- 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.
- AbbVie has successfully completed its negotiations with the
pan-Canadian Pharmaceutical Alliance (pCPA) and a letter of intent
(LOI) has been signed by both parties.
MONTREAL, July 23,
2024 /CNW/ - AbbVie (NYSE: ABBV), today
announced that Canada's Drug
Agency (CDA, formerly CADTH) has issued its first-ever Time-Limited
Reimbursement (TLR)2 recommendation for EPKINLY
(epcoritamab). This recommendation recognizes the unmet need of
adult patients with Relapsed or Refractory Diffuse Large B-Cell
Lymphoma (R/R DLBCL) after two or more lines of systemic therapy
and who have previously received or are unable to receive CAR-T
cell therapy. EPKINLY has also received a positive recommendation
for the same indication from INESSS to list it in Quebec contingent on submission and
reassessment of phase III clinical data once
available.3
As the first company to undertake the new process to bring a
medicine to market through the TLR process, AbbVie is committed to
doing its part to accelerate access to treatments with promising
value and is working together with CDA, pCPA and the provincial
drug plans to support the success of Canada's first early patient access pathway.
The pCPA developed a set of principles and conditions for a pCPA
Temporary Access Process (pTAP)4 that inform the
negotiation process and potential product listing agreements for
any drugs that receive a positive TLR recommendation. AbbVie has
successfully closed its negotiation with the pCPA through the new
pTAP pathway and has signed a letter of intent (LOI). The next step
is for public drug plans across Canada to list EPKINLY on the provincial and
territorial formularies to provide coverage for patients.
"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 Rami Fayed, Vice President
and General Manager, AbbVie Canada. "EPKINLY is the first
medication to be accepted through this process for its clinically
meaningful phase II clinical data. This early access pathway is a
positive step forward that recognizes that time is of the essence
for Canadian patients, especially those living with serious
illnesses."
"DLBCL is a cancer that can rapidly progress and resist
treatment, so the sooner it is treated, the better,"
explains Dr. David MacDonald,
Hematologist at The Ottawa Hospital. "When it comes to accessing
innovative therapies like EPKINLY, where delays can impact both
survival and quality of life, this accelerated pathway responds to
the desire of physicians to give patients a better chance. With its
encouraging clinical efficacy based on phase II data, EPKINLY may
now be available sooner to address the unmet needs of patients with
3L+ DLBCL."
"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
Antonella Rizza, CEO, Lymphoma
Canada. "Given how aggressive DLBCL is, we are thrilled that there
is an additional treatment option available to patients when their
cancer returns."
EPKINLY received Health Canada marketing authorization with
conditions in October 2023 pending
the results of a phase III clinical trial (EPCORE-DLBCL-1) to
verify the clinical benefit. It is a subcutaneous T-cell
engaging bispecific antibody for the treatment of adult patients
with relapsed or refractory (R/R) diffuse large B-cell lymphoma
(DLBCL) not otherwise specified, DLBCL transformed from indolent
lymphoma, high grade B-cell lymphoma (HGBCL), primary mediastinal
B-cell lymphoma (PMBCL) or follicular lymphoma Grade 3B (FLG3b) after two or more lines of systemic
therapy and who have previously received or are unable to receive
CAR-T cell therapy.5 EPKINLY is being co-developed by
AbbVie and Genmab as part of their oncology collaboration.
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.
About AbbVie in Oncology
At AbbVie, we are committed to transforming standards of care for
multiple blood cancers while advancing a dynamic pipeline of
investigational therapies across a range of cancer types. Our
dedicated and experienced team joins forces with innovative
partners to accelerate the delivery of potentially breakthrough
medicines. We are evaluating more than 20 investigational medicines
in over 300 clinical trials across some of the world's most
widespread and debilitating cancers. As we work to have a
remarkable impact on people's lives, we are committed to exploring
solutions to help patients obtain access to our cancer
medicines.
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines
and solutions that solve serious health issues today and address
the medical challenges of tomorrow. We strive to have a remarkable
impact on people's lives across several key therapeutic areas –
immunology, oncology, neuroscience, gynecology and eye care – and
products and services in our Allergan Aesthetics portfolio. For
more information about AbbVie, please visit us at www.abbvie.ca.
Follow AbbVie Canada on X, Instagram, or LinkedIn.
References
|
_____________________________
|
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. AbbVie Corporation.
Available at: https://www.abbvie.ca/en/our-science/products.html.
October 2023.
|
6 What is Lymphoma. Lymphoma
Coalition. https://lymphomacoalition.org/what-is-lymphoma/.
Accessed April 24, 2023.
|
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 Macrophage Properties." J. Immunol.
2013;190(6):2702-2711. DOI: 10.4049/jimmunol.1202588
|
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 Sci Ther. 2015;7(11):347-358.
DOI: 10.4172/1948-5956.1000373.
|
SOURCE AbbVie Canada