. Approximately 91% of positive and conditional CADTH recommendations between January 2012 and December 2015 proceeded to either a pCPA negotiation or an individual provincial negotiation, and approximately 72% of all CADTH recommendations went to a pCPA negotiation (Salek et al, 2019). However, the pCPA seems to be faced with a number of challenges, which ultimately has a substantial impact on delays in patient access to new medicines.…”

“…Currently, there are few guidelines in place and a general lack of clarity with respect to the pCPA process – particularly regarding any internal timeline targets governing various steps in the review process. It is not completely clear what criteria are used by the pCPA in determining whether or not to proceed with negotiations for a particular product, although there appear to be signs of prioritization (Salek et al, 2019). It is possible that the increase in pCPA timelines observed in this study and an earlier study (Salek et al, 2019) could be in part due to the lack of target timelines, and the lack of transparent criteria to negotiate may also be creating inequalities in timelines for different medicines.…”

“…It is difficult to determine whether the pCPA actually has improved the listing processes and whether it can ever meet all needs of such a diverse public payer community. While it may have reduced the burden on individual provinces, it has increased overall times to listing (Salek et al, 2019), and reduced the number of drugs available (Milliken et al, 2015).…”

“…Our recent study, Factors influencing delays in patient access to new medicines in Canada: a retrospective study of reimbursement processes in public drug plans, confirmed that Canadian public reimbursement delays have lengthened in time from regulatory approval (i.e., upon issuance of a Notice of Compliance, NOC) to listing decisions by public drug plans, with increases of 22% in time to list in Quebec, 38% to first provincial listing in any other jurisdiction, and 53% to country-wide listing (Salek et al, 2019). Post-HTA to first provincial listing times, which represents the best-case scenario in terms of the shortest time, increased by 44%.…”

“…Despite the indication that some individual processes across the drug review and funding decision pathway have had some success in reducing their own timelines, Canada continues to experience significant delays in listing of innovative medicines. While parallel regulatory and HTA reviews – that is, pre-NOC HTA reviews – are believed to expedite review processes, overall listing timelines continue to increase and research indicates that this is likely attributable to processes post-HTA, particularly for oncology products (Salek et al, 2019). The aim of this research, therefore, was to conduct a comprehensive analysis of pCPA processing times and times to reimbursement by public payers in Canada.…”