AbbVie's EPKINLY™ Receives First-Ever Time-Limited Reimbursement Recommendation by Canada's Drug Agency
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Time-limited reimbursement (TLR) recommendation is
a new
Canada's Drug Agency (CDA) review process whereby a temporary recommendation is issued based on a phase II clinical data assessment, and the final recommendation is contingent upon a future reassessment of additional evidence (i.e., phase III clinical data)1. - The positive CDA TLR recommendation recognizes the clinical efficacy of EPKINLY based on phase II data (EPCORE NHL-1), and benefits of subcutaneous administration to patients, healthcare professionals and the healthcare system.
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AbbVie Canadian Pharmaceutical Alliance (pCPA) and a letter of intent (LOI) has been signed by both parties.
As the first company to undertake the new process to bring a medicine to market through the TLR process,
"The TLR policy is an important milestone for Canadians hoping to obtain faster access to life-saving medicines for diseases that have limited treatment options," says
"DLBCL is a cancer that can rapidly progress and resist treatment, so the sooner it is treated, the better," explains Dr.
"We are hopeful that the new TLR pathway will lead to the faster availability of, and easier access to lymphoma treatments and treatments for other illnesses, for patients who need them," says
EPKINLY received
Full details on the recommendation, including conditions for reimbursement, are available on the CDA website.
About
DLBCL
DLBCL is a type of aggressive, fast-growing non-Hodgkin's lymphoma (NHL), a cancer that develops in the lymphatic system and affects B cells, a type of white blood cell. DLBCL is the most common type of NHL. Although DLBCL is often curable, many patients are refractory to, or relapse after first-line treatment with standard chemoimmunotherapy. For relapsed and refractory patients, several targeted therapies including T-cell mediated treatments have recently emerged. However, readily available subcutaneous single agent therapies are limited.6,7,8,9
About EPKINLY
EPKINLY is an IgG1-bispecific antibody created using Genmab's proprietary DuoBody® technology. Genmab's DuoBody-CD3 technology is designed to direct cytotoxic T cells selectively to elicit an immune response towards target cell types. It is designed to simultaneously bind to CD3 on T cells and CD20 on B-cells and induces T cell mediated killing of CD20+ cells.5,10,11,12 EPKINLY comes as a concentrate for solution, for SC injection, with each vial containing 4 mg in 0.8 mL (5 mg/mL) and a solution for SC injection, with each vial containing 48 mg in 0.8 mL (60 mg/mL) of epcoritamab.
Please consult the EPKINLY Product Monograph at https://www.abbvie.ca/en/our-science/products.html.
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About
References |
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1 CADTH Procedures for Time-Limited Reimbursement Recommendations: https://www.cadth.ca/sites/default/files/Drug_Review_Process/CADTH_Time_Limited_Procedures.pdf |
2 CADTH Reimbursement Review - CADTH Reimbursement Recommendation. Epcoritamab (Epkinly): https://www.cadth.ca/epcoritamab |
3 INESSS: Drug products undergoing evaluation and evaluated: https://www.inesss.qc.ca/en/themes/medicaments/drug-products-undergoing-evaluation-and-evaluated/extract-notice-to-the-minister/epkinly-6950.html |
4 pCPA Temporary Access Process (pTAP): https://www.pcpacanada.ca/pCPATemporaryAccessProcess |
5
Epkinly (epcoritamab injection/for injection) product monograph. |
6
What is Lymphoma. |
7 Kanas G, Ge W, Quek RGW, et al. Leukemia & Lymphoma. 2022;63(1):54-63. |
8 Crump M, Neelapu SS, Farooq U, et al. Blood. 2017;130(16):1800-1808. |
9 Chao MP. Cancer Manag Res. 2013;5:251-269. |
10 Engelberts PJ, Hiemstra IH, de Jong B, et al. "DuoBody-CD3xCD20 induces potent T-cell-mediated killing of malignant B cells in preclinical models and provides opportunities for subcutaneous dosing." EBioMedicine. 2020;52:102625. DOI: 10.1016/j.ebiom.2019.102625. |
11
Rafiq S, Butchar JP, Cheney C, et al. "Comparative Assessment of Clinically Utilized CD20-Directed Antibodies in Chronic Lymphocytic Leukemia Cells Reveals Divergent NK Cell, Monocyte, and |
12
Singh V, Gupta D, Almasan A. "Development of Novel Anti-Cd20 Monoclonal Antibodies and Modulation in Cd20 Levels on Cell Surface: Looking to Improve Immunotherapy Response." J Cancer |
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