1. Long-term Projections of the Cost of Treatment Under Various Scenarios – Opportunities for Efficiency and Effectiveness? Arin Dutta, Cathy Barker, and Ashley Kallarakal July 19/20, 2014 DRAFT : DO NOT CITE

2. 1. Projecting and costing global HIV treatment  Number on treatment a)Current vs. WHO 2013 need for ARVs b)Scale-up of programmatic coverage c)Migration to 2 nd line treatment  Cost of HIV treatment  Funding gap analysis for HIV treatment 2. Emerging Themes: E 2 in HIV Treatment 3. HPP E 2 analyses  Insights from Kenya, Tanzania, and Mozambique Outline

3. UNAIDS 2014 “Ambitious Treatment Targets: Writing the final chapter of the AIDS epidemic”  Critical intervention in the response: preventing premature mortality and new infections  HIV treatment requires more resources than any other single area of the HIV and AIDS response  UNAIDS : 39% of all resources for HIV  Exciting time in the discussion on ART:  90-90-90 call from UNAIDS: 90% diagnosed, 90% on ART; 90% virally suppressed by 2020 Why focus on HIV Treatment?

4.  93 countries included in the analysis, based on criteria:  More than 1,000 PLHIV in country  Eligible for Global Fund funding for HIV in 2014  Countries grouped into the following 6 regions:  Africa: West and Central (AWC) - 22  Africa: East and Southern (AES) - 20  Latin America and the Caribbean (LAC) - 14  Middle East and North Africa (MENA) - 9  Eastern Europe and Central Asia (EECA) - 12  Asia and the Pacific (AP) - 16 Country Inclusion Criteria

5. Projecting Global HIV Treatment Needs

6. * Depending on current country guidelines as preset in Spectrum. # HIV & TB co-infected with CD4 above 350 (or 500) are a very small proportion; not included in this round of analysis.  Used AIM in Spectrum to estimate projected numbers of adult and pediatric patients that are eligible for ART from 2014- 2020 in each of the 93 countries.  Spectrum AIM was used individually for each country  Two eligibility scenarios:  Current eligibility # :  Adult: CD4<350 or 250* and Option B+ (all HIV+ PW)  Children: CD4<350 for ages 5-14; CD4<750 for ages 24-59 mo.; all under 24 mo. (irrespective of CD4)  WHO 2013 eligibility # :  Adult: CD4<500 and Option B+ (all HIV+ PW)  Children: CD4<500 for ages 5-14; all under 5 (irrespective of CD4) a) ART Need: Methods

7. Global Need for ART: Adults Source: Dutta, Barker, Kallarakal (forthcoming, 2014)

8. Global Need for ART: Pediatric Source: Dutta, Barker, Kallarakal (forthcoming, 2014)

9. * Sources: WHO/PAHO 2013 (“ART in Spotlight: LAC”); WHO et al. TUA Progress Report 2013, etc.  Coverage: Number on ART on Dec. 31 st / Need for ART, Dec. 31 st  Step 1: Established 2013 baseline coverage % for adults and children in each of 93 countries, looking at:  Number on ART from 2013 UNGASS country reports; national reports & documents*, or value in Spectrum (in this order)  Divided this by current need for ART on Dec. 31 st in the country  Step 2: Set possible scale-up paths for countries from this base:  9.17 million on ART in 2012, a 19.8% increase on 2011*  Two scale-up scenarios:  Slow scale-up: 20% annual increase in coverage %  e.g., country’s coverage in 2014: 40%; coverage in 2015: 48%  Fast scale-up: 30% annual increase in coverage % b) ART Coverage: Methods

10. Source: Dutta, Barker, Kallarakal (forthcoming, 2014) 2013 ART Coverage %: Adult Bubble size shows Current ART Need in 2013

11. 2013 ART Coverage %: Pediatric Bubble size shows Current ART Need in 2013 Source: Dutta, Barker, Kallarakal (forthcoming, 2014)

12.  Step 1: Established 2013 split of patients on 1 st vs. 2 nd line ART, adults and children separately (if poss.)  By country: UNGASS 2013 country reports, national data, global/regional reports. WHO regional average used for missing  Step 2: Define region-specific annual migration rate ranges: % of 1 st line moving to 2 nd line, per year  A region has countries classified into “high / med. / low.” This range differs by region. Overall range across regions: 0.5% to 3% p.a.  Country designated within region based on resistance*, LTFU, etc.  Step 3: Migration scenarios by country over 2014-2020:  Base migration: As set above: assumes historical rates continue; increased detection with VL cancelled by lower proximal factors for failure  Higher migration: Migration increases from base : Increased patient load stresses systems; higher detection with VL, etc. – greater switching  E.g.: Country with low migration moves to medium; medium moves to high c) 1 st & 2 nd line ART: methods * Stanford Drug Resistance Database

13. ScenarioIDScenario Definition C20ScaleBM1Number of patients on 1st line ART regiment based on: current ART guidelines; Scale up of ART coverage by 20%, current migration scheme to 2nd line treatment C30ScaleBM1Number of patients on 1st line ART regiment based on: current ART guidelines; Scale up of ART coverage by 30%, current migration scheme to 2nd line treatment C20ScaleHM1Number of patients on 1st line ART regiment based on: current ART guidelines; Scale up of ART coverage by 20%,higher migration scheme to 2nd line treatment C30ScaleHM1Number of patients on 1st line ART regiment based on: current ART guidelines; Scale up of ART coverage by 30%, higher migration scheme to 2nd line treatment WHO20ScaleBM1 Number of patients on 1st line ART regiment based on: WHO2013 ART guidelines; Scale up of ART coverage by 20%, current migration scheme to 2nd line treatment WHO30ScaleBM1 Number of patients on 1st line ART regiment based on: WHO 20103 ART guidelines; Scale up of ART coverage by 30%, current migration scheme to 2nd line treatment WHO20ScaleHM1 Number of patients on 1st line ART regiment based on: WHO 2013 ART guidelines; Scale up of ART coverage by 20%,higher migration scheme to 2nd line treatment WHO30ScaleHM1 Number of patients on 1st line ART regiment based on: WHO 2013 ART guidelines; Scale up of ART coverage by 30%, higher migration scheme to 2nd line treatment Median_1st_lineMedian of all 1st line scenario totals C20ScaleBM2Number of patients on 2nd line ART regiment based on: current ART guidelines; Scale up of ART coverage by 20%, current migration scheme to 2nd line treatment C30ScaleBM2Number of patients on 2nd line ART regiment based on: current ART guidelines; Scale up of ART coverage by 20%, current migration scheme to 2nd line treatment C20ScaleHM2Number of patients on 2nd line ART regiment based on: current ART guidelines; Scale up of ART coverage by 20%, high migration scheme to 2nd line treatment C30ScaleHM2Number of patients on 2nd line ART regiment based on: current ART guidelines; Scale up of ART coverage by 20%, high migration scheme to 2nd line treatment WHO20ScaleBM2 Number of patients on 2nd line ART regiment based on: WHO2013 ART guidelines; Scale up of ART coverage by 20%, current migration scheme to 2nd line treatment WHO30ScaleBM2 Number of patients on 2nd line ART regiment based on: WHO2013 ART guidelines; Scale up of ART coverage by 20%, current migration scheme to 2nd line treatment WHO20ScaleHM2 Number of patients on 2nd line ART regiment based on: WHO2013 ART guidelines; Scale up of ART coverage by 20%, high migration scheme to 2nd line treatment WHO30ScaleHM2 Number of patients on 2nd line ART regiment based on: WHO2013 ART guidelines; Scale up of ART coverage by 20%, high migration scheme to 2nd line treatment Median_2st_lineMedian of all 2nd line scenario totals

14. Projected number of Adults on 2 nd Line ART High: 3.9 million Low: 2.2 million Source: Dutta, Barker, Kallarakal (forthcoming, 2014) Range based on 8 scenarios

15. Projected number of Children on 2 nd Line ART High: 262 thousand Low: 143 thousand Source: Dutta, Barker, Kallarakal (forthcoming, 2014) Range based on 8 scenarios

16. Projected numbers on ART: Adult Based on increasing coverage from current base High : 29.2 million Low : 22.1 million Source: Dutta, Barker, Kallarakal (forthcoming, 2014) Range based on 16 scenarios

17. High: 2 million Low: 1.3 million Source: Dutta, Barker, Kallarakal (forthcoming, 2014) Range based on 16 scenarios Projected numbers on ART: Ped. Based on increasing coverage from current base

18. Cost of HIV Treatment

19.  Used regional average patient-year costs by income category for WHO-preferred regimens  Annual drug costs from WHO Global Price Reporting Mechanism database; as regional averages by income level  Most prices are from 2013 (transactions before 2011 excluded)  Assumed regimen prices stable from 2014 to 2020, in 2013 $  Substituted global averages, matching income level, for any missing region/income level and regimen data  Regimen splits and per year costs reviewed against country-specific costing studies from HPP (2014) and CHAI (2012) Costing Methods: Annual ARVs Adult 1 st lineAdult 2 nd linePediatric 1 st linePediatric 2 nd line TDF + 3TC + EFVZDV+3TC+LPV/rABC+3TC + LPV/rZDV + 3TC + EFV ZDV+3TC+NVPTDF+FTC+LPV/rZDV + 3TC + LPV/rABC + 3TC + EFV ZDV+3TC+EFVABC + 3TC + EFVZDV + 3TC + LPV/r ZDV+3TC+EFVABC + 3TC +LPV/r

20.  Lab costs: 3 scenarios x 3 income levels  Compiled estimates of country-specific unit costs* per test into averages by low, low-middle and middle income level groups  Three cost scenarios per income level: via # tests and unit cost:  Facility-level costs**  Average % of direct commodity costs (ARV and lab) that is spent on personnel and overhead (building utilities and contracted services)  Percentages differ by income level group  Assumed stable percentage of costs from 2014-2020 Costing Methods: Lab and Facility-Level Costs Scenario → High costMedium costLow cost CD41 x yr., avg. unit cost2 x yr., avg. unit cost2 x yr., lowest unit cost Viral load Routine, avg. unit cost Targeted (5%), avg. unit cost Targeted (5%), lowest unit cost Hematology and clinical chemistry 2 x yr., avg. unit cost 2 x yr., lowest unit cost Sources: * HPP 2014, CHAI 2013, MSF 2013; many others; Sources: ** Gallaraga et. al 2011, PEPFAR 2013, many others

21.  Highest cost scenario  Highest numbers on treatment  WHO 2013 eligibility, 30% annual scale-up rate in coverage, highest 2 nd line migration scenario  Highest unit cost for lab  Medium cost scenario  Median numbers on treatment  Medium unit cost for lab  Lowest cost scenario  Lowest numbers on treatment  Current eligibility, 20% annual scale-up rate in coverage, current 2 nd line migration scenario  Lowest unit cost for lab Total costs: Three Scenarios

22. Total Annual ART Costs (93 countries): ARVs, lab, personnel, and facility-level costs High: $8.5 billion Low: $5.5 billion All costs in 2013 US$. Source: Dutta, Barker, Kallarakal (forthcoming, 2014)

23. Disaggregating total costs of ART for 93 countries: Medium Scenario All costs in 2013 US$. Source: Dutta, Barker, Kallarakal (forthcoming, 2014)

24. Proportion of Total Costs 2014- 2020: Medium Scenario Source: Dutta, Barker, Kallarakal (forthcoming, 2014)

25. Sources: PEPFAR 2013 COPs (sum of budget codes HBHC, HKID, HLAB, HTXD, HTXS, HVTB, PDCS, PDTX only); GFATM 2014 disbursement report (July 2014 update)  Annual level of GFATM funding for HIV  Based on late 2013 and 2014 funding disbursements for all open HIV grants, excluding civil society organization PRs  Global total: $558.7 million/year  Annual level of PEPFAR funding for ART  2013 funding commitments for treatment and care for 31 countries  Total: $1.95 billion/year  3 funding gap scenarios:  Largest gap: Highest cost scenario, current GFATM funding stays constant, subtracted 30% from PEPFAR funding (overhead)  Medium gap: Median cost scenario, current PEPFAR and GFATM funding, constant over time  Smallest gap: Lowest cost scenario, current PEPFAR and GFATM funding, constant over time Funding gap analysis: Methods

26. Annual funding gap across 93 countries (prior to domestic contribution) Includes ARV, lab, personnel and overhead costs High: $6.6 billion Low: $2.9 billion All values in 2013 US$. Source: Dutta, Barker, Kallarakal (forthcoming, 2014)

27. High: $4.8 billion Low: $1.7 billion All values in 2013 US$. Source: Dutta, Barker, Kallarakal (forthcoming, 2014) Annual funding gap across 93 countries (prior to domestic contribution) Includes ARV and lab costs only

28. Emerging Themes: E 2 in HIV Treatment

29.  Need to increase cost-efficiency:  Continue to reduce ARV prices and wider use of low-cost WHO- recommended regimens  Example: A 5% reduction in ARV prices could save as much as $1.5 billion from 2014-2020  Reduce facility-level costs  Example: Reducing proportion of direct costs spent on personnel and overhead by 5% would save as much as $485 million from 2014-2020  Reduce lab costs  Example: Reducing unit costs of all lab tests to the lowest current price would save as much as $2.5 billion from 2014-2020  Need to increase effectiveness:  How to increase coverage by 20-30% per year on existing base?  Better use of viral load testing to detect and switch on failure  Prevent large rise in future 2 nd line treatment need Key Findings

30. Potential E 2 Gains across ART cascade Interventions that reduce ART costs Interventions that promote sustained viral suppression up to 90% Decentralize, but maintain viable facility- level patient loads Treatment simplification: new methods to deliver ARVs with lower pill burden; long-term dosing Task shifting: reduce per-patient personnel costs Better patient monitoring whether via virological or immunological testing Further expansion of FDC formulations Community-based models of patient monitoring and adherence support Consolidation of lower cost platforms for viral load testing, even at POC; reduction of reagent costs Treat comorbidities, including malnutrition, to keep patient healthy and in care Critical short-term investments (e.g., new VL equipment) may lead to long-term efficiency and effectiveness gains Interventions that help increase coverage up to 90% or more Reduce cross-cutting delivery challenges Eliminate losses across ART cascade (75% lost from test to treat? Mugglin et al. 2012) Treatment site positioning and strengthening; timing; family-based approaches, structural/social enablers.

31.  Assessment of needs  Serodiscordant couples (also recommended) not included  Coverage projections  Not able to use UNAIDS/WHO 2014 Country Progress Reports, data not released  Costs of ART missing  Costs of OI treatment (non-TB), psychosocial support, nutrition, where these are available  Above-facility level costs (programmatic support, training)  Gap analysis issues  Overestimation of both GFATM and PEPFAR funds - values are not specific to cost categories included. Data not available Limitations of analysis

32. HPP Studies on E 2

33. Lessons Learned from Kenya Efficient interventionsEffective interventions HIV testing; MoH switched testing algorithm to yield highest cost savings while maintaining accuracy Option B+; averts more infant and adult infections than Option B, but at a significant additional cost HCW training; harmonized in-service training curriculum with long-term mentoring is cost- efficient Harm reduction services for key populations; combination package (NSP, MAT, HCT, and ART for PWID) is cost-effective (ICER of $1,600) Screening blood supply for transfusions; cost- benefit ratio of 3 for additional costs to screen all blood vs. averted TTI treatment costs Oral PrEP for sex workers; cost-effectiveness ratio in Kenya is $25 per HIV infection averted; costs could decrease through task shifting New ART guidelines; adopting WHO 2013 guidelines would result in a significant reductions in new HIV infections and premature deaths Workplace interventions; mainstream HIV response, promote prevention programs, fight stigma and discrimination

34. Lessons Learned from Mozambique  Need to increase allocative efficiency:  Target geographic regions and population groups contributing the most to HIV incidence  Need to scale-up biomedical and behavior change interventions to achieve greatest health impact  Revised HIV acceleration plan could avert 113,927 new infections and 145,668 AIDS-related deaths  Need both types of interventions to reach goal of halving HIV incidence by 2017

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