MONTREAL, CANADA, AUGUST 29, 2017
– AbbVie today announced that HUMIRA® (adalimumab) will now be reimbursed in British Columbia, Ontario, New Brunswick, Newfoundland and Labrador, Saskatchewan and Yukon for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response to conventional therapy including corticosteroids, azathioprine and/or 6-mercaptopurine (6-MP), or who are intolerant to such therapies. It is also now covered by the federal Non-Insured Health Benefits (NIHB) program, which provides coverage to nearly one million status First Nations and Inuit peoples.
Ulcerative colitis is a chronic disease of the colon, marked by inflammation and ulceration of the colon mucosa, or innermost lining. Canada has among the highest reported prevalence and incidence of Inflammatory Bowel Disease (IBD) in the world. There are approximately 104,000 Canadians living with UC and approximately 4,500 new cases of UC are diagnosed every year.
“This is great news because it improves public access to another treatment option for Canadians with ulcerative colitis,” says Dr. Brian Bressler, Clinical Associate Professor of Medicine, Division of Gastroenterology, University of British Columbia. “In British Columbia in particular, this means HUMIRA is the only sub-cutaneous option covered by the government and having that treatment option is critical for patients.”
“Ulcerative colitis is a chronic and challenging disease to manage and patients need medications that work,” explains Gail Attara, Chief Executive Officer, Gastrointestinal Society. “Ensuring coverage of these vital biologic medications for patients across the country is essential.”
“The longstanding and extensive experience of HUMIRA® in Canada across numerous indications makes it an important option for those living with ulcerative colitis,” says General Manager, Stéphane Lassignardie, AbbVie Canada. “AbbVie is also committed to developing new advanced innovative therapies in immunology in order to address unmet medical needs.”
HUMIRA® is also approved in Canada in adults for the treatment of rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), Crohn's disease (CD), psoriasis (Ps), hidradenitis suppurativa (HS), uveitis (Uv), as well as in children 2 years of age and older for the treatment of polyarticular juvenile idiopathic arthritis (JIA) and in pediatric patients with Crohn's disease (CD) 13 to 17 of age, ≥ 40kg.
HUMIRA resembles antibodies normally found in the body. It works by blocking TNF-α, a protein that, when produced in excess, plays a central role in the inflammatory responses of many immune-mediated diseases.
HUMIRA is one of the most comprehensively studied biologics available. The overall clinical database for HUMIRA spans 20 years across 13 indications globally (10 in Canada), including more than 100 clinical trials with more than 33,000 patients. HUMIRA is approved in 90 countries and used by more than 1 million patients worldwide.
Any medicines can have side effects. Like all medicines that affect the immune system, HUMIRA can cause serious side effects. Before initiation of, during and after treatment with HUMIRA; patients should be evaluated for active or inactive tuberculosis infection with a tuberculin skin test. For further information, please see the HUMIRA Product Monograph2 available at www.abbvie.ca
About AbbVie Care
Canadians prescribed HUMIRA will have the opportunity to be enrolled in AbbVie Care, AbbVie's signature care program. The program is designed to provide a wide range of customized services including reimbursement and financial support, pharmacy services, lab work reminders and coordination, personalized education and ongoing disease management support throughout the treatment and beyond.
For more information, call 1-866-8-HUMIRA (486472) or consult www.abbviecare.ca
Important Safety Information
HUMIRA is a TNF blocker medicine that affects the immune system and can lower the body's ability to fight infections. Serious infections have happened in people taking HUMIRA. These serious infections include tuberculosis (TB) and infections caused by viruses, fungi, or bacteria that have spread throughout the body. Some people have died from these infections. People should be tested for TB before HUMIRA use and monitored for signs and symptoms of TB during therapy. People at risk of TB may be treated with medicine for TB before starting HUMIRA. Treatment with HUMIRA should not be started in a person with an active infection, unless approved by a doctor. HUMIRA should be stopped if a person develops a serious infection. People should tell their doctor if they live in or have been to a region where certain fungal infections are common, have had TB or hepatitis B, are prone to infections, or have symptoms such as fever, fatigue, cough, or sores.
For people taking TNF blockers, including HUMIRA, the chance of getting lymphoma or other cancers may increase. Some people have developed a rare type of cancer called hepatosplenic T-cell lymphoma. This type of cancer often results in death. If using TNF blockers, including HUMIRA, the chance of getting two types of skin cancer (basal cell and squamous cell) may increase. These types are generally not lifethreatening if created.
Other possible serious side effects with HUMIRA include hepatitis B infection in carriers of the virus; allergic reactions; nervous system problems; blood problems; certain immune reactions, including a lupus-like syndrome; liver problems; and new or worsening heart failure or psoriasis. The use of HUMIRA with other biologics DMARDS (e.g. anakinra or abatacept) or other TNF antagonists is not recommended. People using HUMIRA should not receive live vaccines.
Common side effects of HUMIRA include injection site reactions (redness, swelling, itching, pain or bruising), cough and cold symptoms, headache, rash, nausea, pneumonia, fever and abdominal pain. HUMIRA is given by injection under the skin.
The benefits and risks of HUMIRA should be carefully considered before starting therapy. This is not a complete list of the Important Safety Information for HUMIRA. For additional important safety information, please consult the HUMIRA Product Monograph at www.abbvie.ca
AbbVie is a global, research-driven biopharmaceutical company committed to developing innovative advanced therapies for some of the world's most complex and critical conditions. The company's mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us at www.abbvie.ca
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