|[June 03, 2014]
Quebec Becomes First Province to Reimburse Sovaldi® for the Treatment of Chronic Hepatitis C
MISSISSAUGA, Ontario --(Business Wire)--
Gilead Sciences Canada, Inc. is pleased to announce that the Health and
Social Services Ministry has placed Sovaldi® (sofosbuvir),
the newest treatment for chronic hepatitis C virus (HCV) infection
approved for sale in Canada, on the Liste de m�dicaments (effective June
2, 2014). With this listing, Quebec becomes the first Canadian province
to provide access to Sovaldi for treatment-na�ve patients with genotypes
1 and 4 HCV infection regardless of liver severity.
The listing follows a Priority Review and evaluation by the Institut
national d'excellence en sant� et en services sociaux (INESSS) that
concluded Sovaldi provides therapeutic and clinical value, is cost
effective, is well tolerated, and offers important societal benefits for
the broader population. INESSS reported several advantages of Sovaldi,
including its short treatment duration (12 weeks), positive side effect
profile (anemia and rashes), and administration of one pill once a day
(with pegylated interferon and ribavirin) without the need for a
specific diet. In addition, INESSS stated that Sovaldi fulfills a
significant healthcare need in the treatment of genotype 4, as until
now, only a combination of pegylated interferon and ribavirin had been
A recent analysis, "Health Care Resources Utilization in Hepatitis C
Virus Infection and Cost Associated with Adverse Events: An Analysis of
the Quebec Provincial Drug Reimbursement Program Database", noted that
treatment with previous therapies resulted in lower treatment completion
and cure rates than treatment with Sovaldi. In addition, previous
therapies resulted in significant anemia management costs per patient.2
"Treatment with newer therapies at any stage of infection, with fewer
side effects, is a goal that is both achievable and cost effective,"
said Dr. Marc Bilodeau, Associate Professor of Medicine, Universit� de
Montr�al, and a co-author of the article. "By interveing early, we can
prevent progression to more advanced stages of disease and the
associated adverse outcomes."
Dr. Bilodeau added, "Quebec has recognized the health-system and
societal benefits associated with newer hepatitis C treatment that
improves upon the previous standard of care. As the first province to
reimburse Sovaldi, Quebec has demonstrated its leadership in addressing
this imminent public health issue and providing the opportunity for cure
to more patients."
In the most recent issue of the Canadian Journal of Gastroenterology and
Hepatology, the article, "Burden of disease and cost of chronic
hepatitis C virus infection in Canada", reports that Canada will
experience a significant increase in cases of advanced HCV-related liver
disease over the next 20 years. Estimates include: an 89 per cent
increase in cases of compensated cirrhosis (scarring of the liver with
no loss of function); an 80 per cent increase in cases of decompensated
cirrhosis (severe scarring of the liver with advanced symptoms and loss
of function); a 205 per cent increase in cases of liver cancer, and a
160 per cent increase in cases of liver-related deaths.3
The article also states that associated health care costs will increase
dramatically, mainly attributable to cirrhosis and its complications
including liver cancer and liver transplantation. Authors estimate a 60
per cent increase in longer-term health care costs associated with HCV
until its peak is reached in 2032 (not including antiviral therapy,
virology testing and indirect medical costs).3
"We are pleased that Quebec has recognized the clinical value of Sovaldi
as a curative therapy for treatment-na�ve patients living with genotype
1 or 4 hepatitis C, regardless of their disease severity," said Edward
Gudaitis, General Manager, Gilead Sciences Canada, Inc. "Gilead also
welcomes the province's affirmation that Sovaldi is a cost-effective
medicine that has the potential to reduce the burden of this disease on
the health care system. We look forward to the outcome of additional
reviews of Sovaldi that are being conducted by other provinces and
territories in Canada."
Sovaldi is a once-daily direct-acting
antiviral agent for the treatment of chronic hepatitis C infection.
Sovaldi is indicated for use in genotypes 1 and 4 in combination with
pegylated interferon and ribavirin, and in genotypes 2 and 3 in
combination with ribavirin alone. In clinical studies, Sovaldi has
achieved a cure rate of greater than 90 per cent after 12 weeks of
About Gilead Sciences
Gilead Sciences, Inc. is a
biopharmaceutical company that discovers, develops and commercializes
innovative therapeutics in areas of unmet medical need. The company's
mission is to advance the care of patients suffering from
life-threatening diseases worldwide. Headquartered in Foster City,
California, Gilead Sciences has operations in North and South America,
Europe and Asia Pacific. Gilead Sciences Canada, Inc. is the Canadian
affiliate of Gilead Sciences, Inc. and was established in�Mississauga,
Ontario in 2005.
1. Excerpt from Health and Social Services Ministry; Sovaldi in the
treatment of chronic hepatitis C with genotypes 1 and 4.
2. "Health Care Resources Utilization in Hepatitis C Virus Infection
and Cost Associated with Adverse Events: An Analysis of the Quebec
Provincial Drug Reimbursement Program Database"; Lachine, J et al.
Abstracts accepted at 2013 AASLD, 2013 ISPOR, and 2014 CDDW.
3. "Burden of disease and cost of chronic hepatitis C infection in
Canada"; RP Myers, M Krajden, M Bilodeau, K Kaita, P Marotta, K
Peltekian, A Ramji, C Estes, H Razavi, M Sherman; Canadian
Journal of Gastroenterology and Hepatology, May 2014.
[ InfoTech Spotlight's Homepage ]