DUPIXENT® (dupilumab injection) now publicly reimbursed in Ontario and New Brunswick for the treatment of moderate-to-severe atopic dermatitis
- DUPIXENT® is the only biologic medicine approved by Health Canada to treat moderate-to-severe atopic dermatitis.
- Public reimbursement under the Ontario Exceptional Access Program and the New Brunswick Drug Plans Formulary will apply for Canadians aged 12 and older and when specific criteria are met.
MISSISSAUGA, ON, May 25, 2021 /CNW/ - Sanofi Canada is pleased to announce that Ontario and New Brunswick have listed DUPIXENT® (dupilumab injection) on their respective provincial drug programs for the treatment of moderate-to-severe atopic dermatitis (AD) for Canadians aged 12 years and older when specific criteria are met.
"Atopic dermatitis is a chronic condition that significantly impacts patients well beyond physical symptoms and can cause extensive disruptions to everyday life," says Marissa Poole, Country Lead, Sanofi Canada and General Manager, Sanofi Genzyme Canada. "We appreciate the partnership with the provincial governments to establish these agreements that will enable more Canadians living with moderate-to-severe atopic dermatitis to gain control over their condition and improve their quality of life."
AD, the most common form of eczema, is an inflammatory disease classified by dry, itchy skin. In its moderate-to-severe form, it is characterized by rashes that can cover much of the body, and can include intense, persistent itching, skin lesions and skin dryness, cracking, redness or darkness, crusting and oozing.i Inadequately controlled AD can have a physical, emotional and psychosocial impact, causing sleep disturbance, symptoms of anxiety and depression, and feelings of isolation.ii
"Living with moderate-to-severe atopic dermatitis imposes psychological and physical burden on patients. Dermatitis is often visible. Symptoms, including itch and pain, cause great discomfort often leading to sleep disturbance and feelings of anxiety. Atopic dermatitis impacts patients' mental health and well-being," says Dr. Kim Papp, Dermatologist. "As there is no cure for atopic dermatitis, I welcome any news that more Canadians have access to a treatment that addresses the underlying cause of atopic dermatitis."
Eligibility for DUPIXENT® under the Ontario Exceptional Access Program
Under the Ontario Exceptional Access Program, DUPIXENT® will be reimbursed for persons living with atopic dermatitis who meet the following criteria:
- Is 12 years of age or older; and
- Has been diagnosed with moderate-to-severe AD as defined by an Eczema Area and Severity Index ("EASI") score equal to or greater than 16 points; and
- Has experienced failure to maintain adequate control of their dermatitis with topical prescription therapies; and
- Has experienced failure or intolerance with an adequate trial of phototherapy (where available), methotrexate, and cyclosporine; and
- DUPIXENT® has been prescribed for the patient: by a dermatologist, pediatrician or immunologist; or
- In consultation with a dermatologist, pediatrician or immunologist, and the authorized prescriber includes the consult note with the EAP request.
Eligibility for DUPIXENT® on the New Brunswick Drug Plans Formulary
Criteria for public reimbursement of DUPIXENT® on the New Brunswick Drug Plans Formulary is for patients 12 years of age and older who meet all of the following criteria:
- Refractory or have contraindications to an adequate trial of topical prescription therapies;
- Refractory, intolerant or have contraindications to an adequate trial of phototherapy (where available), methotrexate, and cyclosporine;
- Baseline Physician Global Assessment score of 3 or greater and Eczema Area and Severity Score of 7.1 or greater; and
- Must be prescribed by a dermatologist.
Further information is available on the New Brunswick Drug Plans Formulary Update.
DUPIXENT® is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) proteins and is not an immunosuppressant. Data from DUPIXENT® clinical trials have shown that IL-4 and IL-13 are key and central drivers of the type 2 inflammation that plays a major role in AD.iii
Since its initial approval in 2017, DUPIXENT® remains the only biologic medicine approved by Health Canada for the treatment of patients six years and older with moderate-to-severe AD whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.iv DUPIXENT® is also approved in Canada for the treatment of adult patients with severe chronic rhinosinusitis with nasal polyposis (CRSwNP) and for the treatment of severe asthma in patients 12 years and older.v
DUPIXENT® is jointly developed by Sanofi and Regeneron under a global collaboration agreement.
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i Mount Sinai. Patient Care Atopic Dermatitis. Available from http://www.mountsinai.org/patient-care/health-library/diseases-and-conditions/atopic-dermatitis#risk. Accessed May 14, 2021.
ii Eczema Society of Canada. Atopic Dermatitis Quality of Life Report. Available from https://eczemahelp.ca/wp-content/uploads/2019/02/ESC_Quality-of-Life-Report_Nov-2017-1.pdf. Accessed May 14, 2021.
iii DUPIXENT® Canada Product Monograph. February 22, 2021.
iv DUPIXENT® Canada Product Monograph. February 22, 2021.
v DUPIXENT® Canada Product Monograph. February 22, 2021.
SOURCE Sanofi Canada