Cost-effectiveness of the prevention of parent-to-child transmission guidelines of HIV in India

Abstract

Background

One of the modes of transmission of HIV infection in India is from mother-to-child. In 2014, Prevention of Parent-to-child Transmission (PPTCT) guidelines of HIV in India were implemented which included shifting from Option A to Option B and B+. The aim of the present study was to evaluate health and cost related outcomes after implementation of these new guidelines.

Methods

A decision analytical model was used to compare the PPTCT Option A with the new WHO Option of B and B+. Transmissions in serodiscordant couples and infants at 18 months were considered as health outcomes. The estimation of the cost for PPTCT services and HIV treatment was done using Costing Tool for Elimination Initiatives (CTEI) developed by National Center for Global Health and Medicine (NCGM).

Results

The reduction in transmission rates in HIV infants was 33%. In serodiscordant couples the reduction in risk of HIV transmission from Option A to Option B and B+ was 72% and 87%, respectively. The incremental cost-effectiveness ratio (ICER) per quality adjusted life years (QALY) gained by averting infant infection, and for both infant and partner was US$ 238 and US$ 181 for Option B and US$ 1265 and US$ 947 for Option B+, respectively.

Conclusion

It was found that Options B and B+ are more cost-effective as compared to option A. This effectiveness further increases when prevention of partner infections in Option B and B+ is taken into account.

Introduction

In children below 14 years, the major route of HIV infection is through mother also called as Parent-to-child Transmission (PTCT).¹ The transmission of virus to child from HIV mother is 15%–45% if mother is not treated. However, if effective treatment with antiretrovirals (ARVs) to mother and short course to child during pregnancy, labor, delivery, and breastfeeding² is given, the transmission rate can be reduced to below 5%. Since 2010–2018, globally, 1.4 million new child infections have been averted by administering ARV medicines during pregnancy or as life long therapy to mother. The percentage of women on ARV therapy has risen from 51% in 2010 to 80% in 2017.³

India aims to eliminate vertical transmission by 2020 and AIDS by 2030, as it is a signatory to the UNAIDS goal of elimination. In our country the prevention of parent to child transmission (PPTCT) program was initiated in 2002; and thereafter in Jul 2010, there was the convergence of National AIDS Control Programme with the flagship programme of National Rural Health Mission so as increase coverage of HIV treatment to pregnant women. In 2013, the Department of AIDS Control adopted the WHO guidelines and shifted from Option A to providing ARVs during pregnancy and breastfeeding (Option B) and lifelong ARVs (Option B+)^4,5 anticipating that this shift will reduce the transmission from mother to child below 5%. ARVs help in not only improving HIV positive women’s own health but also benefits the HIV negative partners besides reducing transmission risk to children.^{6, 7, 8}

India implemented the new guidelines for PPTCT in 2014. This paper aims to study the health-related outcomes due to implementation of WHO guidelines for PPTCT in India. The study also aims at evaluating the cost outcomes of the 2013 guidelines of PPTCT in India.

Material and methods

A decision analytical model was used for comparison of the PPTCT Option A with the new WHO 2013 Option of B and B+. Assuming an annual cohort of HIV-infected pregnant women in India was modeled as per Option A of PPTCT after CD4 assessment for ARV initiation. In Option B and B+ ARV is provided without CD4 assessment. The study was approved by the Institutional Ethics Committee and informed consent was obtained from all the subjects.

Main outcomes

We considered the health outcomes as HIV transmission to child at 18 months and HIV transmission to serodiscordant partners. The cost of the program was evaluated using Costing Tool for Elimination Initiative (CTEI)⁹ developed by National Center for Global Health and Medicine (NCGM) in collaboration with Asia–Pacific United Nations Task Force for PPTCT. The CTEI tool is a holistic costing tool which estimates the costs and health outcomes of PPTCT. The aim of this tool is to support countries to estimate the costs of eliminating new pediatric HIV infections and congenital syphilis and improving the health and survival of mothers and children. The tool is for policy-makers and program managers as well as for those involved in the program in the country.

The time horizon considered was 15 years with the baseline year as 2019, long enough, to capture the intended and unintended benefits and harms of the implementation of new PPTCT policy. Thus, PPTCT costs were calculated for treatment of number of new infections in infants and serodiscordant couples averted for 15 years. The incremental cost-effectiveness ratio (ICER) was calculated for the number of infections averted for child and partner as well as the quality-adjusted life years (QALY) gained. All the costs were calculated in US$. QALY gained for single avertion of HIV infection was calculated as difference between QALY without HIV infection and QALY with HIV infection. We assigned a QALY of one for child without HIV infection, i.e., healthy child and 0.83 for HIV infected. WHO criteria⁹ for interpretation of cost-effectiveness was considered.

Data

Demographic and epidemiological data and model input data (Table 1) was obtained from the national surveys, namely NFHS-5¹⁰, conducted in 2019–2021. The chance of perinatal infection was estimated from UNAIDS reference group.¹¹ The costs were estimated for a time zone of 15 years. The inputs on data regarding demographics and PPTCT program were obtained from the latest National AIDS Control Organization reports of 2020 for India.¹² WHO global price reporting mechanism provided was sourced for getting the costs, of the ARVs and the various laboratory tests.¹³ The health services costs were obtained from WHO-CHOICE.¹⁴ All the costs were discounted at 3% annually. Supplementary tables provide the inputs at national level for various variables and calculation of the cost of PPTCT. Sensitivity analysis was carried out by varying the prevalence of HIV among pregnant women in India from 0.1% to 0.5%, and the utilization of health services was ranged from 90% to 99%.

Table 1.

Model inputs.

Input	Value	Reference
Annual number of births (2018–2019)	29,912,600	19
HIV prevalence among pregnant women (%)	0.35%	19
Discordant rate (HIV + women aged 15–49 with HIV-partner	24%	20
CD4 cell count distribution		21
<350	45.4%
>350	54.6%
Perinatal HIV transmission
Peripartum period		22
No prophylaxis CD4<350	27–37%
No prophylaxis CD4>350	15%
Option A/B	2%
ART	2%
Postnatal period	Per month of breastfeeding	23
No prophylaxis CD$<350	1.57%
No prophylaxis CD4>350	0.51%
Option A/B	0.2%
HIV transmission to serodiscordant partner (per 100 person-year)		7,24, 25, 26, 27
No ART CD4<350	9.2%
No ART CD4>350	1.7%
On ART CD4<350	0.7%
On ART CD4>350	0.1%
Health services
Antenatal care attendance (at least once)	84%	19
HIV testing among ANC attendees	82%	19
Quality-of-life years (QALYs)		28
Healthy infant	1
HIV infected infant	0.84

Results

The estimated number of pregnant women in India for 2018–2019 is 29,912,600. With HIV prevalence of 0.35% among pregnant women, there would be 104,694 HIV-positive pregnant women. Assuming 12 months of breastfeeding and applying perinatal HIV infection rate as given in Table 1 with current coverage of PPTCT services, there would be 15,704 new HIV infections coverage by Option A and 10469 by Option B and B+, amounting to a reduction by 33% by shifting the options. Similarly, the new infections in serodiscordant couples would be 2311, 653 and 553 by Option A, B and B+ respectively. This implies a reduction by 72% and 87% by shifting from Option A to B and B+. The costs were estimated by CTEI for various scenarios for Option A, B and B+. The costs were estimated by CTEI for various scenarios for Option A, B, and B+. Two additional scenarios were worked out with improved service coverage to 90% and best service coverage to 99%. The time horizon considered was 15 years. The risk of HIV infection reduced from 11.2% to 6.4% when service coverage is improved to 90% and reduced to 2% with the best service coverage of 99% (Fig. 1). The cost per HIV-positive pregnant women and infant is US$ 105 for Option A and US$ 180 and US$ 104 for Option B with breastfeeding and replacement feeding, respectively. For Option B+, the cost was US$ 218. The total cost of PMTCT services US$ 57, 536, 097 for Option A for an annual cohort of 29, 912, 600 pregnant women (around 29 million women were pregnant in India in 2019), US$ 58, 569, 396 for Option B, and US$ 63, 031, 355 for Option B+ (Fig. 2). Cost for each avertion of new infection in infants was US$ 3, 089 for Option A, US$ 3144 for Option B, and US$ 3384 for Option B+. With the inclusion of partner infection prevention, the cost became US$ 3145 for Option B and US$ 3385 for Option B+. The ICER per QALY gained for per infant infection averted was US$ 238 for Option B and US$ 1265 for Option B+. Similarly, the incremental cost per QALY gained for both infant and partner was US$ 181 for Option B and US$ 947 for Option B+. Since the costs are below the annual GDP per capita of US$ 2099 for India in 2019, Option B and B+ are very cost-effective. The cost effectiveness further increases reduction in partner infections is also considered. Summary cost analysis is shown in Table 2. Figure 2 shows the costs of PPTCT in US$, and Fig. 3 depicts the cost outcomes of PPTCT in US$.

Fig. 1.

Parent-to-child transmission of HIV.

Fig. 2.

Total costs of PPTCT (US$) for 15 years of time horizon.

Table 2.

Summary of cost analysis.

	2010 guidelines	2013 guidelines
	Option A	Option B	Option B+
Costs (US$)
Cost of PPTCT program (For a period of 24 months (from 14 weeks of pregnancy to 18 months after delivery) per annual cohort of 29,912,600 pregnant women which is the estimate for 2019 for India)	57,536,097	58,569,396	63,031,355
Number of infections
Infants	15,704	10,469	10,469
Partners	2311	653	553
Total	18,015	11,122	11,022
QALYs gained
Infants		4345	4345
Partner		5712	5804
Cost per infection averted (US$)
Infant infection only	3089	3144	3384
Infant and partner infection	3089	3145	3385
ICER per QALY gained (US$)
Infant infection only		238	1264.73
Infant and partner infections		180.61	946.77

Fig. 3.

Costs of PPTCT (US$).

Sensitivity analysis was carried out by varying the prevalence of HIV among pregnant women in India from 0.1% to 0.5%, and the utilization of health services were ranged from 90% to 99%. With varying HIV prevalence, the new infant infections ranged from 4487 to 22,434 for Option A to 2991 to 14,956 for Option B and B+. Similarly, new partner infection ranged 660 to 3302, 187 to 933, and 158 to 790 by Option A, B, and B+, respectively. Accordingly, the cost of PPTCT in US$ for 15 years for Option A ranged from US$ 52, 937, 043 to 60, 295, 530, for Option B the cost ranged from US$ 53, 232, 271 to 61, 771, 670, and for Option B+ the costs ranged from US$ 54, 507, 117 to 68, 145, 898. The ICER per QALY gained with consideration of infant and partner both, for Option B, for 0.1% and 0.5% HIV prevalence ranged from US$ 181 to US$ 751, respectively, whereas for Option B+, it ranged from US$ 947 to US$ 3765, respectively. When the utilization of health services varied from 90% to 99%, the HIV transmission rate decreases to 6.4% and 2.0%, respectively. The total cost of PPTCT ranged from US$ 79, 038, 567 to US$ 91, 315, 286 for Option B+, respectively.

Discussion

Our study compared the health and cost outcomes for new PPTCT guidelines of Option B and B+ with Option A. To the best of knowledge, this is the first study in India to conduct the cost-effectiveness of new WHO guidelines. Our study reveals that Option B and B+ are very cost-effective as compared to Option A in India. The new HIV infections in infants reduced by 33% by adopting Option B and B+ which was mainly achieved as ART access increased in pregnant women with <350 CD4 count. The PPTCT program under NACP in India aims for more than 95% HIV testing coverage and offers free counseling and testing for HIV to pregnant women which has resulted in almost 82% of total estimated pregnant women being tested for HIV in India in 2019–2020. It is well documented that, the initiation of ART in pregnant women reduces the risk of child transmission to less than 1%. The shift to new guidelines resulted in 72% reduction in infection rate in serodiscordant couples and also that the new guidelines are very cost-effective when partner infections are accounted for. Cost-effectiveness studies in other countries have also documented that Option B+ is more cost-effective. A study from China¹⁵ found that 2013 guidelines averted around 1017 infections, and QALYs gained were 58,801. Option B+ was more cost-effective with ICER of $32.99 per QALY acquired in infants and $5149 per life year gained in mothers. A simulation model in four countries¹⁶ with similar age of HIV infection found Option B+ as most cost-effective. Similarly, a study in Uganda¹⁷ estimated total cost per health center for the Option B+ and found the biggest driver as the provision of ART to mothers. A study from Malavi¹⁸ also found that Option B+ improved ten-year survival in mothers and also yielded ICER of US$ 455 per life year gained.

Conclusions and recommendations

The rate of HIV infection is reduced by shifting from option A to Option B and B+ in India with an estimated reduction in transmission risk by 33% within current service coverage. There was a reduction in transmission risk by 72% and 87% to serodiscordant partner with option B and B+ respectively. The ICER per QALY gained by averting infant infection and for both infant and partner was US$ 238 and US$ 181 for Option B and US$ 1265 and US$ 947 for Option B+ respectively. Shifting to new WHO guidelines of option B and B+ is very cost effective.

Disclosure of competing interest

The authors have none to declare.

Appendix A. Supplementary data

The following is the supplementary data to this article: