BIMZELX® (bimekizumab) Negotiations with pCPA Concluded Successfully Following Positive CDA and INESSS Recommendations for Adults with Active Psoriatic Arthritis and Adults with Active Ankylosing Spondylitis

Positive CDA and INESSS reimbursement recommendations are an important step towards public access to BIMZELX^®, the first and only treatment approved by Health Canada for eligible patients with active psoriatic arthritis (PsA) or ankylosing spondylitis (AS) that inhibits two key inflammatory cytokines, IL-17A and IL-17F.¹

OAKVILLE, ON, Feb. 28, 2025 /CNW/ - UCB Canada Inc. is pleased to announce that following the positive reimbursement recommendations from Canada's Drug Agency (CDA, formerly the Canadian Agency for Drugs and Technologies in Health/CADTH) and the Institut National d'Excellence en Santé et en Services Sociaux (INESSS), UCB Canada Inc. has successfully concluded negotiations with pCPA (pan Canadian Pharmaceutical Alliance).

CDA has recommended public reimbursement of BIMZELX^® for the treatment of adults with active psoriatic arthritis (PsA) and adults with active ankylosing spondylitis (AS), if it is prescribed by a rheumatologist or a clinician who has experience treating adult patients with active PsA or AS, and if certain other conditions are met. These recommendations were issued on June 3, 2024 and June 4, 2024, respectively.^2,3

INESSS has also recommended the addition of BIMZELX to the provincial List of Medications to Quebec's Minister of Health and Social Services for the treatment of adults with active PsA and adults with active AS, if certain conditions are met. These recommendations were issued on July 3, 2024 and August 1 2024, respectively.^4,5 

"At UCB, we envision a world where all patients in need have access to our therapies," said Andrea Loewendorf, Head, Immunology Business Unit, UCB Canada. "We are pleased and proud of the positive recommendations made by both CDA and INESSS on behalf of BIMZELX for the treatment of PsA and AS. Our hope is that with pCPA negotiations concluded, public reimbursement for BIMZLEX will be implemented in the very near future."

BIMZELX^® is the first and only biologic that inhibits both IL-17A and IL-17F to be approved in Canada. On February 23, 2024, BIMZELX^® received authorization from Health Canada for the treatment of adults with active PsA. On March 11, 2024, the therapy also received approval for the treatment of adults with axial spondyloarthritis (axSpA), including AS and non-radiographic axial spondyloarthritis (nr-axSpA).¹ 

BIMZELX^® is already listed by the majority of Canadian public drug plans for moderate to severe plaque psoriasis.

The CDA and INESSS recommendations are based on the results of Phase III clinical trial data which demonstrated that BIMZELX^® provides clinical benefit compared to placebo^2,3 and supports the therapeutic value of BIMZELX^®4,5 as well as its role as an innovative treatment option for patients with PsA and AS.^6,7,8

"Ankylosing spondylitis is a chronic and debilitating joint condition that negatively affects the quality of life in young patients and impairs their ability to participate in the workforce," said Dr. Sam Aseer, Rheumatologist, Eastern Health. "Bimekizumab is a new and unique molecule that has the potential to effectively treat and improve the well-being of patients with ankylosing spondylitis."

"Inflammatory arthritis includes psoriatic arthritis and, if not treated properly, it causes swelling and pain of the joints. It also causes fatigue. Most importantly, it causes joint damage that leads to chronic pain that is difficult to treat. It also causes deformities," said Dr. Leo Picard, Rheumatologist, Dr. Georges-L.-Dumont University Hospital Centre. "Bimekizumab has been shown in studies to be effective against psoriatic arthritis and psoriasis."

"Ankylosing spondylitis is a chronic, painful, and inflammatory disease that significantly impacts patients' mobility, function, and quality of life," said Dr. Proton Rahman, Distinguished Professor, Memorial University and Chief of Rheumatology, Newfoundland and Labrador Health Services. "Bimekizumab marks a significant breakthrough in the management of this debilitating disease." 

"As both a patient and Board Chair of the Canadian Spondyloarthritis Association (CSA), I am delighted that BIMZELX^® has been approved for the treatment for PsA and nr-axSpA, both forms of spondyloarthritis (SpA)," said Dr. Élie Karam, Chair of the CSA. Ironically, despite being a doctor specializing in the musculoskeletal field, it took years for my diagnosis. Unfortunately, this is not uncommon, as it can take seven to 10 years for many people to be diagnosed with this disease. For those of us battling SpA, resistance to medications can develop over time, making access to new treatments essential. The CSA will continue to work towards timely and equitable access to new treatments for all patients, which is vital for those living with this painful and debilitating condition."

About Psoriatic Arthritis
Psoriatic arthritis (PsA) is both an autoimmune disease and a form of inflammatory arthritis. The immune systems of people with PsA attack the joints, in addition to the skin. It is estimated that 0.2% of adults in Canada have PsA, but the exact numbers are unknown. PsA can develop at any age and up to a third (approximately 30 per cent) of people with psoriasis will develop PsA in their lifetime.⁹

About Ankylosing Spondylitis
Ankylosing spondylitis (AS) is both an autoimmune disease and a type of inflammatory arthritis that affects the spine and the sacroiliac joints that attach the pelvis to the base of the spine. With AS inflammation, the immune system attacks the ligaments and tendons attached to bone in the joints of the spine, causing erosion that that the body tries to repair by forming new bone. The bones of the spine then begin to fuse together, causing the spine to become stiff, inflexible and painful.¹⁰

AS is the most common form of a group of inflammatory arthritis called spondyloarthritis. AS differs from other forms of inflammatory arthritis due to the joints that are affected and the age of onset.¹¹ AS can occur at any  age but typically begins between ages 20 and 40.¹¹ Estimates suggest as many as 1% of the Canadian adult population lives with AS.¹¹

Full details on the recommendation, including conditions for reimbursement, are available on the CDA and INESSS websites.

About BIMZELX® (Bimekizumab Injection)
BIMZELX^® (bimekizumab injection) is indicated for the treatment of adults with active PsA, adults with active AS, and adults with active nr-axSpA who have responded inadequately or are intolerant to conventional therapy, and adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.¹ It is a monoclonal antibody belonging to a group of medicines called interleukin (IL) inhibitors. Monoclonal antibodies are proteins that recognize and bind specifically to certain proteins in the body. This medicine works by reducing the activity of two cytokines called IL-17A and IL-17F, which are present at increased levels in diseases such as PsA, AS and nr-axSpA.^7,8,9

About UCB Canada Inc.
Inspired by patients and driven by science, UCB Canada Inc. is a biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe autoimmune and central nervous system diseases. For more information, please consult https://www.ucb-canada.ca/.

About UCB
UCB, Brussels, Belgium (www.ucb.com) is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With approximately 8,400 people in nearly 40 countries, the company generated revenue of €5.3 billion in 2020. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCB_news. 

References

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¹ BIMZELX^® Product Monograph. UCB Canada. November 27, 2024.

² CDA/CADTH Reimbursement Recommendation: Bimekizumab (Bimzelx). Psoriatic Arthritis. www.cadth.ca/sites/default/files/DRR/2024/SR0803%20Bimzelx%20PsA_Rec_final.pdf. Accessed on June 3, 2024.

³ CDA/CADTH Reimbursement Recommendation: Bimekizumab (Bimzelx). Ankylosing Spondylitis. www.cadth.ca/sites/default/files/DRR/2024/SR0803%20Bimzelx%20PsA_Rec_final.pdf. Accessed on June 4, 2024.

⁴ INESSS Reimbursement Recommendation: BIMZELX Arthrite psoriasique. www.inesss.qc.ca/fileadmin/doc/INESSS/Inscription_medicaments/Avis_au_ministre/Juillet_2024/Bimzelx_APso_2024_06.pdf. Accessed July 16, 2024.

⁵ INESSS Reimbursement Recommendation: BIMZELX Spondylite ankylosante. https://www.inesss.qc.ca/fileadmin/doc/INESSS/Inscription_medicaments/Avis_au_ministre/Aout_2024/Bimzelx_SA_2024_07.pdf. Accessed August 27, 2024.

⁶ McInnes IB, Asahina A, Coates LC, et al. Bimekizumab in patients with psoriatic arthritis, naïve to biologic treatment: a randomised, double-blind, placebo-controlled, phase 3 trial (BE OPTIMAL). Lancet. 2023; 401(10370):25–37.

⁷ Merola JF, Landewé R, McInnes IB, et al. Bimekizumab in patients with active psoriatic arthritis and previous inadequate response or intolerance to tumour necrosis factor-α inhibitors: a randomised, double-blind, placebo-controlled, phase 3 trial (BE COMPLETE). Lancet. 2023;401(10370):38–48.

⁸ van der Heijde D, Deodhar A, Baraliakos X, et al. Efficacy and safety of bimekizumab in axial spondyloarthritis: results of two parallel phase 3 randomized controlled trials. Ann Rheum Dis. Published Online First: January 2023. doi:10.1136/ard-2022-223595.

⁹ Arthritis Society Canada. Psoriatic Arthritis Symptoms and Diagnosis. https://arthritis.ca/about-arthritis/arthritis-types-(a-z)/types/psoriatic-arthritis/psoriatic-arthritis-symptoms-and-diagnosis. Accessed March 2024.

¹⁰ Arthritis Society Canada. Ankylosing Spondylitis. https://arthritis.ca/about-arthritis/arthritis-types-(a-z)/types/ankylosing-spondylitis. Accessed March 2024.

¹¹ Arthritis Foundation. Ankylosing Spondylitis & Nonradiographic Axial Spondyloarthritis. https://www.arthritis.org/diseases/ankylosing-spondylitis. Accessed March 2024.

SOURCE UCB Canada Inc.

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