1 Potential Impact and Cost-Effectiveness of the 2009 “Rapid Advice” PMTCT Guidelines — 15 Resource-Limited Countries, 2010 Andrew F. Auld, Omotayo Bolu,

1

Potential Impact and Cost-Effectiveness of the 2009 “Rapid Advice” PMTCT Guidelines

— 15 Resource-Limited Countries, 2010

Andrew F. Auld, Omotayo Bolu, Tracy Creek, Mary Lou Lindegren,

Emilia Rivadeneira, Helen Dale, Nalinee Sangrujee, Tedd Ellerbrock

Global AIDS Program, Centers for Disease Control and Prevention (CDC), Atlanta, U.S.A

Presented by Andrew F. Auld MBChB

2

Peri-natal HIV Transmission

• Globally, 420,000 infants become HIV-infected annually

• About 90% of infections occur in Africa 60% during pregnancy/birth 40% during breastfeeding

• Antiretroviral drugs (ARVs) known to significantly reduce HIV transmission during pregnancy and birth In 2009 ARVs proven effective during breastfeeding

• Guidelines for the use of ARVs for prevention of mother-to-child transmission (PMTCT): Last published in 2006 Revised in 2009

2006 vs. 2009 WHO PMTCT Guidelines -ART-Ineligible Women Choosing to Breastfeed

2006 PMTCT Guidelines


Option A Option B

Mother

Pregnancy AZT from 28 weeks AZT from 14 weeks

Triple ARV14 weeks –>

end of Breastfeeding

Delivery SDN + AZT-3TC SDN + AZT-3TC

Post-Natal AZT-3TC tail AZT-3TC tail

Infant Post-Natal SDN & AZT tail Daily NVP during BF NVP for 6 weeks

3




Option A Option B

Mother







4




Option A Option B

Mother







5




Option A Option B

Mother







6




Option A Option B

Mother







7




Option A Option B

Mother







8




Option A Option B

Mother







9

Earlier ART for HIV-Infected Pregnant Women

• 2006 WHO Guidelines:

CD4 < 200/µL

CD4 < 350/µL with WHO stage III

All WHO stage IV eligible

• 2009 WHO Guidelines: Earlier ART

CD4 < 350/µL

All WHO stage III/IV eligible

10

11

Rationale & Objectives for Research

• Rationale:

2009 PMTCT guidelines, adopting options A or B for ART-ineligible women, equally effective for HIV prevention (WHO 2009)

Other criteria, e.g. cost-effectiveness, feasibility, are important

• Objectives:

To estimate in 15 resource-limited countries:

- the potential cost-effectiveness

- the potential costs saved, through reduced need to treat HIV-infected children,

if countries choose option A or option B

12

15 Focus Countries of the US President’s Emergency Plan for AIDS Relief

Ethiopia

Uganda

Kenya

Rwanda

Tanzania

Zambia

Mozambique

Haiti

Guyana

Cote d’Ivoire

Nigeria

Namibia

Botswana

South Africa

Vietnam

13

Methods

• Deterministic model:

Follow cohorts of HIV-infected pregnant women and exposed infants born in each of the 15 focus countries during 2010

Three PMTCT scenarios:

- Scenario “A”: 2009 Guidelines with option A for ART-ineligible women

- Scenario “B”: 2009 Guidelines with option B for ART-ineligible women using the least expensive prophylactic regimen (AZT,3TC,EFV)

- Scenario “2006”: 2006 WHO Guidelines

14

Methods

• To estimate cost-effectiveness of scenarios “A” & “B”, estimate:

Incremental cost-effectiveness ratios (ICERs)

- Additional cost per additional life-years gained (LYG) of implementing either scenario “A” or “B” instead of the 2006 Guidelines

• If ICER < Gross Domestic Product (GDP) / Capita:

Highly Cost-effective

15

Methods

• To estimate whether scenarios A & B are cost saving, estimate for each of the scenarios (“A”, “B”, and “2006”):

Total costs incurred by PMTCT program

Total lifetime treatment costs for infected children

• If total costs for scenario A or B < total costs for scenario 2006:

Cost-saving

16

Assumptions and Sensitivity Analysis

• Key input parameters:

PMTCT effectiveness data: Kesho-Bora and Ban

ARV costs and service fees: ARV procurement agencies & costing surveys

• Multivariate sensitivity analysis:

10,000 trials of Monte Carlo simulation created 95% confidence intervals (CI)

Potential Impact and Cost-Effectiveness of Scenarios “A” and “B” of the 2009 PMTCT Guidelines – 15 Focus Countries, 2010

17

Model Outcome Scenario “2006” (95% CI)

Scenario “A”(95% CI)

Scenario “B”(95% CI)

Infant HIV Infections(thousands)

345 (328-361) 242 (231-252) 258 (247-270)

Infections Averted (thousands)

66 (50-82) 169 (159-180) 152 (141-163)

Life-Years Gained (LYG millions)

1.3 (0.7-2.0) 3.2 (2.7-3.6) 2.9 (2.4-3.4)

Additional LYG (millions)

- 1.9 (0.8-2.9) 1.6 (0.4-2.7)

Cost (US $ millions) 64 (55-73) 235 (223-247) 343 (325-362)

Additional Cost(millions)

- 171 (150-192) 288 (252-307)

ICER (US $/LYG)

- 92 (81-107)Equally EffectiveMore Expensive


18





345 (328-361) 242 (231-252) 258 (247-270)


66 (50-82) 169 (159-180) 152 (141-163)


1.3 (0.7-2.0) 3.2 (2.7-3.6) 2.9 (2.4-3.4)


- 1.9 (0.8-2.9) 1.6 (0.4-2.7)

Cost (US $ millions) 64 (55-73) 235 (223-247) 343 (325-362)


- 171 (150-192) 288 (252-307)

ICER (US $/LYG)



19





345 (328-361) 242 (231-252) 258 (247-270)


66 (50-82) 169 (159-180) 152 (141-163)


1.3 (0.7-2.0) 3.2 (2.7-3.6) 2.9 (2.4-3.4)


- 1.9 (0.8-2.9) 1.6 (0.4-2.7)

Cost (US $ millions) 64 (55-73) 235 (223-247) 343 (325-362)


- 171 (150-192) 288 (252-307)

ICER (US $/LYG)



20





345 (328-361) 242 (231-252) 258 (247-270)


66 (50-82) 169 (159-180) 152 (141-163)


1.3 (0.7-2.0) 3.2 (2.7-3.6) 2.9 (2.4-3.4)


- 1.9 (0.8-2.9) 1.6 (0.4-2.7)

Cost (US $ millions) 64 (55-73) 235 (223-247) 343 (325-362)


- 171 (150-192) 288 (252-307)

ICER (US $/LYG)



21





345 (328-361) 242 (231-252) 258 (247-270)


66 (50-82) 169 (159-180) 152 (141-163)


1.3 (0.7-2.0) 3.2 (2.7-3.6) 2.9 (2.4-3.4)


- 1.9 (0.8-2.9) 1.6 (0.4-2.7)

Cost (US $ millions) 64 (55-73) 235 (223-247) 343 (325-362)


- 171 (150-192) 288 (252-307)

ICER (US $/LYG)



22





345 (328-361) 242 (231-252) 258 (247-270)


66 (50-82) 169 (159-180) 152 (141-163)


1.3 (0.7-2.0) 3.2 (2.7-3.6) 2.9 (2.4-3.4)


- 1.9 (0.8-2.9) 1.6 (0.4-2.7)

Cost (US $ millions) 64 (55-73) 235 (223-247) 343 (325-362)


- 171 (150-192) 288 (252-307)

ICER (US $/LYG)



23





345 (328-361) 242 (231-252) 258 (247-270)


66 (50-82) 169 (159-180) 152 (141-163)


1.3 (0.7-2.0) 3.2 (2.7-3.6) 2.9 (2.4-3.4)


- 1.9 (0.8-2.9) 1.6 (0.4-2.7)

Cost (US $ millions) 64 (55-73) 235 (223-247) 343 (325-362)


- 171 (150-192) 288 (252-307)

ICER (US $/LYG)



24





345 (328-361) 242 (231-252) 258 (247-270)


66 (50-82) 169 (159-180) 152 (141-163)


1.3 (0.7-2.0) 3.2 (2.7-3.6) 2.9 (2.4-3.4)


- 1.9 (0.8-2.9) 1.6 (0.4-2.7)

Cost (US $ millions) 64 (55-73) 235 (223-247) 343 (325-362)


- 171 (150-192) 288 (252-307)

ICER (US $/LYG)



25





345 (328-361) 242 (231-252) 258 (247-270)


66 (50-82) 169 (159-180) 152 (141-163)


1.3 (0.7-2.0) 3.2 (2.7-3.6) 2.9 (2.4-3.4)


- 1.9 (0.8-2.9) 1.6 (0.4-2.7)

Cost (US $ millions) 64 (55-73) 235 (223-247) 343 (325-362)


- 171 (150-192) 288 (252-307)

ICER (US $/LYG)



26





345 (328-361) 242 (231-252) 258 (247-270)


66 (50-82) 169 (159-180) 152 (141-163)


1.3 (0.7-2.0) 3.2 (2.7-3.6) 2.9 (2.4-3.4)


- 1.9 (0.8-2.9) 1.6 (0.4-2.7)

Cost (US $ millions) 64 (55-73) 235 (223-247) 343 (325-362)


- 171 (150-192) 288 (252-307)

ICER (US $/LYG)



27





345 (328-361) 242 (231-252) 258 (247-270)


66 (50-82) 169 (159-180) 152 (141-163)


1.3 (0.7-2.0) 3.2 (2.7-3.6) 2.9 (2.4-3.4)


- 1.9 (0.8-2.9) 1.6 (0.4-2.7)

Cost (US $ millions) 64 (55-73) 235 (223-247) 343 (325-362)


- 171 (150-192) 288 (252-307)

ICER (US $/LYG)



28





345 (328-361) 242 (231-252) 258 (247-270)


66 (50-82) 169 (159-180) 152 (141-163)


1.3 (0.7-2.0) 3.2 (2.7-3.6) 2.9 (2.4-3.4)


- 1.9 (0.8-2.9) 1.6 (0.4-2.7)

Cost (US $ millions) 64 (55-73) 235 (223-247) 343 (325-362)


- 171 (150-192) 288 (252-307)

ICER (US $/LYG)



29





345 (328-361) 242 (231-252) 258 (247-270)


66 (50-82) 169 (159-180) 152 (141-163)


1.3 (0.7-2.0) 3.2 (2.7-3.6) 2.9 (2.4-3.4)


- 1.9 (0.8-2.9) 1.6 (0.4-2.7)

Cost (US $ millions) 64 (55-73) 235 (223-247) 343 (325-362)


- 171 (150-192) 288 (252-307)

ICER (US $/LYG)


Average ICER of implementing Scenario “A” Instead of Scenario “2006” – 15 Focus Countries, 2010

30

Threshold for High Cost Effectiveness (Weighted Average GDP - US$1,463)

Point Estimate for ICER of Scenario A vs. 2006 WHO PMTCT Guidelines (US$92)

10,000 Trials of Monte Carlo Simulationfor ICER of Scenario A vs. 2006 WHO Guidelines

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0 .5 1 1.5 2 2.5Additional Life-Years Gained (millions)


31




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Country-Specific ICERs of Implementing Scenario “A” Instead of Scenario “2006” – 15 Focus Countries, 2010

34

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Potential Cost Savings of Implementing PMTCT Scenario “A” Instead of the 2006 PMTCT Guidelines

38

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Total Cost Savings of US$ 18 million

95% CI (US$ 49 million in savings – US$ 68 million in additional expenditure)

43

Limitations

• In establishing 95% CIs, only those input parameters that affected the ICER were varied

• Costs of ARVs are continually changing

44

Public Health Implications

• In 2010, in 15 PEPFAR focus countries, we estimate:

Implementing 2009 WHO Guidelines could nearly triple infections averted

Option “B” is significantly more expensive than option “A”

The 2009 WHO Guidelines with option “A” are:

- highly cost effective

- possibly cost-saving in 9 of 15 PEPFAR focus countries

45

Public Health Implications

• These findings support:

Rapid implementation of the 2009 WHO PMTCT Guidelines

Option “A” the most cost-effective option

Acknowledgements

• Co-authors

• Omotayo Bolu

• Tracy Creek

• Mary Lou Lindegren

• Emilia Rivadeneira

• Helen Dale

• Nalinee Sangrujee

• Tedd Ellerbrock

• Collaborators

• Ray Shiraishi

• Elliot Raizes

• David Bell

• Nick Menzies

• Prahbu Vimanaland

• John Blandford

Thank You!

The findings of this presentation are those of the authors and do not necessarily represent the views of the US Centers for

Disease Control and Prevention

47

Mother-to-Child HIV-Infections among Exposed Children Born in 15 Focus Countries, 2010

48

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0

10,000

20,000

30,000

40,000

50,000

60,000

70,000

80,000

2006 Guidelines - Scenario "2006"

2009 Guidelines - Scenario "A"

2009 Guidelines - Scenario "B"

Nu

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of M

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ana

: Total Infections ~ 345,000



Life-Time Treatment Costs for Infected Children Associated with PMTCT Strategy – 15 Focus Countries, 2010

49

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$-

$20.0

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$60.0

$80.0

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Scenario "2006"

Scenario "A"

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: Total Treatment Costs ~US$ 440 million

: Total Treatment Costs ~US$ 251 million

Varying Costs and Effectiveness of PMTCT Scenario “A” to Assess Effect on ICER – Ethiopia, 2010

50

Ris

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1.5

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$0

$500

$1,000

$1,500

$2,000

$2,500

$3,000

$3,500

$4,000

$4,500

Cost Estimate

5 X Cost

20 X Cost

GDP per Capita

3 X GDP per Capita

Increase in Transmission Risk Above Model Estimate

ICE

R (

US

$ p

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1 Potential Impact and Cost-Effectiveness of the 2009 “Rapid Advice” PMTCT Guidelines — 15 Resource-Limited Countries, 2010 Andrew F. Auld, Omotayo Bolu,

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