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Thousands of Canadians may be denied access to effective new hepatitis B treatment: Drug review committee recommends against full reimbursement of Baraclude(TM) (entecavir)
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Announcement from BMS
MONTREAL, Dec. 5 /CNW/ - Thousands of Canadians with Hepatitis B Virus (HBV) may be denied access to Baraclude(TM) (entecavir) as a result of a restrictive drug reimbursement recommendation issued by the Canadian Expert Drug Advisory Committee. If provinces follow the committee's decision, only patients with documented cirrhosis would have public access to the highly potent new treatment.
The committee's current recommendation reserves entecavir for patients who are at the highest risk of complications from chronic hepatitis infection, i.e., cirrhosis documented on radiologic or histologic grounds and a HBV DNA concentration above 2000IU/mL.
"The committee's decision to restrict access to entecavir will result in a significant proportion of patients having to use treatment that has largely been abandoned in the USA and Europe as substandard," said Dr. Morris Sherman, Chairman of the Canadian Liver Foundation Medical Advisory Committee, Past President of the Canadian Association for the Study of the Liver and a practicing hepatologist who sees many patients with hepatitis B. "These patients will receive inadequate therapy with an unacceptably high rate of developing resistance, leading to compromise of future treatment choices."
Chronic hepatitis B is a serious disease caused by the hepatitis B virus (HBV) that attacks the liver. The virus can cause lifelong infection, cirrhosis (scarring) of the liver, liver cancer, liver failure, and death.
"All patients with hepatitis B deserve affordable access to treatments deemed appropriate by their physicians," added Dr. Sherman. "It is a shame that Canadians are being denied what in many cases might be their best chance for a positive outcome."
Entecavir was approved by Health Canada for treatment of chronic
hepatitis B on June 6, 2006. It works by slowing the progression of hepatitis B by interfering with viral reproduction. It is currently the most potent inhibitor of HBV DNA replication available in Canada. Earlier this year Quebec announced that entecavir would be publicly reimbursed for treatment naive HBV patients and those who are refractory to current drugs.
"BMS is very disappointed with this decision and we intend to resubmit our data package with additional evidence as soon as possible," said Dr. Mitch Shulman, Vice-president, Medical Affairs, BMS Canada. "In all trials, entecavir has demonstrated statistically significant improvements in hepatitis B viral suppression.
Furthermore, resistance to entecavir is very rare during the first three years of therapy. This stands out when it is compared to the current treatment which has been reporting resistance rates in the neighborhood of 70% after four years of therapy."
Chronic viral hepatitis continues to be a major public health and medical problem in Canada. There are an estimated 500,000 to 600,000 people in Canada infected with either the HBV or the HCV. The disease has a high mortality rate (20 per cent to 25 per cent of untreated carriers).(1)
The Canadian Expert Drug Advisory Committee is a part of the Common Drug Review process which provides funding recommendations to all publicly-funded provincial, territorial, and federal drug insurance plans (known as formularies), with the exception of Quebec.
About Bristol-Myers Squibb Canada
Bristol-Myers Squibb Canada is an indirect wholly-owned subsidiary of Bristol-Myers Squibb Company, a global pharmaceutical and related health care products company whose mission is to extend and enhance human life. Bristol-Myers Squibb Company of Canada is a leading provider of medicines to fight cancer, cardiovascular and metabolic disorders, infectious diseases - including HIV/AIDS, nervous system diseases and serious mental illness. Bristol-Myers Squibb Company is listed on the New York Stock Exchange under
the BMY symbol (NYSE:BMY). Bristol-Myers Squibb Canada's operations are headquartered in Montreal, Quebec.
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(1) Canadian Journal of Gastroenterology Vol 21 Suppl. C June 2007
For further information: Marc Osborne, Director, Public Affairs and
Government Relations, Bristol-Myers Squibb Canada, (514) 333-2463, marc.osborne@bms.com; Fiona Robinson, H&K Health, Hill & Knowlton Toronto, (416) 413-4737, fiona.robinson@hillandknowlton.ca
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