Rate/100,000 population of acute & indeterminate* hepatitis B

Rate/100,000 population of acute & indeterminate* hepatitis B

Liver Disease in Canada: A Crisis in the Making An Assessment of Liver Disease in Canada Summary of a report prepared by the Canadian Liver Foundation, March 2013 HEPATITIS B Hepatitis B 2 Incidence of acute hepatitis B is declining Acute hepatitis B infection rate over time eterminate cases are cases in which neither acute hepatitis B nor chronic hepatitis B could be determined with certainty. This may have been to confusing serological tests or to inadequate follow-up. http://www.phac-aspc.gc.ca/id-mi/hepatitisBCan-hepatiteBCan-eng.php

Vaccinated age groups show the greatest decline in acute hepatitis B Acute hepatitis B infection rate by time and by age group determinate cases are cases in which neither acute hepatitis B nor chronic hepatitis B could be determined with certainty. This may have been e to confusing serological tests or to inadequate follow-up. http://www.phac-aspc.gc.ca/id-mi/hepatitisBCan-hepatiteBCan-eng.php Prevalence of chronic hepatitis B in Canadian immigrants Leber et al. The prevalence of hepatitis B in Canada. Submitted manuscript Distribution of chronic hepatitis B in the top 7 provinces Ontario Atlantic Canada Quebec Manitoba Saskatchewan

Alberta British Columbia Leber et al. The prevalence of hepatitis B in Canada. Submitted manuscript Predicted number of hepatitis Binfected persons in Canada to 2020 Leber et al. The prevalence of hepatitis B in Canada. Submitted manuscript Mortality and morbidity of hepatitis B compared to HIV/AIDS Years of life lost Health-adjusted years of life lost Kwong et al. Ontario Burden of Infectious Disease Study 2010 http://www.ices.on.ca/file/ONBOIDS_FullReport_intra.pdf Differences in time of licensing drugs

for hepatitis B in Canada versus US/EU Total time differenc e Lamivudine Adefovir Entecavir Telbivudin e Tenofovi r PegIFN alfa

Versus USA 21 days after 341 days after 444 days after 34 days after 508 days after 301 days

after Versus EU 244 days before 174 days after 10 days before 147 days before 406 days after

433 days after Information provided by Gilead Sciences Canada Inc. Time in review by the common drug review Drug Time in review (months) Adefovir 18 Entecavir 11 Telbivudine

6 (not approved) Tenofovir 6 Reimbursement policies for hepatitis B drugs CDEC Lamivudine Adefovir Entecavir* Telbivudin e Tenofovir

Standard IFN No recommendation: (licensed before CDEC was established) With LAM after development of LAM resistance Recommende d only for patients with cirrhosis Not to be listed

Recommended No recommendation: only for patients with (licensed before CDEC was established) cirrhosis BC PegIFN ALT and viral load LAM failure As per CDEC Not listed As per CDEC 24 wks renewable requirement x 1 if responding Restricted to internal medicine specialists and designated prescribers (except standard IFN, not listed) AB

Not listed SK Special application As per CDEC As per CDEC Not listed As per CDEC 6 months only 48 wks only

MB No restriction As per CDEC with exceptions As per CDEC with exceptions Not listed As per CDEC with exceptions Not listed Not listed

ON F3 or cirrhosis and age >40 yrs QC No restrictions NB Elevated ALT (no restrictions for specialists) LAM resistance As per CDEC

Not listed As per CDEC Not listed LAM resistance only NS Specialist application Usual clinical restrictions only As per CDEC

Not listed As per CDEC Specialist application 24 wks renewable x1 PEI** No info available LAM failure Cirrhosis only and F3 or (includes cirrhosis only

LAM Usual clinical restrictions only resistance) No info. available Naive: 24 wks (eAg+); cirrhosis only; 48 wks (antiHBe+); LAM No cirrhosis Usual clinical restrictions only resistance: F3 and cirrhosis Not listed Not listed

CDEC = Canadian Drug Expert Committee NL Not listed As per CDEC Sources = CADTH, provincial formularies, Kelly Kaita (personal communication) As per CDEC As per CDEC As per CDEC No info. available *Ontario and other provinces allow entecavir to be used for LAM resistance despite all practice guidelines suggesting that entecavir is not appropriate for LAM resistance **Only 96 cases of hepatitis B reported in PEI. Treatment status not known

Hepatitis B vaccination policies by province Province Universal immunization schedule Other groups covered by provincial health ministries British Columbia Neonatal: age 2, 4, 6 months High risk Alberta Grade 5

High risk Saskatchewan Grade 6 High risk Manitoba Grade 4 High risk Ontario Grade 7 High risk Quebec

Grade 4 High risk New Brunswick Neonatal and under age 10 High risk Nova Scotia Grade 7 High risk Prince Edward Island Neonatal: age 2, 4, 15 months

HCV infection; frequent users of blood products Newfoundland Grade 6 High risk he recommended vaccination schedule is neonatal vaccination at birth, 4 weeks and 6 months of age. nly BC adheres fully to the recommended schedule. he definition of high-risk groups is not uniform across provinces. Sources = Provincial ministries of health (for details see full publication) Reported incidence of acute HBV infection in infants: Canada 1992-2007 Macki CO et al. CMAJ 2009; 180:196-202 HEPATITIS

C Cases of hepatitis C notified to Health Canada Source: Public Health Agency of Canada (for details see full publication) Modeled prevalence of hepatitis C in Canada by age cohort Source: Public Health Agency of Canada (for details see full publication) Provincial distribution of hepatitis C cases Source: Public Health Agency of Canada (for details see full publication) Incidence of acute hepatitis C

Source: Public Health Agency of Canada (for details see full publication) Modeled number of cases of acute hepatitis C by age Source: Public Health Agency of Canada (for details see full publication) Modeled incidence of hepatitis C-related deaths Source: Public Health Agency of Canada (for details see full publication) Impact of the top 20 pathogens in health-adjusted life years in Ontario Years of life lost Year equivalents of reduced functioning

Health-adjusted years of life lost Health outcomes for hepatitis C and HIV/AIDS in Ontario Years of life lost Health-adjusted years of life lost Source: Kwong et al. Ontario Burden of Infectious Disease Study 2010 http://www.ices.on.ca/file/ONBOIDS_FullReport_intra.pdf Reduction in hepatitis C-related deaths assuming increased treatment rates Davis GL, et al. Gastroenterology 2010; 138:513-21 Outcomes with universal vs riskbased HCV screening in the USA Source: McGarry et al. Hepatology 2012; 55:1344-55.

Proportions of the infected population unaware of their infected status (USA) Virus Unaware of infection status (% of population) Hepatitis B 65% Hepatitis C 75% Source: Hepatitis and Liver Cancer. Institute of Medicine. Washington. 2013 Reimbursement policies PegIFN alfa plus ribavirin

Boceprevir Telaprevir CDEC No restrictions Fibrosis stage F2 proven by liver biopsy BC ALT >1.5 x ULN Fibrosis stage F2 or elevated ALT* HIV co-infection by adjudication Fibrosis stage F2 AB

Recognized prescribers No fibrosis restrictions* Null responders, HIV co-infection No fibrosis restrictions SK No restrictions As per CDEC,* null responders As per CDEC MB No restrictions

Fibrosis stage F2** or elevated ALT, Null responders As per CDEC ON ALT >1.5 x ULN Fibrosis stage F2** HIV co-infection; Metavir score or equivalent Null responders only QC No restrictions

No restrictions* No restrictions* NB Internal medicine specialists Fibrosis stage F2;** specialist recommendation Null responders As per CDEC NS Hepatologists Fibrosis stage F2;** specialist recommendation

Null responders Fibrosis stage F2 PEI requirement Individual requests Not listed *No biopsy **Metavir score or equivalent in MB; by any method of fibrosis assessment in ON; biopsy or Fibroscan Internal Not listed whereNL available in NB, NS medicine specialists CDEC = Canadian Drug Expert Committee; ULN = upper limit of normal Not listed Not listed

Patients treated for hepatitis C by year in Canada Source: IMS Brogan Inc. Expenditures by the Health Canada on hepatitis C programs, 1999-2004 In addition to PHAC, some provincial governments also have established programs Source: Public Health Agency of Canada (for details see full publication) Provincial government responses to hepatitis C Department/ Division Activities Budget

BC BC Hepatitis Services Surveillance, laboratory and nursing services $1.36 M AB None Support for 3 comprehensive hepatitis C clinics Unknown SK None

None None MB No information provided Unknown Unknown ON Division of HIV/AIDS Disease prevention, community and nursing support

Unknown QC No information provided Unknown Unknown NB None None None NS

None Funding for an HCV clinic $210,000 PEI None None None NL Nurse practitioner support Prepare care plans

$100,000 ALCOHOLIC LIVER DISEASE Alcohol-attributable burden of disease, Canada 2004 Alcohol attributable disease or disorder Disease-adjusted life-years (in 1,000s) Neuropsychiatric disorders 26,682 Accidental injury 18,604

Intentional injury 7,660 Cirrhosis 6,945 Cardiovascular disease 6,924 Cancer 6,268 he West, 9.2% of all-cause disease-adjusted life-years (DALYs) were alcohol related (14.2% for men and 3.4% for women). Source: Norstrom T et al. Drug and Alcohol Review. 2005;24:537. Increase in alcohol consumption in

Canada and BC: 19962007 Source: Kendall PRW. Updated report from the provincial health officer. 2008 Death from alcoholic liver disease is increasing Deaths in Canada from alcoholic liver disease Source: Statistics Canada NON-ALCOHOLIC FATTY LIVER DISEASE Trends in obesity in Canada Obesity rates in Canada by year Source: Obesity_in_canada_2011_en.pdf Cases of diabetes by year Diabetes cases in Canada by year

Source: Statistics Canada CIRRHOSIS AND ITS COMPLICATIONS ICD codes* that are likely associated with death from cirrhosis Chronic viral hepatitis B18 Alcoholic liver disease K70 Chronic hepatitis K73 Fibrosis and cirrhosis of liver

K74 Hepatic fibrosis K74.0 Hepatic failure not specified K72 Primary biliary cirrhosis K74.3 Secondary biliary cirrhosis K74.4 Biliary cirrhosis, unspecified K74.5 Other and unspecified cirrhosis of liver

K74.6 Portal hypertension K76.6 Hepatorenal syndrome K76.7 *In STATSCAN databases Deaths from liver disease Deaths from liver disease by selected category and by year Source: Statistics Canada Death from liver disease is increasing in Canada Deaths from malignant and non-malignant liver disease

Source: Statistics Canada HEPATOCELLULAR CARCINOMA Hepatocellular carcinoma incidence is increasing in Canada Deaths from malignant liver disease by year Source: www.cancer.ca HCC incidence and mortality rates by province (2012) Source: www.cancer.ca Projected incidence of HCC to 2020 Source: Leber A, et al. Submitted manuscript

Projected HBV-related HCC mortality to 2020 Source: Leber A, et al. Submitted manuscript Modeled incidence of HCC related to hepatitis C Source: Public Health Agency of Canada Mortality from primary liver cancers Source: Statistics Canada Mortality from HCC corrected for unspecified liver cancer Source: Statistics Canada RESOURCES TO MANAGE

LIVER DISEASE IN CANADA Resources to manage liver disease Full-time hepatologis ts Liver transplantation program Dedicated hospital beds for liver disease Specialized liver pathology BC

2 1 0 No AB 20 1 SK 0 0 0

No MB 4 0 0 No ON 20 2 For transplant only, shared

2 QC 14 2 Shared, but easy access 2 NB 0 0 0 No

NS 2 1 ? No PEI 0 0 0 No NL

1 0 0 No Shared with GI and other services ces: Peltekian K, Ma M, Bain V, Lilly L, Kaita K, Witt-Sullivan H, Wong P, Willems B, Villeneuve J-P: personal communications No Gastroenterologists and infectious disease specialists in Canada Province Gastroenterologists/

hepatologists Infectious disease British Columbia 71 36 Alberta 94 54 Saskatchewan 10

10 Manitoba 15 18 Ontario 259 138 Quebec 133 59 8

5 16 10 Prince Edward Island 1 0 Newfoundland 9 3 Yukon

0 0 NWT/Nunavut 1 0 New Brunswick Nova Scotia Estimated number of physicians treating hepatitis B patients Province British Columbia All physicians treating HBV 105

Alberta 90 Saskatchewan 29 Manitoba 21 Ontario 253 Quebec 225 New Brunswick

21 Nova Scotia 20 Prince Edward Island ? Newfoundland 6 Yukon ? NWT/Nunavut

? Information provided by Gilead Sciences Canada Inc. Liver transplantation in Canada Source: Canadian Organ Replacement Registry. Annual reports 2010, 2011 COSTS OF LIVER DISEASE Hospitalizations for hepatitis Crelated conditions is are increasing Liver-related hospitalizations for HCV-related conditions in Calgary health Region by year Source: Myers RP, et al. Can J Gastroenterol 2008;22:381-7 The number of procedures in patients with liver disease is increasing Procedures in patients with liver disease by year Source: Federico CA, et al. Liv Int 2012;32:815-25.

Cancer treatment procedures in patients with liver disease Procedures in patients with liver cancer by year Source: Federico CA, et al. Liv Int 2012;32:815-25. In-hospital costs for procedures for liver disease patients 2006-2009 Diagnosis In-hospital costs ($) GI bleed 54,498,246 Liver transplant 28,521,333

Other major intervention 32,818,416 Cirrhosis/alcoholic hepatitis 31,000,037 Other liver disease (excluding malignancy) 10,266,708 Total Source: Canadian Institutes of Health Information. 2012. 157,104,740

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