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

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

An economic evaluation of implementing a decentralized dengue screening intervention under the National Vector Borne Disease Control Programme in Tamil Nadu, South India.

BACKGROUND Lack of effective early screening is a major obstacle for reducing the fatality rate and disease burden of dengue. In light of this, the government of Tamil Nadu has adopted a decentralized dengue screening strategy at the primary healthcare (PHC) facilities using blood platelet count. Our objective was to determine the cost-effectiveness of a decentralized screening strategy for dengue at PHC facilities compared with the current strategy at the tertiary health facility (THC) level. METHODS Decision tree analysis followed a hypothetical cohort of 1000 suspected dengue cases entering the model. The cost-effectiveness analysis was performed at a 3% discount rate for the proposed and current strategy. The outcomes are expressed in incremental cost-effectiveness ratios (ICERs) per quality-adjusted life years gained. One-way sensitivity analysis and probabilistic sensitivity analysis were done to check the uncertainty in the outcome. RESULTS The proposed strategy was found to be cost-saving and ICER was estimated to be -41 197. PSA showed that the proposed strategy had a 0.84 probability of being an economically dominant strategy. CONCLUSIONS The proposed strategy is cost-saving, however, it is recommended to consider optimal population coverage, costs to economic human resources and collateral benefits of equipment

Cost-effectiveness of population-based screening for oral cancer in India: an economic modelling study

Background: Oral cancer screening reduces mortality associated with oral cancer. The current study evaluated the cost-effectiveness of commonly used screening techniques, namely conventional oral examination (COE), toluidine blue staining (TBS), oral cytology (OC), and light-based detection (LBD) in the Indian scenario. Methods: The study used a Markov modelling approach to estimate the cost and health outcomes of four different approaches (COE, TBS, OC, and LBD) for screening oral cancer over time from a societal perspective. The discount rate was assumed as 3%. The outcomes estimated were oral cancer incident cases, deaths averted, and quality-adjusted life years (QALYs). To address the high burden of risk factors (tobacco and/or alcohol) in India, two Markov models were developed: Model A adopted a mass-screening strategy, whereas Model B adopted a high-risk screening strategy versus no screening. Probabilistic sensitivity analysis (PSA) was undertaken to address any parameter uncertainty. Findings: Mass-screening using LBD at three years had the least incident cases (3271.68) and averted the maximum number of oral cancer deaths (459.76). High-risk screening using COE at ten years interval incurred the least lifetime cost of 2,292,816.21 US$(182,794,468.26 INR). The high-risk strategies (US$/QALY), namely COE 5 years (−29.21), COE 10 years (−90.68), TBS 10 years (−60.54), and LBD 10 years (−13.51), were dominant over no-screening. Interpretation: The most cost-saving approach was the conventional oral examination at an interval of 10 years for oral screening in high-risk populations above 30 years of age. Funding: Department of Health Research, Ministry of Health & Family Welfare, Government of India

Economic evaluation of implementing a rapid point-of-care screening test for the identification of hepatitis C virus under National Viral Hepatitis Control Programme in Tamil Nadu, South India

Introduction: Viral hepatitis is a crucial public health problem in India. Hepatitis C virus (HCV) elimination is a national priority and a key strategy has been adopted to strengthen the HCV diagnostics services to ensure early and accurate diagnosis. Methods: To conduct an economic evaluation of implementing a rapid point-of-care screening test for the identification of HCV among the selected key population under the National Viral Hepatitis Control Programme in Tamil Nadu, South India. Economic evaluation of a point-of-care screening test for HCV diagnosis among the key population attending the primary health care centers. A combination of decision tree and Markov model was developed to estimate cost-effectiveness of point-of-care screening test for HCV diagnosis at the primary health care centers. Total costs, quality-adjusted life years (QALYs) of the intervention and comparator, and incremental cost-effectiveness ratio (ICER) were calculated. The model parameter uncertainties which would influence the cost-effectiveness outcome has been evaluated by one-way sensitivity analysis and probabilistic sensitivity analysis. Results: When compared to the tertiary level diagnostic strategy for HCV, the point-of-care screening for selected key population at primary health care level results in a gain of 57 undiscounted QALYs and 38 discounted QALYs, four undiscounted life years and two discounted life years. The negative ICER of the new strategy indicates that it is less expensive and more effective compared with the current HCV diagnosis strategy. Conclusions: The proposed strategy for HCV diagnosis in the selected key population in Tamil Nadu is dominant and cost-saving compared to the current strategy

CHSI costing study-Challenges and solutions for cost data collection in private hospitals in India

INTRODUCTION: Ayushman Bharat Pradhan Mantri Jan Aarogya Yojana (AB PM-JAY) has enabled the Government of India to become a strategic purchaser of health care services from private providers. To generate base cost evidence for evidence-based policymaking the Costing of Health Services in India (CHSI) study was commissioned in 2018 for the price setting of health benefit packages. This paper reports the findings of a process evaluation of the cost data collection in the private hospitals. METHODS: The process evaluation of health system costing in private hospitals was an exploratory survey with mixed methods (quantitative and qualitative). We used three approaches-an online survey using a semi-structured questionnaire, in-depth interviews, and a review of monitoring data. The process of data collection was assessed in terms of time taken for different aspects, resources used, level and nature of difficulty encountered, challenges and solutions. RESULTS: The mean time taken for data collection in a private hospital was 9.31 (± 1.0) person months including time for obtaining permissions, actual data collection and entry, and addressing queries for data completeness and quality. The longest time was taken to collect data on human resources (30%), while it took the least time for collecting information on building and space (5%). On a scale of 1 (lowest) to 10 (highest) difficulty levels, the data on human resources was the most difficult to collect. This included data on salaries (8), time allocation (5.5) and leaves (5). DISCUSSION: Cost data from private hospitals is crucial for mixed health systems. Developing formal mechanisms of cost accounting data and data sharing as pre-requisites for empanelment under a national insurance scheme can significantly ease the process of cost data collection

Cost Effectiveness of a Shorter Moxifloxacin Based Regimen for Treating Drug Sensitive Tuberculosis in India

Globally efforts are underway to shorten the existing 6-month tuberculosis (TB) treatment regimen for drug-sensitive patients, which would be equally effective and safe. At present, there is a lack of evidence on the cost implications of a shorter 4-month TB regimen in India. This economic modeling study was conducted in the Indian context with a high TB burden. We used a hybrid economic model comprising of a decision tree and Markov analysis. The study estimated the incremental costs, life years (LYs), and quality-adjusted life years (QALYs) gained by the introduction of a Moxifloxacin-based shorter 4-month treatment regimen for pulmonary TB patients. The outcomes are expressed in incremental cost-effectiveness ratios (ICERs) per QALYs gained. The cost per case to be treated under the 4-month regimen was USD 145.94 whereas for the 6-month regimen it was USD 150.39. A shorter 4-month TB regimen was cost-saving with USD 4.62 per LY and USD 5.29 per QALY. One-way sensitivity analysis revealed that the cost of the drugs for the 4-month regimen, hospitalization cost for adverse drug reactions, and human resources incurred for the 6-month regimen had a higher influence on the ICER. The probability sensitivity analysis highlighted that the joint incremental cost and effectiveness using QALY were less costly and more effective for 67% of the iteration values. The cost-effectiveness acceptability curve highlights that the 4-month regimen was dominant to both patients and the National TB Elimination Programme in India as compared to the 6-month regimen at different cost-effectiveness threshold values

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