SILIQTM is a new biologic agent indicated by Health Canada for the treatment of moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.1
Plaque psoriasis is the most common type of psoriasis, a chronic non-communicable skin disease that imposes a burden that extends far beyond the physical dermatologic symptoms. 2,3
LAVAL, QC, March 11, 2019 /CNW Telbec/ - Bausch Health Companies Inc. (NYSE: BHC) (TSX: BHC) ("Bausch Health" or "the Company") today announced that the Government of Quebec will publicly fund SILIQ™ (brodalumab), a biologic agent indicated for the treatment of moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy1. As of February 1st, 2019, SILIQ™ will be included on the List of Medications reimbursed under the Régie de l'assurance maladie du Québec (RAMQ), and will be reimbursed for patients who meet specific criteria of the exceptional medications status.
Although many antipsoriatic therapies are ameliorative, few can be used to achieve complete or nearly complete clearance of symptoms3. With SILIQTM now covered under the provincial formulary, patients and health care professionals in Quebec have access to a new treatment option.
"We are pleased with the Quebec government's decision to support adults living with severe plaque psoriasis, a debilitating chronic disease, through reimbursement of SILIQ™," said Richard Lajoie, President and General Manager of Bausch Health, Canada Inc.
"SILIQ™ is the only biologic whose primary endpoint was the achievement of a Psoriasis Area Severity Index (PASI) 100 score reflecting complete skin clearance," said Dr. Yves Poulin, MD, FRCPC. Assistant clinical professor, hôpital Hôtel-Dieu de Québec. "SILIQ™ is the first IL-17 receptor A blocker to neutralize the activity of the family of IL-17 pro-inflammatory cytokines, leading to an efficient and rapid normalization of cutaneous inflammation caused by psoriasis. Having this therapeutic agent with a different mode of action is a major advance in the management of psoriasis."
"The addition of SILIQ™ to the RAMQ drug list is an important milestone for nearly 168,000 people living with psoriasis in Quebec, approximately 40,000 of whom will have, or may develop, a moderate or severe form of the disease,"4 says Kathryn Clay, Executive Director, Canadian Association of Psoriasis Patients (CAPP).
SILIQ™ received its Notice of Compliance (NOC) from Health Canada on March 6, 2018. In addition to the new RAMQ listing, SILIQ™ is also available through private insurance plans. As equitable access to SILIQTM for patients across Canada is a high priority, Bausch Health is actively working with other Canadian provinces for the addition of SILIQTM to their respective public drug plans.
WARNING: SUICIDAL IDEATION AND BEHAVIOUR (SIB)
SILIQ™ has a warning/precaution for the risk in patients with a history of suicidal thoughts or behaviours. A causal association between SILIQ™ treatment and risk of Suicidal Ideation and Behaviour (SIBs) has not been established. SILIQ™ was approved with a comprehensive Patient Support Program that supports patients and healthcare professionals with the prescribing, administration, delivering and monitoring of patients who receive SILIQ™ treatment. The most common adverse reactions were headache, arthralgia, fatigue, oropharyngeal pain, and diarrhea. SILIQ™ is contraindicated in patients with Crohn's disease. Suicidal ideation and behaviour have been reported. Serious infections have occurred; therefore, caution should be exercised when considering the use of SILIQ™ in patients with a chronic infection or a history of recurrent infection. Patients should be evaluated for tuberculosis infection prior to initiating treatment.
Knowing that psoriasis is associated with higher rates of depression, anxiety and Suicidal Ideation & Behaviours (SIBs), Bausch Health will ensure that health care professionals and their patients are informed and educated about SIBs before initiating, and during, treatment with SILIQ™. SIBs have occurred in patients treated with SILIQ™. A causal association between treatment with SILIQ™ and increased risk of SIBs has not been established.
SILIQ™ (brodalumab) is a novel human monoclonal antibody that binds to the interleukin-17 (IL-17) receptor A and inhibits inflammatory signaling by preventing the binding of several types of IL-17 to the receptor. By blocking IL-17 from activating the receptor, SILIQ™ prevents the body from receiving signals that may lead to inflammation. The IL-17 pathway plays a central role in inducing and promoting inflammatory disease processes.
Bausch Health has exclusively licensed the rights to SILIQ™ in Canada from AstraZeneca.
About Bausch Health Companies Inc.
Bausch Health Companies Inc. (NYSE/TSX: BHC) is a global company whose mission is to improve people's lives with our health care products. We develop, manufacture and market a range of pharmaceutical, medical device and over-the-counter products, primarily in the therapeutic areas of eye health, gastroenterology and dermatology. We are delivering on our commitments as we build an innovative company dedicated to advancing global health.
In Canada, the company's prescription product portfolio is focused on eye health, dermatology and cardio-metabolic conditions. More information can be found at the Company's website at https://www.bauschhealth.ca.
1. PRSILIQTM (brodalumab). Product Monograph. Valeant Canada LP. March 6, 2018.
2. World Health Organization. (2016). Global report on psoriasis. World Health Organization. http://www.who.int/iris/handle/10665/204417
3. Canadian Psoriasis Guidelines Committee. Canadian Guidelines for the Management of Plaque Psoriasis, June 2009. http://www.dermatology.ca/psoriasisguidelines
4. Petrella RG, Gregory V, Luciani L and Barbeau M. Characteristics of Chronic Plaque Psoriasis In Canada: A Retrospective Database Study. Value in Health, Volume 17, Issue 3, A284. https://doi.org/10.1016/j.jval.2014.03.1654
SOURCE Bausch Health
For further information: Media: Boyd Erman, Longview Communications, [email protected], Desk: 416 649 8007, Mobile: 416 523 5885, 416 649 8007; Investor Relations: Arthur Shannon, Bausch Health, [email protected], Desk: 514-856-3855, Toll free: 877-281-6642