INCIVEK™ (telaprevir) Now Funded for People With Hepatitis C in Quebec and Saskatchewan
- Vertex working with other provincial funding agencies to make
INCIVEK available to more people in Canada -
LAVAL, Quebec--(BUSINESS WIRE)--
Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced today that
the province of Quebec is now funding INCIVEK™ (telaprevir)
tablets for residents living with chronic hepatitis C. The decision
comes following a priority evaluation by the Institut National
D'Excellence en Santé et en Services Sociaux (INESSS). This decision
includes funding for patients who are being treated for the first time
as well as those who were treated previously, but did not achieve a
sustained virologic response (SVR, or virologic cure), including null
responders. Null responders, or those who do not respond to initial
treatment, have the hardest time achieving a cure. INCIVEK is the only
direct-acting antiviral medicine approved for the treatment of this
group of patients. Funding in Quebec will be provided for patients with
all levels of fibrosis (scarring of the liver) and in combination with
available pegylated-interferon and ribavirin combinations. Earlier this
month, Saskatchewan became the first province in Canada to fund this new
medicine. Vertex is working closely with other provincial reimbursement
agencies to secure funding that will make INCIVEK accessible to more
people with hepatitis C across all of Canada.
"In clinical studies, INCIVEK demonstrated the ability to cure nearly
four out of five people infected by the hepatitis C genotype-1 virus who
had not been previously treated for hepatitis C and to cut treatment
time to 24 weeks for most patients, which marks a fundamental shift in
treatment," said Dr. Marc Bilodeau from the Liver Unit of the Centre
hospitalier de l'Université de Montréal. "The decision by the Minister
of Health and Social Services of Quebec to reimburse INCIVEK underscores
the urgent need for new medicines to treat this potentially
life-threatening but curable disease, which affects about a quarter of a
million people in Canada."
Health Canada approved INCIVEK for use in combination with
pegylated-interferon and ribavirin in August 2011 for adults with
genotype 1 chronic hepatitis C who have not received previous treatment
or who failed a prior course of treatment with an interferon-based
regimen. Vertex received a positive recommendation and criteria to list
INCIVEK for reimbursement in February 2012 through Priority Review
granted by the Common Drug Review (CDR). The approval was based on data
from Phase 3 studies that showed significant improvements in rates of
virologic cure among people with hepatitis C who were treated with
INCIVEK combination therapy compared to pegylated-interferon and
ribavirin alone, regardless of their prior treatment experience:
People new to treatment: 79 per cent vs. 46 per cent
People who did not achieve a viral cure with previous treatment:
Relapsers: 86 per cent vs. 22 per cent
Partial responders: 59 per cent vs. 15 per cent
Null responders: 32 per cent vs. 5 per cent
Rash and anemia are the most serious side effects associated with
INCIVEK. The most common side effects reported with INCIVEK combination
treatment include fatigue, itching, nausea, diarrhea, vomiting, anal or
rectal problems, and taste changes.
"Direct-acting antivirals represent a major step forward in the
treatment of hepatitis C," said Dr. Morris Sherman, Chairman of the
Canadian Liver Foundation. "In order for this new class of medicines to
make a significant impact however, they need to be accessible to all
patients regardless of where they live, financial status or severity of
their disease. The CLF has argued that to effectively treat hepatitis C,
the medical community must have access to the most effective therapies
in order to best meet the needs of their patients. We applaud
Saskatchewan and Quebec for prioritizing the needs of hepatitis
C patients and providing access to this new treatment option."
Eligibility criteria for treatment with INCIVEK in Quebec can be viewed
online at: https://www.prod.ramq.gouv.qc.ca/DPI/PO/Commun/PDF/Liste_Med/Liste_Med/liste_med_2012_04_20_en.pdf
Eligibility criteria for treatment with INCIVEK in Saskatchewan under
the Exception Drug Status program are available at: http://formulary.drugplan.health.gov.sk.ca/FormularyBulletins/Bulletin133Apr2012.pdf.
In addition, INCIVEK is currently accessible to Canadians through most
private health insurers. Vertex has implemented a comprehensive patient
support program called INCIVEK Care™ that is designed to coordinate
reimbursement, provide financial assistance for costs associated with
INCIVEK for people who meet certain program criteria and provide other
support services related to treatment with INCIVEK.
About Hepatitis C
Hepatitis C is a serious liver disease caused by the hepatitis C virus,
which is spread through direct contact with the blood of infected people
and ultimately affects the liver.1 Chronic hepatitis C can
lead to serious and life-threatening liver problems, including liver
damage, cirrhosis, liver failure or liver cancer.1 Though
many people with hepatitis C may not experience symptoms, others may
have symptoms such as fatigue, fever, jaundice and abdominal pain.1
Unlike HIV and hepatitis B virus, chronic hepatitis C can be cured.2
However, approximately 60 per cent of people do not achieve SVR,3,4,5
or viral cure,6 after treatment with 48 weeks of
pegylated-interferon and ribavirin alone. If treatment is not successful
and a person does not achieve a viral cure, they remain at an increased
risk for progressive liver disease.7,8
More than 170 million people worldwide are chronically infected with
Hepatitis C in Canada
Approximately 250,000 people in Canada have chronic hepatitis C and more
than a third of them do not know they are infected. 9 Quebec
accounts for 16 per cent of hepatitis C infections in Canada, and 32,000
cases have been reported in Quebec since 1991.10,11 In 2009,
11,357 cases of hepatitis C were reported in Canada, and of that, 1,793
cases were reported in Quebec.9,11 In 2010, the annual cost
of hepatitis C due to medical treatment and lost productivity in Canada
was estimated to reach $1 billion.12 By 2022, the number of
hepatitis C-related deaths is expected to increase by one-third.13
Vertex creates new possibilities in medicine. Our team discovers,
develops and commercializes innovative therapies so people with serious
diseases can lead better lives.
Vertex scientists and our collaborators are working on new medicines to
cure or significantly advance the treatment of hepatitis C, cystic
fibrosis, rheumatoid arthritis, epilepsy and other life-threatening
Founded more than 20 years ago in Cambridge, MA, we now have ongoing
worldwide research programs and sites in the U.S., U.K. and Canada.
Today, Vertex has more than 2,000 employees around the world, and Science
magazine named Vertex number one on its 2011 list of Top Employers in
the life sciences.
Vertex's press releases are available at www.vrtx.com.
About Vertex in Canada
In 2009, Vertex established a research and development site in Laval,
Quebec through the acquisition of Virochem Pharma, Inc. Vertex employs
approximately 50 researchers and support staff in Laval. For more
information on Vertex, including career opportunities with Vertex
Canada, and to view Vertex's press releases, please visit the company's
corporate website at www.vrtx.com.
(VRTX - GEN)
1 Canadian Liver Foundation. Viral Hepatitis: What You Need
to Know. Available at: http://www.liver.ca/hepatitis/hepatitis-c.aspx.
Accessed April 20, 2012.
2 Pearlman BL and Traub N. Sustained Virologic Response to
Antiviral Therapy for Chronic Hepatitis C Virus Infection: A Cure and So
Much More. Clin Infect Dis. 2011 Apr;52(7):889-900.
3 Manns MP, McHutchison JG, Gordon SC, et al. Peginterferon
alfa-2b plus ribavirin compared with interferon alfa-2b plus ribavirin
for initial treatment of chronic hepatitis C: a randomised trial. Lancet.
4 Fried MW, Shiffman ML, Reddy KR, et al. Peginterferon
alfa-2a plus ribavirin for chronic hepatitis C virus infection. N
Engl J Med. 2002;347:975-982.
5 McHutchison JG, Lawitz EJ, Shiffman ML, et al; IDEAL Study
Team. Peginterferon alfa-2b or alfa-2a with ribavirin for treatment of
hepatitis C infection. N Engl J Med. 2009;361:580-593.
6 Ghany MG, Strader DB, Thomas DL, Seeff, LB. Diagnosis,
management and treatment of hepatitis C; An update. Hepatology.
7 Morgan TR, Ghany MG, Kim HY, Snow KK, Lindsay K, Lok AS.
Outcome of sustained virological responders and non-responders in the
Hepatitis C Antiviral Long-Term Treatment Against Cirrhosis (HALT-C)
trial. Hepatology. 2008;50(Suppl 4):357A (Abstract 115).
8 Veldt BJ, Heathcote J, Wedmeyer H. Sustained virologic
response and clinical outcomes in patients with chronic hepatitis C and
advanced fibrosis. Annals of Internal Medicine. 2007; 147: 677-684.
9 Public Health Agency of Canada. Hepatitis C: Get the facts.
You could have it and not know it. http://www.phac-aspc.gc.ca/hepc/pubs/getfacts-informezvous/index-eng.php.
Updated September 21, 2010. Accessed March 21, 2012.
10 Public Health Agency of Canada. Modeling the incidence of
prevalence of hepatitis C infection and its sequelae in Canada, 2007. http://www.phac-aspc.gc.ca/sti-its-surv-epi/model/results-eng.php.
Updated October 20, 2010. Accessed March 21, 2012.
11 Sante et Services sociaux Quebec. Hepatitis C Virus. http://itss.gouv.qc.ca/?lg=en#/itss/hepatite_c.
Accessed March 21, 2012.
12 Public Health Agency of Canada. A renewed public health
response to address hepatitis C: A summary report of the
priority-setting process and strategic framework to action. http://dsp-psd.pwgsc.gc.ca/collection_2010/aspc-phac/HP40-44-2009-eng.pdf.
Updated June 2009. Accessed March 21, 2012.
13 Sherman M, Sharfran S, Burak K, et al. Management of
chronic hepatitis C consensus guidelines. Can J Gastroenterol.
2007;21 (Suppl C):25C-34C.
Vertex Pharmaceuticals Incorporated
French-speaking press, please contact:
Morin Relations Publiques
Ross, 514-289-8688, poste 236
Source: Vertex Pharmaceuticals Incorporated
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