Universal Opt-Out Screening for HIV in Health Care Settings, Cost Effectiveness in Action Douglas K. Owens, MD, MS VA Palo Alto Health Care System and Stanford University Stanford Health Policy

Source: UNAIDS Total: 35.0 million [33.2 million – 37.2 million] Middle East & North Africa [ – ] Sub-Saharan Africa 24.7 million [23.5 million – 26.1 million] Eastern Europe & Central Asia 1.1 million [ – 1.3 million] Asia and the Pacific 4.8 million [4.1 million – 5.5 million] North America and Western and Central Europe 2.3 million [2.0 million – 3.0 million] Latin America 1.6 million [1.4 million – 2.1 million] Caribbean [ – ] Adults and children estimated to be living with HIV  2013

3 CDC and US Preventive Service Task Force Recommend Screening CDC, prior to September 2006: » Assess risk behaviors; screen high risk » Routine voluntary screening if prevalence is 1% or greater CDC, current » Routine screening in all health care settings (prevalence > 0.1%) USPSTF: Universal screening in health care settings (prevalence > 0.1%)

Rewind, circa 2005: Should voluntary HIV screening be expanded in the U.S?

About one-quarter of HIV-infected people were unaware of their infection More than half of HIV-infected adolescents were unaware 79% of HIV-infected MSM aged were unaware in 5 city survey CDC MMWR Sept 22, 2006, vol 55:No RR-14, see p. 2 and 5 In 2005:

6 HIV infection was often diagnosed late in the course of disease CDC Surveillance: 41% of patients developed AIDS within a year of diagnosis with HIV VA: 40% had CD4 count < 200 at diagnosis Up to 20,000 new infections per year in the U.S from people unaware they are infected (CDC)

8 Two approaches to screening: targeted or routine screening Targeted screening: assess risk behaviors, screen if high risk » MSM » IDU » Multiple partners » Exchange sex for money or drugs or have partners who do » Past or present partners HIV-infected, bisexual, or IDU » History of STD » Blood transfusion between » Requests testing

9 Routine screening offers screening to all people in a specified clinical setting Defined by type of setting » STD clinics » Homeless shelters » TB clinics » Clinics serving MSM Defined by prevalence » CDC: 1% prevalence (early 90’s)

10 Targeted screening: Why not just assess risk behaviors? 10% to 25% of people testing positive report no high-risk behaviors 1 Prospective study 2 in STD clinic: testing only those with reported high-risk behaviors missed 75% of HIV diagnoses Risk assessment likely less reliable in high-risk populations 1Chou et al, Ann Intern Med 2005; 143:55-73; 2Chen et al. Sex Trans Dis 1998; 25:539-43

11 Routine screening: Why not screen everyone? Potential disadvantages: » Medical harms: false-positive test result » Cost » Competing health care priorities

Costs and Effectiveness of Screening

13 Cost effectiveness analysis Compares two or more strategies » E.g., screening to no screening Assesses the incremental benefit and incremental cost of one strategy versus another Calculate the incremental cost-effectiveness ratio: Costs with screening – Costs without screening Benefits with screening – Benefits without screening

14 Interpreting the incremental cost-effectiveness ratio Less than $50,000 per QALY gained – considered good value $50,000 to $100,000 per QALY gained – usually considered good value Greater than $100,000 per QALY gained – sometimes considered expensive

15 We evaluated the costs and benefits of screening* Potential benefits » For HIV+: increased length and quality of life » For community: decreased transmission Costs » Screening and counseling costs » Costs of treatment (HAART, prophylaxis for opportunistic infections) * Sanders et al. NEJM 2005; 352:570-85

16 Screening strategies No screening » Testing for HIV only from case finding for symptomatic patients HIV screening » Symptom-based case finding AND » One-time or recurrent screening

Case Finding Only Screening and Case Finding Markov Model HIV Asymptomatic HIV Symptomatic AIDS UninfectedDeath HIV on HAART AIDS on HAART

What is the benefit to the person identified as having HIV?

Cost effectiveness, including reduction in transmission, 1% prevalence StrategyCostIncremental Cost QALYsIncremental QALYs CE $/QALY No Screening $52, Screening$52,816$ days$15,000

Effect of prevalence on cost effectiveness of screening

21 Screening is cost effective even at low prevalence Including transmission, screening is cost effective when prevalence is above 0.05% Implication: screening is cost effective likely in all but the lowest risk health-care settings

CDC screening guidelines

The American College of Physicians Guidance:

US Preventive Services Task Force Guideline

Summary CEAs demonstrated that screening in the US provided substantial health benefit: » To the HIV+ individual » To the community – reduced transmission The thresholds for CE helped inform the prevalence at which universal screening should be performed. Now in policy statements from CDC, USPSTF, ACP, AAP

Questions? Doug Owens