EVALUATION OF THE PCPA NEGOTIATION TIMELINE PROCESS FOR BRANDED NON ONCOLOGY DRUGS IN CANADA
Author(s)
Katherine Jobin Gervais, BA1, Martin Barbeau, MSc2, Miguel Conant, BA2;
1Bausch Health, Canada Inc., Senior manager, Market Access & Government Affairs, Laval, QC, Canada, 2Bausch Health, Canada Inc., Laval, QC, Canada
1Bausch Health, Canada Inc., Senior manager, Market Access & Government Affairs, Laval, QC, Canada, 2Bausch Health, Canada Inc., Laval, QC, Canada
OBJECTIVES: The pan-Canadian Pharmaceutical Alliance (pCPA) plays a critical role in drug pricing negotiations following Health Technology Assessment (HTA) recommendations. Predictable timelines are critical for manufacturers to plan market access strategies. According to the June 2025 pCPA Dashboard, reported metrics indicate improved timelines between 2020 and 2025. This study aimed to evaluate the duration of the pCPA negotiation process for non-oncology drugs, specifically from HTA recommendation to Letter of Intent (LOI), and assess alignment with pCPA-reported estimates.
METHODS: A retrospective review captured all products that reached a Letter of Engagement (LOE) with the pCPA between January 1, 2023, and May 31, 2025, excluding products that did not conclude their negotiations with a LOI, oncology medicines, biosimilars, and generics. Public data from Canada’s Drug Agency (CDA) and the pCPA were used to measure three intervals: Time Under Consideration (from CDA recommendation to LOE), Active Negotiation (from LOE to LOI), and Total Time (from CDA recommendation to LOI). Durations were calculated as medians in months, and products were grouped by LOE year.
RESULTS: A total of 91 products were included. Median Time Under Consideration was 4.6 months in 2023, 4.2 months in 2024, and 4.5 months in early 2025. Median Active Negotiation durations were 3.9, 5.2, and 4.0 months for the same respective years. Median Total Time from CDA recommendation to LOI was 8.5 months in 2023, 9.4 months in 2024, and 8.5 months in 2025.
CONCLUSIONS: Timelines in our analysis were generally different than pCPA-reported metrics, especially for the Time Under Consideration metric which appeared to be longer. Contributing factors likely include the incorporation of biosimilars in pCPA’s analyses, which enlarges the dataset and lowers medians due to their faster processes. Findings provide manufacturers with clearer expectations of pCPA negotiation timeline for branded non-oncology drugs, supporting improved planning and resource allocation.
METHODS: A retrospective review captured all products that reached a Letter of Engagement (LOE) with the pCPA between January 1, 2023, and May 31, 2025, excluding products that did not conclude their negotiations with a LOI, oncology medicines, biosimilars, and generics. Public data from Canada’s Drug Agency (CDA) and the pCPA were used to measure three intervals: Time Under Consideration (from CDA recommendation to LOE), Active Negotiation (from LOE to LOI), and Total Time (from CDA recommendation to LOI). Durations were calculated as medians in months, and products were grouped by LOE year.
RESULTS: A total of 91 products were included. Median Time Under Consideration was 4.6 months in 2023, 4.2 months in 2024, and 4.5 months in early 2025. Median Active Negotiation durations were 3.9, 5.2, and 4.0 months for the same respective years. Median Total Time from CDA recommendation to LOI was 8.5 months in 2023, 9.4 months in 2024, and 8.5 months in 2025.
CONCLUSIONS: Timelines in our analysis were generally different than pCPA-reported metrics, especially for the Time Under Consideration metric which appeared to be longer. Contributing factors likely include the incorporation of biosimilars in pCPA’s analyses, which enlarges the dataset and lowers medians due to their faster processes. Findings provide manufacturers with clearer expectations of pCPA negotiation timeline for branded non-oncology drugs, supporting improved planning and resource allocation.
Conference/Value in Health Info
2026-05, ISPOR 2026, Philadelphia, PA, USA
Value in Health, Volume 29, Issue S6
Code
HTA85
Topic
Health Technology Assessment
Disease
No Additional Disease & Conditions/Specialized Treatment Areas