HBV Disease Burden and Achieving the WHO Elimination Targets in New Zealand

October 6, 2017

2

Topics

• Base Assumptions

• Outputs» General Population

» 5-year old outputs and scenarios

» Treatment scenario and outputs

• Next Steps

3

HBVGeneral Population

• 5.7% of the population was HBsAg+ in 2001(Robinson 2005)» To report on screening coverage and the distribution of HBsAg (a marker of

chronic hepatitis B virus infection) among participants in the New Zealand Hepatitis B Screening Programme.

• 29% of the HBsAg+ WoCBA were HBeAg+» Applied a regional average from Australasia

» Percent of HBeAg+ with high viral load

90% (Wiseman 2009)

» Percent of HBeAg- with a high viral load

13% (Wiseman 2009)

Robinson T, Bullen C, Humphries W, et al., The New Zealand Hepatitis B Screening Programme: screening coverage and prevalence of chronic hepatitis B infection. The New Zealand Medical Journal 2005; 118(1211): 1-11Wiseman E, Fraser MA, Holden S, et al. Perinatal transmission of hepatitis B virus: an Australian experience. MJA. 2009 190(9): 489-92.

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HBVGeneral Population

Robinson T, Bullen C, Humphries W, et al., The New Zealand Hepatitis B Screening Programme: screening coverage and prevalence of chronic hepatitis B infection. The New Zealand Medical Journal 2005; 118(1211): 1-11

5

HBsAg+ Prevalence by Age

Robinson T, Bullen C, Humphries W, et al., The New Zealand Hepatitis B Screening Programme: screening coverage and prevalence of chronic hepatitis B infection. The New Zealand Medical Journal 2005; 118(1211): 1-11

• Robinson 2005

0.00%

1.00%

2.00%

3.00%

4.00%

5.00%

6.00%

7.00%

8.00%

HBsAg Prevalence by Sex & Age Cohort — 2001

Males Females Overall

6

HBVPercent of HBeAg+ and HBeAg- WoCBA with a High Viral Load

Wiseman E, Fraser MA, Holden S, et al. Perinatal transmission of hepatitis B virus: an Australian experience. MJA. 2009 190(9): 489-92.

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HBVPerinatal Transmission Prophylaxes

• In 2014, 93% coverage of three doses

• In 2014, BD was provided to infants of mother who are HBsAg+

• HBIG to all infants born to HBsAg+ mothers

» Currently, do infants receive BD and HBIG?

• All mothers with a HVL receive Tenofovir (all HBeAg+ are DNA tested and if >10log, then are treated)

0%10%20%30%40%50%60%70%80%90%

100%

General Population Prophylaxes Coverage

BD HepB3 (≥3 doses) % of BD Receiving HBIG

0%10%20%30%40%50%60%70%80%90%

100%

HBsAg+ Prophylaxes Coverage

BD HepB3 (≥3 doses) % of BD Receiving HBIG

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Diagnosis of the General Population

• In 2016, it is assumed that 50,000 individuals have been diagnosed with chronic hepatitis B – 25K in the NZHF and another 25K are diagnosed by GPs and are not reported (expert input)

• Based on data from 2016, 800 new cases are referred to NZHF per year but about 400 seroconvert per year. At the national level about an estimated 1,000 are newly diagnosed annually (expert input)

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• 3,416 patients currently on treatment (PHARMAC)

• What is the number of new patients put on treatment per year?

HBVTreatment in 2015

Input Value# of adults receiving treatment% treated with entecavir% treated with tenofovir% treated with adefovir% treated with lamivudine% treated with interferon

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Methodology to Estimate Liver Transplants Attributed to HBV

• Actual liver transplant data for 1997-2016 was available through ANZA Data.

• Assumed 32% of all transplants were due to HBV (Gane 2002)

Australia and New Zealand Organ Donation Registry Annual Report 2016Gane E, McCall J, Streat S, et al., Liver transplantation in New Zealand: the first four years. The New Zealand Medical Journal 2002; 115(1159):1-13

-

5

10

15

20

25

30

35

40

1997

1998

1999

2000

2001

2002

2003

2004

2005

2006

2007

2008

2009

2010

2011

2012

2013

2014

2015

Actual Transplants HBV-Related Transplants

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HDV

• 21.0% anti-HDV prevalence in HBsAg infected population (Gane 1998)» All patients treated for HBV-related conditions at Middlemore Hospital from

January 1995 to January 1997.

Gane E, Chronic hepatitis B virus infection in South Auckland. New Zealand Medical Journal 1998l; 120-123

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Topics

• Base Assumptions

• Outputs» General Population

» 5-year old outputs and scenarios

» Treatment scenario and outputs

• Next Steps

13

Cascade of Care in 2016

148,750

49,990

24,840

3,420 3,410

-

20,000

40,000

60,000

80,000

100,000

120,000

140,000

160,000

Infected Diagnosed Tx-Eligible & Dx Treated Tx Responders

New ly Infected - 120 New ly Dx Tx-Eligible & Dx Initiate TxPreviously Inf - Tx Ineligible - 97,510 1,000 21,490 70

Previously Inf - Tx Eligible - 51,120 Previously Dx Previously Tx Tx Responders48,990 3,350 3,410

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Outputs – General Population

3.3%3.3%

3.2%

3.1% 3.1%3.0%

2.9%2.9%

2.8%2.7%

2.7%2.6%

2.5%2.5%

2.4%

2.4%

-

20,000

40,000

60,000

80,000

100,000

120,000

140,000

160,000

HBsAg Prevalence

0.00%

1.00%

2.00%

3.00%

4.00%

5.00%

6.00%

7.00%

HBsAg Prevalence by Sex & Age Cohort — 2016

Males Females Overall

In 2016, it is estimated that the prevalence of chronic hepatitis B

in New Zealand is 3.3%, representing 148,750 chronic infections, dropping to 2.4%, 120,300 chronic infections by

2030

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Although total infections is expected to decrease, the number of liver related deaths & HCC is expected to increase

-

20,000

40,000

60,000

80,000

100,000

120,000

140,000

160,000

Total Infected

Base

-100 200 300 400 500 600 700 800 900

1,000

Annual Liver-Related Deaths

Base

-200 400 600 800

1,000 1,200 1,400 1,600 1,800 2,000

Total Infected — Decompensated Cirrhosis

Base

-

500

1,000

1,500

2,000

2,500

Total Infected — HCC

Base

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WHO Hepatitis Elimination Targets

WHO. Combating Hepatitis B and C to Reach Elimination by 2030. Geneva, Switzerland: WHO, 2016.

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To meet the WHO elimination targets, screening and treatment need to be expanded

• The number of newly diagnosed cases needs to increase from 1,000 cases today to 8,000 per year in 2025

• The number of diagnosed high viral load and cirrhotic patients that are on treatment needs to increase from 3,400 to 37,000

• The anti-virals are going generic and the price is expected to drop over 90% in the next two years.

The Global Health Sector Strategy for Viral Hepatitis (GHSSVH) at The World Health Assembly, May 2016

2016 2018 2020 2021 2022 2025

Newly Diagnosed 1,000 2,000 3,000 5,000 7,000 8,000

Treated 3,420 6,800 13,600 20,000 30,000 37,000

Treated Age 15-85 15-85 15-85 15-85 15-85 15-85

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With current treatment, the total number of infections will remain constant, but HBV related morbidity & mortality will decline by 40-75%

-

20,000

40,000

60,000

80,000

100,000

120,000

140,000

160,000

Total Infected

Base WHO Targets

-100 200 300 400 500 600 700 800 900

1,000

Annual Liver-Related Deaths

Base WHO Targets

-200 400 600 800

1,000 1,200 1,400 1,600 1,800 2,000

Total Infected — Decompensated Cirrhosis

Base WHO Targets

-

500

1,000

1,500

2,000

2,500

Total Infected — HCC

Base WHO Targets

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New Zealand is already on track to meet the vaccination targets as the result of its current perinatal prophylaxes coverage

• In the base scenario, HBsAg+ prevalence among 5-year olds will reach ~0.02% in 2030 (below WHO and regional targets)

• With expanded screening & treatment, viral load among pregnant women will drop. leading to a further decrease in mother to child transmission

The Global Health Sector Strategy for Viral Hepatitis (GHSSVH) at The World Health Assembly, May 2016

0.00%

0.02%

0.04%

0.06%

0.08%

0.10%

0.12%

0.14%

HBsAg Prevalence Among 5-Year Olds

WHO Target Base Case

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Anti-HCV RNACost Per Test $15 $325

30.0% 0.20% $7,576 $5,417

20.0% Already Dxed3.3

70.0% 0.46%

3.3% DNA/Viral Load Screening Cost/ Newly Dxed16.7 Status Quo $12,992

80.0% 2.64%

HBsAg+505

96.7% 96.7%No

Yes

No

Yes

No

Yes

The average cost to find one undiagnosed high viral load patient is estimated at $13,000 in the general population

HBsAgprevalence in

NZ

Est. % with a high viral load

% diagnosed in NZ

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The cost finding a new case drops to $8,000 if screening is conducted in high prevalence populations

Anti-HCV RNACost Per Test $15 $325

30.0% 0.60% $2,500 $5,417

20.0% Already Dxed3.3

70.0% 1.40%

10.0% DNA/Viral Load Screening Cost/ Newly Dxed16.7 Status Quo $12,992

80.0% 8.00% SQ High Risk $7,917

HBsAg+167

90.0% 90.0%

Yes

Yes

No

Yes

No

No

HBsAgprevalence is

assumed to be higher

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Under the WHO elimination scenario, by 2025 the % of the population already diagnosed will increase as result of expanded screening

Anti-HCV RNACost Per Test $15 $325

15.0% 0.099% $15,152 $10,833

20.0% Already Dxed6.7

85.0% 0.56%

3.3% DNA/Viral Load Screening Cost/ Newly Dxed33 Status Quo $12,992

80.0% 2.64% SQ High Risk $7,917Status Quo 2025 $25,985

HBsAg+1,010

96.7% 96.7%

Yes

Yes

No

Yes

No

No

HBsAgprevalence in

NZ

% undiagnosed

The cost of finding one new undiagnosed case will increase to

$26,000 per case

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A surveillance system will assure that most of the newly diagnosed cases have not been tested before, which will reduce the cost/case

Anti-HCV RNACost Per Test $15 $325

100.0% 0.66% $2,273 $1,625

20.0% Already Dxed1.0

0.0% 0.0%

3.3% DNA/Viral Load Screening Cost/ Newly Dxed5.0 Status Quo $12,992

80.0% 2.64% SQ High Risk $7,917Status Quo 2025 $25,985

HBsAg+ SQ 2025 w Surveillance $3,898151.5

96.7% 96.7%

Yes

Yes

No

Yes

No

No

% undiagnosed

A national surveillance program will assure that new testing is conducted among the undiagnosed

individuals

Similar economic analyses can be used to negotiate diagnostic prices

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Topics

• Base Assumptions

• Outputs» General Population

» 5-year old outputs and scenarios

» Treatment scenario and outputs

• Next Steps

25

Next Steps