The Impact of Alternate Methodological and Structural Assumptions on Results of Cost-effectiveness Analysis: Empirical Evidence using Three Indian Economic Evaluations.

BACKGROUND: Despite advancement in methods and application of economic evaluations (EEs), there are several uncertainties. OBJECTIVES: To assess the impact of alternate methodological and structural assumptions for four key principles of EE, on the results of cost-effectiveness analysis. MATERIALS AND METHODS: Three previously published model-based EEs were used: (1) Integrated Management of Neonatal and Childhood Illnesses (IMNCIs) intervention; (2) intervention for multiple myeloma, and (3) safety-engineered syringes (SES) intervention. A series of empirical analyses was undertaken to assess the impact of alternate assumptions for discount-rate, time-horizon, study perspective, and health outcome measure, on incremental cost-effectiveness ratio (ICER), and interpretation of cost-effectiveness. RESULTS: Increasing discount rate resulted in an increase in ICERs, for all three case-studies; however, there was no change in the conclusions. Using shorter time-horizons resulted in a significant increase in ICERs, the multiple myeloma intervention remained cost-ineffective, SES intervention became cost-ineffective, whereas IMNCI intervention remained cost-effective, despite a three-fold increase in ICER. On using disability adjusted life years instead of quality adjusted life years, ICERs increased to 0.04, 2 and 4 times for SES, IMNCI and multiple myeloma interventions, respectively. On analyzing results from a societal perspective, a decline in ICERs was observed. The decline was significant for IMNCI where the intervention turned dominant/cost-saving. In the other two case-studies decline in ICERs was modest, 32% for multiple myeloma, and 4% for SES. CONCLUSION: We observed a significant impact of using alternate assumptions on ICERs which can potentially impact resource-allocation decisions. Our findings provide strong argument in favor of standardization of processes and development of country-specific guidelines for conduct of EE.

Cost-effectiveness analysis of 'test and treat' policy for antiretroviral therapy among heterosexual HIV population in India.

Background & objectives: The World Health Organisation recommended immediate initiation of antiretroviral therapy (ART) in all adult human immunodeficiency virus (HIV) patients regardless of their CD4 cell count. This study was undertaken to ascertain the cost-effectiveness of implementation of these guidelines in India. Methods: A Markov model was developed to assess the lifetime costs and health outcomes of three scenarios for initiation of ART treatment at varying CD4 cell count <350/mm[3], <500/mm[3] and test and treat using health system perspective using life-time horizon. A few input parameters for this model namely, transition probabilities from one stage to another stage of HIV and incidence rates of TB were calculated from the data of Centre of Excellence for HIV treatment and care, Chandigarh; whereas, other parameters were obtained from the published literature. Total HIV-related deaths averted, HIV infections averted and incremental cost-effectiveness ratio per quality adjusted life years (QALYs) gained were calculated. Result: Test and treat intervention slowed down the progression of disease and averted 18,386 HIV-related deaths, over lifetime horizon. It also averted 16,105 new HIV infections and saved 343,172 QALYs as compared to the strategy of starting ART at CD4 cell count of 500/mm[3]. Incremental cost per QALY gained for the immediate initiation of ART as compared to ART at CD4 cell count of 500/mm[3] and 350/mm[3] was ₹ 46,599 and 80,050, respectively at reported rates of adherence to the therapy. Interpretation & conclusions: Immediate ART (test and treat) is highly cost-effective strategy over the past criteria of delayed therapy in India. Cost-effectiveness of this policy is largely because of reduction in the transmission of HIV.

Cost of hospital services in India: a multi-site study to inform provider payment rates and Health Technology Assessment.

The 'Cost of Health Services in India (CHSI)' is the first large scale multi-site facility costing study to incorporate evidence from a national sample of both private and public sectors at different levels of the health system in India. This paper provides an overview of the extent of heterogeneity in costs caused by various supply-side factors.A total of 38 public (11 tertiary care and 27 secondary care) and 16 private hospitals were sampled from 11 states of India. From the sampled facilities, a total of 327 specialties were included, with 48, 79 and 200 specialties covered in tertiary, private and district hospitals respectively. A mixed methodology consisting of both bottom-up and top-down costing was used for data collection. Unit costs per service output were calculated at the cost centre level (outpatient, inpatient, operating theatre, and ICU) and compared across provider type and geographical location.The unadjusted cost per admission was highest for tertiary facilities (₹ 5690, 75 USD) followed by private facilities (₹ 4839, 64 USD) and district hospitals (₹ 3447, 45 USD). Differences in unit costs were found across types of providers, resulting from both variations in capacity utilisation, length of stay and the scale of activity. In addition, significant differences in costs were found associated with geographical location (city classification).The reliance on cost information from single sites or small samples ignores the issue of heterogeneity driven by both demand and supply-side factors. The CHSI cost data set provides a unique insight into cost variability across different types of providers in India. The present analysis shows that both geographical location and the scale of activity are important determinants for deriving the cost of a health service and should be accounted for in healthcare decision making from budgeting to economic evaluation and price-setting.

What and how much do the community health officers and auxiliary nurse midwives do in health and wellness centres in a block in Punjab? A time-motion study.

BACKGROUND: The Government of India introduced a new cadre of Community Health Officers (CHOs) in the primary health-care system through the Ayushman Bharat Health and Wellness Centres (HWCs) program. OBJECTIVES: The study aimed to assess the activities performed and time spent by the existing and new primary health-care team members at the HWC level. METHODS: A time and motion study was undertaken in four HWCs in Punjab over a period of 3 months, to assess the time spent by auxiliary nurse midwives (ANMs) and CHOs on different services and activities. Data were collected through direct continuous observation of four CHOs and four ANMs during working hours for a period of 6 consecutive days of a week, along with structured time allocation interviews of all participants. RESULTS: The CHOs spent 5.7 (5.6-5.9) hours per day on duty of which 57% was productively involved in service delivery. The average time spent by ANMs was 4.9 (4.5-5.3) hours per day, with nearly 62% productive time. While the CHOs spent nearly 40% of their time on services for non-communicable diseases (NCDs), the ANMs spent 51% of their time on maternal, infant, child, and adolescent health services. CONCLUSION: The introduction of HWCs and CHOs has nudged the health system toward comprehensive primary health care by placing a renewed emphasis on NCDs. The study provides useful evidence for staff, program implementers, and policymakers, to aid informed decision-making for human resource management.

Cost Effectiveness of Hematopoietic Stem Cell Transplantation Compared with Transfusion Chelation for Treatment of Thalassemia Major.

Hematopoietic stem cell transplantation (HSCT) is the only cure for thalassemia major (TM), which inflicts a significant 1-time cost. Hence, it is important to explore the cost effectiveness of HSCT versus lifelong regular transfusion-chelation (TC) therapy. This study was undertaken to estimate incremental cost per quality-adjusted life-year (QALY) gained with the intervention group HSCT, and the comparator group TC, in TM patients. A combination of decision tree and Markov model was used for analysis. A hospital database, supplemented with a review of published literature, was used to derive input parameters for the model. A lifetime study horizon was used and future costs and consequences were discounted at 3%. Results are presented using societal perspective. Incremental cost per QALY gained with use of HSCT as compared with TC was 64,096 (US$986) in case of matched related donor (MRD) and 1,67,657 (US$2579) in case of a matched unrelated donor transplantation. The probability of MRD transplant to be cost effective at the willingness to pay threshold of Indian per capita gross domestic product is 94%. HSCT is a long-term value for money intervention that is highly cost effective and its long-term clinical and economic benefits outweigh those of TC.

Cost effectiveness of mHealth intervention by community health workers for reducing maternal and newborn mortality in rural Uttar Pradesh, India.

BACKGROUND: A variety of mobile-based health technologies (mHealth) have been developed for use by community health workers to augment their performance. One such mHealth intervention-ReMiND program, was implemented in a poor performing district of India. Despite some research on the extent of its effectiveness, there is significant dearth of evidence on cost-effectiveness of such mHealth interventions. In this paper we evaluated the incremental cost per disability adjusted life year (DALY) averted as a result of ReMiND intervention as compared to routine maternal and child health programs without ReMiND. METHODS: A decision tree was parameterized on MS-Excel spreadsheet to estimate the change in DALYs and cost as a result of implementing ReMiND intervention compared with routine care, from both health system and societal perspective. A time horizon of 10 years starting from base year of 2011 was considered appropriate to cover all costs and effects comprehensively. All costs, including those during start-up and implementation phase, besides other costs on the health system or households were estimated. Consequences were measured as part of an impact assessment study which used a quasi-experimental design. Proximal outputs in terms of changes in service coverage were modelled to estimate maternal and infant illnesses and deaths averted, and DALYs averted in Uttar Pradesh state of India. Probabilistic sensitivity analysis was undertaken to account for parameter uncertainties. RESULTS: Cumulatively, from year 2011 to 2020, implementation of ReMiND intervention in UP would result in a reduction of 312 maternal and 149,468 neonatal deaths. This implies that ReMiND program led to a reduction of 0.2% maternal and 5.3% neonatal deaths. Overall, ReMiND is a cost saving intervention from societal perspective. From health system perspective, ReMiND incurs an incremental cost of INR 12,993 (USD 205) per DALY averted and INR 371,577 (USD 5865) per death averted. CONCLUSIONS: Overall, findings of our study suggest strongly that the mHealth intervention as part of ReMiND program is cost saving from a societal perspective and should be considered for replication elsewhere in other states.

Cost analysis of implementing mHealth intervention for maternal, newborn & child health care through community health workers: assessment of ReMIND program in Uttar Pradesh, India.

BACKGROUND: The main intervention under ReMiND program consisted of a mobile health application which was used by community health volunteers, called ASHAs, for counselling pregnant women and nursing mothers. This program was implemented in two rural blocks in Uttar Pradesh state of India with an overall aim to increase quality of health care, thereby increasing utilization of maternal & child health services. The aim of the study was to assess annual & unit cost of ReMiND program and its scale up in UP state. METHOD AND MATERIALS: Economic costing was done from the health system and patient's perspectives. All resources used during designing & planning phase i.e., development of application; and implementation of the intervention, were quantified and valued. Capital costs were annualised, after assessing their average number of years for which a product could be used and accounting for its depreciation. Shared or joint costs were apportioned for the time value a resource was utilized under intervention. Annual cost of implementing ReMiND in two blocks of UP along and unit cost per pregnant woman were estimated. Scale-up cost for implementing the intervention in entire state was calculated under two scenarios - first, if no extra human resource were employed; and second, if the state government adopted the same pattern of human resource as employed under this program. RESULTS: The annual cost for rolling out ReMiND in two blocks of district Kaushambi was INR 12.1 million (US $ 191,894). The annualised start-up cost constituted 9% of overall cost while rest of cost was attributed to implementation of the intervention. The health system program costs in ReMiND were estimated to be INR 31.4 (US $ 0.49) per capita per year and INR 1294 (US $ 20.5) per registered women. The per capita incremental cost of scale up of intervention in UP state was estimated to be INR 4.39 (US $ 0.07) when no additional supervisory staffs were added. CONCLUSION: The cost of scale up of ReMiND in Uttar Pradesh is 6% of annual budget for 'reproductive and child health' line item under state budget, and hence appears to be financially sustainable.

Cost-effectiveness of human papillomavirus vaccination for adolescent girls in Punjab state: Implications for India's universal immunization program.

BACKGROUND: Introduction of human papillomavirus (HPV) vaccination for adolescent girls is being considered in the Punjab state of India. However, evidence regarding cost-effectiveness is sought by policy makers when making this decision. The current study was undertaken to evaluate the incremental cost per quality-adjusted life-years (QALYs) gained with introduction of the HPV vaccine compared with a no-vaccination scenario. METHODS: A static progression model, using a combination of decision tree and Markov models, was populated using epidemiological, cost, coverage, and effectiveness data to determine the cost-effectiveness of HPV vaccination. Using a societal perspective, lifetime costs and consequences (in terms of QALYs) among a cohort of 11-year-old adolescent girls in Punjab state were modeled in 2 alternate scenarios with and without vaccination. All costs and consequences were discounted at a rate of 3%. RESULTS: Although immunizing 1 year's cohort of 11-year-old girls in Punjab state costs Indian National Rupees (INR) 135 million (US dollars [USD] 2.08 million and International dollars [Int$] 6.25 million) on an absolute basis, its net cost after accounting for treatment savings is INR 38 million (USD 0.58 million and Int$ 1.76 million). Incremental cost per QALY gained for HPV vaccination was found to be INR 73 (USD 1.12 and Int$ 3.38). Given all the data uncertainties, there is a 90% probability for the vaccination strategy to be cost-effective in Punjab state at a willingness-to-pay threshold of INR 10,000, which is less than one-tenth of the per capita gross domestic product. CONCLUSIONS: HPV vaccination appears to be a very cost-effective strategy for Punjab state, and is likely to be cost-effective for other Indian states. Cancer 2017;123:3253-60. © 2017 American Cancer Society.

Impact of m-health application used by community health volunteers on improving utilisation of maternal, new-born and child health care services in a rural area of Uttar Pradesh, India.

OBJECTIVE: To raise the quality of counselling by community health volunteers resulting in improved uptake of maternal, neonatal and child health services (MNCH), an m-health application was introduced under a project named 'Reducing Maternal and Newborn Deaths (ReMiND)' in district Kaushambi in India. We report the impact of this project on coverage of key MNCH services. METHODS: A pre- and post-quasi-experimental design was undertaken to assess the impact of intervention. This project was introduced in two community development blocks in Kaushambi district in 2012. Two other blocks from the same district were selected as controls after matching for coverage of two indicators at baseline - antenatal care and institutional deliveries. The Annual Health Survey conducted by the Ministry of Health and Family Welfare in 2011 served as pre-intervention data, whereas a household survey in four blocks of Kaushambi district in 2015 provided post-intervention coverage of key services. Propensity score matched samples from intervention and control areas in pre-intervention and post-intervention periods were analysed using difference-in-difference method to estimate the impact of ReMiND project. RESULTS: We found a statistically significant increase in coverage of iron-folic acid supplementation (12.58%), self-reporting of complication during pregnancy (13.11%) and after delivery (19.6%) in the intervention area. The coverage of three or more antenatal care visits, tetanus toxoid vaccination, full antenatal care and ambulance usage increased in intervention area by 10.3%, 4.28%, 1.1% and 2.06%, respectively; however, the changes were statistically insignificant. CONCLUSION: Three of eight services which were targeted for improvement under ReMiND project registered a significant improvement as result of m-health intervention.

Out-of-pocket expenditure for hospitalization in Haryana State of India: Extent, determinants & financial risk protection.

BACKGROUND & OBJECTIVES: India aspires to achieve universal health coverage, which requires ensuring financial risk protection (FRP). This study was done to assess the extent of out-of-pocket (OOP) expenditure and FRP for hospitalization in Haryana State, India. Further, the determinants for FRP were also evaluated. METHODS: Data collected as a part of a household level survey conducted in Haryana 'Concurrent Evaluation of National Rural Health Mission: Haryana Health Survey' were analyzed. Descriptive analysis was undertaken to assess socio-demographic characteristics, hospitalization rate, extent and determinants of OOP expenditure and FRP. Prevalence of catastrophic health expenditure (CHE) (more than 40% of non-food expenditure) and impoverishment (Int$ 1.25) were estimated. Multivariate logistic regression was used to assess determinants of FRP. RESULTS: Hospitalization rate was found to be 3106 persons or 3307 episodes per 100,000 population. Median OOP expenditure on hospitalization was ₹ 8000 (USD 133), which was predominantly attributed to medicines (37%). Prevalence of CHE was 25.2 per cent with higher prevalence amongst males [odds ratio (OR)=1.30], those belonging to scheduled caste and scheduled tribes (OR=1.35), poorest 20 per cent households (OR=3.05), having injuries (OR=4.03) and non-communicable diseases (OR=3.13) admitted in a private hospital (OR=2.69) and those who were insured (OR=1.74). There was a 12 per cent relative increase in poverty head count due to OOP payments on healthcare. INTERPRETATION & CONCLUSIONS: Our findings showed that hospitalization resulted in significant OOP expenditure, leading to CHEs and impoverishment of households. Impact of OOP expenditures was inequitably more on the vulnerable groups. OOP expenditure may be curtailed through provision of free medicines and diagnostics and removal of any form of user charges.

Cost of delivering secondary-level health care services through public sector district hospitals in India.

BACKGROUND & OBJECTIVES: Despite an impetus for strengthening public sector district hospitals for provision of secondary health care in India, there is lack of robust evidence on cost of services provided through these district hospitals. In this study, an attempt was made to determine the unit cost of an outpatient visit consultation, inpatient bed-day of hospitalization, surgical procedure and overall per-capita cost of providing secondary care through district hospitals. METHODS: Economic costing of five randomly selected district hospitals in two north Indian States - Haryana and Punjab, was undertaken. Cost analysis was done using a health system perspective and employing bottom-up costing methodology. Quantity of all resources - capital or recurrent, used for delivering services was measured and valued. Median unit costs were estimated along with their 95 per cent confidence intervals. Sensitivity analysis was undertaken to assess the effect of uncertainties in prices and other assumptions; and to generalize the findings for Indian set-up. RESULTS: The overall annual cost of delivering secondary-level health care services through a public sector district hospital in north India was ' 11,44,13,282 [US Dollars (USD) 2,103,185]. Human resources accounted for 53 per cent of the overall cost. The unit cost of an inpatient bed-day, surgical procedure and outpatient consultation was ' 844 (USD 15.5), ' 3481 (USD 64) and ' 170 (USD 3.1), respectively. With the current set of resource allocation, per-capita cost of providing health care through district hospitals in north India was ' 139 (USD 2.5). INTERPRETATION & CONCLUSIONS: The estimates obtained in our study can be used for Fiscal planning of scaling up secondary-level health services. Further, these may be particularly useful for future research such as benefit-incidence analysis, cost-effectiveness analysis and national health accounts including disease-specific accounts in India.

Cost of delivering child health care through community level health workers: how much extra does IMNCI program cost?

BACKGROUND AND METHODS: In the setting of a cluster randomized study to assess impact of the Integrated Management of Neonatal and Childhood Illnesses (IMNCI) program in the district of Faridabad in India, we randomly selected auxiliary nurse midwives (ANM), anganwadi workers (AWW) and accredited social health activists (ASHA) from intervention and control areas to collect cost data using an economic perspective. Bootstrap method was used to estimate 95% confidence interval. RESULTS: The annual per-child cost of providing health services through an ANM, AWW and ASHA is INR 348 (USD 7.7), INR 588 (USD 13.1) and INR 87 (USD 1.9), respectively. The annual per-child incremental cost of delivering IMNCI is INR 124.8 (USD 2.77), INR 26 (USD 0.6) and INR 31 (USD 0.7) at the ANM, AWW and ASHA level, respectively. CONCLUSION: Implementation of IMNCI imposes additional costs to the health system. A comprehensive economic evaluation of the IMNCI is imperative to estimate the net cost implications in India.

Financing Comprehensive Immunization Services in Lao PDR: A Fiscal Space Analysis From a Public Policy Perspective.

INTRODUCTION: A comprehensive package of immunization services is an internal component of the Essential Health Service Package (ESP) implemented by Government of Lao People's Democratic Republic (Lao PDR). Thus, the cost of delivering the immunization program and its feasibility given the fiscal space emerges as an important policy question. The present analysis was undertaken to estimate the total cost of implementing the immunization program under ESP, determinants of total cost and the program's fiscal implications from the government's perspective. METHODOLOGY: We employed a normative costing approach for costing of immunization services under ESP. Standard treatment guidelines (STGs) from both within and outside Lao PDR were considered to identify the resource use for each vaccine delivery. Subsequently, cost per dose administered and fully immunized beneficiary were computed. We assessed the fiscal space for financing immunization services in Lao PDR by adapting the decomposition method given by Tandon et al. RESULTS: In 2019, the estimated total cost of financing immunization in Lao PDR was US$12 million, which will increase in 2025 by 1.75 times, to US$21 million. The per capita budget for immunization needs to increase from about US$2 to US$7. Introduction of newer vaccines in the immunization schedule accounts for the major share (60%) of the increased cost for financing immunization. In view of current fiscal space, the government immunization expenditure (GIE) allocations will be adequate only in a scenario where no new vaccine is introduced under ESP in future years. CONCLUSION: The current fiscal space would fall short of meeting the aspirational goals of ESP-Immunization for the introduction of newer vaccines in Lao PDR. The present analysis of the fiscal space provides important evidence to support a greater role for the Global Alliance for Vaccine Initiative (GAVI) to continue to finance immunization in Lao PDR. A publicly financed immunization model in Lao PDR would require significant strategic amendments with low short-term viability.

Development of the Indian Reference Case for undertaking economic evaluation for health technology assessment.

Background: Health technology assessment (HTA) is globally recognised as an important tool to guide evidence-based decision-making. However, heterogeneity in methods limits the use of any such evidence. The current research was undertaken to develop a set of standards for conduct of economic evaluations for HTA in India, referred to as the Indian Reference Case. Methods: Development of the reference case comprised of a four-step process: (i) review of existing international HTA guidelines; (ii) systematic review of economic evaluations for three countries to assess adherence with pre-existing country-specific HTA guidelines; (iii) empirical analysis to assess the impact of alternate assumptions for key principles of economic evaluation on the results of cost-effectiveness analysis; (iv) stakeholder consultations to assess appropriateness of the recommendations. Based on the inferences drawn from the first three processes, a preliminary draft of the reference case was developed, which was finalised based on stakeholder consultations. Findings: The Indian Reference Case provides twelve recommendations on eleven key principles of economic evaluation: decision problem, comparator, perspective, source of effectiveness evidence, measure of costs, health outcomes, time-horizon, discounting, heterogeneity, uncertainty analysis and equity analysis, and for presentation of results. The recommendations are user-friendly and have scope to allow for context-specific flexibility. Interpretation: The Indian Reference Case is expected to provide guidance in planning, conducting, and reporting of economic evaluations. It is anticipated that adherence to the Reference Case would increase the quality and policy utilisation of future evaluations. However, with advancement in the field of health economics efforts aimed at refining the Indian Reference Case would be needed. Funding: This research received no specific grant from any funding agency, commercial, or not-for-profit sectors. The research was undertaken as part of doctoral thesis of Sharma D, who received scholarship from the Indian Council of Medical Research (ICMR), New Delhi, India.

Evaluating efficiency and equity of prevention and control strategies for rheumatic fever and rheumatic heart disease in India: an extended cost-effectiveness analysis.

BACKGROUND: There is a dearth of evidence on the cost-effectiveness of a combination of population-based primary, secondary, and tertiary prevention and control strategies for rheumatic fever and rheumatic heart disease. The present analysis evaluated the cost-effectiveness and distributional effect of primary, secondary, and tertiary interventions and their combinations for the prevention and control of rheumatic fever and rheumatic heart disease in India. METHODS: A Markov model was constructed to estimate the lifetime costs and consequences among a hypothetical cohort of 5-year-old healthy children. Both health system costs and out-of-pocket expenditure (OOPE) were included. OOPE and health-related quality-of-life were assessed by interviewing 702 patients enrolled in a population-based rheumatic fever and rheumatic heart disease registry in India. Health consequences were measured in terms of life-years and quality-adjusted life-years (QALY) gained. Furthermore, an extended cost-effectiveness analysis was undertaken to assess the costs and outcomes across different wealth quartiles. All future costs and consequences were discounted at an annual rate of 3%. FINDINGS: A combination of secondary and tertiary prevention strategies, which had an incremental cost of ₹23 051 (US$30) per QALY gained, was the most cost-effective strategy for the prevention and control of rheumatic fever and rheumatic heart disease in India. The number of rheumatic heart disease cases prevented among the population belonging to the poorest quartile (four cases per 1000) was four times higher than the richest quartile (one per 1000). Similarly, the reduction in OOPE after the intervention was higher among the poorest income group (29·8%) than among the richest income group (27·0%). INTERPRETATION: The combined secondary and tertiary prevention and control strategy is the most cost-effective option for the management of rheumatic fever and rheumatic heart disease in India, and the benefits of public spending are likely to be accrued much more by those in the lowest income groups. The quantification of non-health gains provides strong evidence for informing policy decisions by efficient resource allocation on rheumatic fever and rheumatic heart disease prevention and control in India. FUNDING: Department of Health Research, Ministry of Health and Family Welfare, New Delhi.

Impact of India's publicly financed health insurance scheme on public sector district hospitals: a health financing perspective.

Background: Districts hospitals in India play a pivotal role in delivering health care services in the public sector and are empanelled under India's national health insurance scheme i.e. Ayushman Bharat Pradhan Mantri Jan Aarogya Yojana (PMJAY). In this paper, we evaluate the extent to which the PMJAY impacts the district hospitals from a financing perspective. Methods: We used cost data from India's nationally representative costing study-'Costing of Health Services in India' (CHSI) to determine the incremental cost of treating PMJAY patients, after adjusting for resources that are paid through supply-side government financing route. Second, we used data on number and claim value paid to public district and sub-district hospitals during 2019, to determine the additional revenue generated through PMJAY. The annual net financial gain per district hospital was estimated as the difference between payments under PMJAY, and the incremental cost of delivering the services. Findings: At current levels of utilisation, the district hospitals in India gain a net annual financial benefit of $ 26.1 (₹ 1839.3) million, which can potentially increase up to $ 41.8 (₹ 2942.9) million with an increase in the share of patient volume. For an average district hospital, we estimate net annual financial gain of $ 169,607 (₹ 11.9 million), increasing up to $ 271,372 (₹ 19.1 million) per hospital with increased utilisation. Interpretation: Demand-side financing mechanisms can be used to strengthen the public sector. Increasing utilisation of district hospitals, by either gatekeeping or improving availability of services will enhance financial gains for district hospitals and strengthen public sector. Funding: Department of Health Research, Ministry of Health & Family Welfare, Government of India.

Development of a Health Technology Assessment Quality Appraisal Checklist (HTA-QAC) for India.

OBJECTIVE: We aim to develop a comprehensive checklist for evaluating Health Technology Assessment (HTA) studies commissioned in India. The primary objective of this work is to capture all vital aspects of an HTA study in terms of conduct, reporting and quality. METHODOLOGY: The development of a quality appraisal checklist included 3 steps. First, a targeted review of the literature was done to gather information on existing HTA checklists. After reviewing these checklists, an initial draft of the HTA quality appraisal checklist (HTA-QAC) for India was prepared with discussion amongst the authors. Second, the draft checklist was reviewed by the members of the Technical Appraisal Committee (TAC) and their feedback was incorporated. Subsequently, the revised checklist was presented at a virtual meeting of the TAC. Finally, a pilot phase was undertaken to apply HTA-QAC for the approved HTA study reports. Three rounds of virtual discussions were held with the researchers who were involved in the conduct of these HTA studies to resolve any discordance in opinion or develop solutions for the problems in the use of the HTA-QAC followed by a further revision of the checklist. RESULTS: The HTA-QAC is divided into two parts: a self-reporting section to be completed by the author, and the other to be completed by the reviewer. The reviewer checklist has two sections: one to review the report and the other to review the model. The author section is in a self-reporting format, which includes details of basic study information, the rationale for the study, policy relevance, study description, study methods, reporting of model parameters, and results. The reviewer section of the checklist focuses on the quality aspect of the conducted study. The domains included in the report review include details on study methodology, results, discussion, and conclusion. The second part of the reviewer section of HTA-QAC constitutes a review of the model in terms of model assumptions, functionality, model inputs, calculations, uncertainty analysis, model output, and model validation. CONCLUSION: We recommend a standardised process of quality appraisal to ensure the high quality of HTA evidence for policy use in the Indian context. The proposed HTA-QAC will help authors to ensure standardised reporting, as well as allow reviewers to assess the quality of analysis.