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Review
. 2025 Jun;14(6):e250024.
doi: 10.57264/cer-2025-0024. Epub 2025 Apr 24.

Time-limited reimbursement and Temporary Access Process for early access to oncology treatments in Canada: a perspective based on the epcoritamab experience

Chakrapani Balijepalli  1 , Lakshmi Gullapalli  1 , Swati Prasad  1 , Nancy Paul Roc  2 , Ana Rusu  2 , Natalia Price  3 , William Dempster  4 , Stephane Barakat  2
Affiliations
Review

Time-limited reimbursement and Temporary Access Process for early access to oncology treatments in Canada: a perspective based on the epcoritamab experience

Chakrapani Balijepalli et al. J Comp Eff Res. 2025 Jun.

Abstract

For years, Canadians have faced long wait times for access to new medicines. These delays are largely attributed to complex health technology assessments, extended price negotiations and protracted provincial listing decisions. To address these challenges, in November 2023, Canada's Drug Agency (CDA) introduced its first early access program - the time-limited reimbursement recommendation (TLR) - aimed at accelerating the reimbursement of promising drugs undergoing Health Canada's Notice of Compliance with Conditions (NOC/c) process. In conjunction, the pan-Canadian Pharmaceutical Alliance developed the Temporary Access Process (pTAP) to support price negotiations for drugs that go through CDA's TLR pathway. AbbVie corporation was the first company to participate in the TLR and pTAP processes with EPKINLY (epcoritamab) - a novel treatment for advanced lymphoma. On 18 June 2024, EPKINLY became the first therapy in Canada to receive a positive CDA TLR recommendation and on 19 July 2024, AbbVie and the pan-Canadian Pharmaceutical Alliance successfully concluded pTAP negotiations. As of 1 November 2024, EPKINLY was listed in nine provinces, achieving a 10.7 month faster time-to-patient than the average time for the standard process, which is significant and meaningful to patients. This achievement demonstrates the potential of the TLR and pTAP processes to improve medicine access timelines for patients. However, an analysis of drugs that received NOC/c status from Health Canada between 2020 and 2024 reveals that very few drugs would have met the current strict eligibility criteria required to benefit from the TLR, limiting the potential benefits of these programs. While TLR and pTAP are promising initiatives, refinements are needed to maximize their impact and ensure faster access to life-saving therapies for Canadian patients.

Keywords: Canada's Drug Agency; epcoritamab; oncology; time-limited reimbursement.

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Conflict of interest statement

Competing interests disclosure

C Balijepalli and L Gullapalli are shareholders of Pharmalytics Group, a company that has served as a consultant to AbbVie and has received research funding from AbbVie. S Prasad is an employee of Pharmalytics Group. NP Roc, A Rusu, N Price and S Barakat are employees of AbbVie. W Dempster co-leads 3Sixty Public Affairs, a company that has served as a consultant to AbbVie and has received policy research funding and speaking fees from AbbVie. The authors have no other competing interests or relevant affiliations with any organization or entity with the subject matter or materials discussed in the manuscript apart from those disclosed.

The authors have no other competing interests or relevant affiliations with any organization or entity with the subject matter or materials discussed in the manuscript apart from those disclosed.

References

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