1

Treatment uptake for chronic hepatitis C

in Australia following availability of

interferon-free treatment

Behzad Hajari, Jason Grebely, Gail V Matthews, Marianne

Martinello, Gregory J Dore

The Kirby Institute, UNSW Australia, Sydney, Australia

2

The Kirby Institute. Hepatitis B and C in Australia Annual Surveillance Report Supplement 2016.

Background: HCV care cascade

2

227,310 186,760 50,170 32,1400

20,000

40,000

60,000

80,000

100,000

120,000

140,000

160,000

180,000

200,000

220,000

240,000

Living withchronic HCV

Diagnosed livingwith chronic HCV

Ever receivedHCV treatment

HCV cured

82%

22%

14%

3

Background: PBS listing of DAAs

3

• In March 2016, interferon-free direct-acting antiviral (DAA)

regimens for HCV infection were listed on the Pharmaceutical

Benefits Scheme (PBS)

• No liver disease stage or drug and alcohol restrictions

Generic name Commercial name Genotype Duration

Sofosbuvir/Ledipasvir Harvoni® GT1 8-24 wks

Sofosbuvir/Daclatasvir Sovaldi®/Daklinza® GT1, 3 12-24 wks

Sofosbuvir/Ribavirin Sovaldi®/Ibavyr® GT2 12 wks

Sofosbuvir/Pegylated interferon-

alfa-2a/Ribavirin

Sovaldi®/Pegasys RBV® GT1, 3, 4-6 12 wks

Paritaprevir/Ritonavir/Ombitasvir/

Dasabuvir +/- Ribavirin

Viekira PAK®

[in May 2016]

GT1 12-24 wks

4

Objectives

4

During March to July 2016:

• To estimate the number of individuals initiating DAA treatment, by

month and jurisdiction

• To estimate the proportion of individuals living with chronic HCV

who initiated DAA treatment, by jurisdiction

• To assess the number of PBS reimbursement-based DAA

prescriptions, by jurisdiction, regimen, and PBS schedule.

5

Methodology

5

Data sources:

• PBS monthly reports of DAA prescriptions processed for

reimbursemento Pharmacies submit prescriptions for reimbursement 2-12 weeks after

dispensing.

o PBS reports of the number of prescriptions are subject to a time lag

between drug dispensing and reimbursement submissions.

• DAA wholesale and expenditure datao DAA sales during March to July 2016

o Medicare expenditure for PBS reimbursement in the same period

o The proportion of wholesale to Medicare expenditure at the same period

was used as an adjustment factor

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Methodology

6

• The wholesale price expenditure on DAA drugs during March to

July was at 1.30 times wholesale price equivalent for PBS

reimbursements reported for the same period.

• An adjustment factor of 1.3 (uncertainty range: 1.1-1.5) was

used to estimate the number of individuals initiated on HCV

treatment in this period.

• July PBS data was used as the core data, considering the

following assumptions and adjustments:o All individuals prescribed 24 weeks DAA, continued treatment up to July.

o The number of individuals prescribed 8 and 12 weeks DAA and completed

the treatment before July was added.

o 5% drop-out for those initially authorised for 12 weeks treatment with

sofosbuvir/ledipasvir but stopped treatment after 8 weeks due to the

clinician’s decision after re-evaluating the patient’s situation.

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Results: DAA treatment: March-July 2016

7

• Number of patient

DAA prescriptions

submitted to PBS:

18,581

• Estimated number

of individuals

initiating DAA:

26,360(range: 22,304 – 30,415)

7,240

14,630

17,880

22,470

26,360

8

Results: DAA treatment by jurisdiction, March-July 2016

8

% of individuals

with HCV,

receiving DAA

9

Results: DAA treatment by jurisdiction, March-July 2016

9

% of individuals

with HCV,

receiving DAA

Australia: 12% (uncertainty range: 10 – 13%)

10

Results: DAA treatment by scheme, March-July 2016

10

11

Results: DAA treatment by regimen, March-July 2016

11

SOF: Sofosbuvir; LDV: Ledipasvir; DCV: Daclatasvir; RBV: Ribavirin;

PrOD: Parataprevir/ritonavir/Ombitasvir/Dasabuvie

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Results: DAA treatment by duration, March-July 2016

12

11%

74%

15%

GT 1,

prior treatment,

cirrhosis

60%

40%

GT 3,

cirrhosis

13

Hajarizadeh B, et al. J Gastroenterol Hepatol 2016 [updated]

Discussion

13

0

5000

10000

15000

20000

25000

30000

1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016(March-July)

IFN-based IFN-free33,690

33,590

Number of individuals initiating HCV treatment in Australia, 1997-2016

14

Discussion

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0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

F0-F3(n=207,123)

F4(n=20,183)

Not-treated

PBS(March-July 2016)

Generic(2015)

Clinical Tials(2014-15)

Early access program(2014-15)

DAA treatment in 2014-16 by liver fibrosis stage

15

Results: DAA treatment in 2014-16 by liver fibrosis stage

15

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

F0-F3(n=207,123)

F4(n=20,183)

Total n = 13,540 (67%)

Total n = 19,795 (10%)

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Conclusion

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• Substantial treatment uptake was observed during the first five months

of DAA therapy in Australia, equating to 12% of total individuals living

with chronic HCV.

• A high proportion of people with cirrhosis (67%) received DAA therapy

during the last three years.

• The current estimate of treatment uptake is a minimum estimate due to

possible delay in submit prescriptions to PBS.

• Ongoing monitoring of the treatment uptake is required

• More detailed analysis of the treatment scale-up, including assessment

of treatment by geography, patient demographics and prescriber type

are required.

• http://kirby.unsw.edu.au/research-programs/vhcrp-newsletters

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Acknowledgements

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The Kirby Institute, UNSW Australia:

• Dr Skye McGregor,

• Dr Richard Gray

• A/Professor Rebecca Guy

Center for Disease Analysis, USA:

• Dr Homie Razavi

Funding:

• The Kirby Institute is funded by the Australian Government

Department of Health.

• This study is funded by:

o NSW Ministry of Health through the Blood-borne viruses and

sexually transmissible infections Research, Strategic

Interventions and Evaluation (BRISE) program

o National Health and Medical Research Council of Australia