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BackgroundNew WHO guidelines recommend initiation of antiretroviral therapy for HIV-positive adults with CD4 counts of 500 cells per μL or less, a higher threshold than was previously recommended. Country decision makers have to decide whether to further expand eligibility for antiretroviral therapy accordingly. We aimed to assess the potential health benefits, costs, and cost-effectiveness of various eligibility criteria for adult antiretroviral therapy and expanded treatment coverage.MethodsWe used several independent mathematical models in four settings-South Africa (generalised epidemic, moderate antiretroviral therapy coverage), Zambia (generalised epidemic, high antiretroviral therapy coverage), India (concentrated epidemic, moderate antiretroviral therapy coverage), and Vietnam (concentrated epidemic, low antiretroviral therapy coverage)-to assess the potential health benefits, costs, and cost-effectiveness of various eligibility criteria for adult antiretroviral therapy under scenarios of existing and expanded treatment coverage, with results projected over 20 years. Analyses assessed the extension of eligibility to include individuals with CD4 counts of 500 cells per μL or less, or all HIV-positive adults, compared with the previous (2010) recommendation of initiation with CD4 counts of 350 cells per μL or less. We assessed costs from a health-system perspective, and calculated the incremental cost (in US$) per disability-adjusted life-year (DALY) averted to compare competing strategies. Strategies were regarded very cost effective if the cost per DALY averted was less than the country's 2012 per-head gross domestic product (GDP; South Africa: $8040; Zambia: $1425; India: $1489; Vietnam: $1407) and cost effective if the cost per DALY averted was less than three times the per-head GDP.FindingsIn South Africa, the cost per DALY averted of extending eligibility for antiretroviral therapy to adult patients with CD4 counts of 500 cells per μL or less ranged from $237 to $1691 per DALY averted compared with 2010 guidelines. In Zambia, expansion of eligibility to adults with a CD4 count threshold of 500 cells per μL ranged from improving health outcomes while reducing costs (ie, dominating the previous guidelines) to $749 per DALY averted. In both countries results were similar for expansion of eligibility to all HIV-positive adults, and when substantially expanded treatment coverage was assumed. Expansion of treatment coverage in the general population was also cost effective. In India, the cost for extending eligibility to all HIV-positive adults ranged from $131 to $241 per DALY averted, and in Vietnam extending eligibility to patients with CD4 counts of 500 cells per μL or less cost $290 per DALY averted. In concentrated epidemics, expanded access for key populations was also cost effective.InterpretationOur estimates suggest that earlier eligibility for antiretroviral therapy is very cost effective in low-income and middle-income settings, although these estimates should be revisited when more data become available. Scaling up antiretroviral therapy through earlier eligibility and expanded coverage should be considered alongside other high-priority health interventions competing for health budgets.FundingBill & Melinda Gates Foundation, WHO.

Objective To estimate the incremental cost over 5 years of a policy switch from the Option B to the Option B+ protocol for the prevention of mother-to-child transmission (PMTCT) of the human immunodeficiency virus (HIV). Methods Data from cost studies and other published sources were used to determine the cost, per woman and per cohort (1000 breastfeeding and 1000 non-breastfeeding women), of switching from Option B (maternal triple antiretroviral [ARV] regimen during pregnancy and breastfeeding plus daily nevirapine for the infant for 6 weeks) to Option B+ (maternal triple ARV regimen initiated during pregnancy and continued for life). The variables used to model the different scenarios were maternal CD4+ T lymphocyte (CD4+ cell) count (350-500 versus >500 cells/[micro]l), rate of decline in CD4+ cells (average, rapid, slow), breastfeeding status (yes, no) and breastfeeding duration (12, 18 or 24 months). Findings For women with CD4+ cell counts of 350-500 cells/pl, the incremental cost per 1000 women was 157 345 United States dollars (US$) for breastfeeding women and US$ 92 813 for non-breastfeeding women. For women with CD4+ cell counts > 500 cells/pl, the incremental cost per 1000 women ranged from US$ 363 443 to US$ 484591 for breastfeeding women and was US$ 605 739for non- breastfeeding women. Conclusion From a cost perspective, a policy switch from Option B to Option B+ is feasible in PMTCT programme settings where resources are currently being allocated to Option B. Objectif Estimer le surcout sur 5 ans d un changement de politique, avec le passage du protocole de l'Option B a celui de l'Option B+ dans le cadre de la prevention de la transmission de la mere a l'enfant (PTME) du virus de fimimunodefidence humaine (VIH). Methodes Des donnees issues d'etudes de couts et d'autres sources publlees ont ete utilisees pour determiner le cout, par femme et par cohorte (1000 femmes qui allaltent et 1000 femmes qui n'allaitent pas), du passage de l'Option B (traitement par tritherapie antiretrovirale [ARV] de la mere pendant la grossesse et l'allaitement, et administration quotidienne de nevirapine a l'enfant pendant 6 semaines) a l'Option B+ (traitement par tritherapie ARV initie pendant la grossesse et ensuite pris a vie). Les variables utilisees pour modeliser les differents scenarios ont ete la numeration des lymphocytes T CD4+ (cellules CD4+) chez la mere (350-500 contre > 500 cellules/[micro]l), la vitesse de la baisse des cellules CD4+ (moyenne, rapide, lente), la situation au regard de l'allaitement maternel (oui, non) et la duree de l'allaitement (12,18 ou 24 mois). Resultats Pour les femmes presentant une numeration des cellules CD4+ de 350-500 cellules/pl, le surcout pour 1000 femmes etait de 157 345 dollars pour les femmes qui allaitent et de 92 813 dollars pour les femmes qui n'allaitent pas. Pour les femmes presentant une numeration des cellules CD4+ > 500 cellules/[micro]l, le surcout pour 1000 femmes etait compris entre 363 443 dollars et 484 591 dollars pour les femmes qul allaitent et de 605 739 dollars pour les femmes qui n'allaitent pas. Conclusion En termes de couts, un changement de politique de l'Option B a l'Option B+ est possible dans le cadre du programme PTME ou les ressources sont actuellement affectees a l'Option B. Objetivo Estimar el coste adicional en 5 anos de un cambio en la politica del protocolo de la opcion B a la opcion B+ para la prevencion de la transmision de madre a hijo (PTMI) del virus de inmunodeficiencia humana (VIH). Metodos Se emplearon datos de estudios de costes y otras fuentes publicadas para determinar el coste, por mujer y por cohorte (1000 mujeres lactantesy 1000 mujeres no lactantes), al cambiar de la opcion B (regimen antirretroviral triple materno [ARV] durante el embarazo y la lactancia materna junto con nevlraplna diaria para el lactante durante 6 semanas) a la opcion B+ (regimen antirretroviral triple ARV Iniciado durante el embarazo y tomado de por vida). Las variables empleadas para modelar los diversos escenarios fueron el recuento de linfocitos (CD4+ celulas) CD4+ T maternos (350-500 frente a > 500 celulas/pl), la tasa de disminucion de CD4+ celulas (media, rapida, lenta), el estado de lactancia materna (si, no) y la duracion de la lactancia materna (12, 18 o 24 meses). Resultados En las mujeres con un recuento de CD4+ de 350-500 celulas/[micro]l, el coste adicional por 1000 mujeres fue 157 345 dolares de los Estados Unidos (US$) para las mujeres lactantes y US$ 92 813 para las mujeres no lactantes. En las mujeres con un recuento de CD4 + celulas de > 500 celulas/[micro]l, el coste adicional por 1000 mujeres vario de US$ 363 443 a US$ 484 591 en las mujeres lactantes y US$ 605 739 en las mujeres no lactantes. Conclusion Desde el punto de vista de los costes, un cambio en la politica de la B opcion a la opcion B+ es factible en la configuracion del programa de PTMI, en el que en la actualidad los recursos se estan destinando a la opcion B., Introduction In July 2011, a United Nations political declaration called for greater efforts to eliminate human immunodeficiency virus (HIV) infection and acquired immunodeficiency syndrome (AIDS). It established commitments and targets, [...]

OBJECTIVE: An analysis was conducted to estimate the costs of different potential post-polio certification immunization policies currently under consideration, with the objective of providing this information to policy-makers. METHODS: We analysed three global policy options: continued use of oral poliovirus vaccine (OPV); OPV cessation with optional inactivated poliovirus vaccine (IPV); and OPV cessation with universal IPV. Assumptions were made on future immunization policy decisions taken by low-, middle-, and high-income countries. We estimated the financial costs of each immunization policy, the number of vaccine-associated paralytic poliomyelitis (VAPP) cases, and the global costs of maintaining an outbreak response capacity. The financial costs of each immunization policy were based on estimates of the cost of polio vaccine, its administration, and coverage projections. The costs of maintaining outbreak response capacity include those associated with developing and maintaining a vaccine stockpile in addition to laboratory and epidemiological surveillance. We used the period 2005-20 as the time frame for the analysis. FINDINGS: OPV cessation with optional IPV, at an estimated cost of US$ 20 412 million, was the least costly option. The global cost of outbreak response capacity was estimated to be US$ 1320 million during 2005-20. The policy option continued use of OPV resulted in the highest number of VAPP cases. OPV cessation with universal IPV had the highest financial costs, but it also had the least number of VAPP cases. Sensitivity analyses showed that global costs were sensitive to assumptions on the cost of the vaccine. Analysis also showed that if the price per dose of IPV was reduced to US$ 0.50 for low-income countries, the cost of OPV cessation with universal IPV would be the same as the costs of continued use of OPV. CONCLUSION: Projections on the vaccine price per dose and future coverage rates were major drivers of the global costs of post-certification polio immunization. The break-even price of switching to IPV compared with continuing with OPV immunizations is US$ 0.50 per dose of IPV. However, this does not account for the cost of vaccine-derived poliovirus cases resulting from the continued use of OPV. In addition to financial costs, risk assessments related to the re-emergence of polio will be major determinants of policy decisions.

Meyer-Rath and Over assert in another article in the July 2012 PLoS Medicine Collection, 'Investigating the Impact of Treatment on New HIV Infections', that economic evaluations of antiretroviral therapy (ART) in currently existing programs and in HIV treatment as prevention (TasP) programs should use cost functions that capture cost dependence on a number of factors, such as scale and scope of delivery, health states, ART regimens, health workers' experience, patients' time on treatment, and the distribution of delivery across public and private sectors. We argue that for particular evaluation purposes (e.g., to establish the social value of TasP) and from particular perspectives (e.g., national health policy makers) less detailed cost functions may be sufficient. We then extend the discussion of economic evaluation of TasP, describing why ART outcomes and costs assessed in currently existing programs are unlikely to be generalizable to TasP programs for several fundamental reasons. First, to achieve frequent, widespread HIV testing and high uptake of ART immediately following an HIV diagnosis, TasP programs will require components that are not present in current ART programs and whose costs are not included in current estimates. Second, the early initiation of ART under TasP will change not only patients' disease courses and treatment experiences--which can affect behaviors that determine clinical treatment success, such as ART adherence and retention--but also quality of life and economic outcomes for HIV-infected individuals. Third, the preventive effects of TasP are likely to alter the composition of the HIV-infected population over time, changing its biological and behavioral characteristics and leading to different costs and outcomes for ART., More versus Less Detailed Cost Functions The results from the HTPN 052 trial reported in August 2011 demonstrated under the controlled conditions of a well-conducted clinical trial that early antiretroviral [...]

Objective To estimate the incremental cost over 5 years of a policy switch from the Option B to the Option B+ protocol for the prevention of mother-to-child transmission (PMTCT) of the human immunodeficiency virus (HIV). Methods Data from cost studies and other published sources were used to determine the cost, per woman and per cohort (1000 breastfeeding and 1000 non-breastfeeding women), of switching from Option B (maternal triple antiretroviral [ARV] regimen during pregnancy and breastfeeding plus daily nevirapine for the infant for 6 weeks) to Option B+ (maternal triple ARV regimen initiated during pregnancy and continued for life). The variables used to model the different scenarios were maternal CD4+ T lymphocyte (CD4+ cell) count (350-500 versus > 500 cells/μl), rate of decline in CD4+ cells (average, rapid, slow), breastfeeding status (yes, no) and breastfeeding duration (12, 18 or 24 months). Findings For women with CD4+ cell counts of 350-500 cells/μl, the incremental cost per 1000 women was 157 345 United States dollars (US$) for breastfeeding women and US$ 92 813 for non-breastfeeding women. For women with CD4+ cell counts > 500 cells/μl, the incremental cost per 1000 women ranged from US$ 363 443 to US$ 484 591 for breastfeeding women and was US$ 605 739 for non-breastfeeding women. Conclusion From a cost perspective, a policy switch from Option B to Option B+ is feasible in PMTCT programme settings where resources are currently being allocated to Option B. [ABSTRACT FROM AUTHOR]

Objective To estimate the incremental cost over 5 years of a policy switch from the Option B to the Option B+ protocol for the prevention of mother-to-child transmission (PMTCT) of the human immunodeficiency virus (HIV). Methods Data from cost studies and other published sources were used to determine the cost, per woman and per cohort (1000 breastfeeding and 1000 non-breastfeeding women), of switching from Option B (maternal triple antiretroviral [ARV] regimen during pregnancy and breastfeeding plus daily nevirapine for the infant for 6 weeks) to Option B+ (maternal triple ARV regimen initiated during pregnancy and continued for life). The variables used to model the different scenarios were maternal CD4+ T lymphocyte (CD4+ cell) count (350-500 versus > 500 cells/μl), rate of decline in CD4+ cells (average, rapid, slow), breastfeeding status (yes, no) and breastfeeding duration (12, 18 or 24 months). Findings For women with CD4+ cell counts of 350-500 cells/μl, the incremental cost per 1000 women was 157 345 United States dollars (US$) for breastfeeding women and US$ 92 813 for non-breastfeeding women. For women with CD4+ cell counts > 500 cells/μl, the incremental cost per 1000 women ranged from US$ 363 443 to US$ 484 591 for breastfeeding women and was US$ 605 739 for non-breastfeeding women. Conclusion From a cost perspective, a policy switch from Option B to Option B+ is feasible in PMTCT programme settings where resources are currently being allocated to Option B. [ABSTRACT FROM AUTHOR]

While the Interagency Task Team on the Prevention and Treatment of HIV Infection in Pregnant Women, Mothers, and Children (IATT) partnership existed before the Global Plan Towards the Elimination of New HIV Infections Among Children by 2015 and Keeping Their Mothers Alive (Global Plan), its reconfiguration was critical to coordinating provision of technical assistance that positively influenced country decision-making and program performance. This article describes how the Global Plan anchored the work of the IATT and, in turn, how the IATT's technical assistance helped to accelerate achievement of the Global Plan targets and milestones. The technical assistance that will be discussed addressed a broad range of priority actions and milestones described in the Global Plan: (1) planning for and implementing Option B+; (2) strengthening monitoring and evaluation systems; (3) translating evidence into action and advocacy; and (4) promoting community engagement. This article also reviews the ongoing challenges and opportunities of providing technical assistance in a rapidly evolving environment that calls for ever more flexible and contextualized responses. The effectiveness of technical assistance facilitated by the IATT was defined by its timeliness, evidence base, and unique global perspective that built on the competencies of its partners and promoted synergies across program areas. Reaching the final goal of eliminating vertical transmission of HIV infection and achieving an AIDS-free generation in countries with the highest HIV burden requires that the IATT partnership and technical assistance remain responsive to country-specific needs while aligning with the current programmatic reality and new global goals such as the Sustainable Development Goals and 90-90-90 targets.

Objective: In Botswana, a 36-month course of isoniazid treatment of latent tuberculosis (TB) infection [isoniazid preventive therapy (IPT)] was superior to 6-month IPT in reducing TB and death in persons living with HIV (PLHIV), having positive tuberculin skin tests (TSTs) but not in those with negative TST. We examined the cost-effectiveness of IPT in Botswana, where antiretroviral therapy (ART) is widely available., Design: Using a decision-analytic model, we determined the incremental cost-effectiveness of strategies for reducing TB and death in 10,000 PLHIV over 36 months., Methods: IPT for 6 months and provision of ART if CD4 lymphocyte count <250 cells per microliter (2011 Botswana policy) was compared with 6 alternative strategies that varied the use of IPT, TST, and ART for CD4 count thresholds, including CD4 <350 and <500 cells per microliter., Results: Botswana policy, 2011 was dominated by most other strategies. IPT of 36 months for TST-positive PLHIV with ART for CD4 <250 cells per microliter resulted in 120 fewer TB cases for an additional cost of $1612 per case averted and resulted in 80 fewer deaths for an additional $2418 per death averted compared with provision of 6-month IPT to TST-positive PLHIV who received ART for CD4 <250 cells per microliter, the next most effective strategy. Alternative strategies offered lower incremental effectiveness at higher cost. These findings remained consistent in sensitivity analyses., Conclusions: A strategy of treating PLHIV who have positive TST with 36-month IPT is more cost effective for reducing both TB and death compared with providing IPT without a TST, providing only 6-month IPT, or expanding ART eligibility without IPT., Competing Interests: The authors have no funding or conflicts of interest to disclose.

Background: New WHO guidelines recommend ART initiation for HIV-positive persons with CD4 cell counts ≤500 cells/µL, a higher threshold than was previously recommended. Country decision makers must consider whether to further expand ART eligibility accordingly., Methods: We used multiple independent mathematical models in four settings-South Africa, Zambia, India, and Vietnam-to evaluate the potential health impact, costs, and cost-effectiveness of different adult ART eligibility criteria under scenarios of current and expanded treatment coverage, with results projected over 20 years. Analyses considered extending eligibility to include individuals with CD4 ≤500 cells/µL or all HIV-positive adults, compared to the previous recommendation of initiation with CD4 ≤350 cells/µL. We assessed costs from a health system perspective, and calculated the incremental cost per DALY averted ($/DALY) to compare competing strategies. Strategies were considered 'very cost-effective' if the $/DALY was less than the country's per capita gross domestic product (GDP; South Africa: $8040, Zambia: $1425, India: $1489, Vietnam: $1407) and 'cost-effective' if $/DALY was less than three times per capita GDP., Findings: In South Africa, the cost per DALY averted of extending ART eligibility to CD4 ≤500 cells/µL ranged from $237 to $1691/DALY compared to 2010 guidelines; in Zambia, expanded eligibility ranged from improving health outcomes while reducing costs (i.e. dominating current guidelines) to $749/DALY. Results were similar in scenarios with substantially expanded treatment access and for expanding eligibility to all HIV-positive adults. Expanding treatment coverage in the general population was therefore found to be cost-effective. In India, eligibility for all HIV-positive persons ranged from $131 to $241/DALY and in Vietnam eligibility for CD4 ≤500 cells/µL cost $290/DALY. In concentrated epidemics, expanded access among key populations was also cost-effective., Interpretation: Earlier ART eligibility is estimated to be very cost-effective in low- and middle-income settings, although these questions should be revisited as further information becomes available. Scaling-up ART should be considered among other high-priority health interventions competing for health budgets., Funding: The Bill and Melinda Gates Foundation and World Health Organization.

Background: In sub-Saharan Africa, patients with advanced HIV experience high mortality during the first few months of antiretroviral therapy (ART), largely attributable to tuberculosis (TB). We evaluated the cost-effectiveness of TB diagnostic strategies to reduce this early mortality., Methods: We developed a decision analytic model to estimate the incremental cost, deaths averted, and cost-effectiveness of 3 TB diagnostic algorithms. The model base case represents current practice (symptoms screening, sputum smear, and chest radiography) in many resource-limited countries in sub-Saharan Africa. We compared the current practice with World Health Organization (WHO)-recommended practice with culture and WHO-recommended practice with the Xpert mycobacterium tuberculosis and resistance to rifampicin test and considered relevant medical costs from a health system perspective using the timeframe of the first 6 months of ART. We conducted univariate and probabilistic sensitivity analyses on all parameters in the model., Results: When considering TB diagnosis and treatment and ART costs, the cost per patient was $850 for current practice, $809 for the algorithm with Xpert test, and $879 for the algorithm with culture. Our results showed that both WHO-recommended algorithms avert more deaths among TB cases than does the current practice. The algorithm with Xpert test was least costly at reducing early mortality compared with the current practice. Sensitivity analyses indicated that cost-effectiveness findings were stable., Conclusions: Our analysis showed that culture or Xpert were cost-effective at reducing early mortality during the first 6 months of ART compared with the current practice. Thus, our findings provide support for ongoing efforts to expand TB diagnostic capacity.

Policy makers face a number of difficult choices as they develop policies to ensure maintenance of a polio-free world following global eradication and certification. These policy decisions include choices about immunization, outbreak response (including whether to create a vaccine stockpile), surveillance, containment, management of chronic excretors, and investment in future research. This paper focuses on identifying the categories of decisions and characterizing the actual factors that country-level policy makers must weigh to manage polio risks during the first 5 years after certification. Building on a comprehensive literature review, we report the results of the first qualitative analysis to: (1) systematically characterize each type of decision and the relevant options during the first 5 years after certification, (2) clearly identify critical factors that influence the choices, and (3) specifically demonstrate the interdependence among the decisions to produce a reduced set of decision options. This paper explicitly focuses on the different perspectives of developed and developing countries in characterizing the options. While the management of polio risk in the postcertification period presents important challenges, this comprehensive approach helps simplify the process by focusing on critical decisions.