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.
Highlights
The publicly financed health insurance system in Canada covers all Canadians for hospital and physician services for free at the point of service, and is provided through federal, and highly decentralized provincial and territorial plans (Marchildon, 2013)
We conducted a review of the total time from Notice of Compliance (NOC) to public reimbursement broken out into individual review processes for the nine provincial jurisdictions participating in CADTH (NIHB, the only federal drug plan with available listings data, is excluded due to limited data points available since its entry into the pan-Canadian Pharmaceutical Alliance (pCPA) process in early 2016)
Canadian Agency for Drugs and Technology in Health reimbursement recommendations issued through the Common Drug Review (CDR) and Pan-Canadian Oncology Drug Review (pCODR) process between 2012 and 2016 and available on CADTH website were cross-referenced with the Health Canada NOC database (Health Canada, 2017b) to confirm the NOC date for all new product submissions and indications submitted to CADTH
Summary
The publicly financed health insurance system in Canada covers all Canadians for hospital and physician services for free at the point of service, and is provided through federal, and highly decentralized provincial and territorial plans (Marchildon, 2013). The federal, provincial and territorial governments provide drug plans that cover various populations. Around two-thirds of the population is estimated to be eligible to be covered by a public drug program across the country, based on eligibility criteria (Dinh and Sutherland, 2017), only one-third of the Canadian population receives public drug plan benefits (CIHI, 2017). Provincial and territorial public drug plans likewise cover various specific populations and each plan makes decisions about eligibility coverage criteria and benefits. Some provinces have Pharmacare (a monopolistic government-run public plan under which everyone is eligible), most individuals do not qualify to receive any reimbursement benefits because their deductibles are set high compared to their actual drug expenses in order to protect against catastrophic drug costs
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