VABYSMO® (faricimab injection) receives positive CADTH recommendation for the treatment of Diabetic Macular Edema (DME) in adults
- This CADTH recommendation is the latest step towards public access to VABYSMO® (faricimab injection) for the estimated 60,000 adults in Canada requiring treatment for Diabetic Macular Edema (DME)
Provincial jurisdictions will make the final decision on public reimbursement
MISSISSAUGA, ON – November 3, 2022 Hoffmann-La Roche Limited (Roche Canada) is pleased to announce that on October 31, 2022, the Canadian Agency for Drugs and Technologies in Health (CADTH) Canadian Drug Expert Committee (CDEC) recommended VABYSMO® (faricimab injection) for public reimbursement. This recommendation, the second for VABYSMO, is for the treatment of diabetic macular edema (DME) in adults, one of the leading causes of vision loss in Canada.
“This positive recommendation from CADTH is an important step in our collective goal of preserving vision for patients suffering from DME across the country.'' said Dr. Varun Chaudhary, Chief of Ophthalmology & Professor of Surgery at Hamilton Regional Eye Institute, McMaster University. “Clinical trials with faricimab injection have demonstrated favorable vision gains in patients with DME and also demonstrated how this agent can be used in a personalized treatment approach, which may reduce treatment burden. Both of these elements are critical to improving outcomes for patients suffering with this very common cause of vision loss in Canada.”
VABYSMO provides a unique dual mode of action by targeting both VEGF-A and Ang-2 proteins, two key drivers of vascular instability that have been associated with vision-threatening retinal conditions.[3,4,5] This is the first treatment in Canada for DME that blocks both pathways.[6,7,8,9] The CADTH recommendation acknowledges that VABYSMO can be given at an interval of up to every 16 weeks, which could potentially address the unmet need for treatments that can be given at longer treatment intervals.
“Access to treatment is critical to prevent blindness, maintain independence and improve the quality of life for people living with diabetic macular edema,” said Dr. Larissa Moniz, Director, Research and Mission Programs, Fighting Blindness Canada. “With CADTH's recommendation, Fighting Blindness Canada encourages all provinces to extend funding for this additional treatment option which may reduce the burden of frequent injections for people living with DME.”
Roche Canada is delighted that CADTH has recognized the clinical evidence and benefit shown by VABYSMO for use in Canadians living with DME. This milestone marks the second positive recommendation for VABYSMO, following the recent recommendation from CADTH for the treatment of neovascular (wet) age-related macular degeneration in September 2022. Roche Canada now looks forward to working together with the provinces and jurisdictions to help ensure both patient populations have access to this new treatment.
About Diabetic Macular Edema
Affecting an estimated 15.7 per cent of Canadians with diabetes, diabetic macular edema (DME) is a vision-threatening retinal condition associated with blindness and decreased quality of life when left untreated.11 DME occurs when damaged blood vessels in the retina leak into and cause swelling in the macula–the central area of the retina responsible for the sharp vision needed for reading and driving. The number of people with DME is expected to grow as the prevalence of diabetes increases.
About VABYSMO® (faricimab injection)
VABYSMO is a humanized bispecific immunoglobulin G1 (IgG1) antibody that acts through inhibition of both Ang-2 and vascular endothelial growth factor A (VEGF-A). By inhibiting VEGF-A, faricimab suppresses endothelial cell proliferation, neovascularization and vascular permeability. By inhibiting Ang-2, faricimab is thought to increase vascular stability and desensitize blood vessels to the effects of VEGF-A. Ang-2 levels are increased in some patients with DME.
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1 CNIB Foundation. The Cost of Vision Loss Report – Blindness in Canada. Available at: https://cnib.ca/en/sight-loss-info/blindness/blindness-canada?region=on. Accessed on October 3, 2022
2 CDEC final recommendation, Faricimab (VABYSMO), October 2022. Available at: https://www.cadth.ca/sites/default/files/DRR/2022/SR0729%20Vabysmo%20-%20Confidential%20Final%20CADTH%20Recommendation-KH_BF%20-%20KH-meta.pdf. Accessed on October 31, 2022.
3 Review of Neovascular Age-Related Macular Degeneration Treatment Options – American Journal of Managed Care. Available at: https://www.ajmc.com/view/review-of-neovascular-agerelated-macular-degeneration-treatment-options. Accessed on October 3, 2022
4 Fighting Blindness Canada. Eye Diseases - Age Related Macular Degeneration. Available at: https://www.fightingblindness.ca/eyehealth/eye-diseases/age-related-macular-degeneration. Accessed on October 3, 2022
5 CNIB Foundation. Sight Loss Info – Age-related Macular Degeneration. Available at: https://cnib.ca/en/sight-loss-info/your-eyes/eye-diseases/age-related-macular-degeneration?region=on. Accessed on October 3, 2022
6 VABYSMO Product Monograph, May 27, 2022.
7 EYLEA Product Monograph, February 10, 2022.
8 LUCENTIS Product Monograph, September 28, 2022.
9 BEOVU Product Monograph, Feb 17, 2022.
10 Gonder, John R. et al. "Costs And Quality Of Life In Diabetic Macular Edema: Canadian Burden Of Diabetic Macular Edema Observational Study (C-REALITY)". Journal Of Ophthalmology, 2014. Available at: https://www.hindawi.com/journals/joph/2014/939315/#abstract. Accessed on October 3, 2022
12 National Eye Institute. Learn About Eye Health - Macular Edema. Available at: https://www.nei.nih.gov/learn-about-eye-health/eye-conditions-and-diseases/diabetic-retinopathy. Accessed on October 3, 2022
13 Gonder, John R. et al. "Costs And Quality Of Life In Diabetic Macular Edema: Canadian Burden Of Diabetic Macular Edema Observational Study (C-REALITY)". Journal Of Ophthalmology, 2014. Available at: https://www.hindawi.com/journals/joph/2014/939315/#abstract. Accessed on October 3, 2022
For further information: Amy Haddlesey, Strategic Communications, Hoffmann-La Roche Limited,
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