In December 1982, the Centers for Disease Control and Prevention (CDC) reported receiving reports of unexplained immunodeficiency and opportunistic infections (OIs) in children under 2 years of age, including 2 cases in New York City. An additional 6 cases of young children with OIs and immunodeficiencies were under investigation and another 12 young children (between 1 and 4 years of age) were reported with immunodeficiencies but without OIs, all reported from New York City, New Jersey, and California. Addressing the initial 4 cases, the CDC notes that “[t]ransmission of an ‘AIDS agent’ from mother to child, either in utero or shortly after birth, could account for the early onset of immunodeficiency in these infants.”1
As part of its response to the beginnings of what was to become the AIDS epidemic, the New York State Department of Health (NYSDOH) began extensive efforts in 1987 to determine the prevalence, distribution, and trends of HIV infection in the populations of the state. Among the populations selected for blind testing of available blood samples to provide “windows” on the epidemic were newborns, whose antibody seroprevalence reflected HIV infection in childbearing women.2 “For each of these windows, the objectives were to (1) establish the baseline prevalence and geographic distribution of infection; (2) monitor trends of infection overall and in various populations, including age and racial/ethnic groups; and (3) use the information to target and design preventive activities.”2
Eliminating mother-to-child transmission (MTCT) of HIV has been one of New York State's (NYS) public health priorities. The CDC has also adopted the goal of eliminating MTCT of HIV, which it defines as a transmission rate of less than 1% of exposed infants and less than 1 case of MTCT of HIV per 100,000 live births.3 In 1990, the results of NYS's newborn seroprevalence study showed that almost 1900 HIV-positive women gave birth in the state.4 Between 475 and 760 of these women's newborns were estimated to be HIV-infected, corresponding to an estimated transmission rate of 25%–40%.5 Within less than 25 years, in 2013, fewer than 460 HIV-positive women gave birth in NYS, with only 2 of their infants infected—a transmission rate of 0.5%. In 2013, with a transmission rate of 0.5% and 0.85 cases of MTCT of HIV per 100,000 live births, the state met both criteria set by the CDC for eliminating MTCT of HIV. This reduction in MTCT of HIV in NYS was accomplished through a multifaceted public health program comprising interventions, including universal newborn HIV testing through the state's Newborn Screening Program (NSP) beginning in 1997, intended to maximize the benefits of advances in both the diagnosis and treatment of HIV infection.6 This article reports the results of an analysis intended to estimate a financial return on investment (ROI) of NYS's efforts to prevent MTCT of HIV.
Estimating NYS's investment during the 16-year period for several categories of services that were directly associated with preventing MTCT of HIV-involved combining program and surveillance data with costs for specific services. Program and surveillance data from several sources administered by the NYSDOH were used to project the number of MTCTs of HIV that were averted. The methods for collecting and using these program and surveillance data from various sources have evolved over time, details of which have been previously published.4 Collection of program and surveillance data has been multidisciplinary, with the active participation of HIV/AIDS surveillance staff, technical and scientific staff in the Wadsworth Center (the NYSDOH public health laboratory), and NYSDOH AIDS Institute staff who oversee and monitor programs and services for compliance with NYS regulations and requirements associated with reimbursement and/or grant funding.
We calculated the ROI from the perspective of NYS for the 16-year period 1998 through 2013 for the expenditures on HIV counseling and testing, zidovudine (ZDV) prophylaxis for mothers and their newborns, and a portion of the NYSDOH's NSP attributable to HIV antibody screening of newborns. The ROI was calculated as program benefits (the averted HIV-related medical costs associated with perinatal HIV infections prevented) divided by the expenditures and provides the return on $1 invested in the state's efforts to eliminate MTCT of HIV. We used the following formula to calculate the ROI:
An ROI greater than $1 would indicate that benefits (savings in terms of treatment costs averted) exceeded the investment made to achieve those benefits.
Estimating Intervention Costs to Prevent MTCT
The following categories of service are directly associated with preventing MTCT and are included in this analysis: prenatal HIV counseling and voluntary testing of pregnant women not known to be HIV-infected, as required by state regulation; repeat testing of HIV-negative women in their third trimester that was recommended by the NYSDOH in 2007; increased frequency of CD4 and viral load testing during the final 20 weeks of pregnancy; initiating ZDV prophylaxis for pregnant women at 12–14 weeks of pregnancy and which continued through 40 weeks; and initiating ZDV prophylaxis for newborns. In addition and beginning in 1999, health care facilities received enhanced Medicaid payments for HIV counseling during expedited testing rendered during labor and delivery. The state's Medicaid fee schedule was the basis for payments for these services, whether mother and infant were covered by Medicaid or not. Finally, a portion of costs of the state's NSP was included in the cost calculation, as this program serves as a safety net for identifying exposed infants. All clinical services were priced at the Medicaid fee schedule and expressed in 2013 US dollars.
Estimating the Number of HIV-Infected Women Giving Birth
The numbers of pregnant women who were either aware of their HIV status or required HIV testing during pregnancy or at labor and delivery to determine their HIV status were derived from reports made to the state's NSP. (As of February 1997, HIV antibody testing was added to the state's NSP panel of tests conducted on all infants born in the state. Each mother's prenatal test history was collected on the infant's newborn screen blood collection form). In addition, as part of the NYSDOH's Maternal-Pediatric HIV Prevention and Care (MPPC) Program, the prenatal, delivery, infant neonatal, and pediatric records for each HIV-exposed birth event were reviewed to assure that the mother was counseled and tested for HIV during pregnancy and that mother and infant are offered antiretroviral (ARV) prophylaxis with ZDV if the mother was identified as HIV-infected. We also used the results of these reviews to estimate the number and proportion of women who were Medicaid recipients (Birth facilities received enhanced payment through the Medicaid program for HIV counseling of Medicaid recipients when expedited HIV testing was provided during labor and delivery).
Projecting the Number of MTCTs of HIV and HIV Medical Care Costs Averted
When routine screening of newborns for HIV through the state's NSP began in New York in 1997, the incidence of MTCT of HIV was 11.5%.4 To project the number of HIV-infected infants that would have been born between 1998 and through 2013, we assumed this prevalence would continue and extrapolated for each year of that 16-year period. The difference between these projected and actual numbers of perinatally HIV-infected children is calculated for each of those years and then summed.
Threshold and Sensitivity Analysis
We conducted a threshold analysis to determine the fewest number of MTCTs at which ROI values would be $1.00 or positive. As our analysis is performed retrospectively, based on the state's experience, key parameters were known with certainty. For example, the percentage of HIV-infected mothers receiving prenatal HIV testing increased from 50% during 1997 (the year before our analysis) to 95% by 2002 and has been maintained at 96% since 2004.4 Although current costs for HIV testing and medications were used to determine the ROI, we can account for the sensitivity of the base case analysis to these costs through the threshold analysis.
We used a recently published estimate of lifetime HIV-related medical care costs to estimate the costs averted from preventing an MTCT of HIV. This value, given as $357,498 (expressed in 2013 US dollars), includes HIV-related prescription drugs, hospitalization, laboratory testing, and outpatient care over an average survival time of 35.2 years depending on the timing of diagnosis (early versus late) and CD4 count at diagnosis, entry into care, and initiation of ARV therapy.7,8
Calculating the Return on Investment
We project that 1205 cases of MTCT of HIV would have occurred in NYS during the 16-year period ending 2013 if the 11.5% rate of MTCT of HIV would have continued, compared with the 307 transmissions that were identified through the state's Maternal-Pediatric HIV Prevention and Care Program for the same period, a reduction of 898 infections or 74.5%. Table 1 and Figure 1 present the difference between the projected and actual numbers of perinatally HIV-infected children between 1998 and 2013. HIV-related medical care costs saved from averting these perinatal infections were estimated to be $321.03 million (898 HIV infections averted × $357,498). As shown in Table 2, expenditures for services directly associated with preventing MTCT of HIV, including an allocation of costs for the state's NSP, total $81.07 million.
To calculate the financial ROI, we divide the estimated amount of HIV medical care costs averted by the expenditures for services directly associated with preventing MTCT of HIV. This calculation—$321.03 million/$81.07 million—yields an ROI value of $3.96, a savings of almost $4 for every $1 invested. Net savings—the difference between $321.03 million in estimated costs averted and the $81.07 million in expenditures incurred to achieve these averted costs—is $239.96 million.
The threshold analysis demonstrated that with as few as 224 MTCTs averted (just under 25% of the projected 898 infections) or with almost a 4-fold increase in program costs, ROI values would remain positive. Similarly, ROI values remain positive under the assumption that, rather than remain constant, the MTCT rate of 11.5% experienced in 1997 declined at a uniform pace each year to reach 0.5% by 2013 (Data not shown).
Our findings demonstrate that, on the basis of a business case, the state's investment in clinical services and programs to eventually eliminate MTCT of HIV disease produced substantial dollar savings in averted HIV medical care for infants born of HIV-infected mothers. The analysis provides justification—albeit retrospectively—for the decision to allocate resources in terms of the benefits realized. For every $1 invested in preventing perinatal HIV infections, almost $4 in HIV treatment costs have been saved.
The ROI perspective allows us to examine the value of the benefits associated with an investment of resources to achieve those benefits. We view the expenditures directed to efforts to prevent MTCT of HIV, not as costs but as an investment, as befits providing a business case for a program to demonstrate that the program is at least cost-neutral, if not cost-saving.9,10 This perspective recognizes the ultimate goal of eliminating MTCT of HIV and the improvements in the health of both newborns and their HIV-infected mothers that have been and continued to be achieved. Our study does not attempt to measure all short- and long-term benefits from averting MTCT of HIV but represents a relatively conservative assessment of the savings that accrued from the implementation of the efforts of the state and its partners to achieve the elimination of MTCT of HIV.
An important limitation to our analysis is our assumption that the 11.5% rate of MTCT of HIV, which was the rate experienced in the state in 1997 as determined from the routine screening of newborns that was implemented in that year, would continue. Some drop in this rate might have occurred in 1998 and in the following years without state-supported interventions established to be effective in MTCT prevention. However, changes in medical practice alone would not likely have shown the rapid benefit realized from the speed with which the implementation of practices such as prenatal HIV testing and ARV therapy of mothers and infants, the population-based surveillance made possible by the state's NSP, as well as the educational and regulatory pressures exerted statewide by the NYSDOH and its partners to assure that best practices were implemented quickly, supported, and sustained. Nevertheless, a threshold analysis shows that the break-even point for the state's investment would be to prevent only 224 perinatal HIV infections, corresponding to just under a 25% decrease in the number of transmissions and far less than our projected reduction. Smaller numbers of HIV infections averted than projected in our base case analysis, should infants born to HIV-infected mothers later acquire HIV (eg, through breastfeeding or should infants fail to complete their course of treatment), would still result in a positive ROI even while recognizing that an HIV infection is not averted but only delayed (thereby reducing the projected cost savings).11
In addition, our analysis was conducted from the perspective of NYS. Other funding support from commercial and other third-party payors, the federal government, or community-level investments to prevent MTCT are not included in this analysis. This should not be taken to discount the importance of these resources, and Medicaid payment levels were used to value the services accessed by both Medicaid and non-Medicaid populations.
NYS has developed a comprehensive system of HIV-related prevention and health care services for its residents, including NYS-specific clinical guidelines that recommend combination ARV therapy for all HIV-infected adolescents/adults.12,13 This includes combination ARV therapy to all pregnant women for maternal indications.13 HIV-positive residents of NYS also have excellent access to ARV medications through Medicaid, private insurance, and the NYSDOH's AIDS Drugs Assistance Program.
Consequently, we restricted this analysis to care provided to pregnant women that was over and above care provided to nonpregnant women, specifically additional HIV counseling and laboratory monitoring and ZDV prophylaxis. A January 30, 1998 Morbidity and Mortality Weekly Report14 on recommendations for use of ARV drugs in pregnant HIV-infected women for maternal health and reducing perinatal transmission stated that the 3-part ZDV chemoprophylaxis regimen (antepartum and intrapartum and neonatal) should be recommended for all HIV-infected pregnant women to reduce the risk for perinatal transmission, whether or not an ARV therapy regimen has already been initiated. If the current therapeutic regimen a pregnant HIV-infected woman is receiving does not contain ZDV, the addition of ZDV or substitution of ZDV for another nucleoside analog ARV is recommended.14 This recommendation remained constant through our study period.
In other respects, we feel our analysis has taken a conservative perspective. In estimating the total amount of HIV treatment costs saved, we used a recently published cost per HIV infection averted that considered care for an adult whose life expectancy after infection (per our calculation) exceeded 35 years and which assumed an average age at infection of 35 years (Farnham et al8 provided life expectancy after infection by ranges of CD4 count and estimates of the proportions of persons diagnosed with HIV within these ranges. We used these to determine an average weighted life expectancy or survival time of 35.2 years after infection). To our knowledge, the most recent estimates of lifetime treatment costs for perinatally HIV-infected children were based on shorter survival times.15,16 As survival time increases among perinatally-infected HIV newborns, as has been demonstrated in older populations,17 we would expect that treatment costs would increase as well.16 In addition, whereas only HIV treatment costs were used, costs for social, cognitive, or developmental conditions or other caregiver services that perinatally HIV-infected children may require15 were not reflected in the lifetime HIV treatment cost figure we used.
Our analysis demonstrates the positive financial return that was achieved through implementing prevention efforts to achieve the reduction in and gradually the elimination of MTCT of HIV. However, this is not to ignore the resulting reduction in human suffering that was realized as well and attributable not just to the state's investment in prevention and care services but also from the evolving standards of care for HIV-infected pregnant mothers and their HIV-exposed infants. The implementation of these standards has been and continues to be funded, in part, through the state's Medicaid program and other sources of support including private health insurance and put into practice by those caring for these populations.
Elimination of MTCT of HIV is not a one-time accomplishment but requires ongoing efforts that will require constant evaluation and refocusing of public health activities. Among the challenges that will be faced include sustaining high rates of prenatal HIV testing; ensuring that all HIV-exposed newborns have complete diagnostic testing; recognizing and addressing the intensive multisystem needs of women with such comorbidities as mental health and substance abuse, especially in the face of such psychosocial stressors as poverty and homelessness; the varied cultural and linguistic characteristics of immigrant populations; and, above all, sustaining the necessary resources to maintain an effective public health program that is intended to address these and other challenges to eliminating MTCT of HIV.
The authors acknowledge the advice and recommendations of Alvaro Carrascal, MD and Humberto Cruz, both formerly of the NYSDOH's AIDS Institute. The authors also acknowledge Felicia Schady and Ira Feldman for their review of an earlier draft and their thoughtful comments and suggestions and Wilson Miranda for assistance with data collection.
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