— Reimbursement of Harvoni Within Five Months of
Health Canada Notice of Compliance Brings Patients Earlier Opportunity
for a Cure —
MISSISSAUGA, Ontario, Mar 24, 2015 (BUSINESS WIRE) —
Gilead Sciences Canada, Inc. (Gilead Canada) today announced that
multiple provinces will provide public access to Harvoni™
(ledipasvir/sofosbuvir), the first once-daily, single tablet regimen for
the treatment of chronic hepatitis C virus (HCV) genotype 1 infection in
adults. In Canada, it is estimated that more than 250,000 Canadians are
living with chronic HCV infection, with thousands of new cases diagnosed
each year.1 Genotype 1 infection represents an estimated 65
per cent of patient cases.2
Public reimbursement comes after a positive recommendation from the
Common Drug Review, and as a result of a productive collaboration
between Gilead Canada and the Pan-Canadian Pharmaceutical Alliance
(pCPA) to ensure participating provinces are able to provide timely
access to patients in need of curative treatment. This review, co-led by
the BC Ministry of Health and the Ontario Ministry of Health and
Long-Term Care, resulted in an agreement with member provinces to fund
the innovative therapy for patients.
“We have been waiting for an innovative therapy like Harvoni since
interferon was first used to treat the disease,” said Dr. Alnoor Ramji,
Clinical Associate Professor of Medicine (Gastroenterology and
Hepatology), University of British Columbia. “This is a transformative,
interferon-free therapy, with a combination of high cure rates, good
tolerability and simplicity of treatment. Harvoni provides patients with
the confidence to commit to therapy and a very high probability to
achieve a cure.”
Current treatments include interferon and ribavirin that often exclude
patients from treatment or lead to early discontinuation of treatment
due to associated side effects. Harvoni represents a significant advance
in the treatment of genotype 1 HCV infection, the most prevalent
genotype in Canada. Harvoni is the only once-daily, single tablet
regimen that offers cure rates between 94 and 99 per cent, eliminates
the need for interferon and ribavirin, and shortens the duration of
treatment to as little as eight weeks for many patients. Eight weeks of
treatment with Harvoni can be considered for treatment-naïve patients
without cirrhosis who have baseline HCV viral load below 6 million
IU/mL. Recently, the Canadian Association for the Study of the Liver
updated the Canadian consensus guidelines on the management of hepatitis
C and recommended Harvoni as first-line therapy for all genotype 1
patients.
“Today’s announcement recognizes the significant health-system and
societal benefits associated with curing this disease and preventing its
complications,” said Dr. Paul Marotta, Associate Professor, University
of Western Ontario and with London Health Sciences Centre. “Access to
Harvoni will help us confront this serious public health issue and start
formulating longer-term solutions that may prove relevant to the
hepatitis C disease elimination efforts across Canada.”
In a recent article, “Burden of disease and cost of chronic hepatitis
C virus infection in Canada,” (Canadian Journal of
Gastroenterology and Hepatology), leading Canadian hepatitis C
specialists highlighted an expected 205 per cent increase in cases of
liver cancer, a 160 per cent increase in liver-related deaths, and a 60
per cent increase in total healthcare costs over the next 20 years.2
Recently, the article was recognized with a scientific award for its
groundbreaking research in Canada.
In addition to Harvoni, Gilead Canada’s Sovaldi® (sofosbuvir)
has also been listed for public reimbursement for chronic HCV genotypes
1, 2 and 3 infection in multiple provinces.
“We live in an era of rapid evolution in the treatment of chronic
hepatitis C infection, and Gilead Canada is pleased that our
collaboration with the pCPA has allowed multiple provinces to recognize
the clinical value of Harvoni as a simple, well tolerated and curative
therapy for patients living with genotype 1 HCV,” said Edward Gudaitis,
General Manager, Gilead Sciences Canada, Inc. “Gilead Canada will
continue to work closely with all provinces and territories to bring
this cost-effective, once-daily treatment to patients across Canada.”
Read complete press release here
