- Effective February 28, Ontario will become the first province to reimburse ZEPATIER® (elbasvir/grazoprevir), a simple one pill, once daily, 12 week no ribavirin regimen for most patients, and will be followed by British Columbia on March 21
- In addition to patients with liver fibrosis stage F2+, patients with liver fibrosis stage F0 and F1 with poor prognostic factors, who had no public access to a potential cure under existing public plans, are now eligible for treatment
- Patients with CHC genotypes 1 and 4, with chronic kidney disease (CKD) and intraveinous drug users - representing the highest number of new cases1 - will have access to treatment
KIRKLAND, QC, Feb. 22, 2017 /CNW Telbec/ - An estimated 185,000 people in Ontario and British Columbia have hepatitis C, a chronic liver disease that, if left untreated, can lead to cirrhosis, liver cancer and liver transplants.2 Merck Canada Inc. today announced that the Government of Ontario and of British Columbia are strengthening their commitment in the global fight against hepatitis C by becoming the first provinces to reimburse ZEPATIER® (elbasvir/grazoprevir). Zepatier is indicated in the treatment of chronic hepatitis C genotypes 1, 3 or 4 infections in adults patients.3 The product monograph with detailed product indication is available online by clicking here.
"We're pleased to have worked with the pan-Canadian Pharmaceutical Alliance (pCPA) and participating jurisdictions to provide access to Zepatier to patients who need it, including those at higher risk," says Chirfi Guindo, President and Managing Director, Merck Canada Inc. "Hepatitis C is a curable disease, and today's announcement brings us one step closer to eradicating the virus in Canada."
For the first time special populations, including hepatitis C patients with fibrosis stage F0 and F1 who are co-infected with human immunodeficiency virus (HIV) or hepatitis B virus or who have chronic kidney disease (CKD), will be eligible for treatment as of February 28th under the Ontario Drug Benefit Program (ODB), and as of March 21st under B.C.'s PharmaCare program.
"The publicly funded availability of Zepatier in Canada for hepatitis C treatment represents a major milestone in the access to care for patients; not only those patients with advanced liver damage or cirrhosis have access to treatment but now those who may progress to more serious liver damage in the future can be cured. The dedication of Merck to addressing clinical studies in targeted and specific populations in need such as those with cirrhosis, advanced kidney disease and those who inject drugs, allow all treaters to use this treatment regimen to cure their patients safely," said Dr. Sergio Borgia, Medical Director and Corporate Division Head of the Infectious Disease Program at William Osler Health System.
These provincial public funding announcements follow the World Health Organization's (WHO) adoption of the first global health strategy on viral hepatitis, which includes a goal of 30% reduction in new cases of hepatitis B and C by 2020 and a 10% reduction in mortality, as well as increased access to treatment for hepatitis B and C.4 In June 2016, the Government of Canada announced its commitment in the global fight against viral hepatitis with the adoption of the Global Strategy on Viral Hepatitis. It has for objective to eliminate hepatitis B and C by 2030.5
About Hepatitis C
Hepatitis C is a chronic liver disease caused by the hepatitis C virus (HCV). In Canada, an estimated 250,000 individuals are infected with HCV, but many don't know it. Hepatitis C is a leading cause of health-related problems including cirrhosis, liver cancer and liver transplants. New treatments can cure hepatitis C and prevent further liver damage.6
There are at least six distinct HCV genotypes (genotypes 1–6). In Canada, genotype 1 represents 65% of the infections, genotype 2 and 3 represent approximately 14% and 20% respectively of the cases while genotypes 4, 5 and 6 are considered rare.7 Knowing which genotype a person carries helps determine the best treatment option.8
Today, injection drug use accounts for an increasingly high proportion of cases of hepatitis C infection. In people who inject drugs, the frequency of infection is estimated to be between 57%–90%.9
Merck's Commitment to HCV
For nearly 30 years, Merck, known has MSD outside Canada and the United States, has been at the forefront of the response to the HCV epidemic. Merck employees are dedicated to applying their scientific expertise, resources and global reach to deliver innovative healthcare solutions that support people living with HCV worldwide.
For over a century, Merck has been a global healthcare leader working to help the world be well. Merck is known as MSD outside the United States and Canada. Through our prescription medicines, vaccines, biologic therapies, and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to healthcare through far-reaching policies, programs and partnerships. For more information about our operations in Canada, visit www.merck.ca and connect with us on YouTube and Twitter @MerckCanada.
Forward-Looking Statement of Merck & Co., Inc., Kenilworth, N.J., USA
This news release of Merck & Co., Inc., Kenilworth, N.J., USA (the "company") includes "forward-looking statements" within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company's management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.
Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company's patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.
The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company's 2015 Annual Report on Form 10-K and the company's other filings with the Securities and Exchange Commission (SEC) available at the SEC's Internet site (www.sec.gov).
ZEPATIER® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
1 PHAC, 2011. Hepatitis C in Canada: 2005-2010 Surveillance Report. Centre for Communicable Diseases and Infection Control, Infectious Disease Prevention and Control Branch. http://publications.gc.ca/collections/collection_2012/aspc-phac/HP40-70-2012-eng.pdf (accessed February 2017)
2 Ontario Ministry of Health and Long-Term Care, 2012.. Hepatitis C. Online: http://www.health.gov.on.ca/en/public/programs/hepatitis/hep_c.aspx/en/self.html (accessed February 2017)
3 Merck Canada Inc. Zepatier Product Monograph. Updated July 22, 2016. p.3
4 WHO, 2016. Sixty-ninth World Health Assembly closes. Online: http://www.who.int/mediacentre/news/releases/2016/wha69-28-may-2016/en/ (accessed February 2017)
5 Canadian Society for International Health (CSIH), 2016. Canada Takes a Stand Against Viral Hepatitis. Online: http://www.newswire.ca/news-releases/canada-takes-a-stand-against-viral-hepatitis-583289331.html (accessed February 2017)
6 CLF. Hepatitis C. Online: http://www.liver.ca/liver-disease/types/viral_hepatitis/Hepatitis_C.aspx (accessed February 2017)
7 Myers, Robert P. and all, 2015. Canadian journal of Hepatology. An update on the management of chronic hepatitis C:2015 consensus guidelines from the Canadian Association for the Study of the Liver. Online: http://www.liver.ca/files/Professional_Education___Partnerships/Information___Resources_for_HCP/CASL_Hep_C_Consensus_Guidelines_Update_-_Jan_2015.pdf (accessed February 2017)
8 CDC, 2016. Hepatitis C FAQs for Health Professionals. Online: http://www.cdc.gov/hepatitis/HCV/HCVfaq.htm (accessed June 2016)
9 Wedemeyer, H. Chapter 80 Hepatitis C. In: Feldman, M, Friedman, LS, et al., editors. Sleisenger and Fordtran's Gastrointestinal and Liver Disease. 10th ed. Philadelphia, PA: Saunders; 2015. p. 1332-52.p.1336
SOURCE Merck Canada Inc.
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