- Alberta, Saskatchewan and the Non-Insured Health
Benefits (NIHB) Program list MAVIRET on their formularies
- MAVIRET is the first and only 8-week, pan-genotypic
treatment for chronic hepatitis C patients without cirrhosis and
who are new to treatment*1
- MAVIRET is the only pan-genotypic treatment approved for use
in patients across all stages of chronic kidney disease
MONTREAL, April 4, 2019 /CNW/ - AbbVie (NYSE: ABBV), a
global, research and development-based biopharmaceutical
company, announced that MAVIRET™ (glecaprevir/pibrentasvir tablets)
is now reimbursed in Alberta,
Saskatchewan and the Non-Insured
Health Benefits (NIHB) Program. MAVIRET is a once-daily,
ribavirin-free treatment for adults with chronic hepatitis C virus
(HCV) infection across all major genotypes (GT1-6).2 It
is the only 8-week, pan-genotypic treatment for patients without
cirrhosis and who are new to treatment.*
"Hepatitis C is a public health issue that affects approximately
300,000 Canadians. Over time, chronic hepatitis C can lead to
cirrhosis, liver cancer and death," explains Dr. Samuel S. Lee, MD, Professor of Medicine and
hepatologist at the University of
Calgary. "In order to reach the elimination target set by
the World Health Organization, we not only need concerted efforts
by governments, health care professionals and patient associations,
but as well access to curative treatments like MAVIRET."
In Alberta, MAVIRET is listed
effective April 1, 2019, under
Special Authorization on the AB Health Drug Benefit List for
treatment-naïve or treatment-experienced adult patients with
chronic hepatitis C infection who meet all of the following
criteria3:
- Prescribed by or in consultation with a hepatologist,
gastroenterologist or infectious disease specialist (except on a
case-by-case basis, in geographic areas where access to these
specialties is not available); AND
- Laboratory confirmed hepatitis C genotype 1, 2, 3, 4, 5, 6;
AND
- Laboratory confirmed quantitative HCV RNA value within the last
6 months; AND
- Fibrosis stage of F0 or greater (Metavir scale or
equivalent).
"Saskatchewan remains in the
midst of a unique hepatitis C (HCV) epidemic, with many more young
persons and women infected compared to the rest of Canada. Increased screening and testing is
needed as many persons remain undiagnosed, and enhanced
supports are required to link those diagnosed to treatment and
care," said Dr. Alexander Wong, MD,
FRCPC, assistant professor of Infectious Diseases, University of Saskatchewan. "Having a new treatment
option like MAVIRET, which can cure nearly all uncomplicated
HCV-infected persons in only eight weeks, is a welcome and exciting
addition to the drug formulary in Saskatchewan."
In Saskatchewan, MAVIRET is
listed effective April 1, 2019, on
the Saskatchewan formulary as an
Exception Drug Status (EDS) product, for treatment naïve and
treatment experienced adult patients with chronic hepatitis C
infection (regardless of fibrosis stage) according to the following
criteria4:
- Laboratory confirmed hepatitis C genotype 1, 2, 3, 4, 5 or 6;
AND
- Laboratory confirmed quantitative HCV RNA value within the last
six months; AND
- Treatment is prescribed by a hepatologist, gastroenterologist
or an infectious disease specialist or other prescriber experienced
in the treatment of hepatitis C as determined by the Drug
Plan.
For the Non-Insured Health Benefits program (NIHB), MAVIRET is
listed effective April 1, 2019, under
Limited Use on the NIHB Drug Benefit List for treatment-naïve or
treatment-experienced adult patients with chronic hepatitis C
infection who meet all of the following criteria:
- Prescribed by or in consultation with a hepatologist,
gastroenterologist or infectious disease specialist (except on a
case-by-case basis, in geographic areas where access to these
specialties is not available); AND
- Laboratory confirmed hepatitis C genotype 1, 2, 3, 5, 6;
AND
- Laboratory confirmed quantitative HCV RNA value within the last
6 months; AND
- Fibrosis stage of F0 or greater (Metavir scale or
equivalent).
The efficacy and safety of MAVIRET was evaluated in nine Phase
2-3 clinical trials, in over 2,300 patients with genotype 1, 2, 3,
4, 5 or 6 HCV infection and with compensated liver disease (with or
without cirrhosis).
About MAVIRET™
MAVIRET™ is indicated in Canada for the treatment of chronic hepatitis
C virus (HCV) infection in adults across all major genotypes
(GT1-6).5 MAVIRET is a pan-genotypic, once-daily,
ribavirin-free treatment that combines glecaprevir (100 mg), an
NS3/4A protease inhibitor, and pibrentasvir (40 mg), an NS5A
inhibitor, dosed once-daily as three oral tablets.5
MAVIRET is an 8-week, pan-genotypic virologic cure**
for use in patients without cirrhosis and who are new to
treatment,*1 such patients comprising the majority of
people living with HCV. MAVIRET is also approved as a treatment for
patients with specific treatment challenges, including those with
compensated cirrhosis across all major genotypes, and those who
previously had limited treatment options, such as patients with
severe chronic kidney disease (CKD), post-liver and -renal
transplant recipients *** and those patients with genotype 3
infection.5 It is the only pan-genotypic treatment
approved for use in patients across all stages of
CKD.5
Glecaprevir (GLE) was discovered during the ongoing
collaboration between AbbVie and Enanta Pharmaceuticals (NASDAQ:
ENTA) for HCV protease inhibitors and regimens that include
protease inhibitors.
*Patients without
cirrhosis and new to treatment with DAAs [either treatment-naive or
not cured with previous IFN-based treatments ([peg]IFN +/- RBV or
SOF/RBV +/- pegIFN)].
|
**Patients who
achieve a sustained virologic response at 12 weeks post treatment
(SVR12) are considered cured of hepatitis
C.
|
***MAVIRET is
recommended for 12 weeks in liver or kidney transplant recipients
who are HCV GT-1 to 6 treatment-naïve (TN) or GT-1, -2, -4, -5, -6
PRS- treatment experienced. A 16-week treatment duration should be
considered in transplant patients who are GT-1 NS5A inhibitor
experienced (NS3/4A inhibitor-naïve) or GT-3 PRS- treatment
experienced.
|
About AbbVie
AbbVie is a global, research and
development-based biopharmaceutical company committed to
developing innovative advanced therapies for some of the world's
most complex and critical conditions. The company's mission is to
use its expertise, dedicated people and unique approach to
innovation to markedly improve treatments across four primary
therapeutic areas: immunology, oncology, virology and neuroscience.
In more than 75 countries, AbbVie employees are working every day
to advance health solutions for people around the world. For more
information about AbbVie, please visit us
at www.abbvie.ca and www.abbvie.com. Follow
@abbvieCanada and @abbvie on Twitter or view careers on
our Facebook or LinkedIn page.
1 Decisions Resources Group.
Hepatitis C virus: disease landscape & forecast 2016. January
2017.
|
2 CADTH Canadian Drug Expert
Committee Recommendation – Final:
https://www.cadth.ca/sites/default/files/cdr/complete/SR0523_Maviret_complete-Jan-25-18.pdf.
Accessed April 2019.
|
3 Alberta
Health.
https://idbl.ab.bluecross.ca/idbl/lookupCoverageCriteria.do?productID=0000084466&priceListID=0013.
Accessed April 2019.
|
4 Government of Saskatchewan.
Saskatchewan Drug Plan.
http://formulary.drugplan.ehealthsask.ca/PDFs/APPENDIXA.pdf.
Accessed April 2019.
|
5 MAVIRET
(glecaprevir/pibrentasvir tablets) Product Monograph. Date of
Preparation: August 16, 2017. Date of Revision: November 28, 2018.
http://www.abbvie.ca/content/dam/abbviecorp/ca/en/docs/MAVIRET_PM_EN.pdf.
Accessed April 2019.
|
SOURCE AbbVie