INDIA: Program Towards Elimination of Tuberculosis (P167523) (Program-for-Results) Technical Assessment Report DECEMBER 18, 2018 A. Background: Country and Disease Context 1. With roughly one-sixth of the world’s population, India, to a great extent, drives progress in global health and human development. From 2005 to 2016, India’s GDP per capita increased from USD 971 to USD 1,862 (constant 2010), among the highest proportional increases of any large country within the same time frame. Despite this rapid increase in national wealth and the corresponding sharp reduction in extreme poverty, relative poverty has persisted. Using the $3.20 per day poverty line for lower-middle-income countries (LMIC), in 2011 the percentage of the population living below poverty line in India was 60%, i.e. 763 million people. India’s significant progress in improving health services and outcomes is evidenced by the increase in life expectancy from 58 years in 1990 to 66 years in 2015. Rapid improvement is observable in many health indicators, notably Sustainable Development Goals (SDGs) for maternal and infant and child mortality. 2. India’s economic transition is matched by a shift from primarily communicable diseases to a dual disease burden. Although the communicable disease burden has lessened, it is still high relative to India’s economic peers and coupled with rising levels of non-communicable diseases (NCDs). In India, communicable diseases, NCDs, and nutritional deficits dominate the rankings of mortality and illness.1 The contribution of communicable and non- communicable disease varies quite dramatically among states in both absolute and relative terms, with Empowered Action Group (EAG)2 states having communicable diseases as three of the top-five causes of Disability- Adjusted Life Year (DALY) loss (Figure 1). 3. TB’s contribution to death and disability in India is significant. TB is a bacterial disease characterized by airborne transmission and pulmonary involvement. While readily treatable in most cases, TB requires early detection and sustained treatment to prevent secondary transmission or recurrent disease. Drug-resistant TB (DR- TB) is a serious challenge and individuals with resistance to rifampicin (the therapeutic anchor of standard anti-TB treatment) suffer severe additional health and socioeconomic consequences. DR-TB treatment is highly expensive, often intolerable, and usually ineffective; affected individuals are three times more likely to die or fail treatment.3 4. In 2017, the WHO estimated between 1.9–3.8 million TB cases occurred in India, and 0.37–0.46 million TB deaths. India accounts for approximately 27% of the world’s 10.4 million new TB cases, and 29% of the 1.8 million TB deaths globally. With a fifth of the world’s TB burden, including a quarter of DR-TB cases, India is a major battleground against TB globally. The WHO and the World Bank have recommended TB treatment as a core indicator for assessing progress towards Universal Health Coverage (UHC). 5. Most concerning, India accounts for 1 million (30%) of the world’s 3.4 million “missing� TB cases, referring to the gap between estimated TB incidence and validated detection by national TB programs. Such patients are “missed� when health systems fail to detect, diagnose, treat, or report. Access barriers contribute to missing TB, particularly among vulnerable populations that are hard to reach, such as migrants, miners, refugees, children, and people living with HIV (PLWHA). In India and elsewhere, most missing cases are believed to be patients treated by private providers but never reported under the national programs. The net effect is that many of these people will die or continue to be sick and transmit the disease or, if treated with improper drugs, contribute to the growing menace of drug resistance. Together, missing TB cases and DR-TB pose the principal threats to successful TB control in India. 1 ICMR and IHME, Health of the Nation’s States, 2018. Available at http://www.healthdata.org/policy-report/india-health- nation’s-states 2 Bihar, Chattisgarh, Jharkhand, Madhya Pradesh, Odisha, Rajasthan, Uttar Pradesh, and Uttarakhand. 3 Dheda K et al. The epidemiology, pathogenesis, transmission, diagnosis, and management of multidrug-resistant, extensively drug-resistant, and incurable tuberculosis. Lancet Resp Med, 2017;5(4):291-360. 1 Figure 1: Leading causes of DALY, by state group. India, 2016.4 6. Improving TB control would improve India’s overall health and economic development. TB is one of the top five causes of death among adults ages 30-69 years and is strongly associated with poverty. TB is driven by heightened susceptibility among populations who are: malnourished or immune-compromised; exposed to air pollution; and residing in densely populated areas, where transmission is intensified.5 TB disproportionately afflicts poor families and poses high economic and social costs. The combination of high disease burden, socioeconomic impact, and predilection for economically productive ages makes TB a costly drag on India’s development. In 2016, TB caused India to lose an estimated 23.7 billion USD (around 1% of India’s GDP in 2016), and patients often deal with catastrophic out-of-pocket expenditures. 6 On the other hand, these same extensive externalities make TB control one of the most cost-effective health interventions available. Unlike many chronic diseases, TB is detectable and curable. Early diagnosis and effective treatment of TB prevents secondary transmission, amplifying cost-effectiveness. Expanded TB control is predicted to prevent 180,000 deaths in India by 2025 at an additional annual cost of approximately $430 million. Across a broad range of assumptions about valuation of life and discount rate, Vassal et al have estimated that each rupee spent yields benefits of 11.9—71.9 rupees, providing a compelling economic argument for additional investment in TB control.7 4 ICMR and IHME, Health of the Nation’s States, 2018. Available at http://www.healthdata.org/policy-report/india-health- nation’s-states 5 Oxlade O, Murray M (2012) Tuberculosis and Poverty: Why Are the Poor at Greater Risk in India? PLoS ONE 7(11): e47533. https://doi.org/10.1371/journal.pone.0047533 6 Goodchild M, et al. A cost-benefit analysis of scaling up tuberculosis control in India. 2011;15(3):358-62. 7 Vassal A. The Economic case for investment in tuberculosis control, post 2015. Copenhagen Consensus. Available at http://www.copenhagenconsensus.com/publication/india-perspective-tuberculosis. 2 B. Government Program Revised National TB Control Program 9. India’s government program is the Revised National TB Control Program (RNTCP), managed by the Ministry of Health and Family Welfare’s (MOHFW) Central TB Division (CTD). This centrally-sponsored scheme aims to achieve universal access to TB control services in India. Between 1998 and 2006, the RNTCP scaled up availability of basic TB services nationwide, establishing a network of 13,000 microscopy centers and 400,000 treatment providers. During this period, RNTCP was supported by International Development Association (IDA) financing of US$115 million, while other international partners, notably the WHO, provided substantial support to facilitate initial service establishment. Between 2006 and 2012, the RNTCP sustained its expansion, improved services for poor and high-risk groups, and initiated MDR-TB services. A second IDA credit of US$179 million accounted for about 45% of the total spent by the central government program during the six-year period, while other international partners financed another 40%. Significant resources are also applied to TB services by state governments. TB mortality and incidence are estimated to be slowly declining. Since 1998, the RNTCP has detected and treated more than 20 million TB cases via basic microscopy services and directly-observed treatment at public dispensaries or community-based treatment supporters. India’s RNTCP also detects and treats more DR-TB than any other country in the world. The National Strategic Plan for TB control 10. The government’s RNTCP is guided by the National Strategic Plan for TB control (NSP-TB) 2017-2025, which includes expanded activities with the potential to meaningfully accelerate the reduction in TB incidence. The NSP-TB differs from previous plans in that it prioritizes expanding private provider engagement, improving the coverage and quality of TB and DR-TB detection and treatment, and building stronger surveillance systems and public health management. The NSP-TB also begins to address the more complicated challenges of social support and TB prevention. Figure 2: Vision, Goal, Strategic Pillars, and Priorities in India’s National Strategic Plan for TB Control, 2017-20258 VISION: TB-Free India with zero deaths, disease and poverty due to TB GOAL: To achieve a rapid decline in burden of TB, morbidity and mortality, while working towards elimination of TB in India by 2025 Detect Treat Prevent Build • Improved diagnostics • Reduce losses in cascade of care • Scale-up airborne infection • Restructure TB program • Private provider engagement with support systems control in high-risk settings • Build high-level political • Universal screening for drug- • Free anti-TB drugs for public and • Expand treatment of latent TB commitment resistant TB private TB cases infection in contacts and high-risk • Systematic screening of high-risk • Enhanced TB regimens individuals populations • Patient-friendly adherence • Address social determinants of monitoring TB among high-risk communities • Elimination of catastrophic costs and families with social support 11. In 2018 at Delhi’s End TB Summit organized by the MOHFW, WHO-SEARO, and the Stop TB Partnership, India’s Prime Minister declared TB to be one of India’s top health priorities, and that the country would seek to 8 Adapted from: National Strategic Plan for TB Elimination, 2017–2025. Ministry of Health and Family Welfare, Central TB Division, available at http://www.tbcindia.nic.in 3 eliminate TB by 2025. He formally launched the “TB-Free India� campaign to progress “mission-mode� activities articulated in the NSP-TB.9 12. Modeling the NSP-TB has quantified the potential impact of successful implementation of each key element. As shown in Figure 3, engaging private providers and reducing losses during the course of diagnosis and treatment in all TB patients is predicted to yield a 24–58% reduction in TB incidence by 2035.10 Additional gains may be possible if early case detection were to be prioritized in urban slums—where transmission is highest—and among groups with clinical or social risk factors for TB. Figure 3: Predicted effects of improved TB control under the NSP-TB, in TB Incidence and mortality, by cumulative strategic input. PSE=private sector engagement. Optimized cascade=Reducing patient loss to follow-up. ACF=active case finding 13. The NSP-TB has proposed an aggressive set of programmatic goals for 2020 and 2025, with expectations for transformative changes in service delivery 2020 (Table 1). While the ability of TB control to delivery incidence reductions as laid out in the NSP is uncertain, outcome targets for 2020 provide clear near-term guidance for the scale and scope of the service expansion challenge facing India. In particular, TB case notification is expected to increase to 3.6 million annually, with 2 million coming from the private sector, representing an eleven-fold increase from baseline private sector notifications. Additional service delivery goals include near-universal coverage (80%) for drug-susceptibility testing (DST), as well as social support payments to 80% of notified TB patients. 9 Press information Bureau, Government of India. March 14, 2018. Available at http://www.pib.nic.in/newsite/PrintRelease.aspx?relid=177354. 10 JF Vesga, S Khaparde, R Rao, B Vadera, K Rade, S Kumta, P Dewan, AS.Nair, and Nim Arinaminpathy. Modelling the impact of India’s National Strategic Plan for Tuberculosis. Presented at: World Lung Health Conference, 2018, The Hague, Netherlands. 4 Table 1: Top-level impact and outcome indicators from the NSP-TB. Source: MOHFW Baseline Target IMPACT INDICATORS 2015 2020 2023 2025 1. To reduce estimated TB incidence rate (per 100,000 217 142 77 44 population) (112-355) (76-255) (49-185) (36- 158) 2. To reduce estimated TB prevalence (per 100,000 320 170 90 65 population) (280-380) (159-217) (81-125) (56-93) 3. To reduce estimated mortality due to TB (per 32 (29-35) 15 (13-16) 6 (5-7) 3 (3-4) 100,000 population) 4. To ensure no family should suffer catastrophic cost 35% 0% 0% 0% due to TB OUTCOME INDICATORS 1. Total TB patient notification (in millions) 1.74 3.6 2.7 2 2. Total patient Private providers notification (in 0.19 2 1.5 1.2 millions) 3. MDR/RR TB patients notified 28,096 92,000 69,000 55,000 4. Proportion of notified TB patients offered DST 25% 80% 98% 100% 5. Proportion of notified patients initiated on 90% 95% 95% 95% treatment 6. Treatment success rate among notified DSTB 75% 90% 92% 92% 7. Treatment success rate among notified DRTB 46% 65% 73% 75% 8. Proportion of identified targeted key affected 0% 100% 100% 100% population undergoing active case finding 9. Proportion of notified TB patients receiving financial 0% 80% 90% 90% support through Direct Benefit Transfers (DBT) 10. Proportion of identified/eligible individuals for 10% 60% 90% 95% preventive therapy / LTBI s - initiated on treatment (Source: RNTCP) C. The Program Towards Elimination of TB (PTETB) 14. The proposed Program Towards Elimination of TB (PTETB) Program (“P�) is a performance for results (PforR) credit. The Program Development Objective (PDO) is to improve the coverage and quality of TB control interventions in the private and public sector in targeted states of India. The PTETB addresses a defined subset of the government program (“p�) and focuses on four areas of RNTCP and NSP-TB activities. These include: 1) private provider engagement, 2) patient and provider support through direct benefits transfer (DBT), 3) DR-TB, and 4) surveillance/information and communications technology (ICT). Transformational changes in the four results areas covered will be required to meet the ambitions and targets of the NSP-TB and the TB-free India campaign. Building on the prior decade’s emphasis on public sector case management and quality of care, and aligned with the NSP-TB, the PTETB proposes to incentivize performance against private provider engagement and DR-TB management. The PTETB emphasizes new services and capabilities required for sustained universal access to TB services nationwide, wherever patients may seek care: namely, DBT services, contracting capacity, and robust information and ICT. The strategy map below (Figure 4), organized by NSP thematic pillar, outlines the relationship between existing services, results included in the PTETB, and key disbursement linked indicators (DLIs). 5 Figure 4: Strategy map showing relationship PILLAR NSP EXISTING TB PROGRAM NSP RESULTS AREA (RA) KEY DISBURSEMENT LINKED between prior TB program EMPHASIS ("p") INCLUDED IN PTETB ("P") INDICATOR emphasis, and the NSP priority results areas Public sector case finding (RA 1) Private provider supported by PTETB, and key Systematic screning of high engagment Private TB notification Detect risk populations (RA 2) DBT incentives disbursement linked indicators. Basic microscopy (RA 3) Expanded DR-TB DST coverage DST for DR-TB detection detection, public and private Abbreviations: NSP=National (RA 1) Private provider Free TB drugs for all patients engagement, via PPSA Private TB treatment success Strategic Plan for TB Control Treat (RA 2) DBT incentives 2017-2025. DST=Drug (RA 2+4) Patient social & Private TB Treatment success susceptibility testing. DR- Adherence support and monitoring nutritional support via DBT DBT coverage (RA 4) Patient tracking via ICT TB=Drug resistant TB. DBT=direct benefits transfer. Prevent PPSA=Private provider Expand treatment of Latent (RA 3) Scaling up airborne infection control in high-risk Expanded training & planning TB infection for airborne infection control support agency. settings ICT=Information and communication technology. High level Political (RA 1-4) Restructure TB Human Resources plan & Commitment program progress HR=Human resources. Build (RA 1) Private provider Strengthened HR for TB Human Resources plan & engagement, technical services progress support 15. Based on economic classifications used in the government’s budget and expenditure reporting, Program activities and interventions are covered under five expenditure categories at CTD level, and six expenditure categories in nine targeted states. 16. The overall expenditure framework for the government program for 2019-2024 is estimated at US$6.9 billion. The PforR Program cost is estimated around US$1.334 billion. The World Bank financing is US$400 million, or 30% of government program financing (Table 2). Table 2. Program Financing Source Amount (US$ million) % of Total IBRD (PforR) 400 30% Government 934 70% Total Program Costs 1,334 100% D. Strategic Relevance and Soundness of the Program 17. The PTETB identifies process bottlenecks and attempts to incentivize national and state authorities to develop solutions. The PforR Program design has clear causal links between the challenges, interventions, incentives, and expected results and the majority of solutions have already been articulated in the NSP-TB. The DLIs have been chosen to incentivize the transformational changes required to achieve the TB control goals articulated in the NSP-TB. The DLIs and intermediate results attempt to identify those processes and results that are indicative of tangible progress in this programmatic transformation. D1. Result Area 1: Private Sector Engagement Strategic relevance 6 18. Engaging private providers is the biggest challenge and greatest opportunity for improving TB control in India. Private providers dominate India’s general health care provision and TB services, with an estimated 80% of people with TB first turning to private healthcare providers.11 These providers include Rural Health Practitioners12, chemists and pharmacies, laboratories, indigenous systems of medicine, General Practitioners, and specialists. Analysis of pharmaceutical sales data suggested that 2 million TB patients may be treated in the private sector every year, which is more than those currently detected and treated by the public sector.13 19. Private providers do not adequately care for TB patients in India. In a highly competitive marketplace, private provider priorities are to provide short-term relief to their patients, to retain them, and to generate revenue. Therefore, private providers typically provide or prescribe antibiotics, supplements and even steroids, often ordering chest x-rays but rarely sputum microscopy, and CBNAAT14 remains too expensive for most patients. If symptoms persist, anti-TB drugs may be prescribed, but regimens are often inappropriate, and patients rarely comply with a full course of treatment. Private providers have little or no capacity for record-keeping, patient follow-up, or contact tracing. Studies since 1991 have documented the very poor quality of TB care amongst private providers.15,16 A standardized patient study in two cities in India in 2015-16 found the following: i) among MBBS and non-MBBS providers and across four case scenarios suggestive of TB, only 35% of interactions resulted in standards-compliant care; ii) a microbiological diagnostic test was ordered in only 31% of interactions; and iii) an average of 3.1 medications were prescribed per interaction, but anti-TB medication was prescribed in only 5% of cases.17 20. Prior efforts to engage private providers for TB care in India have had limited success. The RNTCP has articulated guidelines and “schemes� for engaging private providers since 1999, but they were not prioritized and depended on the initiative of over-stretched local officials. These guidelines were last updated in 2014 and the majority of activity was confined to Maharashtra and Gujarat. Joint Monitoring Missions in 2003, 2006, 2008, and 2012 all noted the same lack of attention to the issue, in spite of various USAID and Global Fund supported projects. The 2008 Joint Monitoring Mission found that just 1.5% of RNTCP expenditure was dedicated to schemes to engage NGOs and private providers. The 2012 review noted that a new Composite Index for monitoring performance within the RNTCP had allocated just 4% of points to efforts to improve engagement of private providers and NGOs, and it estimated that private providers contributed just 2-3% of case findings that year. 21. As measured by effective coverage, India’s performance in engaging private healthcare providers lags behind that of some of the other high-burden countries in Asia. While recent increases in private TB case notifications have surpassed those of Indonesia, Philippines, and Myanmar to approach those of Pakistan and Bangladesh, these other countries have maintained high levels of overall treatment success even as the share of privately notified patients has increased. 18 India’s overall national treatment success rate fell to 69% for the 2016 notification cohort because privately-notified cases were not routinely provided treatment support, adherence monitoring, or outcome reporting, with only 12% reported treatment success amongst the privately notified patients. 11 Ministry of Health and Family Welfare, National Strategic Plan for Tuberculosis Elimination, 2017-25, p. 25 12 Also known as Rural Medical Practitioners, less Than Fully Qualified Practitioners, and quacks 13 N. Arinaminpathy, D. Batra, S. Khaparde, T. Vualnam, N. Maheshwari, L. Sharma, S. Nair and P. Dewan, "The number of privately treated tuberculosis cases in India: an estimation from drug sales data," Lancet Infectious Diseases, 2016 14 Cartridge-Based Nucleic Acid Test, market leader Xpert MTB/RIF, currently costs at least R/ 2,200 ($33) in the private market 15 M. Uplekar and D. S. Shepard, "Treatment of tuberculosis by private general practitioners in India," Tubercle, vol. 72, no. 4, pp. 284-290, December 1991 16 J. Das, A. Kwan, B. Daniels, S. Satyanarayana, R. Subbaraman, S. Bergkvist, R. Das, V. Das and M. Pai, "Use of standardised patients to assess quality of tuberculosis care: a pilot, cross-sectional study," Lancet Infectious Diseases, vol. 15, November 2015. Also: A. McDowell and M. Pai, "Treatment as diagnosis and diadgnosis as treatment: empirical management of presumptive tuberculosis in India," International Journal of TB and Lung Disease, vol. 20, no. 4, 2016. 17 M. Uplekar and D. S. Shepard, "Treatment of tuberculosis by private general practitioners in India," Tubercle, vol. 72, no. 4, pp. 284-290, December 1991 18 Notification levels compared as percent of estimated incidence. WHO (2018) Engaging private health care providers in TB care and prevention: a landscape analysis. 7 22. In recent years, innovative strategies have been proposed, but not implemented. The 2012-2017 NSP endorsed the idea of contracting Private Provider Interface Agencies (PPIA)19 to engage private providers on behalf of the RNTCP and proposed the establishment of a Technical Support Group (TSG) for Private Provider Mix (PPM) at national and state levels, modeled on the experience of similar structures for NGO contracting in HIV/AIDS and Contraceptive Social Marketing. Unfortunately, the TSG was never established and targets in the NSP were limited to processes, such as the number and percent of districts in which private providers notify patients. 23. In line with the 2017 National Health Plan, with its emphasis on private provider contracting via strategic purchasing, India’s NSP-TB 2017-2025 represents a major change in approach to engage private providers on a scale commensurate with their role in the Indian health market. 20 Selected targets are highlighted below (Table 3). Table 3: Selected Private Provider engagement metrics from the NSP-TB, Baseline vs Targets in 2020 and 2025 Metric from NSP-TB 2017-2025 2015 Plan targets (baseline) Number of TB notifications from private 0.184 m 2 million in 2020 providers 1 million in 2025 (anticipating hoped- for reductions in TB incidence) Proportion of all notified TB cases that is 11% 56% in 2020 contributed by private providers 50% in 2025 Proportion of privately-notified TB patients that 2% 30% in 2020 have microbiological confirmation 45% in 2025 Treatment success rate amongst privately 13% 90% by 2020 notified patients 90% sustained through 2025 Proportion of private providers paid an 0 80% in 2020 incentive or honorarium through Direct Benefit 90% in 2025 Transfer 24. As Figure 5 indicates, the NSP envisions that almost the entire increase in case finding will come from private providers, and from 2018, private notifications will surpass those of the public sector. If India’s plan succeeds, it will be the first major high-burden country with a dominant private healthcare sector to align its TB program with its population’s care-seeking patterns. The RNTCP has taken on the unique challenge of addressing private providers for TB when broader health systems are struggling to do so. The urgent need for TB control may not be able to wait for broader health system developments. Failure to engage private providers for TB control, when they have such a prominent role in the health system, would make it impossible to achieve NSP goals. 19 Also known recently as Private Patient Support Agencies, PPSA 20 Government of India, "National Health Policy 2017," 2017. 8 Figure 5: Public and Private TB Notifications in India, 2012-2017 (actual) and 2017-2021 (Planned) Technical soundness 25. The proposed strategies included in the NSP and supported by the PTETB Program are credible approaches to private provider engagement by a vertical health program (Figure 6). The first approach is direct engagement of private providers by RNTCP contractual staff. Previous constraints to this approach (including insufficient numbers of field staff and a focus on public provision) have been partially alleviated by increases in RNTCP field staff over the last few years. The second strategy, contracting NGO intermediary organizations, has been occasionally implemented via project approach, with limited scale or sustainability. External funders have supported larger-scale Public-Private Support Agencies (PPSA) charged with end-to-end engagement of private providers for notification, diagnosis, and treatment. The Global Fund JEET project is an effort to replicate the PPSA approach; however, there are concerns whether this approach can be sustained and expanded at the scale needed throughout India. 26. Private provider engagement will require rapid development and roll-out of digital technologies. The Nikshay case-based registration system has been in use since 2012, but as discussed in greater detail separately, has been re-deployed to be user-friendly and robust, and with integrated diagnostics, drugs logistics, adherence monitoring tools, and DBT payments via PFMS. This integrated system offers the potential to receive, validate, and reimburse providers for services via digital microtransactions. Such a system could delivery efficient digitally- enabled strategic purchasing on a massive scale, with trust, accountability, and rapid-cycle performance management, embracing hundreds of thousands of different actors (providers, laboratories, chemists and patients) for millions of TB cases per year across India. Technical design and implementation challenges to transform Nikshay today into a functional payment system as envisioned are quite substantial, but the most difficult pieces are already in place. The vision is highly ambitious but is perhaps the most critical approach for long term sustainability of private provider engagement. 9 Figure 6: Conceptual approach to private provider engagement incorporated in India’s NSP-TB. Hundreds of thousands of providers (chemists, labs, GPs, informal providers, hospitals) Engagement Models ~ 2 million patients Provider-Patient RNTCP engages RNTCP engages Contracted Private Providers Private Providers Intermediaries and supports engage Private patients Contracted NGOs Providers and support patients support patients Digitally-Enabled Strategic Purchasing Nikshay 2.0 and National Call Centre to facilitate notification; linked to PFMS for DBT to patients Systems Support and providers, vouchers management for diagnostics and drugs, and adherence technologies; with job aids for frontline workers and their supervisors; and powerful analytics and dashboards for accountability and transparency Regulatory Enforcement Penalties for failure to comply with Mandatory Notification and Schedule H-1 Table 4: Strengths and weaknesses in current pathways to scale for private provider engagement Strategy Details Potential Challenges Direct RNTCP • Deployment of several hundred • Most comfortable • Not yet able to engagement contractual PPM Coordinators, in approach for RNTCP ensure treatment addition to thousands of other • Demonstrated ability to adherence or field staff increase notifications quality of care Contracting • Contract NGOs for support roles: • Demonstrated ability to • GOI reluctance intermediaries sputum transport, lab technicians, increase case-finding and and lack of adherence support assure successful capacity for large- • Issue more substantial contracts treatment outcomes scale contracting for end-to-end PPSA (heretofore • Few NGOs with donor-funded) skills and experience at scale Digitally- • User-friendly digital case-based • Efficiency at scale • Design and enabled mass registry • Transparency implementation purchasing of • 99DOTS adherence monitoring • Data and analytics for of complex data private • Call Centers to support management systems services notifications, treatment support • Attractive to PPs because • DBT/PFMS payments to patients, reliable, impersonal providers and treatment • Facilitates rapid testing supporters and adoption of • Potentially, vouchers for private adaptations diagnostics and drugs • Accountability for public funds Regulatory • Mandatory notification decrees, • Increases motivation for • Inconsistent enforcement with penalties for non-compliance providers to notify enforcement • DGCI enforcement of Schedule H1 10 27. The two outreach models and the data systems are in turn reinforced by enforcement of regulatory sanctions. The decree for mandatory notification of TB cases, issued in 2012, has recently been modified to include chemists and provide for penalties. While anti-TB drugs have long been listed under Schedule H1, which requires chemists and pharmacies to sell them only under prescription and to record and report details of each sale, the Drug Controller General of India (DCGI) has recently increased enforcement efforts in some areas. With the exception of the digital systems, which will be nationwide, the four approaches may be deployed separately or in combination, with the anticipation that digitally-enabled service reimbursement direct to providers may eclipse other approaches over time. The strengths and constraints of each may be summarized as follows (Table 4). 28. The feasibility and efficacy of the proposed approaches have been demonstrated in pilot projects, with key lessons adopted for scale-up. Projects to engage private providers, both in India and elsewhere, have consistently demonstrated that it is possible to work with private providers to increase case notification and ensure treatment outcomes that compare with those of the public sector. 21 The strongest evidence of feasibility has been generated from pilot projects funded by the Gates Foundation from 2015 to 2018. In Mumbai and Patna, NGO intermediaries were responsible for engaging private providers, facilitating their patients’ access to molecular testing and drugs, supporting treatment adherence, and recording and reporting all necessary data. In two other districts (Mehsana in Gujarat, and Nagpur in Maharashtra) the local RNTCP staff took on the roles performed by NGOs in the other sites. The main innovation was the use of digital systems —including a Call Center—to facilitate notification, monitoring, and referrals. This made possible a second innovation: the use of vouchers and e-vouchers to enable privately-notified patients to access drugs and diagnostics from private chemists and labs at no cost to them.22 The results were impressive. Private case notifications increased 2.0–4.5- fold over four years, treatment success rates were around 74%, and the proportion of privately-notified patients with microbiological confirmation reached 40%–50%. Evaluation found that engaged chemists are more likely to refer customers with persistent cough and are not selling TB drugs without prescription, while engaged providers are more likely to use chest x-rays and microbiological testing. 23 Costs and unit-costs of initiatives to engage private providers, while varying considerably as one would expect in different contexts and in particular at different levels of scale, appear to be similar to the costs of delivering care through public services. 29. Perhaps the single most important lesson learned in efforts to engage private providers for TB, both in India and elsewhere, is the importance of flexibility, innovation, and adaptation.24 While there are common themes, there is no single operational model: health markets differ significantly from one setting to another, successful implementers have demonstrated the ability to adjust approaches over time, and innovative approaches continue to emerge. This presents a challenge for funding mechanisms, such as those of governments and the Global Fund, which find it easier to support very standardized activities. A potential solution to this tension lies in output-based contracting approaches that encourage flexibility in inputs and tactics as long as defined results and quality standards are met. 30. Institutional architecture to achieve these targets has been substantially enhanced over the past five years, removing many bottlenecks for success. a. Political commitment: The most dominant improvement has been political commitment to TB control. The Prime Minister’s personal commitment to TB elimination has created unprecedented pressure to perform throughout the system, together with adequate budgetary resources, while the current government’s orientation towards strategic purchasing from private providers has made the 21 Dewan, P; Lal, S; Lonnroth, K; Wares, F; Uplekar, M; Sahu, S; Granich, R; Chauhan, LS, (2006) Improving tuberculosis control through public-private collaboration in India: literature review. BMJ, dpi:10.1136/bmj.3B73B.473252.7C 22 Papineni, S; Jha, N; Saha, KN; Gupta, D; Khaparde, S; Kulshestra, N; Das, P; Vadera, B; Rade, K; Mishra, BK; Shukla, P; Gopalakrishnan, G; Hazarika, A; Dewan, P. (2018) Effective service delivery for TB patients seeking care from private practitioners in Patna, India. Under review. 23 Data from the QUTUB project. Publication pending. http://www.qutubproject.org 24 WHO (2018) Engaging private health care providers for TB care and prevention: a landscape analysis 11 ambitious new strategy possible. Continued commitment, pressure, and resources will be required if this vision is to be realized. b. Policies: The foundations of an innovative approach were laid in 2012 with making TB notification mandatory, the development of a case-based electronic TB notification system (Nikshay), issuance of decrees banning serological tests, and the decision to align RNTCP regimens with those commonly used in the private sector by adopting daily Fixed Dose Combination drugs and developing unified Standards for TB Care in India (STCI). 25 c. Field staffing levels: During the 2012-2017 NSP period, there was a significant increase in the numbers of RNTCP staff in key positions to support engagement of private providers (Table 5), and to meet the expanding requirements for managing DR-TB. PPM Coordinator positions at state and district levels began to be filled from 2015. The number of STS and TBHV has also increased significantly although as yet these cadres are not systematically deployed to support adherence of the private TB patients for whom notification data is obtained. Table 5: Number of selected RNTCP cadres in-position at year end26 2017 % of Cadre 2014 2015 2016 2017 sanctioned PPM Coordinator 295 348 396 56% Senior Treatment Supervisor 3,066 3,794 4,251 4,753 78% TB Home Visitor 1,702 3,177 3,038 3,061 82% d. Direct Benefits Transfer (DBT) and ICT: Introduction of DBT for nutritional benefits for all notified patients, as well as payments to Treatment Supporters and Private Providers, offers a transformational incentive (Section D2). The overhaul of Nikshay as version 2.0, with enhanced functionality for engaging private providers, is a crucial force-multiplier to reach the multitudes of private providers with any degree of feasibility (Section D4). 31. Further reforms to the institutional architecture were included in the NSP but remain pending. The first is the re-activation of the National Technical Working Group on PPM, with enhanced membership and a mandate to advise RNTCP on strategies and implementation models, draw in expertise from outside the TB field, and review progress. The second is the functional restructuring of the program at CTD and state levels to establish a Division for Partnerships, ACSM and Patient Support, headed by a Deputy Director General. 32. The Program is synergistic with Global Fund supported efforts to initiate scale-up of private provider engagement. The latest Global Fund grants, 2018-20, include $40m (20% of the total) for NGOs to support the RNTCP in scaling up private provider engagement across 23 states. Under the Joint Effort for Elimination of TB (JEET) project, three Principal Recipients27 have contracted seven NGO Sub-Recipients28, and more than 2,100 field workers will be deployed in 15 states (Table 6). In 42 cities, the Global Fund will engage private providers, facilitate private patients’ access to RNTCP diagnostics, drugs and cash benefits, and help ensure treatment compliance. They will also help states and approximately 350 additional districts to contract NGOs for further scale-up. 25 MOHFW and WHO India, "Standards for TB Care in India," 2014. 26 Source: RNTCP Annual Status Reports (sum of state-wise data) 27 CHAI, PATH/CHRI and FIND 28 World Health Partners (WHP), World Vision India, Lepra, Mamta, Alert, Karnataka Health Promotion Trust (KHPT) and Maharashtra Janvikas Kendra (MVK) 12 33. In the nine target states, JEET will: a. Support 1,484 staff, including 181 of the Principal Recipients and 1,303 of their NGO Sub-Recipients, with a $10.5m budget for subrecipients. b. Facilitate 690,000 private notifications over three years in 36 urban areas for PPIA, while the targets in the remaining districts total 766,000, of which 459,707 (60%) will be attributed to JEET. c. Establish small Program Management Units at the state level to support the development of contracting capacity. d. During the period of overlap with the Bank credit (4/19-3/21), contribute 1 million private notifications in the nine focus states, of which 59% from the PPSA sites and 41% from their support to non-PPSA districts. Table 6: Global Fund JEET inputs and targets in World Bank priority states Principal Staff SR Budget Targets: PPSA Targets: Non-PPSA @ 60% Recipient Sub-Recipient (US$, 3 1/18 - 4/19 - 4/20 - 1/18 - 4/19 - 4/20 - State (PR) PPSA Cities (SR) PR SR years) 3/19 3/20 3/21 3/19 3/20 3/21 Assam CHRI Kamprup Metro-Guwahati WVI 7 18 131,873 592 1,512 2,336 1,001 2,556 3,950 Bihar CHAI Dharbanga WHP 13 32 271,134 5,019 9,463 9,463 3,657 27,093 60,772 Karnataka FIND Bangalore KHPT 16 145 1,526,090 6,848 16,613 19,652 2,078 8,710 15,658 Madhya Pradesh CHAI Indore, Bhopal Lepra 17 86 634,342 4,538 13,340 13,340 5,302 15,366 33,902 Maharashtra CHRI 13 (1) TB Alert, MJK,WVI 36 373 2,867,395 15,241 38,901 60,105 11,849 30,339 46,953 Rajasthan CHAI Jaipur WVI 14 59 411,203 4,026 11,836 11,836 5,040 17,306 39,192 Tamil Nadu CHAI Chennai WVI 18 108 788,061 2,635 7,808 7,808 3,577 13,760 30,378 Uttar Pradesh CHRI 15 (2) Lepra, Mamta 50 403 3,296,977 53,792 137,303 212,145 8,018 20,465 31,626 West Bengal FIND Kolkata & Howrah WHP 17 98 719,588 7,562 10,069 10,639 1,947 8,890 17,830 Total 181 1,303 10,514,791 99,661 245,334 344,988 41,468 141,929 276,311 (1) Pune, Pimpri Chinchwad, Aurangabad, Sholapur, Kolhapur, Raigarh, Nashik, Navi Mumbai, Thane, Kalyan Dhombivli & BN, Mira Bhayander % VV-W (2) Varanasi, Jaunpur, Allahabad, Gorakhpur, Lucknow, Kanpur, Agra, Ghaxiabad, Meerut, Aligarh, GB Nagar, Jhansi, Mathura, Bareilly, Moradabad PPSA = Private Patient Support Agency (smetimes referred to as Public-Private Interface Agency) intensive NGO-led engagement Non-PPSA refers to light-touch support for PP engagement and contracting in other districts, where 60% of total private notifications will be attributed to JEET 34. The JEET program, which began to generate initial results from August 2018, will very likely achieve an increase in private TB notifications and treatment success, and implementation of the Nikshay 2.0 and DBT systems, over the first two years of the World Bank credit. The results and sustained impact of JEET are likely to be limited by critical project design features, notably the rigid application of the specific operational model used in the UATBC Mumbai project to very different contexts and the restricted opportunities for Sub Recipient implementing organizations to develop skills or capacity. 35. Early efforts have not met the ambitious targets, and India is quickly falling behind the NSP service expansion ambitions (Table 7). Total private provider notifications in India increased ten-fold from 2013 to 384,000 in 2017, constituting by then 21% of the total notifications and corresponding to 14% of estimated incidence (Table 8). Private notifications in the first nine months of 2018 are up 31% over the same period in 2017. But these private notifications still represent only a small fraction of the total number of private facilities in the country and have not been yet been met by commensurate improvements in treatment outcome reporting. To come even remotely close to NSP targets requires dramatic increases in numbers of notifying private providers routinely supporting TB case finding/notifications, and monitoring adherence to treatment and outcome reporting. Over time, as engagement strategies penetrate local healthcare markets, we would expect to see increases in the number of primary care providers and the proportion of notifications coming from this level of the health system. 13 Table 7: Key performance metrics for private provider engagement in TB, 2015-2025 (planned in NSP and actual to-date) Performance Metric 2015 2016 2017 2018 201 202 202 2022 202 202 202 9 0 1 3 4 5 No. privately Plan 0.225 0.75 1.26 1.6 1.8 1.57 1.35 1.08 0.9 notified (m) 5 patients Actua 24,024 39,662 53,730 successfully l treated(a) Treatment Plan 25% 50% 70% 80% 90% 90% 90% 90% 90% success Actua 13% 12% 14% amongst l privately notified patients No. privately Plan 0.9 1.5 1.8 2.0 2.0 1.75 1.5 1.2 1.0 notified (m) patients Actua 184,80 330,18 383,78 500,000(b ) l 2 6 4 Private Plan 38% 50% 54% 56% 56% 56% 56% 52% 50% contribution Actua 11% 19% 21% to total case l notification Privately Plan 10% 15% 25% 30% 35% 40% 42% 45% 45% notified Actua 2% 3% n/a patients with l microbiologica l confirmation Private Plan 25% 50% 80% 80% 90% 90% 90% 90% 90% Providers paid Actua 0% incentive l through DBT/PFMS A) This is not an indicator in the NSP but is implied as a function of case notification and treatment success B) Projected based on data to September 2018 14 Table 8: Numbers of PPs notifying TB cases, and the numbers of cases they notify, 2012-2018 Description 2012 2013 2014 2015 2016 2017 2018* Number of facilities notifying Hospital/Clinic/Nursing Home etc.(multi) 47 1,578 3,049 4,823 7,129 8,517 5,192 Laboratory 2 120 286 484 870 1,105 614 Private Practitioner/Clinic etc.(single) 57 1,813 3,715 4,999 7,141 9,981 6,360 Total 106 3,511 7,050 10,306 15,140 19,603 12,166 Cases Notified Hospital/Clinic/Nursing Home etc.(multi) 132 19,631 49,631 79,103 163,778 Laboratory 132 1,430 1,444 27,628 29,783 Private Practitioner/Clinic etc.(single) 2,842 17,535 55,339 77,881 136,625 Total 3,106 38,596 106,414 184,612 330,186 - - Average case notified per notifying provider Hospital/Clinic/Nursing Home etc.(multi) 3 12 16 16 23 - - Laboratory 66 12 5 57 34 - - Private Practitioner/Clinic etc.(single) 50 10 15 16 19 - - Total 29 11 15 18 22 - - * Through September 2018 36. Treatment success among privately notified patients was estimated at just 12% for the cohort of patients notified in 2016. Table 9 shows treatment outcomes data for the nine priority states and for India, for the 2016 cohort. Almost all available treatment success and outcome data has been attributable to the externally-funded PPIAs in Maharashtra and Bihar, highlighting that systems for capturing notifications have not been matched by systems to monitor and sustain patients on treatment, or record treatment outcomes. Table 9: Treatment outcomes for privately notified TB patients, priority states, 2016 notification cohort No. % Private Treatment Treatment % Outcome State notifications Success Success Reported* Assam 3,021 - 0% 0% Bihar 37,981 13,213 35% 47% Karnataka 8,730 28 0% 1% Madhya Pradesh 16,743 15 0% 0% Maharashtra 72,967 16,686 23% 30% Rajasthan 16,724 1 0% 0% Tamil Nadu 13,972 18 0% 0% Uttar Pradesh 37,174 53 0% 0% W. Bengal 4,477 1 0% 0% Subtotal 211,789 30,015 14% 19% India 330,186 38,056 12% 16% 37. Potential constraints to success pose a series of technical risks. Table 10 below summarizes seven major constraints likely to result in continued underperformance relative to the ambitious targets established in the NSP. It also identifies approaches to addressing these constraints that have been discussed during the project design. 15 Table 10: Summary of constraints to private provider engagement, their impact, and key mitigating approaches Constraint Impact Mitigation Molecular diagnostic Failure to deliver undermines PP trust Expand public molecular diagnostic capacity capacity to meet demand Reduced notification rate Voucher-based purchasing of molecular from private providers Excessive reliance on clinical Dx diagnostics and digital x-ray from private labs FDC access for privately- Reduced value for PPs and patients Voucher-based purchasing of private FDCs notified patients Failure to deliver undermines trust that meet quality specifications Will and/or capacity for Slow roll-out of PPE Rapid contracting of qualified TSU strategic contracting of Inputs focus prevents adaptation New guidelines focus on outputs vs inputs intermediaries and other Late payments and low budgets deter Appropriate costing/rates adjusted annually partners contractors Prompt payment commitment, learning from JSY etc. DBT roll-out and Reduced value proposition for Equal prioritization of private beneficiaries prioritization of public patients and PPs Rigorous performance data review patients Call Center and Nikshay 2.0 Difficulty notifying private patients Prioritize de-duplication and DQA development, utilization Inaccurate data for M&E Continued access to top quality developers and priorities Impact on DBT, adherence and Adequate resources and professional referrals management for Call Center Adherence support and Continued very low treatment RNTCP staff support adherence of all notified data in areas without success patients contracted partners Increase in DR TB Increased staff numbers Scale up 99DOTS etc. Capacity of intermediary Slow uptake of PPIA contracting Budget senior management, indirect costs organizations Poor performance in PPIA Dedicated opportunities for cross-learning D2. Result Area 2: Direct benefits transfer Strategic relevance 38. DBT ensures seamless delivery of monetary benefits directly into a beneficiary account and/or access to in-kind benefits at last mile, thereby reducing redundant steps and resulting in timely delivery of benefits. The basic premise is to enable a frictionless interaction between government and citizens in welfare programs. DBT can increase efficiencies in government payment systems. The system can provide the end user with a range of financial services in addition to on-time government payments. 39. DBTs are increasingly used by the GOI and State governments to channel resources to households and individuals. Overall, the GOI has declared 499 schemes spread across 63 ministries as DBT (Cash/In-kind) applicable schemes. Out of 499 schemes, 434 schemes are reported as DBT-enabled and total cumulative direct benefits transfers undertaken since inception amounts to approximately USD 67 billion. An efficient DBT program will not only allow government to substantially save by alleviating leakages and/or pilferages but will also enable government to ensure digitization of scheme data, eligibility determination, targeting of beneficiaries, electronic identification of beneficiaries, reducing inclusion and exclusion errors, automated coordination within the government, and improved transparency and accountability. 40. Prior efforts to roll out DBT have provided ample learning experiences. The first major program to incorporate DBT principles and approach was LPG Subsidy (PAHAL) program, where the subsidy was transferred directly into beneficiary accounts. Currently, the PAHAL program has more than 220 million active LPG consumers and transfers subsidies to approximately four million beneficiaries daily. A parallel example is the Bihar: 16 Government-to-Person Health Payment Project. Designed to address the high administrative burden, long delays, and low efficacy of multiple incentive schemes, a G2P payments project automates the recording, verification, and calculation of health payments. The project is currently live in 37 out of 38 districts in Bihar. Lessons from prior DBT projects are summarized in Table 11. Table 11: Summary of lessons from prior GOI and global DBT projects Increased dependence on a Banking System poses risks for uptake. Since the benefits are now directly transferred into a designated beneficiary account, the system depends on availability of banking networks, like bank branches and business correspondents, especially in rural areas. Citizen grievance redressal mechanisms must be incorporated at inception. Digitization of payments, especially Aadhaar-enabled benefit disbursement, often fails, leaving beneficiaries without easy recourse and program managers with additional administrative resolution burdens. For instance, a citizen might not be aware into which bank account he/she has received the benefits. Therefore, there is an imperative need to develop a robust grievance redress policy and mechanism. Information, Education and Communication (IEC) on schemes is essential for success. Adoption of DBT within a program results in major process re-engineering and introduction of new processes. Hence, it is important to develop an effective IEC campaign which can help alleviate beneficiary grievances. In the LPG subsidy program, it was observed that adoption of short messaging system (SMS) to communicate with beneficiaries regarding their payments, due dates, etc. is an effective communication strategy. Reconciliation of payments between the host and PFMS systems is required to mitigate errors in distribution and lack of information for addressing grievances. The GOI has mandated payments of Centrally Sponsored Scheme beneficiaries through PFMS system. The PFMS system has a front-end and back-end integration with scheme system and payment system. Therefore, it has been observed that reconciliation of payment records between scheme system and PFMS system is not necessarily seamless. This leads to instances of registration of beneficiary grievances. 41. While digital payments will address the fraud and de-duplication, they do introduce a challenging dimension of access to benefits. The GOI is continuously striving to improve access to financial services in rural areas. One such effort is the introduction of Bank Mitras or Business Correspondents. It will be important for National Health Mission at State level to coordinate with State Level Bankers Committee (SLBC) to address financial access concerns. 42. India has deployed DBT for TB patients to increase nutritional and social support for patients seeking care in public and private sector. TB patients are poor and suffer from significant health associated costs and commonly experience catastrophic health expenditure. Roughly one third of TB patients experience catastrophic health expenditure, yet only one fifth of economic loss is due to direct medical costs. Income loss constituted three fifths of economic loss, hence service provision alone will not ameliorate the poverty-amplifying effect of TB. The RNTCP has recently deployed DBT to mitigate some of the socioeconomic costs associated with TB, and with the secondary goal of driving behavior changes. The four schemes, their eligibility criteria, amounts authorized for disbursement, primary objectives, secondary objectives, and expected annual costs are summarized in Table 11. 43. The RTNCP has developed an online platform called Nikshay 2.0, a web-based case-based monitoring application used by health functionaries at various levels across the country. The RNTCP has deployed mobile devices to more than 10,000 RTNCP program staff at the block level to enable the users of Nikshay 2.0 to enter patient data and notifications in real time. Mobile devices or linkages to Nikshay 2.0 are not yet available at the 17 PHI level beyond the existing ICT infrastructure (desktops with variable internet connections) currently and heterogeneously provided by State health systems. Technical soundness 44. The RTNCP’s DBT program, as designed, is incredibly important to the NSP-TB and the PDO. Given the current very early trajectory, the DBT is uncertain to achieve the primary objectives (outlined below) due to both design and implementation concerns. 45. The NSP-TB proposes Patient Support in the form of nutritional support (Nikshay Poshan Yojna, NPY) to every TB patient as one of the key interventions. The inclusion of patients from the private sector is envisaged to empower patients to demand notification and adherence. By using an ICT based benefits transfer system, the program aims to prevent leakages and delays in transfer of benefits with effective targeting so that the benefits only flow to the intended beneficiary. The program will provide a monthly support of Rs.500 per month to patients to incentivize treatment completion via DBT for treatment support (notification, travel, monthly collection of drugs and follow-up examinations) for all TB patients to address catastrophic costs (Table 12). The cost to provide this social and nutritional support is for all the projected 9 million TB patients. In addition to inclusion of nutritional support under DBT incentives provided to i) Treatment Supporters, ii) Travel reimbursements to Tribal patients, and iii) Private Practitioners are also included under the DBT scope. Table 12: Costs and characteristics of the DBT schemes for TB RNTCP DBT Patients (NPY) Tribal patients Treatment TB notification Scheme supporters Eligibility Beneficiaries are TB Beneficiaries Beneficiaries are Private providers are patients under RNTCP are every tribal treatment enrolled in the Nikshay eligible for nutritional TB patient supporters who data base and those who support in two treated under may be notify TB cases. installments of Rs. 500 RNTCP individual each. volunteers or NGOs providing support to TB patient. They are provided honorarium based on the category of the case. Amounts 1000 INR 750 INR 1000 INR, 1500 500 INR (2 installments) authorized INR & 5000 INR Primary Reduce socioeconomic Provider Incent Encourage notification of objective impact of TB, with additional participation in TB cases additional coverage for support unconditional financial out of pocket mechanism for support to facilitate expense TB patients improved nutrition for every patient Secondary Encourage providers to Improved Improved Honoraria to soften objectives comply with adherence and adherence and acknowledged notification, for Success rate Success rate administrative burden of eligibility. Improved 18 adherence and Success notification and RTNCP rate. engagement 46. There are several dependencies for the DBT program for TB to succeed. Evaluations of the DBT program, as required by the PAP, will be necessary to guide the adequacy of design and implementation arrangements to achieve primary, or at least secondary, objectives as designed. a. First, DBT systems for dispersal of funds require streamlining, namely PFMS integration. The Program incentivizes strengthening of the Nikshay 2.0 ICT platform by way of integration with the PFMS for enabling DBT and streamlining financial operations with National Health Mission and Aadhaar (Unique ID) platform, which will enable authentication of beneficiaries, thus preventing any duplication or fake entries in the system. Reconciliation of payments between Nikshay and PFMS will be critical, as it will allow concerned officials to address queries of beneficiaries. Partial integration with PFMS has been achieved, yet the existing program poses substantial administrative burdens on users. Currently DBT as implemented by RNTCP is not yet fully harnessing the potential of the digital payments ecosystem. The manual Print-Payment Advice in PFMS poses substantial uptake and administrative delays at the district and subdistrict levels. The Digital Signature based approvals in PFMS of benefits would speed dispersal to all beneficiaries. Transition would require both policy and system changes. The PFMS system supports exchange of digitally signed files. However, as a practice National Health Mission at the state level has continued with the practice of manual submission of payment advice to their sponsor banks. To enable the change, a notification shall be required from the Center to all National Health Mission across the country to adopt digital submission of payment files. Majority of National Health Mission at state-level will require support in issuance of digital signatures at district and block to concerned officials and further would require support in capacity building. Further integration of Nikshay 2.0 and PFMS will allow officials to disburse benefits in a timely manner. Implementation concerns are partially addressed by key system changes included as DLI, that are required for DBT to succeed. b. Second, systems for addressing grievances need to be developed. The Program includes a “Beneficiary Satisfaction Survey�, and for the government program supports the development of Grievance Redressal Policy and supports the strengthening of the centralized call-center to continuously monitor and address challenges under DBT. c. Third, RTNCP needs a communication strategy on DBT. Developing a robust communication platform will be key in delivering messages as well information on benefits status. For any program to succeed, it is imperative there is an effective communication strategy. The National Strategic Plan discusses advocacy and communication program, “TB Mukt Bharat,� as one its priority activities. It also highlights challenges in the form of lack of involvement in TB ACSM by general health staff, competing priorities, lack of coordination, etc. The GOI plans to address the challenges by way of strategic interventions for advocacy, media campaigns, and community level engagement. It is important that the GOI develop a strategy to engage with respective TB patients through communities and on an individual basis, which will lead to increased adherence and success rates. d. Fourth, the ICT has to work for the users and clients, especially private providers. The World Bank program supports the development of four modules for each of the type of beneficiaries conceived under the TB program. Key dependency for success is the adequacy of ICT system uptake and deployment by not only RNTCP program staff, but by PHI and providers, and most crucially by private providers. To minimize data entry errors and reduce delays in benefits disbursement, RNTCP program proposes to distribute adequate number of hand-held devices at PHI level, which will allow 19 the concerned official to record data in real-time. For the Program to positively influence NSP implementation, the DBT system function will have to be actively monitored and supported. 47. Early data on DBT uptake are encouraging only for the NPY scheme and for public sector patients. The NPY scheme has yet to be applied to privately-notified TB patients, despite availability. Similarly, concerns have been raised that uptake may be poor for the notification honorarium, due to the reluctance of some private providers to receive formal honorarium payments from government. The strategic value of this specific honorarium, implemented by government, towards promoting private provider engagement remains hypothetical. D3. Result Area 3: Response to drug resistant TB Strategic relevance 48. Drug resistant TB persists largely due to ongoing transmission from patients who are treated empirically with standard anti-TB treatment, without screening for at least rifampicin resistance. In drug-resistant infections, failure to detect means failure to treat. While standard daily-dosed anti-TB drugs cost approximately $50 per 6- month regimen, drug costs for rifampicin-resistant TB and variants is 30-60 times more. Variants include multi- drug resistant TB (i.e. resistance to both rifampicin and isoniazid, MDR-TB) and extensively-drug resistant TB (i.e. MDR-TB with additional resistance to fluoroquinolones and second-line injectables, XDR-TB). MDR-TB treatment is highly toxic and poses extensive health and economic costs on patients and families. Detection and treatment of drug-resistant TB is also far costlier to public health systems, as diagnostic testing can be costly and must be applied to large numbers of TB patients, to find and treat the subset of drug-resistant TB. Deaths from drug- resistant TB now account for about one-third of all antimicrobial resistance deaths worldwide. India has the largest burden of drug-resistant TB of any country in the world, not in terms of proportion, but in sheer numbers. 49. A recently completed national anti-TB drug resistance survey found that roughly 1/4 of TB patients in Indi have some form of anti-TB drug resistance, and that 1/16 of all TB cases had MDR-TB. Among MDR-TB cases, 1/5 were also resistant to fluoroquinolones, and would thus require additional treatment with newer, even more- costly anti-TB drugs, such as bedaquiline or delamanid. These survey findings translate to an estimated 147,000 cases of MDR-TB per year, and an estimated 30,000 patients for year who (under current Indian TB treatment guidelines) should receive newer anti-TB drugs. The cascade of care, as represented from 2013 meta-analysis of the cascade of care, clearly indicates case finding as the key problem, and attrition in the cascade of care as a secondary, significant challenge.29 29 Subbaraman R et al. The Tuberculosis Cascade of Care in India’s Public Sector: A Systematic Review and Meta-analysis. PlosMed 2016:10;1371. https://doi.org/10.1371/journal.pmed.1002149. 20 Figure 7: Cascade of care for MDR TB patients, 2013 cohort, estimated to present to the public sector 50. DR-TB is an example of a market failure, where the condition is relatively uncommon, affects mainly the poor, and is very costly to treat, poses some infectious risks to care providers, and has extensive public health implications. Accordingly, little DR-TB care exists in the private sector, and the disease detection treatment has by default been the responsibility of the public sector. India has made remarkable strides in the establishment of DR- TB services, particularly in the expansion of laboratory infrastructure in public facilities for the detection of drug- resistant TB. In the first six months of 2018, RNTCP reported screening approximately ~300,000 individuals for rifampicin resistance – a remarkable achievement, but still only roughly 1/3 of the potential screening of notified TB patients required to detect and treat MDR-TB existing cases and curtail ongoing transmission of drug-resistant TB. Ambitious targets proposed in the NSP-TB are proving difficult to meet (Table 13, Figure 8). While DR-TB reference culture and drug susceptibility labs (CDST) have been established as per plan targets, decentralized molecular laboratory and testing infrastructure has lagged. Patient coverage of detection and treatment of rifampicin resistant TB, reflected in DST testing coverage and RR-TB treated, has likewise lagged behind ambitions. Table 13: Targets and achievements in drug-resistant TB services, 2017. Source, RNTCP. Metric 2016 2017 Target Achieved Target Achieved Culture and DST labs 66 69 73 81 Molecular labs 651 1245 DR-TB treatment centers 143 148 143 250 Patients screened for DR-TB * * Pending 30% Patients treated for DR-TB 32958 36000 35950 53460 Treatment success (prior cohort) Pending Pending 21 Figure 8: Progress against key DR-TB Indicators (end 2017) vs Targets in the NSP-TB (Source: RNTCP) 51. Underlying reasons for slow patient coverage lie in (a) diminishing returns on testing, and (b) limited decentralization of diagnostics services, and (c) limited services for privately-treated TB patients. a. Diminishing returns are expected as testing indications broaden and the highest risk patients in the public sector are already being screened. The RNTCP is expanding DST to begin screening low-risk patients in the public sector, and accordingly the number needed to screen to find a case of RR-TB will increase. Increasing testing coverage among TB patients cared for by public health facilities is necessary, but insufficient. b. Diagnostic services remain centralized at the District level, and in medical colleges and reference centers. TB detection is decentralized, and inability to decentralize DST leads to inevitable fallouts in the cascade of care. Decentralization of rapid molecular DST has been demonstrated by RNTCP to the block level, with 90% coverage of notified TB patients.30 c. The RNTCP has adopted a policy of universal DST, where all diagnosed TB patients should be screened for at least rifampicin resistance. Very few patients in the private sector are screened for DR-TB. Finding all rifampicin-resistant TB necessarily requires comprehensive screening of all diagnosed TB patients, including patients seeking care in the private sector. Genuine control of drug-resistant TB would require universal drugs susceptibility testing (DST) and linkage of detected patients to treatment. The RNTCP has demonstrated feasibility of promoting subsidized DST for privately notified TB patients, achieving 60% DST among adult pulmonary notification routinely and sustainably in Mumbai and Patna and 40% DST among pediatric TB patients in multi-city demonstrations. 52. Treatment success for patients with rifampicin-resistant TB and its variants has been equally dismal under the RNTCP as in other settings, with less than half of patients surviving and completing treatment 30 Sachdeva KS, Raizada N, Sreenivas A, van't Hoog AH, van den Hof S, Dewan PK, et al. (2015) Use of Xpert MTB/RIF in Decentralized Public Health Settings and Its Effect on Pulmonary TB and DR-TB Case Finding in India. PLoS ONE 10(5): e0126065. https://doi.org/10.1371/journal.pone.0126065 22 successfully. Improving treatment success requires sorting patients with rifampicin-resistant TB to the correct regimens and sustaining those patients on treatment. The base regimen for rifampicin-resistant TB endorsed by RNTCP is now nine months, far shorter and easier to tolerate and complete than previous regimens. Patients with fluoroquinolone resistance are now recommended for a bedaquiline-enhanced regimen, which has proven to be independently associated with improved outcomes and reduced mortality. Technical soundness 53. The proposed Program appropriately directs efforts at the bottlenecks for DR-TB control. Proposed activities under the Program involve incentivizing achievement of universal DST. Testing is the most essential activity for DR-TB control to succeed. The RNTCP has achieved >85% linkage to treatment. Similarly, poor treatment outcomes in DR-TB have been associated with fluoroquinolone resistance and poor adherence.31 54. The attention to DR-TB control aligns with the Program focus on private provider engagement. Screening for drug-resistant TB has been shown to promote private provider engagement. RNTCP’s policy to offer free diagnostics services for drug-resistant TB increases the value proposition that RNTCP can offer to private providers for complying with TB notification. Similarly, testing privately-notified TB patients offers a rich source of high-risk individuals, and will contribute to testing targets. The RNTCP’s experiences in Mumbai and Patna are instructive – with high levels of testing of privately notified TB cases, Mumbai could detect more than 3,500 cases, or 30% of MDR-TB cases citywide; Patna detected nearly 800 MDR-TB cases, 75% of all MDR-TB over the project period.32 55. An underappreciated component of DR-TB control involves improving airborne infection control in high- risk settings. This activity is subject to monitoring under the results framework and calls for advocacy and attention to a usually neglected area of importance to both epidemic control and in retaining human resources for healthcare of drug-resistant TB. Facility-by-facility infection control assessments and plans are the globally- recommended best practice. India established clear guidelines in 2012, yet implementation has been limited to a few pilot centers. The Program appropriately includes attention to airborne infection control in the results framework. D4. Result Area 4: Improving surveillance and ICT systems to support quality of care and surveillance functions Strategic relevance 56. India has an estimated incidence of 2.74 million TB cases per year with credible uncertainty between 1.7- 3.4 million. Sub national surveys reveal a wide geographical variation in the TB epidemic across the country with high to low TB prevalence, HIV-TB coinfection and DR-TB across districts and states. Paradoxically, in rural areas TB prevalence is higher, but the annual risk of TB infection is lower, and vice-versa in urban areas. The prevalence of TB in India is higher in men as compared to women, in line with the global trend. 57. Estimating India’s TB disease burden and tracking progress in TB control has been challenging. TB incidence is not counted but estimated based on expert opinion and modeling, making it highly uncertain. For the past 20 years, India has lacked a surveillance system capable of capturing TB patients diagnosed and treated by private providers. 31 Parmar MM, Sachdeva KS, Dewan PK, Rade K, Nair SA, Pant R, et al. (2018) Unacceptable treatment outcomes and associated factors among India's initial cohorts of multidrug-resistant tuberculosis (MDR-TB) patients under the revised national TB control programme (2007–2011): Evidence leading to policy enhancement. PLoS ONE 13(4): e0193903. https://doi.org/10.1371/journal.pone.0193903 32 Pipenini et al. Effective service delivery for TB patients seeing care from the private sector in Patna. 2018. Publication pending; available on request. 23 58. In other settings, where all diagnosed TB cases are reported to public health authorities, TB programs just count their cases and use adjusted notification to track incidence. In India, this would require a system that completely captured TB cases from both the public and private health care systems. Notification of TB cases by private providers, however, remains low, despite administrative orders issued by the MOHFW and GOI. In 2017, a total of 1.9 million cases were notified—of which 1.48 million cases were from the public sector and 0.39 million from the private sector. The low case reporting is matched by low coverage of public health services included in the Standards of TB care, such as HIV testing or screening for DR-TB. The coverage gap between public and private TB notifications is summarized in Figure 9. Figure 9: Public and private TB notifications, and coverage subsequent public health services expected for HIV-testing TB patients, and drug-susceptibility testing. 59. Estimates derived from commercial sales of anti-TB drugs indicate that the private health sector is treating roughly double the number of TB cases, compared to the public sector 33. The under-enthusiasm of private providers to report TB cases is unsurprising, given the absence of systems for incentives, penalties, provider services, or patient support. The gap in private sector notification makes country-wide TB notification data an unreliable proxy for tracking TB incidence in India, nationally or locally, and makes evaluating the impact of national and local interventions exceptionally challenging. 60. The crucial need for improving surveillance was recognized by the Joint Monitoring Mission (JMM) 2015 and the JMM and the NSP-TB have made several recommendations and plans to improve TB surveillance in the country (Table 14). 33 Arinimanpathy N et al. The number of privately treated tuberculosis cases in India: an estimation from drug sales data. Lancet Infect Dis. 2016 Nov; 16(11): 1255–1260. 24 Table 14: Prior recommendations (with source) and current progress on improving TB surveillance in India Recommendation or Proposed Activity (Source) Progress, 2018 Systems Establishment of an all India TB estimates group to prepare Joint ICMR-IHME-MOHFW working group on robust estimates of TB incidence (JMM 2015) disease burden estimation, as part of State Disease Burden Estimation initiative, using GBD methodology. Outputs included in first national report. WHO estimates remain independently developed. Strengthening of case based routine surveillance using an Nikshay version 2.0 developed and released ICT supported system of every patient (JMM 2015) nationwide, October 2018, including mobile reporting. Analytics not yet included in current development/deployment, with uncertainty on development partners and pathway. Analysis of prevalence and mortality trends utilizing data Not implemented from IT based case reporting Establishment of TB surveillance units at State and District Not implemented levels (NSP-TB) Routine anti-TB drug resistance surveillance from notified Insufficient coverage to implement; laboratory TB cases subject to DST (JMM 2015, NSP-TB) data systems not integrated into Nikshay to allow for meaningful routine analysis of surveillance data. Active case finding among high risk communities for case- Health-worker driven house-to-house finding and surveillance value symptom-based screening deployed by States and Districts for high risk communities, with varying degrees of coverage and data capture. Numerators reported in RNTCP annual reports. Surveys National disease prevalence survey (JMM 2015) Underway after 2 year administrative and planning delay, completion end 2019. National anti-TB drug resistance survey (JMM 2015) Completed, report published. Inventory studies (JMM 2015, NSP-TB) Proposed repeatedly, never left planning stages. 61. Historically, the RNTCP used paper-based quarterly aggregate reporting to monitor the program. The launch of ‘Nikshay’ a web enabled case-based monitoring system in 2012 facilitated the shift from aggregate to case-based reporting. Nikshay was developed jointly by the MOHFW and NIC and was built with the aim of shifting to digital case-based TB patient notification and tracking, and to modernize program supervision, monitoring, and management. Significant concerns were raised about the quality and timeliness of data by the JMM 2015, but no independent surveillance system evaluation has been conducted. The effort was challenged by (1) underinvestment in development and human resources, (2) dated architecture, not suited for mobile solutions and the transition of ICT infrastructure to cloud-based solutions, and (3) irregular utilization by States and Districts, compromising the potential of the solution as a real-time tool. 62. Recognizing this, Nikshay 2 was launched in September 2018. The latest mobile-enabled version of this IT-enabled application now integrates patients from both public and private sector health care systems, for both drug sensitive and drug resistant TB cases, and includes integration of a variety of adherence monitoring tools and services. The application includes mobile and call center-based interface, for which an initial call center using an 25 empaneled private vendor has been established, with 50 seats catering to a few initial states. The system by design offers real-time notification and monitoring of patients throughout the cascade of care, allowing for mobile-driven alerts to patients and health staff to reduce attrition. The major features of Nikshay 2, as implemented or in the design pipeline, are summarized in Table 15. Institutional arrangements for ongoing development, hosting, deployment support, and steering for Nikshay 2, including financing, are shown below in Table 16. Because this is a new program, the current status is reflected along with the envisaged future state, as related by RNTCP. Table 15: Software and integrations deployed or in development for Nikshay 2 Deployed • Robust unified Patient Centric Architecture for Public and Private sector • Integrated Patient Management for Drug Sensitive TB and Drug Resistance TB • Web and Mobile based application • Efficient management by integrating users and processes • Access to Real time patient data, alerts & task lists • DBT enabled for TB Patient Incentive to TB Patients for nutrition support (Nikshay Poshan Yojana) In Development • Referral and transfer of patients from one geography to another • Multiple episode management (for given patient) • De-duplication • User Management • Add newer task lists • Enable digital signature-based approvals for DBT • Enable DBT for other benefit schemes • Geo-tagging Integrations live, as of October 2018 • Public Finance Management System (PFMS) • Adherence Technologies (99D and MERM) Integrations pending • Aadhaar Integration • e-Aushadhi • CBNAAT • Trunaat • Qure AI • Bhuvan (ISRO) • API integration for patient notification from private providers • Customer Relationship Management (CRM) tool of the Contact Center) • Adherence Technologies (ZMQ and Caredose) 26 Table 16: Implementation arrangements for Nikshay 2, current status and future state Current status Future state Overall roadmap, � Launched pan-India � 3-team streamlined agile development steering, and � CTD, WHO, ICT Cell, Call Centre, and steering approach. monitoring Everwell, and JEET/PPSAs � Steering committee for monitoring � Ad-hoc ongoing monitoring of and review process by CTD Roles � Program Team (CTD & WHO) – Build and steer the overall ICT Vision by guiding and enabling other teams in accordance with the needs of the program � Everwell Team – Architect and develop the integrated ICT solution � ICT Cell - Perform all the ancillary technical operations which are critical to successful implementation of Nikshay as – Technical support to users, Testing, Training support and Program Reporting/ Analytics. � Contact Centre – Perform as the Level 1 of technical support to Nikshay users across the country Hosting � Azure - Platform as a Service � NIC cloud or vendor who is PaaS (PaaS) capable Training and change � At launch of Nikshay 2.0, the � A structured plan for ongoing training management of central WHO team and Everwell of RNTCP users (across all levels) to be States, District, and teams trained the trainers - WHO prepared Sub-district field Consultants and select RNTCP � The scope of Nikshay 2.0 Training can staff nationwide representatives from states. be enhanced to include other aspects These trainers are training the such as – capacity building on using DTOs who in turn are training mobile devices/ applications, soft- their staff skills, Program protocol changes etc. � Extensive training content � The scope should also cover aspects of (documents, videos and FAQs) the process to be followed and the were prepared and uploaded in Roles &Responsibilities of the various the Nikshay 2.0 website individuals (users Contact center � 50 seats (UP+MH) � 250 seats (nationwide, with regional Features centers) � Citizen (Queries & Grievances) Additional features � TB Patients (Queries & � Linkage for Govt. FDC issuance Grievances) � Incentives information / linkage � Public Sector (RNTCP) staff Information on monthly refill � Patient notification � Outbound counseling � Patient details update � Linkage for Govt. FDC issuance (demographics, test results, � Incentives information / linkage adherence, regimen, outcome � Information on monthly refill etc.) � Private Providers � Patient notification � Nikshay users - Level 1 Technical Support (across India) Business analytics, � Highly rudimentary - Presently � Selection and adoption of an reporting, and data two dashboards and a register independent analytics/visualization management are generated in on the Live tool to cater to reporting needs of the database. 27 program by being integrated with Nikshay � Multiple summary reports as prescribed by Technical Operational Guidelines (TOG) � Multiple Line lists as prescribed by Technical Operational Guidelines (TOG) Technical soundness 63. Surveillance system and ICT enhancements are integral for achievement of the PDO. The PTETB Program identifies improvement in surveillance systems and in the ICT services as essential activities for achievement of TB control objectives. The enormous uncertainty in expected TB notifications makes it challenging for managers to understand when coverage has been achieved, and if collective efforts in a given area are yielding accelerated reductions in TB and DR-TB. Accordingly, strengthening surveillance systems and ICT have been given due importance in the Program design and allocation of reimbursement against achievements. 64. Private provider engagement requires functional ICT to succeed and effective surveillance to track. Effective reach of private providers will require first capturing those private notifications, and then linking them to public services (especially payments, testing, and adherence support). The surveillance and ICT systems serve as a force multiplier for public staff, bringing the power of tracking and task lists into each TB program actor’s pockets. The system also brings a contact center as a force multiplier for public staff to reach providers and patients alike, none of which can reliably be assumed to engage with an app. 65. India’s ICT system is capable of delivering the promised value, subject to a major effort to integrate the system in routine program operations. With India’s approach, the pitfall of application fragmentation is precluded in this ecosystem. Government staff and contracted supporters via interface agencies are being forced use the same ICT system for integration of activities and supervision. Forward-looking application integrations to laboratory devices, laboratory information systems, to PFMS for e-payments, and adherence systems are already in place. 66. Tracking PTETB Program progress will require an effectively implemented ICT system. The Program’s focus on improving the functionality and quality of data and Nikshay has cross-cutting value. A new nationwide system usually takes years to stabilize in terms of data capture and utilization. Given that the Program is launching now and relying on Nikshay data for most indicators, early confidence in Nikshay data is crucial to confidently disburse and track progress against the PDO. 67. Nikshay 2 is newly deployed nationwide and will take time to stabilize. However, there are concerns about the system, including high-level challenges below. a. Data integrity and duplication are design concerns in Nikshay 2 deployment which must be addressed at Program onset. Previous and current surveillance and ICT systems posed significant risk of duplicate registrations, particularly with multiple mandatory notifications from private provides, laboratories, and chemists. Unless information is integrated longitudinally, large numbers of incomplete orphan data will accumulate. Duplicate registration is a theoretical risk, with no evidence till date of systematic problems. Nonetheless, future de-duplication implementation is expected based on (a) Aadhar number, (b) names and phone numbers, and (c) account information. 28 b. Program management, reporting, supervision and monitoring support from Nikshay are rudimentary and require strengthened development. c. Integration of AADHAAR—the GOI’s unique identification program—into Nikshay is robust but requires adjustment for recent national developments. The uniqueness of an individual is achieved through the process of biometric de-duplication. As per the latest available statistics approximately 1.19 billion unique Aadhaar numbers have been issued. Recently, the Supreme Court of India in its ruling has mandated that there should not be denial of service due to lack of Aadhaar. Hence to adhere to the ruling of the Supreme Court, Nikshay 2.0 would have to adopt a two-pronged strategy to ensure successful authentication of beneficiaries (Table 17). Table 17. Aadhar integration opportunities for the TB ICT system Beneficiaries with Aadhaar number (90% of population): integrates with the Aadhaar platform and leverages the available biometric, demographic, and OTP-based authentication services. Beneficiaries without Aadhaar number (10% of population & refusers, for exception handling): Recording of Government issued identification document. The data quality enhancement tool should trigger if this option used excessively. In partnership with the UIDAI, RNTCP can refer beneficiaries for Aadhaar enrollment. The UIDAI-issued 28-digit temporary enrolment ID should be captured in Nikshay 2.0 and replaced with the Aadhaar number when available. 68. The program appropriately focuses on processes and systems for early milestones, and validation of system performance in later activities. Accordingly, early DLIs for system development, in particular program guidelines for supervision and monitoring, and system deployment of de-duplication, are crucial early Program milestones. The actual performance of the surveillance system will be severely tested by the proposed DLI validation protocol. Verification activities for key DLIs, i.e. private notifications, treatment outcomes, DBT disbursal, and microbiological testing are subject to primary data verification, from patients and laboratories. Simply put, India’s system will have to perform very well for these disbursements to be issued. 69. The Program is technically sound and expected to provide some measure of the secondary objectives. The Program’s support for private provider engagement is the backbone of the collaboration. Improving care among privately-treated TB patients in India is arguably the single most-important delivery intervention available globally. Better TB detection and treatment supported by the project is expected to provide some degree of economic protection for affected households. 70. It is uncertain if the primary objective of DBT services will me be met; the value and health impact of improving nutrition has yet to be justified. Robust evaluation and steering would be crucial to ensure that the primary objective can be achieved. The two variables that CTD can play are coverage (proportion of persons who receive the benefit) and amount of the benefit. Evaluation will likely point to how the program could be supported. 71. In addition to the direct health and economic benefits to the poor, the Program is likely to bring additional indirect benefits to the health care system and economic growth. Better case detection and treatment of TB avoids future disease burden and medical costs. Without property treatment and control, a TB patient could infect up to ten people. For those receiving sub-optimal treatment or having poor medication adherence, there is higher chance of developing MDR-TB, which is significantly more challenging and expensive to treat. By scaling up high-quality TB diagnosis and treatment in the private sector, this project will contribute to reduce the TB disease burden and prevent further TB and MDR-TB cases. The program will incentivize the electronic information system (e-Nikshay) for surveillance of TB and MDR-TB, de-duplication and patients record reconciliation, expenditure tracking and public financial management, drug logistics management, and patient case management. 29 72. Leveraging the electronic information system, better information reporting and management is expected to enhance the efficiency of program management and TB service delivery, including beyond the program time horizon. The use of DBT could lower transaction costs compared to the traditional benefit transfer programs and leads to cost-savings to the public financial management system. A previous World Bank program supporting the GOI DBT Bharat Portal estimated a saving of 17% of expenditure due to elimination of duplicate, non-existent and ineligible beneficiaries. The program design heavily emphasizes on improving the central and states government’s capacity to incentivize private sector performance, which is relevant for India’s health reforms beyond TB. The valuable lessons generated, and capacities built around output-based strategic purchasing, and incentives through direct benefit transfer could have positive externality on other disease areas and inform India’s future health reforms. 73. Continuous and smooth supply of good quality assured anti-TB drugs and all related commodities is an essential activity under the RNTCP. Annual procurement of anti-TB drugs, equipment, and diagnostics is centrally planned, coordinated, and implemented through a well-defined procurement mechanism. 74. Supply chain management, consumption, and monitoring was earlier being done through quarterly aggregate reporting. ‘Nikshay Aushadhi’ a web-based logistics and supply chain management tool, has been implemented to enable real time visibility into stock status at all levels (SDS, DTC, TUs and PHIs) and enable forecasting, quantification and further distribution of TB drugs and diagnostics (Table 18). The supply chain management through Nikshay Aushadhi is presently working up to sub district level and is to be implemented up to PHI and TU level with data accuracy. Supply chain and logistics management are not presently integrated into Nikshay 2, and so patient-level drug supply tracking is not yet feasible. 75. If effectively implemented, Nikshay Aushadhi would help to determine the drug position, expiry details, routine/ADR requirements, at all levels on a real-time basis. Collection of data from the PHI level would enable improved forecasting of TB drugs and diagnostics. Integration of this application with Nikshay 2 mobile could in theory allow PHIs to record drug issuance and facilitate more timely data. This could lead to improved forecasting of drugs and diagnostics. A parallel value of this effort is that recording drug issuance could provide patient level drug-refill data that might improve validity of remote adherence monitoring. Table 18: Key functionality of Nikshay Aushadhi Provision to maintain expiry date / shelf life for drugs wherever applicable Online indenting of drugs – Quarterly basis or on need-based request (ADR) Ease of demand generation & forecast Ability of online tracking of drug inventory at various levels throughout the states Help in better planning, execution & control on demand & supply across states Various alert generation facility with different colors Ability to generate customized Reports Ability to locate drugs using many search criteria in all Institutions throughout the states Bar Code Interface for unique identification of drugs Record transactions while moving items from one location to another through RO / DTA Help & Solution Desk for Users 30 E. Program Technical risks and mitigation strategies 76. Based on the integrated risk assessment carried out during preparation, the overall risk of the Program is considered Moderate. The most significant area of risk is related to the program’s institutional capacity and associated risks to DLIs which is rated as Substantial (See below). The technical design of the Program is sound. The four results areas are built on successful pilots and global evidence on TB control. In addition, the NSP 2017- 25 is well thought out and prioritizes high impact interventions. GOI financing for TB control has been increasing significantly and there is continued government commitment at the highest levels. 77. Institutional Capacity for Implementation and Sustainability: Substantial. Although the CTD team has considerable experience implementing a Bank-supported project, the CTD has limited technical capacity to manage the implementation of some novel interventions proposed under the PforR operation—specifically, the envisaged rapid scale-up of the private sector engagement and the DBT. The CTD will need a rapid scale-up of staff capacity in these technical areas to guarantee high quality implementation at scale. Instrument-related and other capacity building activities for key stakeholders and CTD and state levels involved will be continued throughout preparation and implementation phases, including under the Annual Capacity Building Plan. The MOHFW will develop a human resource plan and implement it as part of the Program Action Plan monitored under the PTETB PforR. 78. Some specific risks in technical design, implementation and M&E, and the mitigation measures are summarized in Table 19. Table 19: Summary of risks and mitigation strategies Risks Mitigation Risks in Technical design Inadequate behavior changes by • Ongoing surveillance for non-notified patients via drug private providers – inadequate value sales cross-reference in select areas, as check for proposition for notification, testing, notification coverage trends treatment services • Implementation research to understand and address gaps in uptake • Increase support for notification at hub hospitals (hub agents) • Re-consider mechanisms of drug delivery to more closely match the model from pilot projects, i.e. from public supply-based to proven voucher-based approach. Incentives / honoraria are perverse, • Ongoing, routine validation of notifications and services yielding falsified notification/service from call center, with feedback on validity to local claims for reimbursements (or are program managers. perceived as potentially false, and are • Integrate findings from IVA to program evaluation and not actively implemented by staffs) steering. Quality of services (testing, sustaining • Increased staff numbers or contracting for manpower for treatment) not monitored service support • Increase use of adherence tools, novel delivery services Current DBT process and amounts not • Technical support for evidence-based revision of scheme optimized and may not get adjusted to values, including via TSU meet program performance needs. • Increase flex for DBT approach and adjusted payments based on local scenario Risks for Institutional arrangements 31 Uncertainty surrounding continuation • Two-pronged approach of use of AADHAAR or other of AADHAAR if there is change in government issued identification methods political economy post elections in mid- 2019 TSU may not be effectively integrated • Involve State early in selection and operations of TSU. with RNTCP and NHM operations • Seek transition to State contracting of TSU and funding, especially before JEET concludes Guidelines issued by CTD do not • Active surveillance by TSU network for policy uptake and necessarily get applied by states aggressive advocacy for state bottlenecks. • Adaptation of guidelines to feedback from States, where the guidelines are not meeting State needs. Risk of non-implementation Failure to develop and roll-out Nikshay • Prior results and DLI to provide some development 2 and the Call Center as designed incentive; technical assistance to strengthen/evolve systems to meet needs. • Continued access to top quality developers • Adequate resources and professional management for Call Centre States do not execute guidelines of • Rapidly develop and empower TSU to support purchasing purchasing of private services, do not activities. expand PPIA to cities beyond JEET • Develop new guidelines, with reimbursement against starter sites, or sustain JEET-catalyzed outputs (as opposed to cost inputs) PPIA sites • Appropriate costing/rates adjusted annually Molecular diagnostic services do not • Adjust policies to include easily-accessible and available- expand as planned to meet demand by everywhere voucher-based purchasing of diagnostics from private providers, or for DR-TB private lab networks. expansion needs PPE constrained by lack of access to • Technical assistance for strategic purchasing guidelines drugs and diagnostics because RNTCP reluctant to purchase from private • TSU, and technical assistance for revision of partnership providers guidelines States unwilling to contract intermediaries, or do so with very • Technical assistance, especially via WHO consultants’ restrictive input-based arrangements, network budgets that are too low, and delayed payments RNTCP Field Staff do not take up • Task lists via Nikshay 2 responsibilities for privately-treated • Monitoring and supervision based on task list completion patients DBT selectively provided to public • Monitoring and supervision of DBT, automating reports to patients and not privately treated provide DBT uptake by source of treatment patients, or not applied to some (public/private) and for marginalized populations. marginalized populations Risk related to M+E Lack of local disease burden • Consider expanding sequential district level prevalence information, and lack of information on surveys after national prevalence survey completed in which areas TB cases are not accessing 2019, at least in sentinel districts any part of the health system, public or private 32 • Integrate active case finding efforts into surveillance system, to understand where ACF yield is higher, and to target similar areas. Lack of information on adequacy of • Establish sentinel surveillance and comprehensive drug private notification sales and laboratory monitoring, as in inventory studies, to allow for an estimate of under-notification. Inadequate Nikshay data quality or • Data quality enhancement tools can be used, and data validity- i.e. the timeliness, quality operators could be deployed to improve data completeness, consistency, duplication quality and authenticity of program-reported data • Use of AADHAAR, telephone number and bank account number to authenticate identity and avoid duplication • Feedback of findings from independent verification into quality enhancement F. Institutional Arrangements 79. Current structures: The management of the TB program is well embedded within the MOHFW at the central level, the National Health Mission, and the general health system at the state and district levels. Both at the state and district level a multi-stakeholder health society is responsible for planning, budgeting and administration of the program. Table 20 summarizes the governance structure of program at various levels. Table 20: Governance structure of program at various levels Level Administrative Head Technical Head General Health System Central Secretary – Health and Family Welfare, DDG-TB Additional Secretary (Health), Joint Secretary in charge of TB State Principal Secretary- Health and Family State TB Officer Director- Health Services Welfare and Mission Director- NHM District District Collector/Deputy Commissioner District TB Officer District Health Officer/Chief Medical Officer/Civil Surgeon 80. The CTD is the nodal agency for the national TB program. CTD is headed by the DDG (TB) and consists of four to five full time staff from the central health service of the rank of CMO. CTD also has contractual staff such as national consultants and experts in procurement and finance who are either supported from the domestic budget or through donor agencies. An organizational structure consisting of separate functional units headed by a CMO was recommended for the CTD in the operational guidelines of 2005 but not implemented (Figure 10). At the state level, the TB program is managed by the state TB officer (STO) who is a fulltime officer of the rank of additional director or joint director from the health department. The state TB cell consists of fulltime officers such as the Director STDC, Deputy STO and contractual staff like TB-HIV coordinator, PPM coordinator, DRTB coordinator, State Accountant, Procurement Officer etc. At the district level, the district TB officer manages the program through the district TB center and is supported by a medical officer (MO-DTC), DR-TB/HIV-TB coordinator, PPM coordinator and accountant as well as the medical officer TB control (MO-TC), senior treatment supervisor (STS) and senior TB lab supervisor (STLS) at the sub-district level. The state level institutional support mechanism 33 explained above is effectively replicated across states, regardless of size or institutional support systems in these states. The country wide status regarding sanctioned positions and available staff at the state and district level are given in Table 21, 22, and 23. Figure 10: CTD organizational structure 81. Many positions are vacant both at state and district levels, constraining the institutional capacity of the program. This observation holds nationwide but is more pronounced in priority states included within the Program boundaries. 82. A comprehensive human resources (HR) plan has been included in the Program to encourage CTD and at the state level to meet the scale and ambition of the NSP. The CTD and State TB Cell may need to be restructured (as proposed by the NSP-TB) into four divisions with commensurate increase in both technical and operational staff to cater to the widening program mandate. Inclusion in the HR plan should be a strategy to address programmatic vacancies. Since TB control efforts are part and parcel of the National Health Mission, these drives will necessarily be in tandem with HR recruitment efforts of the state and district health societies. 83. Technical support units (TSUs) have been suggested to be established at national and state levels. Expertise of the private or non-government sector will be tapped in areas such as DBT, PPIA, ACSM, procurement, and supply chain management to help the TB program achieve its mandate efficiently and effectively. Long term sustainability will be considered so that the existing structures do not collapse once the policy attention diminishes. Considering the fact that program management units are in already in existence under the JEET project and the also lag time required for procurement, the TSUs at state level are planned from Year 2 onwards. 84. Redefine Center-State Compact: The TB program is a centrally driven program. The policies and strategies are conceptualized and designed at the central level using a ‘one size fits all’ approach. This design is fundamentally challenged to deal with a disease that has wide geographical variations in its trends between states. One approach pursued in other development programs, such as Swachh Bharat Abhiyan, have redefined the center-state compacts by allotting states an incentive grant for designed and implementing state specific interventions that are customized to meet their requirements. This could be a 100% grant, similar to central sector scheme, that could be over and above their allocation under the NHM PIP for a particular year. Table 21: Status of state level positions in RNTCP Position Sanctioned In place % Vacant Epidemiologist (APO) 34 18 47.1 MO – STC 35 21 40.0 TB-HIV Coordinator 34 16 52.9 PPM Coordinator 24 14 41.7 DR TB Coordinator 27 8 70.4 34 State IEC Officer 38 33 13.2 State Accountant 45 38 15.6 Technical Officer- 26 10 61.5 Proc. and Logistics DEO-STC 41 38 7.3 Pharmacist – SDS 48 40 16.7 Store Assistant – SDS 56 37 33.9 Director (STDC) 23 23 0.0 Table 22: Status of district level positions in RNTCP (nationwide, 2017) Position Sanctioned In place % Vacant Senior MO – DR TB Centre 156 94 39.7 Counsellor – DR TB Centre 148 78 47.3 Statistical Assistant(SA) DR TB Centre 163 118 27.6 MO – DTC 465 361 22.3 Medical Officer TB-Control (MO-TC) 5262 4626 12.1 Senior DR TB –TB HIV supervisor 785 699 11 District PPM Coordinator 689 382 45 Accountant 668 451 32.4 Senior Treatment Supervisor (STS) 6086 4753 22 Senior TB Lab Supervisor (STLS) 2914 2522 13.5 Lab. Techs. (LT) – RNTCP Contractual 5061 4290 15.2 Tuberculosis Health Visitor (TBHV) 3711 3061 17.5 Table 23: Status of Key HR positions in 9 high burden states, 2017 State MO-TC STS STLS LT TBHV S* P** S* P** S* P** S* P** S* P** Assam 154 73 153 146 78 76 95 85 34 32 Bihar 534 508 534 158 228 145 558 381 95 15 Karnataka 196 196 273 194 136 132 181 164 217 192 Maharashtra 401 383 460 409 318 287 336 319 527 508 Madhya Pradesh 228 183 253 201 166 141 246 202 215 167 Rajasthan 283 263 283 262 152 92 67 23 90 33 Tamil Nadu 137 137 461 461 143 143 359 359 371 371 Uttar Pradesh 993 661 998 830 412 388 978 910 498 450 West Bengal 461 414 462 388 193 162 380 337 373 183 S=Sanctioned, P=in place 85. An adequate governance structure and coordination arrangements are positioned to implement the program. First, the MOHFW Central TB Division is the nodal agency, and the World Bank Group country team is the responsible unit for this credit. The World Bank and MOHFW have an extensive and productive history of working together to finance TB control support. Second, the arrangement with other involved supporting donors and technical agencies have been formalized at the MOHFW level. Third, the accountability for achievement of disbursable results will be verified by an independent verification agency. Last but not least, very high level of country ownership in these two initiatives is a major enabling factor for the future Program results. Some opportunities to improve the institutional structure of the TB program in the NSP-TB are summarized in Table 24. 35 Table 24: Opportunities to improve the institutional structure of the TB program in the NSP-TB Implementing TB elimination efforts in a ‘mission mode’ with heightened levels of political and administrative commitment. Set up the national TB elimination board, a policy making body at the highest level chaired by the Prime Minister and a similar board at the state level. Establish four division structure at national and state levels, in charge of programmatic areas. Scale up of technical support both nationally and in the states, including surveillance units at both district and state levels. Include of newer components such as daily regimen, HIV-TB, MDTB, pediatric TB, private sector partnerships, pharmacovigilance as part of the training and adopting e-learning methodologies to cater to the increased training demand due to integration with NHM. Establish Comprehensive HR plan for CTD and States. G. Expenditure framework 86. The GOI is highly committed to TB control. Over the past 4 years, the GOI’s central level budget allocation to TB increased at an average nominal rate of 31% annually (26% real, net inflation), and the budget increased hiked to 70% in 2018. Further budget increase for TB (estimated at 12% nominal increase annually) is expected during program implementation. Given India’s high GDP growth rate projection (7.8% in 2019), and GOI commitment to TB control and elimination, funding sustainability and resource predictability do not incur major risks to the program. 87. The GOI’s budget outturn in the past three years shows reasonably well-functioning budget allocation and execution, ranging from 87% to 150%. For FY18 the utilization is 150% of the original budget, on account of an increased donor commitment, leading to a substantial increase in the Externally Aided Component. 88. Program Expenditure Needs: The projected total PforR expenditure requirements are shown in Table 25. The largest expenditure category would be procurement of first- and second-line anti-TB drugs, equipment, and laboratory materials by the CTD for distribution to nine states, accounting for 62.8% of total program expenditure requirement. Other relevant expenditure categories (mostly at the state level, with a small proportion at the CTD level) include: private sector support (PPM, NGO, PP support), salaries and benefits, honorarium, supervision and monitoring, training, and patient support and transportation. Only a proportion of expenditures in these categories is relevant to the PforR program, as some activities on public sector TB management that TB divisions perform are not within this PforR program boundaries. Other TB activities and expenditures not directly related to the Program are excluded (civil works, other major procurement, hiring and maintenance of vehicles, and miscellaneous office operations). State level expenditures are funded by both central level grant transfer and state government budget contribution. 89. The projection used historical expenditures as the base and adopted a need-based approach to estimate future expenditures. The expenditures relevant to the Program in the CTD and the nine states in FY2017-18 were identified by budget lines (Table 26). Annual expenditure growths for each budget line were assumed proportional to the yearly targets of relevant DLIs. Specifically, expenditure needs for drugs and supplies, private sector support, and honorarium were calculated using targeted number of cases and per case costs. To meet DLI targets on private sector engagement and direct benefit transfer, GOI TB expenditures on related categories (i.e., private sector support, honorarium, patient support, and transportation) would need to grow more rapidly than historical growth rates upon program implementation and grow more rapidly than other categories. The expected increase in these expenditure categories will provide more incentives for more efficient TB service delivery and value for money. 36 Table 25: Estimated PforR program expenditure needs by economic classifications Implementin Amount (US$ Economic Classification/Budget Line % of Total g Entity million) Central TB Supplies & Materials - Procurement of Anti TB Drugs， Division equipment, and laboratory materials 837 62.8% 9 States TB Private sector support (PPM, NGO, PP support) 224 16.8% Cells, and Salaries and Benefits 133 10.0% Central TB Honorarium 95 7.1% Division Training 17 1.3% Supervision and monitoring 15 1.1% Patient support & transportation 13 1.0% Total over program period 1,334 100.0% Table 26: Government TB Expenditures relevant to PforR Program results areas (2017-18) Budget Head/FMR % of Total Code Expenditure Activity Expenditure (US$) Central TB Division Supplies & Materials - Release for 2210.06.001.09.10.21 101,297,175 77.01% Procurement of Anti TB Drugs/Equipment 2210.06.001.09.08.20 Other Administrative Expenses 0 0.00% 2210.06.001.09.08.26 Advertising & Publicity 0.26% 340,275 2210.06.001.09.08.28 Professional Services 0.00% 1,368 2210.06.001.09.08.31 Cash Grants to NGOs & NRLs 4.74% 6,235,198 9 Targeted States H.2 Laboratory Materials 2,367,440 1.80% H.3 Honorarium 2,392,249 1.82% H.6 Training 763,370 0.58% H.9 PPM Focused Personnel/NGO/PP Support 4,245,294 3.23% H.12 Contractual Services 12,345,119 9.39% H.15 Procurement of Drugs 61,925 0.05% H.17 Procurement of Equipment 393,896 0.30% H.18 Patient Support & Transportation Charges 200,414 0.15% H.19 Supervision & Monitoring 826,816 0.63% Annual Increment (Program Management 0.01% H.20 Staff) 13,724 H.21 EPF (Employer's Contribution) 48,191 0.04% Total 131,532,454 100.00% Table 27: Government TB Expenditures relevant to PforR Program results areas by implementing entity (2017-18) Program implementation agencies State TB Cell Total Budget Head Central TB Karnata Madhya Mahara Rajasth Tamil Uttar West (FMR Code) Expenditure Activity Division Assam Bihar ka Pradesh shtra an Nadu Pradesh Bengal 37 Central level Supplies & Materials - 2210.06.001 Release for Procurement of .09.10.21 101,29 Anti TB Drugs/Equipment 101,297,175 7,175 2210.06.001. Other Administrative 0 09.08.20 Expenses 2210.06.001. Advertising & Publicity 09.08.26 340,275 2210.06.001. Professional Services 09.08.28 1,368 2210.06.001. Cash Grants to NGOs & NRLs 09.08.31 6,235,198 State level 119,33 286,3 2,367,4 H.2 LABORATORY MATERIALS 108,826 104,217 329,663 232,294 272,006 7 21 687,232 227,546 40 119,38 42,83 1,066,63 2,392,2 H.3 HONORARIUM 54,003 125,711 178,995 351,568 264,108 3 1 1 189,020 49 110,33 28,98 763,37 H.6 TRAINING 14,355 12,427 127,522 23,319 64,986 4 0 106,260 275,187 0 PPM FOCUSED PERSONNEL/NGO/PP 192,01 44,87 1,651,56 4,245,2 H.9 support 160,317 26,079 775,235 237,114 709,568 2 3 9 448,528 94 2,230,0 700,31 1,809, 4,650,10 12,345, H.12 CONTRACTUAL SERVICES 542,708 791,956 850,572 769,865 80 4 518 7 - 119 16,80 H.15 PROCUREMENT OF DRUGS 835 5,854 13,838 2,665 - - 9 21,923 - 61,925 PROCURMENT OF 144,2 393,89 H.17 EQUIPMENT - 5,692 39,599 79,807 - 56,728 37 67,832 - 6 PATIENT SUPPORT & 16,75 200,41 H.18 TRANSPORTATION CHARGES 4,506 6,792 18,186 23,066 29,542 10,360 0 54,625 36,586 4 SUPERVISION & 109,90 132,2 826,81 H.19 MOINTORING 33,776 2,164 99,986 31,623 204,090 8 14 61,483 151,572 6 Annual Increment (Programme Management H.20 Staff) - - 660 - 13,064 - - - - 13,724 EPF (Employer's H.21 contribution) - - 1,110 25,955 21,126 - - - - 48,191 1,080,8 2,435,3 1,777,27 3,808,5 1,418,3 2,522, 8,367,66 1,328,44 124,95 Total 101,297,175 919,326 92 65 5 71 75 532 2 0 5,612 Table 28. Projected Program Expenditure Baselines Project Year 1 Project Year 2 Project Year 3 Project Year 4 Project Year 5 % increase compared to Actual expenditures in Projected expenditure Projected expenditure Projected expenditure Projected expenditure Projected expenditure Projected expenditure compared to previous compared to previous compared to previous compared to previous compared to previous projected % increase projected % increase projected % increase projected % increase projected % increase previous year in 2018-19 Category 2017-18 year year year year year 1 1 1 1 1 1 Supplies & Materials - Procurement 104,120,43 117,65 3 2 2 2 2 2 of Anti TB Drugs/Equipment 6 6,092 % 131,774,823 % 147,587,802 % 165,298,338 % 185,134,139 % 207,350,236 % 2 2 2 2 2 2 14,888 0 0 0 0 0 0 Salaries and Benefits 12,407,034 ,441 % 17,866,130 % 21,439,355 % 25,727,227 % 30,872,672 % 37,047,206 % 5 8 7 8 6 4 Private sector support (PPM, NGO, 6,367, 0 8 9 0 4 0 PP support) 4,245,294 941 % 11,981,176 % 21,471,764 % 38,607,645 % 63,311,468 % 88,567,202 % 5 8 6 5 5 5 3,588, 0 8 0 0 0 2 Honorarium 2,392,249 373 % 6,746,142 % 10,765,119 % 16,147,679 % 24,221,519 % 36,762,883 % 4 5 5 4 4 876,42 6 0 0 0 0 1 Supervision and monitoring 826,816 4 % 1,226,994 % 1,840,491 % 2,760,737 % 3,865,032 % 5,450,120 % 2 5 5 5 4 4 916,04 0 0 0 0 0 3 Training 763,370 4 % 1,374,065 % 2,061,098 % 3,091,647 % 4,328,306 % 6,186,958 % 7 8 8 8 8 6 340,70 0 0 0 0 0 6 Patient support & transportation 200,414 3 % 613,266 % 1,103,878 % 1,986,981 % 3,576,566 % 5,934,084 % 38 1 2 1 2 2 2 124,955,61 144,63 6 4 8 0 1 3 Total 2 4,019 % 179,571,499 % 212,243,765 % 253,934,640 % 308,180,561 % 380,150,284 % Program Financing: Total projected cost of the PTETB (RNTCP four results areas) in nine targeted states and at CTD level is US$1.334 billion (Table 28). Within the boundaries of the Program, there is no other direct source of funding from other development partners. World Bank financing of the Program would be US$400 million, or 30% of the cost of the four result areas. The GOI’s budget will contribute to 70% of the program cost. Table 28: Program Financing Source Amount % of Total (US$ million) IBRD (PforR) 400 30% Government 934 70% Total Program Costs 1,334 100% 90. The US$1.334 billion total projected cost of the P4R Program was estimated to contribute to 74% of total government expenditures on TB in the nine targeted states (including state-level expenditures and distribution of anti-TB drugs from the CTD to states), or 25% of the funding required by India’s NSP-TB. H. Economic Analysis 91. An economic analysis was conducted to estimate the costs, health impact, and economic return of the Program. As a TB program has long-term health benefits, the outcomes were modeled over a 20-year time horizon. Costs were calculated in USD, and health benefits were estimated in terms of TB mortality, and disability- adjusted life years (DALYs) due to TB. Data from India and international literature were used, and various assumptions were made. Sensitivity analysis were conducted for multiple likely scenarios (Table 29). Table 29: Key Inputs and Assumptions Used for the Cost-Benefit Analysis Key Inputs Base Scenario Low Scenario High Scenario Discount rate of the future 3% 5% 3% health benefits Basic discount rate 7.5% 3% 10% GDP per capita growth 5% 4% 10% rate Effect of TB treatment • Success TB treated would reduce mortality (from 16% to 0 for TB, and from 50% to 0 for MDR-TB). • One successful treatment will prevent 1.3 future contact infections, among which 14% will develop TB 92. Project costs: The total cost of the P4R Program (RNTCP 4 results areas) within the project period (2019- 2024) is estimated to be US$1.334 billion, among which the World Bank financing would be US$400 million. 39 93. Health benefits: Based on DLI target setting, the program health benefits (i.e. death and DALYs averted) in the nine program states were projected (Table 28). The project benefits in each year were calculated as the difference between the program targets and the counterfactual scenario (assumed the same as in 2017). Over the program period (2019-2024), the program will prevent 308,350 deaths and around 591,286 DALYs. Though program interventions will end on 2024, the program will have health benefits over a longer time period. From 2019 to 2038, the program is estimated to avert 4.16 million DALYs (Table 30 and Figure 11). Table 30: Program Health Benefit Total Health 2019- 2020- 2021- 2022- 2023- Total Result areas (2019- benefits 20 21 22 23 24 (2025-38) 24) Private Estimated 10,131 25,971 47,571 70,380 96,531 250,582 Sector Death averted Engagement in TB Estimated 9,827 33,968 76,366 121,984 201,219 443,365 2,829,468 Control DALYs averted Estimated 7,604 12,272 14,204 12,382 11,306 57,768 Death averted MDR-TB Estimated 7,376 18,701 31,104 41,132 49,607 147,921 736,175 DALYs averted Estimated 17,735 38,242 61,774 82,762 107,836 308,350 Death averted Total Estimated 17,203 52,670 107,470 163,117 250,827 591,286 3,565,643 DALYs averted Figure 11: Total DALYs averted by year compared to the counterfactual scenario 300,000 250,000 200,000 DALYs Averted 150,000 100,000 50,000 - 2024 2031 2019 2020 2021 2022 2023 2025 2026 2027 2028 2029 2030 2032 2033 2034 2035 2036 2037 2038 Year 40 94. Cost-effectiveness: In the base scenario, the program is estimated to prevent 308,350 deaths and 4.16 million DALYs due to TB. The cost per DALY averted is US$2,747. Applying India’s GDP per capita (US$1,940 in 2017) as the threshold for cost-effectiveness as recommended by the WHO, the program is highly cost-effective. Applying the same threshold (US$1,940) as the societal willingness-to-pay for better health, the total health benefits of the program will be US$5.45 billion. 95. Financial analysis and return to investment: In the base scenario, the program will have a benefit-to-cost ratio of 5.58, IRR of 54%, and NPV of US$3.79 billion, indicating good value of investment. In the low and high scenarios, the program still has reasonable benefit-to-cost ratio, IRR, and NPV (Table 31). Table 31: Financial Analysis Base scenario Low scenario High scenario Benefit-to-Cost ratio (BCR) 5.58 5.65 8.22 IRR 54% 43% 83% NPV (US$ billion) 3.79 4.42 6.36 96. Public investment in TB in general, and TB care in the private sector in particular, can be justified for four reasons: a. TB patients are generally poor. TB is more prevalent among the poor and is closely associated with poverty. However, poor people have lower ability to pay for care in the private sector. Without public investment, TB will further spread in the population, and compromise the productivity of poor patients, driving poor households further into poverty. Public sector financing is therefore important to improve TB service access for the poor and to reduce impoverishment due to disease. Additionally, and independently, improved services have been predicted to reduce TB-related catastrophic costs by 6-19%, with benefits incurring among the poorest.34 b. The private health marketplace is failing to address TB. As with other infectious diseases, TB has strong negative externality, and the private market tends to under-provide TB care, particularly for more-costly drug-resistant forms of disease. Public investment is needed to address this persistent market failure. c. Public investment can significantly leverage the private sector. While crowding out majority private sector care provision from minority public services seems infeasible, public investment to incentivize private sector performance is a crucial, underutilized tool available to the GOI. Strategically, this project invests public funding in the forms of: 1) incentives for performance of private providers (through DBT), 2) government capacity enhancement to contract private sector providers and intermediary agencies, and 3) strengthening the information system to improve surveillance and management capacity of public and private providers. By providing direct contracting and financial incentives through DBT, this project aims to address the market failure and under-provision of TB care in the private sector. 34 Verguet et al. Catastrophic costs potentially averted by TB control in India and South Africa: A modelling study. Lancet Global Health. 2017;5(11)e1123-e1132. 41 d. Investing in improved TB care via the private sector is a good use of scarce public resources. Multiple health economists have separately considered the effects of increasing investment on TB and have returned resounding endorsements. Vassal et al, for the Copenhagen Consensus, has argued engaging private sector care for TB has higher return to investment (179.4 to 1) than most public health interventions (including nutrition and hygiene interventions and cervical cancer screening) and many non-health public interventions (such as e-marketing for farmers and supporting startup incubators). Laxminarayan et al, for the Disease Control Priorities Initiative and using extended cost- effectiveness analysis, has predicted that extending public financing to 90% of TB patients (implicitly via effective private provider engagement) would avert about 80 deaths per million population, two- thirds among the bottom two income quintiles.35 Further benefit could accumulate by crowding out expenditure on private care, which has been shown to be inefficient and often ineffective. 35 Disease Control Priorities, 3rd Edition. Series Editor, R Laxminarayan. Available at http://dcp- 3.org/sites/default/files/chapters/DCP3%20Major%20Infectious%20Diseases_Ch11.pdf 42