Consequences of Canada’s Drug Agency Reimbursement Recommendations for New Medicines and Pan-Canadian Pharmaceutical Alliance Price Negotiations on Patient Access

Nigel SB Rawson1– 4 1Independent Researcher, Saskatoon, SK, Canada; 2Macdonald-Laurier Institute, Ottawa, ON, Canada; 3Canadian Health Policy Institute, Toronto, ON, Canada; 4Fraser Institute, Vancouver, BC, CanadaCorrespondence: Nigel SB Rawson, Email [email protected]: Prescription drugs are excluded from Canada’s federal legislation covering health care. Each provincial government has developed its own drug plan. To get new prescription medicines listed in these plans, developers must pass regulatory review, health technology assessment and price negotiation, and convince individual government plans to list their drugs. The objective of this research is to assess how many reimbursement recommendations issued by Canada’s Drug Agency (CDA) have clinical and/or price conditions and what the consequences are.Methods: Data were obtained on drugs with CDA recommendations issued between January 2020 and December 2024, together with dates of price negotiations between the pan-Canadian Pharmaceutical Alliance (pCPA) and manufacturers by the end of July 2025 and listings in government plans relating to the same drugs by early November 2025.Results: Of 344 CDA recommendations, only three (0.9%) were unconditional reimbursement, 291 (84.6%) reimbursement with clinical criteria and/or a price condition, and 50 (14.5%) no reimbursement. Median time for CDA reviews was 221 days (interquartile range (IQR): 199– 282 days). Where recommended to achieve cost-effectiveness of $50,000/quality-adjusted life-year, median reduction was 74.5% (IQR: 50.0%-90.0%). Median time for the pCPA to decide whether to negotiate was 128 days (IQR: 73– 191 days) and median negotiation time was 131 days (IQR: 82– 219 days). The median time between submission to CDA and pCPA outcome was 518 days (IQR: 394– 633 days). Government drug plan listing rates for drugs successfully negotiated with the pCPA ranged from 58.6% to 91.6%. Five patients had prior-authorization requests to a private insurer for costly drugs denied because the drugs had conditional CDA recommendations.Conclusion: CDA and pCPA processes take considerable time and listing decisions by government drug plans add extra time before potential access by patients. Nearly all CDA reimbursement recommendations, which are intended for government drug plans (not private payers), are conditional.Plain Language Summary: The purpose of this work is to evaluate how many recommendations for coverage of new medicines were issued between 2020 and 2024 by Canada’s Drug Agency (CDA), which assesses the cost-effectiveness of drugs for coverage by government drug plans (except Quebec’s), and examine the time taken by CDA to do its work. The time taken by the pan-Canadian Pharmaceutical Alliance (pCPA), which negotiates drug prices with manufacturers for all government drug plans, to perform its activities is also evaluated, as is how many drugs were actually listed by these drug plans. Almost all CDA recommendations to cover drugs are conditional on clinical criteria for how the drugs should be used and/or a price reduction condition. Price reduction recommendations are substantial (half are more than 74%). CDA took longer than its target time of up to 180 days in 98% of its reviews. The pCPA took much longer than its performance target to decide whether to negotiate with drug developers for almost 80% of the drugs and exceeded its target time to negotiate for 51%. Government drug plans are not required to cover drugs that have successfully passed CDA and pCPA processes and, consequently, listing rates in the plans ranged from 58.6% to 91.6% by early November 2025. CDA and pCPA processes take considerable time and listing decisions by government drug plans add extra time before potential access by patients. Although not designed to do so, CDA recommendations can influence access decisions by adjudicators for private drug plans.Keywords: health technology assessment, drug price negotiation, government drug plan coverage, private insurance, Canada