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COST-EFFECTIVENESS OF THE WORLD HEALTH ORGANIZATION TREATMENT GUIDELINES IN AFRICA Eran Bendavid Philip Grant, Annie Talbot, Douglas Owens, Andrew Zolopa.

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Presentation on theme: "COST-EFFECTIVENESS OF THE WORLD HEALTH ORGANIZATION TREATMENT GUIDELINES IN AFRICA Eran Bendavid Philip Grant, Annie Talbot, Douglas Owens, Andrew Zolopa."— Presentation transcript:

1 COST-EFFECTIVENESS OF THE WORLD HEALTH ORGANIZATION TREATMENT GUIDELINES IN AFRICA Eran Bendavid Philip Grant, Annie Talbot, Douglas Owens, Andrew Zolopa Stanford University

2 Motivation (1) – new guidelines 2  When to start: CD4 count of 350 cells/mm 3  What to start: one of four regimens containing AZT, TDF, NVP, or EFV  What not to start: regimens containing d4T

3 Motivation (2) – resource environment 3

4 Next few slides 4  Framing the question  Approach 1. Model structure 2. Assumptions  Results 1. Comparative effectiveness 2. Cost-effectiveness  Implications

5 Evaluating the WHO guidelines 5 What is the comparative effectiveness and cost-effectiveness of the 1 st line regimens recommended in the new guidelines, as well as the regimen in most common use? 1. Tenofovir + lamivudine + efavirenz (TDF/3TC/EFV) 2. Tenofovir + lamivudine + nevirapine (TDF/3TC/NVP) 3. Zidovudine + lamivudine + efavirenz (AZT/3TC/EFV) 4. Zidovudine+ lamivudine+ nevirapine (AZT/3TC/NVP) 5. Stavudine + lamivudine + nevirapine (d4T/3TC/NVP)

6 Model structure Badri (Lancet 2006), Lawn (AIDS 2009), Holmes (JAIDS 2006) 6  Simulation of HIV disease and treatment calibrated to South African data  Simulated individual patient histories  Calculate population average life expectancies, quality-adjusted life expectancies, and costs  A few illustrative patient histories look like this…

7 Simulation example 7 Start ART Failure Tuberculosis CD4 log VL

8 Model structure 7 Start ART Failure Tuberculosis CD4 log VL

9 Simulation example 7 Start ART Failure PCP 2 nd line Toxicity CMV CD4 log VL

10 TB + blip Start ART Simulation example 7 log VL CD4

11 Simulation example 7 Start ART CD4 log VL

12 Assumption 1 – virologic failure Gallant (NEJM 2006, JAMA 2004), Smith (JID 2005 ), Arribas (JAIDS 2008), Nachega (AIDS 2008) 8 RegimenFailure (Yr1)Failure ( Yr3) TDF/3TC/EFV12% (8-16%)24% (16-32%) TDF/3TC/NVP18% (12-24%)31% (22-40%) AZT/3TC/EFV17% (10-24%)31% (20-42%) AZT/3TC/NVP25%(16-34%)46% (32-60%) d4T/3TC/NVP18% (12-24%)31% (22-40%)

13 Assumption 2 – toxicities Haubrich (AIDS 2009), Arribas (JAIDS 2008), Gallant (JAMA 2004, NEJM 2006), Amoroso (CROI 2007) 9 RegimenToxicitiesRate (1 year)Substitution TDF/3TC/EFV Lipoatrophy Renal failure 6% 1% No substitution TDF → AZT TDF/3TC/NVP Lipoatrophy Renal failure Hepatotoxicity 6% 1% 6.3% No substitution TDF → AZT NVP → EFV AZT/3TC/EFV Lipoatrophy Anemia 23% 6% AZT → TDF AZT/3TC/NVP Lipoatrophy Anemia Hepatotoxicity 23% 6% 6.3% AZT → TDF NVP → EFV d4T/3TC/NVP Lipoatrophy Neuropathy Lactic acidosis Hepatotoxicity 30% 25% 0.5% 6.3% d4T → TDF NVP → EFV

14 Assumption 3 - costs WHO, Global Price Reporting Mechanism 10 Annual regimen costs are substantially different  TDF/3TC/EFV : $675  TDF/3TC/NVP : $538  AZT/3TC/EFV : $384  AZT/3TC/NVP : $247  d4T/3TC/NVP : $121

15 Results – comparative effectiveness 11 RegimenQuality- adjustedlife years (disc.) Life years (discounted) Mean number of opportunistic diseases TDF/3TC/EFV11.2712.822.03 TDF/3TC/NVP11.0812.542.18 AZT/3TC/EFV10.6912.722.07 AZT/3TC/NVP10.4712.392.22 d4T/3TC/NVP10.3112.512.17

16 Results – cost-effectiveness 12 10.2 10.4 10.6 10.8 11.0 11.2 11.4 7,5008,0008,5009,0009,50010,000 Lifetime costs (Discounted 2009 USD) Discounted QALYs AZT/3TC/NVP d4T/3TC/NVP

17 Results – cost-effectiveness 12 10.2 10.4 10.6 10.8 11.0 11.2 11.4 7,5008,0008,5009,0009,50010,000 Lifetime costs (Discounted 2009 USD) Discounted QALYs AZT/3TC/NVP d4T/3TC/NVP TDF/3TC/NVP $1,045/QALY gained

18 Results – cost-effectiveness 12 10.2 10.4 10.6 10.8 11.0 11.2 11.4 7,5008,0008,5009,0009,50010,000 Lifetime costs (Discounted 2009 USD) Discounted QALYs AZT/3TC/NVP d4T/3TC/NVP TDF/3TC/NVP $1,045/QALY gained AZT/3TC/EFV

19 Results – cost-effectiveness 12 10.2 10.4 10.6 10.8 11.0 11.2 11.4 7,5008,0008,5009,0009,50010,000 Lifetime costs (Discounted 2009 USD) Discounted QALYs AZT/3TC/NVP d4T/3TC/NVP TDF/3TC/NVP $1,045/QALY gained AZT/3TC/EFV TDF/3TC/EFV $5,950/QALY gained

20 Implications 13  d4T-containing regimens are more expensive and less effective than AZT-containing regimens, supporting their elimination from the guidelines  While there are no trials directly comparing AZT/3TC/EFV with TDF/3TC/NVP, the latter appears to be more effective and less costly than the former under a broad set of assumptions  Consideration should be given to recommending TDF/3TC/NVP over AZT/3TC/EFV in usual circumstances  Using World Health Organization thresholds for cost-effectiveness TDF/3TC/NVP may be considered cost-effective in most African settings, but AZT/3TC/NVP is the least costly regimen

21 In Collaboration With Philip Grant – Stanford Infectious Diseases Annie Talbot – Stanford Infectious Diseases Doug Owens – Stanford Health Policy Andrew Zolopa – Stanford Infectious Diseases Acknowledgment National Institute of Allergy and Infectious Diseases

22

23 Assumption 1 – virologic failure 8 RegimenFailureYr1FailureYr3Range TDF/3TC/NVP18%31%12-24%, 22-40% AZT/3TC/EFV17%31%10-24%, 21-41% AZT/3TC/NVP25%46%16-34%, 32-60% d4T/3TC/NVP18%31%12-24%, 22-40% TDF/3TC/EFV12%24%8-16%,16-32%

24 Results – comparative effectiveness 11 RegimenQuality- adjusted life years (disc.) Life expectancy (discounted) Mean number of opportunistic diseases TDF/3TC/EFV11.2712.822.03 TDF/3TC/NVP11.0812.542.18 AZT/3TC/EFV10.6912.722.07 AZT/3TC/NVP10.4712.392.22 d4T/3TC/NVP10.3112.512.17

25 Results – comparative effectiveness 11

26 Assumption 1 – virologic failure 8 Risk of virologic failure varies by ART regimen  Lowest failure: tenofovir + lamivudine + efavirenz  2 nd lowest: zidovudine + lamivudine + efavirenz  3 rd and 4 th lowest: tenofovir + lamivudine + nevirapine ; stavudine + lamivudine + nevirapine  Highest failure: zidovudine + lamivudine + nevirapine

27 Assumption 2 of 3 9 ARV drugs have associated risk of toxicities  Stavudine (lipoatrophy, neuropathy, lactic acidosis)  Zidovudine (lipoatrophy, anemia)  Tenofovir (lipoatrophy, renal failure)  Nevirapine (hepatotoxicity) Quality of life is decreased with toxicities (least with lipoatrophy, most with lactic acidosis)

28 TDF/3TC/EFV 10.2 10.4 10.6 10.8 11.0 11.2 11.4 7,5008,0008,5009,0009,50010,000 Lifetime costs (Discounted 2009 USD) Discounted QALYs TDF/3TC/NVP AZT/3TC/EFV AZT/3TC/NVP d4T/3TC/NVP $1,045/QALY gained $5,950/QALY gained

29 Next few slides 29  Framing the question (1 slide)  Approach 1. Model structure (2 slides) 2. Assumptions (3 slides)  Results and implications 1. Comparative effectiveness (2 slides) 2. Cost-effectiveness (2 slides)

30 Assumption 1 – virologic failure 8 RegimenFailure Yr 1Failure Yr 3Range TDF/3TC/EFV12%24%8-16%, 16-32% TDF/3TC/NVP18%31%12-24%, 22-40% AZT/3TC/EFV17%31%10-24%, 21-41% AZT/3TC/NVP25%46%16-34%, 32-60% d4T/3TC/NVP18%31%12-24%, 22-40%

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