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

Abstract

This analysis follows our recent study showing that Canadian public reimbursement delays have lengthened from regulatory approval to listing decisions by public drug plans and delayed public access to innovative medicines, mainly due to processes following the Common Drug Review (CDR) and the pan-Canadian Oncology Drug Review (pCODR). Public drug plans participate in a pan-Canadian Pharmaceutical Alliance (pCPA) joint negotiation process before making decisions about whether or not to reimburse a product reviewed through CDR and pCODR. This research aims to report the findings from a comprehensive analysis of pCPA process times, times to reimbursement by public payers in Canada, and to explore the opportunities to reduce total delays in public reimbursement with a specific focus on the pCPA process. An analysis was conducted of pCPA timelines with respect to making decisions about products and indications reviewed through CDR/pCODR, and focusses on three separate time components: time to begin negotiating, time spent negotiating, and time to implement the negotiation (i.e., time to list) in each of nine jurisdictions (i.e., 10 provinces of Canada, excluding Quebec). This study demonstrates the role of post-CDR/pCODR processes in large and lengthening delays to listing new medicines. Notably, oncology products have experienced the longest increases in time to begin negotiating and to complete negotiations. Trends in listing times post-pCPA across provinces are less clear, however, it appears that consistency in terms of timelines across provinces is not happening quite so smoothly for oncology products compared to non-oncology products. Listing rates also appear to be declining for non-oncology products, although this trend is less conclusive for oncology products. Challenges need to be addressed to improve efficiency, transparency, and ultimately reduce pCPA timelines and total timelines to public reimbursement. Suggested ways to improve and streamline the listing process are: (1) transparent target timelines and associated performance incentives for the pCPA and public plan decisions, (2) parallel HTA-pCPA processes to enable pCPA negotiations to start part-way through the HTA review and allow pCPA negotiation information to be fed back into the HTA review, and (3) innovative agreements that consider patient input and earlier coverage with real-world evidence development.

International Price Comparisons of Anticancer Drugs: A Scheme for Improving Patient Accessibility

“…The anticancer drugs examined in this study were reimbursed at a median time of 669 days (mean = 687 days) after market approval. Although there are large variations in the time to reimbursement compared with that in other countries, the median period is significantly longer in Korea than in other countries (ranging from 89 days to 422 days) [ 13 , 14 ]. Overall, variations in the time of drug approval to patient access may be attributed to patient preferences, assessment criteria, and reimbursement schemes.…”

“…The Korean government spent an average of 601 days to make a reimbursement decision for new anticancer drugs between 2009 and 2014 [ 12 ]. Although there are large variations in the time to reimbursement compared with that in other countries, the median period for oncology drugs is still significantly longer in Korea than in other countries: 89 days in Canada, 212 days in France, 320 days in Spain, 321 days in the United Kingdom (UK), and 422 days in Italy [ 13 , 14 ]. Many cancers have a higher chance of being cured if diagnosed and treated early, so creating policies to expedite patient access to advanced anticancer drugs is critical for saving lives and reducing the overall societal economic burden.…”

A Critical Discourse Analysis of Intellectual Property Rights Within NAFTA 1.0: Implications for NAFTA 2.0 and for Democratic (Health) Governance in Canada

“…The Pan-Canadian Pharmaceutical Alliance faces challenges such as an increasing backlog of drugs awaiting negotiation and appears to be taking more time to initiate or decline negotiations. 31 There also seems to be lack of transparency in the negotiation process and in selecting the criteria informing the decision-making process. 31 Finally, the alliance only negotiates drug prices for public drug plans, which limits its negotiating power, as there are more than 100,000 private drug insurance plans in Canada that are excluded from the negotiations.…”

The Pathway for New Cancer Drug Access in Canada

“…While the negotiated prices of generic medications are transparent and generally apply to the whole market, the negotiated prices of innovative medicines are confidential and only apply to the participating payers. Further, the pCPA does not publish formal review or negotiation timelines, nor the criteria used in decision-making [ 30 ]. Studies have suggested that the time from the CADTH pCODR recommendation to the pCPA negotiation publication for oncology drugs took as long as 371 days in 2016 [ 30 ].…”

“…Further, the pCPA does not publish formal review or negotiation timelines, nor the criteria used in decision-making [ 30 ]. Studies have suggested that the time from the CADTH pCODR recommendation to the pCPA negotiation publication for oncology drugs took as long as 371 days in 2016 [ 30 ].…”