The projects described were supported by T32 AI007433, R01 AI058736, R01 AI from NIAID, P30 AI from HU CFAR, & NIH Fogarty International Center The contents are solely the responsibility of the author and do not necessarily represent the official views of the awarding offices Emily P. Hyle, MD Division of Infectious Diseases Massachusetts General Hospital Conflicts of interest: None HIV, Communicable, and Non-Communicable Diseases: Costs and Cost-Effectiveness of Integrated Care

1.Global response to the HIV pandemic 2. Costs, cost-effectiveness, and modeling 3. Data needed to assess the value of integration Overview

Global Response to HIV Pandemic

Funding for the Global Response

Three Questions for Any Intervention 1.Is it effective? Does it work? ** If it is not effective, it is not cost-effective.** 2.Is it cost-effective? What is its value? 3.Where and how can it best be implemented? Is it affordable?

“Cost-Effective” = “Cheap” “Cost-Effective” = “Saves money” “Cost-Effective” = Additional benefit worth the additional cost Common Misconceptions

Formal methodology to assess the comparative value of at least 2 interventions Two different outcome measures: –Cost: $, Rand, Rupee –Effectiveness: Years of life saved (YLS) QALYs or DALYs Incremental cost-effectiveness ratio (ICER): Additional Resource Use Additional Health Benefits Cost-Effectiveness Analysis

The Commission on Macroeconomics and Health and WHO have suggested that interventions are: Cost-effective: the ICER is <3 x GDP per capita for that country Very cost-effective: the ICER is <1 x annual GDP per capita for that country Macroeconomics and Health: WHO WHO-CHOICE Cost-Effectiveness Thresholds

Examines the impact of a new intervention on one or multiple payers –Specific payer perspective –Specific site –Limited to a defined budgetary horizon Annual 5-year Budget Impact Analysis

Objective To project the cost-effectiveness of early compared to delayed ART for treatment and prevention in serodiscordant couples Analyses were conducted for two countries, South Africa and India, to assess regional differences in value Collaboration: HPTN 052/CEPAC-I Walensky et al., NEJM

Mathematical model of HIV natural history and treatment Clinical and resource utilization data from South Africa and India Cohort and ART efficacy parameters from HPTN 052 trial (Cohen et al, NEJM 2011) Methods: CEPAC-International Model* *Funded by NIAID R37 AI42006, R01 AI058736, R01 AI093269

1)Delayed ART (CD4 <250/µl) 2)Early ART (at presentation) Evaluate outcomes in: –Clinical benefit, cost and transmissions –5-year and lifetime horizons Methods: Two Strategies Walensky et al., NEJM

Life expectancy (years) Costs (USD 2011) ICER † ($/YLS) Delayed ART13.815,100-- Early ART15.816, † Including projected survival losses and cost increases associated with 1 st - and 2 nd -order transmissions per capita GDP in South Africa: $8,100 Walensky et al., NEJM Results: Cost-Effectiveness (Lifetime, South Africa)

Data Needed: Cost-Effectiveness of Integrated Care Screening Treatment Costs Quality of Life Epidemiology Cost- Effectiveness Analysis

Effectiveness: Data Needed Epidemiology: –Prevalence –Incidence –Attributable mortality

Effectiveness: Data Needed Screening: –Test characteristics –Linkage to care after positive screening Treatment: –Effectiveness of management or cure –Adverse events Quality of life: –With or without symptoms –Effects of stigma

Resource Utilization: Data Needed Infrastructure: –Effects of using existing sites and personnel –Fixed vs. marginal costs –Impact of economies of scale Staff training: –In multiple domains –Decentralized vs. specialized sites Monitoring and evaluation: –Diversity of outcomes –Quality control

Integrated clinical care for HIV patients could offer opportunities to improve outcomes for good value Model-based budget impact and cost- effectiveness analyses are critical to understanding how to expand or integrate care, especially when resources are limited Data are needed to inform such analyses, which can help to prioritize resources and scale-up to improve patient outcomes Conclusions

United States Nalini Anand, JD, MPH Wafaa El-Sadr, MD, MPH, MPA Paolo Miotti, MD KM Venkat Narayan, MD, MSc Sten Vermund, MD, PhD South Africa Kogie Naidoo, MBChB Linda-Gail Bekker, MD, PhD Keren Middlekoop, MBChB, PhD Robin Wood, MBBCh, MMed Acknowledgements MGH Medical Practice Evaluation Center Ingrid Bassett, MD, MPH Andrea Ciaranello, MD, MPH Kenneth Freedberg, MD, MSc N. Kaye Horstman, PhD, MPH Robert A. Parker, ScD, Cstat Rochelle Walensky, MD, MPH Jordan Francke Michael Girouard Melanie Gaynes Margo Jacobsen Sarah Park Marion Robine Amanda Su

Is It Worth It? Comparison of Strategies     Incremental Health Benefits Incremental Cost Yes No (Evaluate ICER) Evaluate ICER

ParameterInput Mean CD4 (cells/μL) wk virologic suppression92% Loss to follow-up rate (/100 py)3.4 Average partners (/mo) South Africa0.014 India0.007 Transmission rate (/100 py) Model Input Parameters: Cohort, Treatment, and Transmission

South AfricaIndia ART (/mo)13 11 OI treatment300-1, Routine care300-2, per capita GDP*8,1001,500 1 WHO Global Price Reporting Mechanism *WHO thresholds: “Very cost-effective”: <1x per capita GDP *“Cost-effective”: <3x per capita GDP Model Input Parameters: Costs (2011 US$)

Results: Cost-effectiveness (Lifetime) Life expectancy (years) Costs (USD 2011) ICER † ($/YLS) South Africa Delayed ART13.815,100-- Early ART15.816, India Delayed ART14.27,300-- Early ART15.88, † Including projected survival losses and cost increases associated with 1 st - and 2 nd -order transmissions per capita GDP: South Africa ($8,100); India ($1,500) Walensky et al. NEJM

The “Tutu Tester” Cape Town, South Africa 4,000 people, HIV prevalence 10.2% Hypertension 38.2% Diabetes 4.1% Govindasamy et al, PLoS One PEPFAR Supplement to AI

Cost-effectiveness Ratios for Other Screening Programs C-E ratio Screening Program ($/QALY)* Reference HIV screening inpatients $38,600Walensky AJM 2005 HIV screening every 5 years high risk patients $50,000Paltiel NEJM 2005 Breast cancer screeningSalzmann Annual mammogram, 50–69 y/o $57,500Ann Intern Med 1997 Colon cancer FOBT + SIG q5y, adults 50–85 y/o $57,700 Frazier JAMA 2000 Diabetes Mellitus, Type 2 fasting plasma glucose, adults >25 y/o $70,000CDC JAMA 1998 *All costs adjusted to 2001 US dollars

C-E Ratio Intervention Agent ($/QALY)*Reference PCP/Toxo proph. TMP-SMX $2,800 Freedberg JAMA 1998 ART AZT/3TC/EFV $11,700 Freedberg NEJM 2001 Resistance Test ---$20,200 Weinstein Annals 2001 Resistance Test (naïve) --- $23,900 Sax CID 2005 Inpt HIV screening --- $38,600 Walensky AJM 2005 MAC proph.Azithromycin $43,300 Freedberg JAMA 1998 HIV screening q5y --- $50,000P altiel NEJM 2005 high risk patients high risk patients Cost-effectiveness Ratios for HIV Care *All costs adjusted to 2001 US dollars