Source: Sanofi (EURONEXT: SAN) (NYSE: SNY)
* CADTH recommendation for Dupixent™ disregards patient input
and ignores clinical value
LAVAL, QC, July 10, 2018 /CNW Telbec/ - Sanofi Genzyme is
disappointed with the recent recommendation by the Canadian Agency
for Drugs and Technologies in Health (CADTH) to not reimburse
Dupixent™, one of the most important recent pharmacological
innovations for the treatment of adult patients with
moderate-to-severe atopic dermatitis (AD). This recommendation
disregards patient input and ignores the product's clinical value
and the potential improvement to patient and caregiver
quality-of-life (QoL).
CADTH recommendation positions Canada as global outlier in AD
treatment
In 2017, Health Canada, the US Food and Drug Administration
(FDA) and the European Medicines Agency (EMA) approved Dupixent™
based on its clinical value and benefits to patients with
moderate-to-severe AD. The FDA also granted a priority review and
Breakthrough Therapy designation for Dupixent™. These designations
expedite the review process and are only given to products the
agency deems to have a particularly significant impact on the
treatment of the disease.
Moreover, the National Institute for Health Care Excellence
(NICE) recently issued a positive Final Appraisal Determination for
Dupixent™ for routine use on the National Health Service in
England, paving the way for the
first targeted biologic for adults with moderate to severe atopic
dermatitis.
Within Canada, the Institut
national d'excellence en santé et en services sociaux (INESSS),
in Québec, has also recognized the clinical value of Dupixent™.
Sanofi Genzyme looks forward to working with the Ministère de la
Santé et des Services sociaux (Ministry of Health and Social
Services) to achieve public reimbursement quickly for patients in
need.
If the provincial, territorial and federal drug plans adopt
CADTH's recommendation, Canada
risks becoming a global outlier in AD treatment options as it
conflicts with local and major global public reimbursement
bodies.
A detrimental impact on patients with atopic
dermatitis
The CADTH recommendation, made public on July 9, after consultation with the agency's
Canadian Drug Expert Committee (CDEC), could have a highly
detrimental effect on access to this medication for patients with
moderate-to-severe AD. CADTH recommendations have an influence on
reimbursement decisions by jurisdictional public drug plans,
potentially leading to the therapy being rejected for public
reimbursement. This would limit access to therapy for patients
dependent on public drug plans, and would restrict physicians from
prescribing the most appropriate treatment option. Contrary to the
CADTH negative recommendation, the value of Dupixent™ has been
recognized by private employer benefits plans, being covered by the
majority of private payer plans across Canada.
"I am disappointed. My colleagues are disappointed. Many of
my patients who suffer from this severe disease and had hope for a
new medication will be devastated when I break the bad news to
them", says Dr. Melinda Gooderham,
Dermatologist, Peterborough Regional Health Centre and Assistant
Professor, Department of Medicine at Queen's University.
Dupixent™: innovative treatment for patients with atopic
dermatitis
Dupixent™ (dupilumab), is the first biologic therapy in
Canada to target the root cause of
AD – a form of eczema – to treat adult patients whose moderate to
severe disease is not adequately controlled with topical
prescription corticosteroids or when those therapies are not
advisable.1 The therapy was approved by Health Canada on
November 30, 2017 after clinical
studies showed an acceptable safety profile with a significant
improvement in the condition of patients' skin and reduction in
itch within the first four months of biweekly
treatment.2 The medicine is jointly developed by
Regeneron and Sanofi under a global collaboration agreement.
Moderate to severe AD can be debilitating and
negatively impacts Quality of Life
Atopic dermatitis, a form of eczema, is a chronic inflammatory
disease with symptoms often appearing as a rash on the
skin.3,4,5,6 Moderate-to-severe atopic dermatitis is
characterized by rashes often covering much of the body, and can
include intense, persistent itching and skin dryness, cracking,
redness, crusting, and oozing.7 Itch is one of the most
burdensome symptoms for patients and can be
debilitating.8 In addition, people with
moderate-to-severe atopic dermatitis experience impaired quality of
life, including disrupted sleep, and increased anxiety and
depression symptoms along with their disease.9
Recommendation discourages future innovation
The recommendation reached by CADTH is contrary to the Canadian
government's own commitment to invest in innovation and may have
detrimental effects on patients' health.
"Sanofi Genzyme is committed to helping the atopic dermatitis
community, but the challenges of researching new treatment
solutions cannot be overstated," says Peter
Brenders, General Manager, Sanofi Genzyme Canada. "We should
work collectively to break down roadblocks to innovation in the
best interest of patients, so that we may find sustainable
solutions that keep therapeutic decision-making in the hands of
patients and their physicians, where it belongs."
As one of the largest investors in research and development,
Sanofi in Canada has been
investing approximately 20% of its revenues year-after-year in
Canadian biopharma research, bringing new innovative health
solutions to Canadians – and the world.
About Sanofi – www.sanofi.ca
Sanofi is dedicated to supporting people through their health
challenges. We are a global biopharmaceutical company focused on
human health. We prevent illness with vaccines, provide innovative
treatments to fight pain and ease suffering. We stand by the few
who suffer from rare diseases and the millions with long-term
chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is
transforming scientific innovation into healthcare solutions around
the globe.
Sanofi entities in Canada
employ more than 2,000 people. In 2017, we invested $123 million in R&D in Canada, creating jobs, business and
opportunity throughout the country.
Follow us on Twitter and on YouTube.
Sanofi, Empowering Life
_______________________________
|
1
|
Dupixent™ (dupilumab)
Product Monograph. Page 3. November 30, 2017.
|
2
|
Dupixent™ (dupilumab)
Product Monograph. November 30, 2017.
|
3
|
Eichenfield et al.
Guidelines of Care for Atopic Dermatitis. AAD 2014, pp.
118.
|
4
|
Guideline to
treatment, European Dermatology Forum.
http://www.euroderm.org/edf/index.php/edf-guidelines/category/5-guidelines-miscellaneous?download=36:guideline-treatment-of-atopic-eczema-atopic-dermatitis.
Accessed November 27, 2017.
|
5
|
Gelmetti and
Wolleberg, BJD 2014, Atopic dermatitis- all you can do from the
outside. Page 19.
|
6
|
National Institutes
of Health (NIH). Handout on Health: Atopic Dermatitis (A type of
eczema) 2013.
|
7
|
Mount Sinai. Patient
Care Atopic Dermatitis. Available at:
http://www.mountsinai.org/patient-care/health-library/diseases-and-conditions/atopic-dermatitis#risk.
Accessed November 27, 2017.
|
8
|
Zuberbier T et al.
Patient perspectives on the management of atopic dermatitis. J
Allergy Clin Immunol vol. 118, pp. 226-232, 2006.
|
9
|
National Institutes
of Health (NIH). Handout on Health: Atopic Dermatitis (A type of
eczema) 2013.
|
SOURCE Sanofi Canada