Quebec Becomes First Province to Reimburse Sovaldi® for the Treatment of Chronic Hepatitis C

~ Priority Review by INESSS Provides Recommendation to Treat Patients with Genotypes 1 and 4 HCV Infection Regardless of Fibrosis Level ~

MISSISSAUGA, ON, June 3, 2014 /CNW/ - 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 médicaments (effective June 2, 2014).  With this listing, Quebec becomes the first Canadian province to provide access to Sovaldi for treatment-naïve 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 santé 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 used.¹

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, Université de Montréal, and a co-author of the article.  "By intervening 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-naïve 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."

About Sovaldi

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 treatment.

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. 

References:

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.

SOURCE: Gilead Sciences, Inc.

Cara Miller, Gilead Sciences, Inc., 1-650-522-1616