Cost-effectiveness and budget impact of adding tranexamic acid for management of post-partum hemorrhage in the Indian public health system.

BACKGROUND: Postpartum hemorrhage (PPH) is the global leading cause of maternal mortality, affecting nearly 3 to 6 percent of all women giving birth in India. The World Health Organization (WHO) has updated its guidelines to recommend the early use of intravenous (IV) tranexamic acid (TXA) in addition to standard care for all diagnosed PPH cases. This study aimed to assess the cost-effectiveness of introducing TXA for PPH management in the Indian public health system. METHODS: A decision analytic model was built using a decision tree to determine the cost-effectiveness of administering IV TXA to women experiencing PPH within 3 h of birth to existing management with uterotonics and supportive care. Using a disaggregated societal perspective, the costs and consequences for a hypothetical cohort of women experiencing PPH in public health facilities was estimated. The model was populated using probabilities, clinical parameters, and utilities from published literature, while cost parameters were largely derived from a primary economic costing study. The primary outcome of interest was the incremental cost-utility ratio (ICUR). Associated clinical events and net benefits were estimated. One-way and probabilistic sensitivity analysis (PSA) was undertaken. The budget impact was estimated for a national-level introduction. RESULTS: For an estimated annual cohort of 510,915 PPH cases in India, the addition of IV TXA would result in a per-patient disaggregated societal cost of INR 6607 (USD 95.15) with a discounted gain of 20.25 QALYs, as compared to a cost of INR 6486 (USD 93.41) with a discounted gain of 20.17 QALYs with standard care PPH management. At an ICUR value of INR 1470 per QALY gained (USD 21), the addition of IV TXA is cost-effective in Indian public health settings. The intervention is likely to prevent 389 maternal deaths, 177 surgeries, and 128 ICU admissions per 100,000 PPH cases. The findings are robust under uncertainty, with 94.5% of PSA simulations remaining cost-effective. A cumulative increase of 2.3% financial allocation for PPH management over five years will be incurred for TXA introduction. CONCLUSIONS: Addition of tranexamic acid for primary PPH management, as recommended by WHO, is cost-effective in Indian public health settings. Policy guidelines, training manuals, and facility checklists should be updated to reflect this recommendation.

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 of providing family planning services & management of pregnancy outcomes at public health facilities in India.

Background & objectives: Lack of costing data is a critical gap that exists in the field of family planning (FP) in India. The aim of this study was to estimate health system costs of FP in India for existing modern methods, and potential newer methods (etonorgestrel implant and levonorgestrel intrauterine device) and pregnancy-related services in India. Methods: A bottom-up micro-costing study was conducted in five public health facilities of an Indian State. Data of last one year were collected from existing hospital records and hospital staff was interviewed. Collected data were analyzed using standard costing methods. Results: Package costs of delivering FP services ranged from ₹ 807 (95% CI 685, 931) for condoms and ₹ 10,539 (8796, 12269) for tubal ligation. Estimates of etonorgestrel implant and levonorgestrel intrauterine system were ₹ 3,200 (2800, 3625) and 3,426 (3232, 3623). Cost of antenatal care along with vaginal delivery, caesarean and abortion were ₹ 10,916 (8744, 13078), 22,136 (17570, 26910) and 8,574 (6791, 10379), respectively. One way sensitivity analysis showed that the three most influential factors on the costs of FP services were prices of drugs and consumables, number of beneficiaries and health personnel cost. Interpretation & conclusions: The present study has generated package costs for FP and pregnancy-related services in India which could be used by publicly-funded insurance schemes, for budgeting, economic evaluations and improve resource allocation of services. The cost estimates from this study add to the limited literature in India on costs of FP.

Cost of Surgical Care at Public Sector District Hospitals in India: Implications for Universal Health Coverage and Publicly Financed Health Insurance Schemes.

BACKGROUND: In low- and middle-income countries (LMICs), provisioning for surgical care is a public health priority. Ayushman Bharat Pradhan Mantri-Jan Aarogya Yojana (AB PM-JAY) is India's largest national insurance scheme providing free surgical and medical care. In this paper, we present the costs of surgical health benefit packages (HBPs) for secondary care in public district hospitals. METHODS: The costs were estimated using mixed (top-down and bottom-up) micro-costing methods. In phase II of the Costing of Health Services in India (CHSI) study, data were collected from a sample of 27 district hospitals from nine states of India. The district hospitals were selected using stratified random sampling based on the district's composite development score. We estimated unit costs for individual services-outpatient (OP) visit, per bed-day in inpatient (IP) and intensive care unit (ICU) stays, and surgical procedures. Together, this was used to estimate the cost of 250 AB PM-JAY HBPs. RESULTS: At the current level of utilization, the mean cost per OP consultation varied from US$4.10 to US$2.60 among different surgical specialities. The mean unit cost per IP bed-day ranged from US$13.40 to US$35.60. For the ICU, the mean unit cost per bed-day was US$74. Further, the unit cost of HBPs varied from US$564 for bone tumour excision to US$49 for lid tear repair. CONCLUSIONS: Data on the cost of delivering surgical care at the level of district hospitals is of critical value for evidence-based policymaking, price-setting for surgical care and planning to strengthen the availability of high quality and cost-effective surgical care in district hospitals.

Cost-effectiveness of uterine balloon tamponade devices in managing atonic post-partum hemorrhage at public health facilities in India.

OBJECTIVE: Post-partum hemorrhage (PPH) is the leading direct cause of maternal mortality in India. Uterine balloon tamponade (UBT) is recommended for atonic PPH cases not responding to uterotonics. This study assessed cost-effectiveness of three UBT devices used in Indian public health settings. METHODS: A decision tree model was built to assess cost-effectiveness of Bakri-UBT and low-cost ESM-UBT alternatives as compared to the recommended standard of care i.e. condom-UBT intervention. A hypothetical annual cohort of women eligible for UBT intervention after experiencing atonic PPH in Indian public health facilities were evaluated for associated costs and outcomes over life-time horizon using a disaggregated societal perspective. Costs by undertaking primary costing and clinical parameters from published literature were used. Incremental cost per Disability Adjusted Life Years (DALY) averted, number of surgeries and maternal deaths with the interventions were estimated. An India specific willingness to pay threshold of INR 24,211 (USD 375) was used to evaluate cost-effectiveness. Detailed sensitivity analysis and expected value of information analysis was undertaken. RESULTS: ESM-UBT at base-case Incremental Cost-Effectiveness Ratio (ICER) of INR -2,412 (USD 37) per DALY averted is a cost-saving intervention i.e. is less expensive and more effective as compared to condom-UBT. Probabilistic sensitivity analysis however shows an error probability of 0.36, indicating a degree of uncertainty around model results. Bakri-UBT at an ICER value of INR -126,219 (USD -1,957) per DALY averted incurs higher incremental societal costs and is less effective as compared to condom-UBT. Hence, Bakri-UBT is not cost-effective. CONCLUSION: For atonic PPH management in India, condom-UBT offers better value as compared to Bakri-UBT. Given the limited clinical effectiveness evidence and uncertainty in sensitivity analysis, cost-saving result for ESM-UBT must be considered with caution. Future research may focus on generating high quality comparative clinical evidence for UBT devices to facilitate policy decision making.

Translating Research to Policy: Setting Provider Payment Rates for Strategic Purchasing under India's National Publicly Financed Health Insurance Scheme.

BACKGROUND: In 2018, the Government of India launched Ayushman Bharat Pradhan Mantri-Jan Aarogya Yojana (AB PM-JAY), a large tax-funded health insurance scheme. In this paper, we present findings of the Costing of Health Services in India (CHSI) study, describe the process of use of cost evidence for price-setting under AB PM-JAY, and estimate its fiscal impact. METHODS: Reference costs were generated from the first phase of CHSI study, which sampled 11 tertiary public hospitals from 11 Indian states. Cost for Health Benefit Packages (HBPs) was estimated using mixed (top-down and bottom-up) micro-costing methods. The process adopted for price-setting under AB PM-JAY was observed. The cost of each HBP was compared with AB PM-JAY prices before and after the revision, and the budgetary impact of this revision in prices was estimated. FINDINGS: Following the CHSI study evidence and price consultations, 61% of AB PM-JAY HBP prices were increased while 18% saw a decline in the prices. In absolute terms, the mean increase in HBP price was ₹14,000 (₹450-₹1,65,000) and a mean decline of ₹6,356 (₹200-₹74,500) was observed. Nearly 42% of the total HBPs, in 2018, had a price that was less than 50% of the true cost, which declined to 20% in 2019. The evidence-informed revision of HBP prices is estimated to have a minimal fiscal impact (0.7%) on the AB PM-JAY claims pay-out. INTERPRETATION: Evidence-informed price-setting helped to reduce wide disparities in cost and price, as well as aligning incentives towards broader health system goals. Such strategic purchasing and price-setting requires the creation of systems of generating evidence on the cost of health services. Further research is recommended to develop a cost-function to study changes in cost with variations in time, region, prices, skill-mix and other factors.

A systematic review on clinical effectiveness, side-effect profile and meta-analysis on continuation rate of etonogestrel contraceptive implant.

BACKGROUND: Unintended pregnancies (UIP) have a significant impact on health of women and the health budget of countries. Contraception is an effective way to prevent UIPs. The study objective was to collate evidence on clinical effectiveness of etonogestrel subdermal implant (ESI), continuation rate and side effect profile among eligible women of reproductive age group, as compared to levonorgestrel intrauterine system (LNG-IUS), copper intrauterine device (Cu-IUD) and depot medroxy progesterone acetate injections; other types of contraceptive implants were excluded as comparators. METHODS: The protocol of the systematic review was registered in Prospero (registration number: CRD42018116580). MEDLINE via PubMed, Cochrane library and web of science were the electronic databases searched. A search strategy was formulated and studies from 1998 to 2019 were included. Clinical trial registries and grey literature search was done. Critical assessment of included studies was done using appropriate tools. A qualitative synthesis of included studies was done and a meta-analysis was conducted in RevMan software for continuation rates of ESI as compared to other long acting reversible contraceptives (LARC) e.g. LNG IUS and Cu-IUD. RESULTS: The search yielded 23,545 studies. After excluding 467 duplicates, 23,078 titles were screened and 51 studies were included for the review. Eight of the 15 studies reporting clinical effectiveness reported 100% effectiveness and overall pearl index ranged from 0 to 1.4. One-year continuation rates ranged from 57-97%; 44-95% at the end of second year and 25-78% by 3 years of use. Abnormal menstruation was the most commonly reported side effect. There was no significant difference in bone mineral density at 1 year follow-up. The meta-analyses showed that odds ratio (OR) of 1-year continuation rate was 1.55 (1.36, 1.76) for LNG-IUS vs. ESI and 1.34 (1.13, 1.58) for copper-IUD vs. ESI; showing that continuation rates at the end of one-year were higher in LNG-IUS and copper-IUD as compared to ESI. CONCLUSION: ESI is clinically effective and safe contraceptive method to use, yet 1-year continuation rates are lower as compared to LNG-IUS and copper-IUD, mostly attributed to the disturbances in the menstruation.

Cost Effectiveness of Introducing Etonorgestrel Contraceptive Implant into India's Current Family Welfare Programme.

OBJECTIVES: The aim of this study was to provide evidence to policy makers on cost effectiveness and budget impact for the introduction of the etonorgestrel implant into the Indian public health system. METHODS: An economic evaluation was conducted to ascertain the potential costs and outcomes of adding the etonorgestrel implant to the public health system of India as compared to the current scenario. A decision analytical model (Markov cohort) was conceptualized from a societal perspective, where a hypothetical population of 15-year-old females was followed until menopause. The primary outcome was incremental cost-utility ratio (ICUR). Sources for model inputs included country-level secondary data analysis, government reports, an observational primary costing study, a systematic review of etonorgestrel implant and targeted literature reviews. One-way and probabilistic sensitivity analyses (OWSA and PSA) were performed to account for uncertainty. The impact of etonorgestrel implant introduction on the annual Indian health budget was also analysed. RESULTS: The base-case ICUR was 16,475 Indian rupees (INR) (USD 232) per quality-adjusted life-year gained, which showed the etonorgestrel implant to be very cost effective (ICUR below willingness-to-pay threshold of INR 137,945 [USD 1943]). OWSA showed that discount rate, percentage of people who do not use contraceptives and costs of managing side effects were the important parameters that affected ICUR. PSA showed that ICUR values of all 1000 Monte Carlo simulations were cost effective. Budget impact analysis showed that introduction of the implant would account for < 1% of the total annual health budget of India, even if acceptance of the implant varied between 0.2 and 4%. CONCLUSION: Adding the etonorgestrel implant to the public health system would be cost effective for India, with a feasible budgetary allocation.

Many women in India do not use methods to prevent pregnancy (contraception) despite not wanting to get pregnant, due to a number of reasons. As a result, a high number of pregnancies that are either unplanned or unwanted affect the health of these women and their families and in turn the economy of the country. The government of India wishes to increase the number of contraceptive choices so that more women could prevent unwanted pregnancies. One such method under consideration is 'Implant'. It is a match-stick sized plastic rod that contains a medicine called Etonorgestrel that acts like a female hormone. This stick is placed under the skin of the arm of the woman and can be left there for three years to prevent pregnancy.Our study answers an important question as to whether introducing Etonorgestrel containing implant in the government's family planning program would be good value for money and what would its impact be on the national annual health budget. To answer this question, we compiled evidence and simulated how introducing implant would affect health and costs.Our study showed that the introduction of Etonorgestrel containing implant into the Indian public health system would be good value for money. The cost to the government would be relatively low considering the extent of improvement in health. The expenditure to roll-out this contraceptive would amount to less than 1% of the annual health budget of India even if the use of the new method would vary between 0.2 to 4%.

Process evaluation of health system costing - Experience from CHSI study in India.

BACKGROUND: A national study, 'Costing of healthcare services in India' (CHSI) aimed at generating reliable healthcare cost estimates for health technology assessment and price-setting is being undertaken in India. CHSI sampled 52 public and 40 private hospitals in 13 states and used a mixed micro-costing approach. This paper aims to outline the process, challenges and critical lessons of cost data collection to feed methodological and quality improvement of data collection. METHODS: An exploratory survey with 3 components-an online semi-structured questionnaire, group discussion and review of monitoring data, was conducted amongst CHSI data collection teams. There were qualitative and quantitative components. Difficulty in obtaining individual data was rated on a Likert scale. RESULTS: Mean time taken to complete cost data collection in one department/speciality was 7.86(±0.51) months, majority of which was spent on data entry and data issues resolution. Data collection was most difficult for determination of equipment usage (mean difficulty score 6.59±0.52), consumables prices (6.09±0.58), equipment price(6.05±0.72), and furniture price(5.64±0.68). Human resources, drugs & consumables contributed to 78% of total cost and 31% of data collection time. However, furniture, overheads and equipment consumed 51% of time contributing only 9% of total cost. Seeking multiple permissions, absence of electronic records, multiple sources of data were key challenges causing delays. CONCLUSIONS: Micro-costing is time and resource intensive. Addressing key issues prior to data collection would ease the process of data collection, improve quality of estimates and aid priority setting. Electronic health records and availability of national cost data base would facilitate conducting costing studies.

Addressing the Cost Data Gap for Universal Healthcare Coverage in India: A Call to Action.

The Indian health system is undergoing significant reform toward more evidence-informed and inclusive health policy as the country strives toward the achievement of Universal Health Coverage for its 1.3 billion population. Cost information plays a key role in the evidence arsenal of Universal Health Coverage-oriented policy by informing decisions such as the setting reimbursement rates for government-sponsored health insurance packages of care, strategic purchasing of health services, and in prioritizing available resources to maximize value of health sector investments. However, extensive and quality health facility cost data in India are limited. As a result, there is an increasing and urgent need to generate and disseminate healthcare cost information. This article discusses the need for cost information and the current initiatives that are progressing this agenda. The first is a national cost database and website hosting cost data collected from 200 public sector facilities across 6 Indian states at each level of the care delivery system by a consortium of health research institutes. This database is the first of its kind in India and will serve as a central resource for researchers and decision-makers for information on healthcare costs. The second is a nationwide costing study of healthcare at both private and public facilities. By improving the availability of cost data in India, raising its profile and demonstrating its utility, it is hoped that the database and new costing efforts will lead to greater recognition of the importance of good quality data to inform health policy and enable more evidence-informed decision-making.

Identification of key proteins of cultured human intestinal cells involved in interaction with enteroaggregative Escherichia coli.

Enteroaggregative Escherichia coli (EAEC) adherence to human intestinal tissue is known to be mediated by aggregative adherence fimbriae (AAF). However, the host cell molecules involved in EAEC adherence remain uncharacterized. In the present study, four key membrane glycoproteins of cultured human intestinal epithelial cells (INT-407) were found to be involved in the interaction with the T8 strain of EAEC. Nine membrane proteins of INT-407 cells were found to interact with EAEC-T8, of which four were identified as fibronectin, epidermal growth factor receptor (EGFR), Thrombospondin-1 (TSP1) and glucose-regulated protein (GRP-94). Our findings were validated by Western blot using antibody against each identified protein. The adherence of EAEC-T8 to INT-407 cells was reduced to c. 26, 29, 37 and 76% in the presence of the antibody against GRP-94, EGFR, fibronectin and TSP-1, respectively. These findings were further substantiated by flow cytometry, where the final mean fluorescence intensity value of the INT-407 cells (c. 1075) resulting from adherent-labelled bacteria was found to be reduced to c. 26, 132, 228 and 597 in the presence of antibody against GRP-94, EGFR, fibronectin and TSP-1. We propose that GRP-94, EGFR, fibronectin and TSP-1 are involved in the aggregative adherence of EAEC-T8 to INT-407 cells.