Market access and uptake of new antiviral drugs for the
treatment of hepatitis
Homie Razavi – Center for Disease Analysis
November 14, 2013
Viral Hepatitis Prevention Board Meeting, Croatia
The new therpies & diagnostics have the potential to
completely change the HCV treatment paradigm in 2014-2017
Therapies
Point of Care New Diagnostics
» simeprevir (TMC-435)
» Immunoassays – MBio
» sofosbuvir (GS-7977)
» Qualitative RNA tests – Daktari,
Mbio, Wave 80
» ABT-333/ ABT-450/r/ ABT-267
» faldaprevir (BI-201335)
» daclatasvir (BMS-790052)
• Higher cure rates
» Quantative RNA tests – Alere,
Daktari, Iquuam, Wave 80
» Genotyping – Celera, Wave 80,
Cepheid
• Shorter duration of treatment
• Testing done in the field of office
• Fewer side effects
• Rapid results
• All oral therapies
• Potential for lower cost
Source: UNTAID Hepatitis C Medicines and Diagnostics in the Context of HIV/HCV Co-Infection: A Scoping Report
2
Even before the launch of the protease inhibitors, there was
considerable variability in the number of treated HCV patients
2004
2010
Annual Number of Treated Patients
25,000
20,000
15,000
10,000
-43%
-12%
-11%
6%
193%
726%
157%
5,000
64%
-5%
41%
33%
125% 37%
-13%
65%
16%
6%
453%
120%
13%
195%
57%
0
The number of treated patients declined in 2013 across most countries in anticipation
of new therapies.
Source: CDA’s analysis of Peg-IFN sales data in each country. Presented at EASL 2012.
3
HCV treatment rate has historically been low due to its low
priority, efficacy, side-effects of current therapies
8.0%
7.2%
On average, only 50%
of the treated patients
were cured.
7.0%
Treatment Rate
6.0%
5.0%
4.0%
3.0%
4.4%
3.4%
3.5%
3.0%
3.0%
2.6%
2.9%
2.2%
2.3%
2.0%
1.5%
2.1%
1.3%
1.5%
1.1%
1.1%
1.0%
1.0%
1.0%
Median
0.7%
0.3%
0.7%
0.5%
0.0%
Source: CDA’s analysis of Peg-IFN sales data in each country & prevalence of HCV by country. Presented at EASL 2012. 4
However, the HCV infected patients are aging and progression
to late stage liver diseases
The number of HCV related cirrhotic cases will increase by 20%,
decompensated cirrhosis by 30%, HCC by 40%, and liver related deaths by 40%.
HCV Related Decomp Cirrhosis,
HCC, & Liver Related Deaths
HCV Related Cirrhotic Cases
70,000
HCV Infected Population (Viremic)
HCV Infected Population (Viremic)
540,000
520,000
500,000
480,000
460,000
440,000
420,000
400,000
60,000
50,000
40,000
30,000
20,000
10,000
-
Cirrhotics
Decomp Cirrhotics
HCC
Liver Related Deaths
5
A patient with fibrosis will cost the healthcare system $200-700
annually
Chronics Hepatitis C
$2,000
'07
$1,800
$1,400
'03
$1,200
'98
$1,000
$800
'96
Americas
Asia Pacific
'03
'00
UK
France
Belgium
Taiwan
New Zealand
Japan
Australia
Canada
Brazil
$0
'98
'07
Switzerland
'06
'07
'98
'00
'02
'02'02
'05
'05
'05
'05
'96
'03
'00
Sweden
'05
'98
'03
Spain
'06
$200
'05
'05
'03
'01
Portugal
'96
$400
Italy
'05
'05
Netherlands
'06
$600
Germany
Cost (US dollars adjusted to 2010)
$1,600
Europe
Source: El Khoury AC, Wallace C, Klimack WK, Razavi H. Economic burden of hepatitis C-associated
diseases: Europe, Asia Pacific, and the Americas. J Med Econ 2012 Mar 30;15(5):887-96.
6
A patient with compensated cirrhosis will cost the healthcare
system $500-$2,000 annually
Compensated Cirrhosis
$3,500
'07
$2,500
'98
'03
'06
$2,000
'99
'99
'03
'05
'05
'96
'99
'99
$1,500
'03
'99
'06
'05
'03
'96
'06
'94
'05
$500
'99
'05
'02
'96
'07
'05
'98
'02
Asia Pacific
Sweden
Spain
Portugal
Netherlands
Italy
Germany
France
New Zealand
Japan
Australia
Canada
Brazil
Americas
Belgium
'00
$0
'00
'98
'00
'05
'00
UK
'01
Switzerland
$1,000
Taiwan
Cost (US dollars adjusted to 2010)
$3,000
Europe
Source: El Khoury AC, Wallace C, Klimack WK, Razavi H. Economic burden of hepatitis C-associated
diseases: Europe, Asia Pacific, and the Americas. J Med Econ 2012 Mar 30;15(5):887-96.
7
A patient with compensated cirrhosis will cost the healthcare
system $5,000-$20,000 annually
Decompensated Cirrhosis
$60,000
Cost (US dollars adjusted to 2010)
$50,000
'06
$40,000
$30,000
'06
'07
'98
$20,000
'96
'06
$10,000
'03
'99
'96
'02
'08
'02
'00
Americas
Asia Pacific
UK
Switzerland
Sweden
Spain
Portugal
Netherlands
Italy
Germany
France
Belgium
Taiwan
New Zealand
Japan
Australia
Canada
Brazil
$0
Europe
Source: El Khoury AC, Wallace C, Klimack WK, Razavi H. Economic burden of hepatitis C-associated
diseases: Europe, Asia Pacific, and the Americas. J Med Econ 2012 Mar 30;15(5):887-96.
8
A patient with HCC will cost the healthcare system $5,000$25,000 annually
Hepatocellular Carcinoma
$90,000
'06
$70,000
$60,000
'05
$50,000
'06
Asia Pacific
'98
'03
'99
'98
'99
UK
'02
Germany
Taiwan
New Zealand
Japan
Australia
Canada
Brazil
Americas
'99
'99
'03
'03
'03
$0
'99
'05
Spain
'96
'01
'99
'96
France
'05
$10,000
'98
'96
Portugal
$20,000
'00
'07
'00
Sweden
'06
Netherlands
'98
'05
'05
'02
Switzerland
'94
$30,000
Italy
$40,000
Belgium
Cost (US dollars adjusted to 2010)
$80,000
Europe
Source: El Khoury AC, Wallace C, Klimack WK, Razavi H. Economic burden of hepatitis C-associated
diseases: Europe, Asia Pacific, and the Americas. J Med Econ 2012 Mar 30;15(5):887-96.
9
A liver transplantation will cost the healthcare system $50,000$250,000
Liver Transplantation
$500,000
$450,000
'00
'05
$350,000
$100,000
'05
$50,000
'05
'96
'00
'06
'01
Taiwan
New Zealand
Japan
Australia
Canada
Brazil
'02
'96
'03
'03
'03
$0
Americas
'05
'99
'03
Asia Pacific
'99
'08
'00
'87
'01
'01
'98
'99
'99
'05
'00
'07
'96
'98
'00
'02
'98
'99
'90
'03
UK
'05
'96
'98
'99
'91
France
$150,000
'01
'06
'02
'98
'02
'98
'02
Switzerland
'92
'05
Sweden
'94
'98
'96
Spain
$200,000
'01
'01
'94
Portugal
'01
Netherlands
$250,000
Italy
'06
Germany
$300,000
Belgium
Cost (US dollars adjusted to 2010)
$400,000
Europe
Source: El Khoury AC, Wallace C, Klimack WK, Razavi H. Economic burden of hepatitis C-associated
diseases: Europe, Asia Pacific, and the Americas. J Med Econ 2012 Mar 30;15(5):887-96.
10
Drug prices – determines access but there are many factors
that influence the final price
• The pharmacoeconomic
Lifetime Cost
F2
F3
Liver
Trans.
F1
HCC
F0
Decomp
Cirrhosis
Stage of HCV
Progression
Cirrhosis
Lifetime Cost of a Male 30-35 years old (in the US)
$76,000 $95,800 $124,800 $144,700 $163,100 $205,900 $89,000 $384,000
• Reference pricing
» Romania uses the minimum drug price any of the following countries –
Austria, Belgium, Bulgaria, Czech Republic, Germany, Greece, Hungary,
Italy, Lithuania, Poland, Slovakia, and Spain.
• Rebates
11
The drug price is only part of the story
• Add-on support
» Reimburse the countries for the cost of diagnosis
» Provide medical education for physician and nurses
» Patient hotline to help with side effects/ compliance
• Reimbursements
» Patient assistant programs
12
Access is also determined by the complexity of needed
diagnostics and treatment
Diagnosis
2013
Immunoassay:
Identify the
presence of HCV
antibodies
Qualitative
Assay: Confirm
the presence of
the HCV RNA
Genotype
Assay: Inform
treatment duration
Quantitative
Assay: Measure
the viral load at
baseline
Liver Test: Select
more advanced
patients for
treatment
Cost per test:
$17-55 1
Cost per test:
$37-55 2
Cost per test:
$20-4783
Cost per test:
$17-804
Cost per test: 5
Biopsy: $570-1,625
Other: $100-295
1,000
Screened
960 Cases
HCV (-)
2014
to
2015
After
2016
Treatment Decision
40 Cases
HCV (+)
8 Cases
RNA (-)
Qualitative
Assay: Confirm
the presence of
the HCV RNA
Genotype
Assay: Inform
treatment duration
Quantitative
Assay: Measure
the viral load at
baseline
Liver Test: Select
more advanced
patients for
treatment
Cost per test:
$5-8 6
Cost per test:
$37-55
Cost per test:
$20-478 3
Cost per test:
$17-804
Cost per test:
$100-295 5
Cost per test:
$10-40 7
Post Treatment
Quantitative
Assay: Measure
viral load &
monitor progress
(up to 4 tests)
Quantitative
Assay: Measure
viral load &
confirm cure
Cost per test:
$17-804
Cost per test:
$17-804
32 Cases
RNA (+)
Immunoassay
(Point of Care):
Identify the
presence of HCV
antibodies
Qualitative
Assay (Point of
Care): Confirm
the presence of
HCV RNA
Treatment Monitoring
Quantitative
Assay: Measure
viral load &
confirm the
absence of HCV
RNA
Cost per test:
$17-804
Quantitative
Assay: Measure
viral load &
confirm cure
Qualitative
Assay (Point of
Care): Confirm
the absence of
HCV RNA at the
end of treatment
Cost per test:
$10-40 7
Qualitative
Assay (Point of
Care): Confirm
the absence of
HCV RNA & cure
Cost per test:
$17-804
Cost per test:
$10-40 7
Source: UNTAID Hepatitis C Medicines and Diagnostics in the Context of HIV/HCV Co-Infection: A Scoping Report
13
Treating HCV is not a simple task
Viral Load - High
Viral Load - High
Treatment Naive
Viral Load - Low
F0-F2
Viral Load - High
Treatment Naive
Tx Exp - Relapser
Viral Load - Low
Viral Load - High
Tx Exp - Null Responders
Viral Load - Low
G1
Viral Load - Low
Viral Load - High
Treatment Naive
Viral Load - Low
F3-F4
Viral Load - High
F0-F2
Tx Exp - Relapser
Viral Load - Low
Viral Load - High
Tx Exp - Null Responders
Viral Load - Low
Decision to Treat
Viral Load - High
Viral Load - High
Treatment Naive
Viral Load - Low
F0-F2
Viral Load - High
Tx Exp - Relapser
Tx Exp - Relapser
Viral Load - Low
Viral Load - High
Tx Exp - Null Responders
Viral Load - Low
G2
Viral Load - Low
Viral Load - High
Treatment Naive
Viral Load - Low
F3-F4
Viral Load - High
Tx Exp - Relapser
Viral Load - High
Viral Load - Low
Viral Load - High
Tx Exp - Null Responders
Viral Load - Low
Viral Load - High
Treatment Naive
Tx Exp - Null Responders
Viral Load - Low
F0-F2
Viral Load - High
Tx Exp - Relapser
Viral Load - Low
Viral Load - Low
Viral Load - High
Tx Exp - Null Responders
Viral Load - Low
G3
Viral Load - High
Treatment Naive
G1
Viral Load - Low
F3-F4
Viral Load - High
Tx Exp - Relapser
Viral Load - Low
F3-F4
Viral Load - High
Tx Exp - Null Responders
Viral Load - Low
Viral Load - High
Treatment Naive
Viral Load - Low
F0-F2
Viral Load - High
Decision to Treat
Tx Exp - Relapser
Viral Load - Low
Viral Load - High
Tx Exp - Null Responders
Viral Load - Low
G4/5/6
G2
Viral Load - High
Treatment Naive
Viral Load - Low
F3-F4
Viral Load - High
G3
Tx Exp - Relapser
Viral Load - Low
Viral Load - High
Tx Exp - Null Responders
Viral Load - Low
G4/5/6
14
How do we provide access to the new therapies and
diagnostics?
• Education of the stakeholders – Governments, companies, and patients
• National and international guidelines
• Simplifying treatment and diagnosis
15