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.

Does Public Spending Reflect the Need for Health: A Cross-sectional Analysis at District Level in India.

BACKGROUND: There is mixed evidence on the extent of association between the allocation of public revenue for healthcare and its indicators of need. OBJECTIVE: In this study, we examined the relationship between allocations through state health financing (SHF) and the Central Government with infant mortality. MATERIALS AND METHODS: District-wise infant mortality rate (IMR) was computed using National Family Health Survey-4 data. State-wise data for health budgets through SHF and National Health Mission (NHM, a Centrally Sponsored Scheme), were obtained for the year 2015-16. We used a multivariable analysis through generalized linear model method using identity-link function. RESULTS: We found per capita SHF (₹3169) to be more than 12 times that of public health spending per capita through NHM (₹261). IMR was lower in districts with higher SHF allocation, although statistically insignificant. The allocation through NHM was higher in districts with higher IMR, which is statistically significant. Every unit percentage increase in per capita net state domestic product and female literacy led to 0.31% and 0.54% decline, while a 1% increase in under-five diarrhoea prevalence led to 0.17% increase in IMR. CONCLUSION: The NHM has contributed to enhancing vertical equity in health-care financing. The States' need to be more responsive to the differences in districts while allocating health-care resources. There needs to be a focus on spending on social determinants, which should be the cornerstone for any universal health coverage strategy.

Cost-effectiveness analysis of surgical masks, N95 masks compared to wearing no mask for the prevention of COVID-19 among health care workers: Evidence from the public health care setting in India.

BACKGROUND: Nonpharmacological interventions, such as personal protective equipment for example, surgical masks and respirators, and maintenance of hand hygiene along with COVID-19 vaccines have been recommended to reduce viral transmission in the community and health care settings. There is evidence from the literature that surgical and N95 masks may reduce the initial degree of exposure to the virus. A limited research that has studied the cost-effective analysis of surgical masks and N95 masks among health care workers in the prevention of COVID-19 in India. The objective of this study was to estimate the cost-effectiveness of N95 and surgical mask compared to wearing no mask in public hospital settings for preventing COVID-19 infection among Health care workers (HCWs) from the health care provider's perspective. METHODS: A deterministic baseline model, without any mask use, based on Eikenberry et al was used to form the foundation for parameter estimation and to estimate transmission rates among HCWs. Information on mask efficacy, including the overall filtering efficiency of a mask and clinical efficiency, in terms of either inward efficiency(ei) or outward efficiency(e0), was obtained from published literature. Hospitalized HCWs were assumed to be in one of the disease states i.e., mild, moderate, severe, or critical. A total of 10,000 HCWs was considered as representative of the size of a tertiary care institution HCW population. The utility values for the mild, moderate and severe model health states were sourced from the primary data collection on quality-of-life of HCWs COVID-19 survivors. The utility scores for mild, moderate, and severe COVID-19 conditions were 0.88, 0.738 and 0.58, respectively. The cost of treatment for mild sickness (6,500 INR per day), moderate sickness (10,000 INR per day), severe (require ICU facility without ventilation, 15,000 INR per day), and critical (require ICU facility with ventilation per day, 18,000 INR) per day as per government and private COVID-19 treatment costs and capping were considered. One way sensitivity analyses were performed to identify the model inputs which had the largest impact on model results. RESULTS: The use of N95 masks compared to using no mask is cost-saving of $1,454,632 (INR 0.106 billion) per 10,000 HCWs in a year. The use of N95 masks compared to using surgical masks is cost-saving of $63,919 (INR 0.005 billion) per 10,000 HCWs in a year. the use of surgical masks compared to using no mask is cost-saving of $1,390,713 (INR 0.102 billion) per 10,000 HCWs in a year. The uncertainty analysis showed that considering fixed transmission rate (1.7), adoption of mask efficiency as 20%, 50% and 80% reduces the cumulative relative mortality to 41%, 79% and 94% respectively. On considering ei = e0 (99%) for N95 and surgical mask with ei = e0 (90%) the cumulative relative mortality was reduced by 97% and the use of N95 masks compared to using surgical masks is cost-saving of $24,361 (INR 0.002 billion) per 10,000 HCWs in a year. DISCUSSION: Both considered interventions were dominant compared to no mask based on the model estimates. N95 masks were also dominant compared to surgical masks.

Modeling the cost-effectiveness of school-based supervised toothbrushing program in reducing the dental caries burden in India.

BACKGROUND: Supervised toothbrushing (STB) significantly reduces the incidence and progression of dental caries. School years present a favorable age for introducing such healthy habits for a lifetime. AIM: To estimate the cost-effectiveness of implementing a STB program in India in preventing dental caries incidence. DESIGN: An operational framework of a national STB program was devised. A mathematical model was then developed to evaluate this program's clinical effectiveness and economic impact in the Indian scenario. This study considered a hypothetical cohort of the Indian population aged from 6 to 75 years. Two groups were compared: no intervention and STB in government schools. The health outcomes assessed were a number of tooth caries incidences averted and quality-adjusted life years gained. RESULTS: The STB program in the government schools of India would prevent at least one tooth from developing caries in an individual's lifetime. Considering the current treatment-seeking behavior, the STB program saves INR 153 (US$ 1.95) per carious tooth incidence averted and INR 22 202 (US$ 283) per QALY gained. CONCLUSION: In India, the school-based STB program is expected to be a cost-effective strategy for reducing the dental caries burden and its associated treatment costs.

Healthcare cost accounting in the Indian hospital sector.

Setting reimbursement rates in national insurance schemes requires robust cost data. Collecting provider generated cost accounting information is a potential mechanism for improving the cost evidence. To inform strategies for obtaining cost data to set reimbursement rates, this analysis aims to describe the role of cost accounting in public and private health sectors in India and describe the importance, perceived barriers, and facilitators to improving cost accounting systems. In-depth interviews (IDI) were conducted with 11 key informants. The interview tool guide was informed by a review of published and grey literature and government websites. The interviews were recorded for both audio and video and transcribed. A thematic coding framework was developed for the analysis. Multiple discussions were held to add, delete, classify, or merge the themes. The themes identified were: the status of cost accounting in the Indian hospital sector, legal and regulatory requirements for cost reporting, challenges to implementing cost accounting, and recommendations for improving cost reporting by healthcare providers. The findings indicate that the sector lacks maturity in cost accounting due to a lack of understanding of its benefits, limited capacity, and weak enforcement of cost reporting regulations. Providers recognize the value of cost analysis for investment decisions but have mixed opinions on the willingness to gather and report cost information, citing resource constraints and a lack of trust in payers. Additionally, heterogeneity among providers will require tailored approaches in developing cost accounting reporting frameworks and regulations. Healthcare cost accounting systems in India are rudimentary with a few exceptions, raising questions about how to source these data sustainably. Strengthening cost accounting systems will be contingent upon developing standardized formats that generate sufficient information for policymaking, are acceptable to private providers, and can be integrated with the existing data management systems.

Healthcare Cost of Cochlear Implantation in India.

Making evidence-based policy decisions is challenging when there is a lack of information, especially when deciding provider payment rates for publicly funded health insurance plans. Therefore, the goal of this study was to estimate the cost of a cochlear implant operation in a tertiary care setting in India. We also looked at the patients' out-of-pocket (OOP) expenses for the cochlear implant surgery. From the perspectives of the patients and the healthcare systems, we assessed the financial costs of the cochlear implantation procedure. A bottom-up pricing model was used to assess the cost that the healthcare system would bear for a cochlear implant procedure. Information on all the resources (both capital and ongoing) required to offer cochlear implantation services for hearing loss was gathered over the course of a year. 120 individuals with hearing loss who had cochlear implantation surgery disclosed their out-of-pocket (OOP) costs, which included both direct medical and non-medical expenses. All costs for the budgetary year 2018-2019 were anticipated. The unit health system spent ₹ 151($2), ₹ 578($7.34) and ₹ 37,449($478) on ear exams, audiological evaluations, and cochlear implant surgeries, respectively. Per bed-day in the otolaryngology ward, hospitalization cost ₹ 202($2.6), or ₹ 1211($15.5). The estimated average out-of-pocket cost for a cochlear implant operation was ₹ 682,230($8710). Our research can be used to establish package rates for publicly funded insurance plans in India, plan the growth of public sector hearing care services, and do cost-effectiveness assessments on various hearing care models. Supplementary Information: The online version contains supplementary material available at 10.1007/s12070-023-04389-7.

Cost-Effectiveness Analysis of Denosumab in the Prevention of Skeletal-Related Events Among Patients With Breast Cancer With Bone Metastasis in India.

PURPOSE: Denosumab is clinically superior to zoledronic acid (ZA) for preventing and delaying time to first and subsequent skeletal-related events (SREs) among patients with breast cancer (BC) with bone metastases. We evaluated the cost and health benefits of denosumab and ZA (once every 4 weeks and once every 12 weeks) among four different molecular subtypes of BC with bone metastases in India. MATERIALS AND METHODS: A Markov model was developed in Microsoft Excel to estimate lifetime health consequences and resulting costs among cohort of 1,000 patients with BC with bone metastasis, for three intervention scenarios, namely denosumab (once every 4 weeks), ZA (once every 4 weeks), and ZA (once every 12 weeks). The health outcomes were measured in terms of SREs averted and quality-adjusted life-years (QALYs) gained. The cost of each intervention scenario was measured using both the health system and the patient's perspectives. Indirect costs because of lost productivity were not included. The future costs and outcomes were discounted at the standard rate of 3%. RESULTS: Over a lifetime, the incremental number of SREs averted with use of denosumab once every 4 weeks (compared with ZA once every 4 weeks and once every 12 weeks) among patients with luminal A, luminal B, human epidermal growth factor receptor 2-enriched, and triple negative breast cancer were estimated as 0.39, 0.26, 0.25, and 0.19, respectively. The number of QALYs lived were slightly higher in the denosumab arm (1.45-2.80) compared with ZA once every 4 weeks and once every 12 weeks arms (1.44-2.78). However, denosumab once every 4 weeks was not found to be a cost-effective alternative for either of the four molecular subtypes of breast cancer. ZA once every 12 weeks was found to be a cost-effective option with an average cost-effectiveness ratio ranging between ₹68,254 and ₹73,636. CONCLUSION: ZA once every 12 weeks is the cost-effective treatment option for BC with bone metastases in India. The present study findings hold significance for standard treatment guidelines under India's government-funded health insurance program.

Cost-Effectiveness of Novel Agent Regimens for Transplant-Eligible Newly Diagnosed Multiple Myeloma Patients in India.

BACKGROUND: Survival outcomes for multiple myeloma have improved dramatically since the introduction of novel therapeutic agents. While these drugs are highly effective in improving survival outcomes and quality of life in patients with multiple myeloma, they come at a significant cost. We assessed the cost-effectiveness of bortezomib-based triplet or quadruplet drug regimens in isolation and followed by autologous hematopoietic stem cell transplantation (AHSCT) for the treatment of newly diagnosed multiple myeloma (NDMM) in the Indian context. METHODS: A Markov model was developed to assess the health and economic outcomes of novel drug regimens with and without AHSCT for the treatment of NDMM in India. We estimated the lifetime quality-adjusted life-years (QALYs) and costs in each scenario. The incremental cost-effectiveness ratios (ICERs) were computed and compared against the current willingness-to-pay threshold of a one-time per capita gross domestic product of ₹146,890 (US$1,927.70) for India. Parameter uncertainty was assessed through Monte Carlo probabilistic sensitivity analysis. RESULTS: Among seven treatment sequences, the VCd (bortezomib, cyclophosphamide, dexamethasone) alone arm has the lowest cost and health benefits as compared to four treatment sequences, namely VTd (bortezomib, thalidomide, dexamethasone) alone, VRd (bortezomib, lenalidomide, dexamethasone) alone, VRd plus AHSCT and DVRd (Daratumumab, bortezomib, lenalidomide, dexamethasone) plus AHSCT. It was found that VTd plus AHSCT and VCd plus AHSCT arms were extendedly dominated (ED) by combination of two alternative treatments. Among the five non-dominated strategies, VRd has a lowest incremental cost of ₹ 2,20,093 (US$2,888) per QALY gained compared to VTd alone followed by VRd plus AHSCT [₹3,14,530 (US$4,128) per QALY gained] in comparison to VRd alone. None of the novel treatment sequences were found to be cost-effective at the current WTP threshold of ₹1,46,890 (US$1,927.7). CONCLUSION: At the current WTP threshold of one-time per capita GDP (₹ 146,890) of India, VRd alone and VRd plus AHSCT has 38.1% and 6.9% probability to be cost-effective, respectively. Reduction in current reimbursement rates of novel drugs, namely VRd, lenalidomide, and pomalidomide plus dexamethasone under national insurance program and societal cost of transplant by 50%, would make VRd plus AHSCT and VTd plus AHSCT cost-effective at an incremental cost of ₹40,671 (US$34) and ₹97,639 (US$1,281) per QALY gained, respectively.

Health-related quality of life and its determinants among cancer patients: evidence from 12,148 patients of Indian database.

BACKGROUND: Cancer survivors experience a decrement in health-related quality of life (HRQoL) resulting from the disease as well as adverse effects of therapy. We evaluated the HRQoL of cancer patients, stratified by primary cancer site, stage, treatment response and associated adverse events, along with its determinants. METHODS: Data were collected from 12,148 patients, sampled from seven purposively chosen leading cancer hospitals in India, to elicit HRQoL using the EuroQol questionnaire comprising of 5-dimensions and 5-levels (EQ-5D-5L). Multiple linear regression was used to determine the association between HRQoL and various socio-demographic as well as clinical characteristics. RESULTS: Majority outpatients (78.4%) and inpatients (81.2%) had solid cancers. The disease was found to be more prevalent among outpatients (37.5%) and inpatients (40.5%) aged 45-60 years and females (49.3-58.3%). Most patients were found to be in stage III (40-40.6%) or stage IV (29.4-37.3%) at the time of recruitment. The mean EQ-5D-5 L utility score was significantly higher among outpatients [0.630 (95% CI: 0.623, 0.637)] as compared to inpatients [0.553 (95% CI: 0.539, 0.567)]. The HRQoL decreased with advancing cancer stage among both inpatients and outpatients, respectively [stage IV: (0.516 & 0.557); stage III (0.609 & 0.689); stage II (0.677 & 0.713); stage I (0.638 & 0.748), p value < 0.001]. The outpatients on hormone therapy (B = 0.076) showed significantly better HRQoL in comparison to patients on chemotherapy. However, palliative care (B=-0.137) and surgery (B=-0.110) were found to be associated with significantly with poorer HRQoL paralleled to chemotherapy. The utility scores among outpatients ranged from 0.305 (bone cancer) to 0.782 (Leukemia). Among hospitalized cases, the utility score was lowest for multiple myeloma (0.255) and highest for testicular cancer (0.771). CONCLUSION: Older age, lower educational status, chemotherapy, palliative care and surgery, advanced cancer stage and progressive disease were associated with poor HRQoL. Our study findings will be useful in optimising patient care, formulating individualized treatment plan, improving compliance and follow-up.

Economic Evaluation of Targeted Therapies for Anaplastic Lymphoma Kinase- and ROS1 Fusion-Positive Non-Small Cell Lung Cancer in India.

PURPOSE: Targeted therapies, such as crizotinib and ceritinib, have shown promising results in treating non-small cell lung cancer (NSCLC) with specific oncogenic drivers like anaplastic lymphoma kinase (ALK), c-ros (ROS1) oncogene, etc. This study aims to assess the cost-effectiveness of these therapies for patients with NSCLC in India. METHODS: The Markov model consisted of three health states: progression-free survival, progressive disease, and death. Lifetime costs and consequences were estimated for three treatment arms: crizotinib, ceritinib, and chemotherapy for patients with ALK- and ROS1-positive NSCLC. Incremental cost per quality-adjusted life-year (QALY) gained with crizotinib and ceritinib was compared to chemotherapy and assessed using a willingness-to-pay threshold of one-time per capita gross domestic product in India. RESULTS: The total lifetime cost per patient for ALK-positive NSCLC was ₹332,456 ($4,054 US dollars [USD]), ₹1,284,100 ($15,659 USD), and ₹2,337,779 ($28,509 USD) in the chemotherapy, crizotinib, and ceritinib arms, respectively. The mean QALYs lived per patient were 1.20, 2.21, and 3.34, respectively. For patients with ROS1-positive NSCLC, the total cost was ₹323,011 ($3,939 USD) and ₹1,763,541 ($21,507 USD) for chemotherapy and crizotinib, with mean QALYs lived per patient of 1.16 and 2.73, respectively. Nearly 92% and 81% reduction in the price of ceritinib and crizotinib is required to make it a cost-effective treatment option for ALK- and ROS1-positive NSCLC, respectively. CONCLUSION: Our study findings suggest that the prices of ceritinib and crizotinib need to be reduced significantly to justify their value for inclusion in India's publicly financed health insurance scheme for treatment of patients with locally advanced/metastatic ALK- and ROS1-positive NSCLC, respectively.

Cost-Effectiveness Analysis of Systemic Therapy for Intensification of Treatment in Metastatic Hormone-Sensitive Prostate Cancer in India.

BACKGROUND AND OBJECTIVE: Androgen-deprivation therapy is the mainstay of treatment for patients with newly diagnosed metastatic hormone-sensitive prostate cancer (mHSPC). However, the intensification of treatment with either docetaxel or novel anti-androgens (abiraterone-acetate plus prednisone [AAP], enzalutamide, and apalutamide) is being recommended based on the improved clinical outcomes and quality of life among patients. This study aimed to determine the most cost-effective drug for treatment intensification for patients with mHSPC in India. METHODS: A Markov model was developed with four health states: progression-free survival, progressive disease, best supportive care, and death. Lifetime costs and consequences were estimated for four treatment sequences: AAP-first, enzalutamide-first, apalutamide-first, and docetaxel-first. Incremental cost per quality-adjusted life-year (QALY) gained with a given treatment option was compared against the next best alternative and assessed for cost effectiveness using a willingness to pay threshold of 1 × per capita gross domestic product in India. RESULTS: We estimated that the total lifetime cost per patient was ₹1,367,454 (US$17,487), ₹2,168,885 (US$27,735), ₹7,678,501 (US$98,190), and ₹1,358,746 (US$17,375) in the AAP-first, enzalutamide-first, apalutamide-first, and docetaxel-first treatment sequence, respectively. The mean quality-adjusted life-years lived per patient were 4.78, 5.03, 3.22, and 2.61, respectively. The AAP-first sequence incurs an incremental cost of ₹4014 (US$51) per quality-adjusted life-year gained as compared with the docetaxel-first sequence, with a 87% probability of being cost effective at the willingness-to-pay threshold of 1 × per-capita gross domestic product of India. The use of AAP-first also incurs an incremental net monetary benefit of ₹396,491 (US$5070) as compared with the docetaxel-first treatment sequence. Nearly a 48% reduction in the price of enzalutamide is required to make it a cost-effective treatment sequence as compared with AAP-first in India. CONCLUSIONS: We concur with the inclusion of standard-dose AAP in India's publicly financed health insurance scheme for the intensification of treatment in mHSPC as it is the only cost-effective sequence among the various novel anti-androgens when compared with the docetaxel-first treatment sequence. Furthermore, a systematic reduction in the price of enzalutamide would further help to improve clinical outcomes among patients with mHSPC.

National hospital costing systems matter for universal healthcare: the India PM-JAY experience.

India envisions achieving universal health coverage to provide its people with access to affordable quality health services. A breakthrough effort in this direction has been the launch of the world's largest health assurance scheme Ayushman Bharat Pradhan Mantri Jan Arogya Yojana, the implementation of which resides with the National Health Authority. Appropriate provider payment systems and reimbursement rates are an important element for the success of PM-JAY, which in turn relies on robust cost evidence to support pricing decisions. Since the launch of PM-JAY, the health benefits package and provider payment rates have undergone a series of revisions. At the outset, there was a relative lack of cost data. Later revisions relied on health facility costing studies, and now there is an initiative to establish a national hospital costing system relying on provider-generated data. Lessons from PM-JAY experience show that the success of such cost systems to ensure regular and routine generation of evidence is contingent on integrating with existing billing or patient information systems or management information systems, which digitise similar information on resource consumption without any additional data entry effort. Therefore, there is a need to focus on building sustainable mechanisms for setting up systems for generating accurate cost data rather than relying on resource-intensive studies for cost data collection.

Protocol for a quasi-experimental study to ascertain the effectiveness of using eKnee School approach to impart self-care education to patients suffering from knee osteoarthritis during COVID-19 pandemic.

BACKGROUND: Knee osteoarthritis (KOA) patients seek improvement in their quality of life by attaining independence in activities of daily living. Literature recommends nonpharmacological intervention as first-line treatment for KOA. The study aims to ascertain the effectiveness of online supervised nonpharmacological intervention sessions of virtual knee school (eKS) training among mild and moderate KOA patients in comparison to routine care during COVID-19 pandemic and assessment of cost-effectiveness of eKS against the routine care for KOA patients during COVID-19 pandemic. MATERIALS AND METHODS: A quasi-experimental pre-post with control group, enrolling 50 participants each in two groups: usual/routine KOA care or usual care plus KS interventions via virtual mode. Our primary outcome measures are pain, quality of life, and incremental cost-effectiveness ratio. Secondary outcomes include performance-based tests (30-second chair test, timed up and go test, 6-minute walk test) and patient satisfaction. Intervention fidelity will be assessed with a priori checklist tailored to eKS assessing adherence, dose, quality, and user engagement in the key components. Quantitative data collection will be conducted at baseline and 6 months. Descriptive data analysis will be carried for quantitative data. For qualitative data, the thematic analysis will be performed; we propose to undertake a deterministic and probabilistic sensitivity analysis to address the issue of uncertainty in the present cost-effectiveness analysis model. CONCLUSION: The management of KOA through virtual mode emphasizes the concepts of patient-as-person, family-centered, with socially interactive approach. The study will provide information on the effectiveness of nonpharmacological interventions for improving the quality of life of patients suffering from KOA through virtual knee school. Nevertheless, pitfalls in running eKS will be noted, which will help improve all aspects of online medical communications in the future.

Human Resources for Health in Haryana, India: What can be Done Better?

Introduction: Health systems in developing countries suffers from both input and productivity issues. We examined the status of three domains of human resources for health, i.e., availability and distribution, capacity and productivity, and motivation and job-satisfaction, of the health-care workforce employed in the public health system of Haryana, a North Indian state. Methodology: The primary data were collected from 377 public health facilities and 1749 healthcare providers across 21 districts. The secondary data were obtained from government reports in the public domain. Bivariate and multivariate statistical techniques were used for evaluating district performances, making inter-district comparisons and identifying determinants of motivation and job-satisfaction of the clinical cadres. Results: We found 3.6 core health-care workers (doctors, staff nurses, and auxiliary nurses-midwives) employed in the public health-care system per 10,000 population, ranging from 1.35 in Faridabad district to 6.57 in Panchkula district. Around 78% of the sanctioned positions were occupied. A number of inpatient hospitalizations per doctor/nurses per month were 17 at the community health center level and 29 at the district hospital level; however, significant differences were observed among districts. Motivation levels of community health workers (85%) were higher than clinical workforce (78%), while health system administrators had lowest motivation and job satisfaction levels. Posting at primary healthcare facility, contractual employment, and co-habitation with family at the place of posting were found to be the significant motivating factors. Conclusions: A revamp of governance strategies is required to improve health-care worker availability and equitable distribution in the public health system to address the observed geographic variations. Efforts are also needed to improve the motivation levels of health system administrators, especially in poorly performing districts and reduce the wide gap with better-off districts.

Refining the provider payment system of India's government-funded health insurance programme: an econometric analysis.

OBJECTIVES: Reimbursement rates in national health insurance schemes are frequently weighted to account for differences in the costs of service provision. To determine weights for a differential case-based payment system under India's publicly financed national health insurance scheme, the Ayushman Bharat Pradhan Mantri Jan Arogya Yojana (PM-JAY), by exploring and quantifying the influence of supply-side factors on the costs of inpatient admissions and surgical procedures. DESIGN: Exploratory analysis using regression-based cost function on data from a multisite health facility costing study-the Cost of Health Services in India (CHSI) Study. SETTING: The CHSI Study sample included 11 public sector tertiary care hospitals, 27 public sector district hospitals providing secondary care and 16 private hospitals, from 11 Indian states. PARTICIPANTS: 521 sites from 57 healthcare facilities in 11 states of India. INTERVENTIONS: Medical and surgical packages of PM-JAY. PRIMARY AND SECONDARY OUTCOME MEASURES: The cost per bed-day and cost per surgical procedure were regressed against a range of factors to be considered as weights including hospital location, presence of a teaching function and ownership. In addition, capacity utilisation, number of beds, specialist mix, state gross domestic product, State Health Index ranking and volume of patients across the sample were included as variables in the models. Given the skewed data, cost variables were log-transformed for some models. RESULTS: The estimated mean costs per inpatient bed-day and per procedure were 2307 and 10 686 Indian rupees, respectively. Teaching status, annual hospitalisation, bed size, location of hospital and average length of hospitalisation significantly determine the inpatient bed-day cost, while location of hospital and teaching status determine the procedure costs. Cost per bed-day of teaching hospitals was 38-143.4% higher than in non-teaching hospitals. Similarly, cost per bed-day was 1.3-89.7% higher in tier 1 cities, and 19.5-77.3% higher in tier 2 cities relative to tier 3 cities, respectively. Finally, cost per surgical procedure was higher by 10.6-144.6% in teaching hospitals than non-teaching hospitals; 12.9-171.7% higher in tier 1 cities; and 33.4-140.9% higher in tier 2 cities compared with tier 3 cities, respectively. CONCLUSION: Our study findings support and validate the recently introduced differential provider payment system under the PM-JAY. While our results are indicative of heterogeneity in hospital costs, other considerations of how these weights will affect coverage, quality, cost containment, as well as create incentives and disincentives for provider and consumer behaviour, and integrate with existing price mark-ups for other factors, should be considered to determine the future revisions in the differential pricing scheme.

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.

Validating the rigour of adaptive methods of economic evaluation.

BACKGROUND: There has been a lot of debate on how to 'generalise' or 'translate' findings of economic evaluation (EE) or health technology assessment (HTA) to other country contexts. Researchers have used various adaptive HTA (aHTA) methods like model-adaptation, price-benchmarking, scorecard-approach, etc., for transferring evidence from one country to other. This study was undertaken to assess the degree of accuracy in results generated from aHTA approaches specifically for EE. METHODS: By applying selected aHTA approaches, we adapted findings of globally published EE to Indian context. The first-step required identifying two interventions for which Indian EE (referred to as the 'Indian reference study') has been conducted. The next-step involved identification of globally published EE. The third-step required undertaking quality and transferability check. In the fourth step, outcomes of EE meeting transferability standards, were adapted using selected aHTA approaches. Lastly, adapted results were compared with findings of the Indian reference study. RESULTS: The adapted cost estimates varied considerably, while adapted quality-adjusted life-years did not differ much, when matched with the Indian reference study. For intervention I (trastuzumab), adapted absolute costs were 11 and 6 times higher than the costs reported in the Indian reference study for control and intervention arms, respectively. Likewise, adapted incremental cost and incremental cost-effectiveness ratio (ICER) were around 3.5-8 times higher than the values reported in the Indian reference study. For intervention II (intensity-modulated radiation therapy), adapted absolute cost was 35% and 12% lower for the comparator and intervention arms, respectively, than the values reported in the Indian reference study. The mean incremental cost and ICER were 2.5 times and 1.5 times higher, respectively, than the Indian reference study values. CONCLUSION: We conclude that findings from aHTA methods should be interpreted with caution. There is a need to develop more robust aHTA approaches for cost adjustment. aHTA may be used for 'topic prioritisation' within the overall HTA process, whereby interventions which are highly cost-ineffective, can be directly ruled out, thus saving time and resources for conducting full HTA for interventions that are not well studied or where evidence is inconclusive.

Cost of screening, out-of-pocket expenditure & quality of life for diabetes & hypertension in India.

Background & objectives: The Government of India has initiated a population based screening (PBS) for noncommunicable diseases (NCDs). A health technology assessment agency in India commissioned a study to assess the cost-effectiveness of screening diabetes and hypertension. The present study was undertaken to estimate the cost of PBS for Type II diabetes and hypertension. Second, out-of-pocket expenditure (OOPE) for outpatient care and health-related quality of life (HRQoL) among diabetes and hypertension patients were estimated. Methods: Economic cost of PBS of diabetes and hypertension was assessed using micro-costing methodology from a health system perspective in two States. A total of 165 outpatients with diabetes, 300 with hypertension and 497 with both were recruited to collect data on OOPE and HRQoL. Results: On coverage of 50 per cent, the PBS of diabetes and hypertension incurred a cost of ₹ 45.2 per person screened. The mean OOPE on outpatient consultation for a patient with diabetes, hypertension and both diabetes and hypertension was ₹ 4381 (95% confidence interval [CI]: 3786-4976), ₹ 1427 (95% CI: 1278-1576) and ₹ 3932 (95% CI: 3614-4250), respectively. Catastrophic health expenditure was incurred by 20, 1.3 and 14.8 per cent of patients with diabetes, hypertension and both diabetes and hypertension, respectively. The mean HRQoL score of patients with diabetes, hypertension and both was 0.76 (95% CI: 0.72-0.8), 0.89 (95% CI: 0.87-0.91) and 0.68 (95% CI: 0.66-0.7), respectively. Interpretations & conclusions: The findings of our study are useful for assessing cost-effectiveness of screening strategies for diabetes and hypertension.

What, Where, and How to Collect Real-World Data and Generate Real-World Evidence to Support Drug Reimbursement Decision-Making in Asia: A reflection Into the Past and A Way Forward.

BACKGROUND: Globally, there is increasing interest in the use of real-world data (RWD) and real-world evidence (RWE) to inform health technology assessment (HTA) and reimbursement decision-making. Using current practices and case studies shared by eleven health systems in Asia, a non-binding guidance that seeks to align practices for generating and using RWD/RWE for decision-making in Asia was developed by the REAL World Data In ASia for HEalth Technology Assessment in Reimbursement (REALISE) Working Group, addressing a current gap and needs among HTA users and generators. METHODS: The guidance document was developed over two face-to-face workshops, in addition to an online survey, a face-to-face interview and pragmatic search of literature. The specific focus was on what, where and how to collect RWD/ RWE. RESULTS: All 11 REALISE member jurisdictions participated in the online survey and the first in-person workshop, 10 participated in the second in-person workshop, and 8 participated in the in-depth face-to-face interviews. The guidance document was iteratively reviewed by all working group members and the International Advisory Panel. There was substantial variation in: (a) sources and types of RWD being used in HTA, and (b) the relative importance and prioritization of RWE being used for policy-making. A list of national-level databases and other sources of RWD available in each country was compiled. A list of useful guidance on data collection, quality assurance and study design were also compiled. CONCLUSION: The REALISE guidance document serves to align the collection of better quality RWD and generation of reliable RWE to ultimately inform HTA in Asia.