First Time-Limited Reimbursement Recommendation Supports Earlier Patient Access to a Promising Cancer Treatment

Patients in Canada with advanced-stage lymphoma are 1 step closer to accessing the first drug to receive a time-limited reimbursement recommendation from Canada’s Drug Agency.

Epcoritamab (brand name Epkinly) is a subcutaneous bispecific antibody used to treat adults with relapsed or refractory large B-cell lymphoma who have received 2 or more lines of systemic therapy and have previously received or are unable to receive chimeric antigen receptor (CAR) T-cell therapy. We issued a draft recommendation for this drug in May 2024 and a final recommendation on June 18, 2024.

The manufacturer, AbbVie Corporation, recently announced the successful completion of negotiations with the pan-Canadian Pharmaceutical Alliance and that a letter of intent has been signed by both parties.

Time-limited recommendations are an example of our efforts to modernize our reimbursement review processes with the goal of supporting timely access to promising new therapies. Our process builds on Health Canada’s Notice of Compliance with Conditions policy and our recommendations are subsequently used to inform negotiations through the Temporary Access Process at the pan-Canadian Pharmaceutical Alliance.

About Time-Limited Recommendations

A time-limited recommendation is a recommendation to publicly fund a drug or drug regimen for a certain period of time. This recommendation is based on the condition the manufacturer will conduct ongoing clinical studies to address uncertainty in the evidence. Canada’s Drug Agency will conduct a future reassessment of that additional evidence, which will lead to a final reimbursement recommendation. There are clear criteria to determine which drugs are eligible for the time-limited recommendation category.

The new recommendation category was introduced in September 2023 to help provide earlier access to promising new drugs that target the unmet needs of people in Canada living with severe, rare, or debilitating illnesses.

Canada’s Drug Agency is grateful to AbbVie Corporation and the pan-Canadian Pharmaceutical Alliance for sharing their learnings about the new recommendation category and collectively working through our accelerated pathway to give patients faster access to treatment.