Impact of health benefit package policy interventions on service utilisation under government-funded health insurance in Punjab, India: analysis of Ayushman Bharat Pradhan Mantri Jan Arogya Yojana (PM-JAY).

Background: The design of health benefits package (HBP), and its associated payment and pricing system, is central to the performance of government-funded health insurance programmes. We evaluated the impact of revision in HBP within India's Pradhan Mantri Jan Arogya Yojana (PM-JAY) on provider behaviour, manifesting in terms of utilisation of services. Methods: We analysed the data on 1.35 million hospitalisation claims submitted by all the 886 (222 government and 664 private) empanelled hospitals in state of Punjab, from August 2019 to December 2022, to assess the change in utilisation from HBP 1.0 to HBP 2.0. The packages were stratified based on the nature of revision introduced in HBP 2.0, i.e., change in nomenclature, construct, price, or a combination of these. Data from National Health System Cost Database on cost of each of the packages was used to determine the cost-price differential for each package during HBP 1.0 and 2.0 respectively. A dose-response relationship was also evaluated, based on the multiplicity of revision type undertaken, or based on extent of price correction done. Change in the number of monthly claims, and the number of monthly claims per package was computed for each package category using an appropriate seasonal autoregressive integrated moving average (SARIMA) time series model. Findings: Overall, we found that the HBP revision led to a positive impact on utilisation of services. While changes in HBP nomenclature and construct had a positive effect, incorporating price corrections further accentuated the impact. The pricing reforms highly impacted those packages which were originally significantly under-priced. However, we did not find statistically significant dose-response relationship based on extent of price correction. Thirdly, the overall impact of HBP revision was similar in public and private hospitals. Interpretation: Our paper demonstrates the significant positive impact of PM-JAY HBP revisions on utilisation. HBP revisions need to be undertaken with the anticipation of its long-term intended effects. Funding: Deutsche Gesellschaft für Internationale Zusammenarbeit (GIZ).

Analysis of quality of life of patients with refractive errors in India.

INTRODUCTION: It is important to determine the health-related quality of life (HRQoL) to devise population-based cost-effective service delivery models. The present study aimed to evaluate the HRQoL of patients with refractive errors (RE) using generic and vision-specific instruments, identify the determinants of HRQoL, and examine the validity between the quality-of-life instruments for refractive errors. METHODS: Face-to-face interviews were conducted with 515 participants with RE using generic as well as vision-specific HRQoL measures. Mean EuroQol-five dimensions-five levels (EQ-5D-5L) utility value, National Eye Institute-Visual Function Questionnaire-25 (NEI-VFQ-25) composite score, and EuroQol-Visual analogue scale (EQ-VAS) score were computed, and determinants of quality of life were determined using generalized linear regression model. The validity between generic and disease-specific measures was ascertained using Pearson's coefficient. RESULTS: The mean EQ-5D-5L utility score for patients with RE was estimated as 0.72 (95% CI: 0.70-0.75). The mean NEI-VFQ-25 composite score and EQ-VAS score were 71.3 (95% CI: 69.8-73), and 74.7 (95% CI: 73.4-76.1), respectively. Visual acuity, gender, and presence of co-morbidities were significantly associated with quality of life. The concurrence between the generic and vision-specific instruments was found to be low to moderate. CONCLUSION: The findings of the study indicate the importance of the value of quality of life for patients with RE, which could be taken into account by health administrators, doctors and researchers to carry out economic evaluations, since these measures provide a basis for an evaluation more precisely the impact of RE and guide the determination of efficient ways to alleviate the burden of treatable visual impairment. More research is required to explore the potential integration of a vision component, the sixth dimension, into the EQ-5D-5L instrument, given the moderate agreement observed between the generic and specific assessment tools.

Reorienting health systems towards Primary Health Care in South Asia.

This series, "Primary health care in South Asia", is an effort to provide region-specific, evidence-based insights for reorienting health systems towards PHC. Led by regional thinkers, this series draws lessons from five countries in South Asia: Bangladesh, India, Nepal, Pakistan, and Sri Lanka. This is the last paper in the series that outlines points for future action. We call for action in three areas. First, the changing context in the region, with respect to epidemiological shifts, urbanisation, and privatisation, presents an important opportunity to appraise existing policies on PHC and reformulate them to meet the evolving needs of communities. Second, reorienting health systems towards PHC requires concrete efforts on three pillars-integrated services, multi-sectoral collaboration, and community empowerment. This paper collates nine action points that cut across these three pillars. These action points encompass contextualising policies on PHC, scaling up innovations, allocating adequate financial resources, strengthening the governance function of health ministries, establishing meaningful public-private engagements, using digital health tools, reorganising service delivery, enabling effective change-management processes, and encouraging practice-oriented research. Finally, we call for more research-policy-practice networks on PHC in South Asia that can generate evidence, bolster advocacy, and provide spaces for cross-learning. Funding: WHO SEARO funded this paper. This source did not play any role in the design, analysis or preparation of the manuscript.

Incidence of Kawasaki disease among children in Chandigarh, India during 2015-2019: a trend analysis.

Background: Only limited information exists regarding the epidemiology of Kawasaki disease (KD) in low-income and middle-income countries. The present study provides the incidence of KD during 2015-2019 in Chandigarh, north India. Our centre follows the largest KD cohort in India. Methods: Children with KD at Chandigarh diagnosed during January 2015-December 2019 were enrolled in the study. Annual incidence rates were determined using decadal growth rates of the National Census 2011. We computed the incidence of KD in children aged <5, and <15 years. We also undertook linear trend analysis using our incidence data from 1994 to 2019. Findings: During 2015-2019, 83 patients (66 males, 17 females) were diagnosed with KD in Chandigarh. Incidence rates during these 5 years were 5.64, 9.25, 9.11, 9.87, and 9.72/100,000 in children aged <5 years, and 2.65, 4.44, 3.86, 5.07, 4.74/100,000 in children aged <15 years. The median age at diagnosis was 48 months (range: 12 days to 15 years). Compared to previous data (2009-2014), there was a 53.1% increase in annual incidence of KD in children aged <5 years, and a 53.7% increase in children aged <15 years. Coronary artery abnormalities during acute phase were noted in 16.9%, and in 7.2% of patients at 6 weeks of follow-up. The trend analysis indicated a monthly rise of 0.002 cases per 100,000 children aged <5 years, and 0.0165 cases per 100,000 children aged <15 years. Interpretation: The incidence of KD has continued to show an upward trend in Chandigarh over the period 2015-2019. This may indicate a true rise in the occurrence of KD or may reflect better disease ascertainment as a result of greater awareness about KD amongst healthcare professionals. Funding: None.

Establishing national hospital costing systems: insights from the qualitative assessment of cost surveillance pilot in Indian hospitals.

OBJECTIVE: The Indian Government launched Ayushman Bharat Pradhan Mantri Jan Arogya Yojana (PM-JAY), the world's largest health insurance scheme, in 2018. To reform pricing and gather evidence on healthcare costs, a hospital cost-surveillance pilot was initiated among PM-JAY empanelled hospitals. We analysed the process and challenges from both healthcare providers and payer agency's perspectives and offer recommendations for implementing similar systems in lower- and middle-income countries. DESIGN: We employed an open-ended, descriptive and qualitative study design using in-depth interviews (IDI) as the data collection strategy. SETTINGS: The interviews were conducted in both virtual and face-to-face modes depending on the convenience of the participants. The IDIs for the National Health Authority (NHA) officials and all providers in Kerala were conducted virtually, while face-to-face interviews were conducted and in Haryana and Chhattisgarh. PARTICIPANTS: Staff from 21 hospitals in three states (Haryana, Chhattisgarh and Kerala), including officials from State Health Agency (n=5) and NHA (n=3) were interviewed. RESULTS: The findings highlight significant challenges in reporting cost data at the hospital level. These include a shortage of trained staff, leading to difficulties in collecting comprehensive and high-quality data. Additionally, the data collection process is resource-intensive and time-consuming, putting strain on limited capacity. Operational issues with transaction management system, such as speed, user-friendliness and frequent page expirations, also pose obstacles. Finally, current patient records data has gaps, in terms of quantity and quality, to be directly put to use for pricing. CONCLUSION: Accurate cost data is vital for health policy decisions. Capacity building across healthcare levels is needed for precise cost collection. Integration into digital infrastructure is key to avoid burdening providers and ensure quality data capture.

The state of primary health care in south Asia.

The south Asian region (SAR) is home to 1·74 billion people, corresponding to 22% of the global population. The region faces several challenges pertaining to changing epidemiology, rapid urbanisation, and social and economic concerns, which affect health outcomes. Primary health care (PHC) is a cost-effective strategy to respond to these challenges through integrated service delivery, multi-sectoral action, and empowered communities. The PHC approach has historically been an important cornerstone of health policy in SAR countries. However, the region is yet to fully reap the benefits of PHC-oriented health systems. Our introductory paper in this Lancet Series on PHC in the SAR describes the existing PHC delivery structure in five SAR nations (ie, Bangladesh, India, Nepal, Pakistan, and Sri Lanka) and critically appraises PHC performance to identify its enablers and barriers. The paper proposes investing in a shared culture of innovation and collaboration for revitalisation of PHC in the region.

Ventilator-associated pneumonia - What price does the public health system pay?

BACKGROUND: Ventilator-associated pneumonia (VAP) is the commonest healthcare-associated infection (HAI) in intensive care units (ICU), especially in trauma patients. VAP imposes a significant cost burden on the healthcare ecosystem. However, there are few data from the developing world. METHODOLOGY: We conducted this study in the trauma ICU (TICU) of PGIMER, Chandigarh, from October 2021 to December 2022. The incidence, incidence density, and average length of stay (ALOS) of both VAP and non-VAP patients were established. The health system cost was assessed using a mixed (top-down and bottom-up) micro-costing approach. We collected data for all the resources (direct and indirect costs) utilized during service delivery and estimated the health system cost per bed per day. RESULTS: In this study, 494 patients were admitted to TICU, of which 484 received Mechanical Ventilation (MV) and 47 developed VAP. We included 41 and 44 patients with and without VAP. The VAP incidence rate was 9.7% and the VAP incidence density was 10.79/1000 MV days. The ALOS for VAP patients was 21 days, and for non- VAP patients was 8.2 days. Our study estimated a total health system cost of INR 25,927 per bed per day. The health system cost of treating a VAP patient was INR 544,467 compared to INR 207,416 for a non-VAP patient. CONCLUSION: Treatment of VAP poses substantial costs for the health system and patients. There is a need to focus on preventing VAP, which would eventually reduce the length of stay and the resultant financial impact on the health system and the patient.

Understanding the extent of economic evidence usage for informing policy decisions in the context of India's national health insurance scheme: Ayushman Bharat Pradhan Mantri Jan Aarogya Yojana (PM-JAY).

INTRODUCTION: Ayushman Bharat Pradhan Mantri Jan Aarogya Yojana (PM-JAY) is one of the world's largest tax-funded insurance schemes. The present study was conducted to understand the decision-making process around the evolution (and revision) of health benefit packages (HBPs) and reimbursement rates within PM-JAY, with a specific focus on assessing the extent of use of economic evidence and role of various stakeholders in shaping these policy decisions. METHODS: A mixed-methods study was adopted involving in-depth interviews with seven key stakeholders involved in HBP design and reimbursement rates decisions, and a survey of 80 government staff and other relevant stakeholders engaged in the implementation of PM-JAY. The data gathered were thematically analysed, and a coding framework was developed to explore specific themes. Additionally, publicly available documents were reviewed to ensure a comprehensive understanding of the decision-making processes. RESULTS: Findings reveal a progressive transition towards evidence-based practices for policy decisions within PM-JAY. The initial version of HBP relied heavily on key criteria like disease burden, utilisation rates, and out-of-pocket expenditures, along with clinical opinion in shaping decisions around the inclusion of services in the HBP and setting reimbursement rates. Revised HBPs were informed based on evidence from a national-level costing study and broader stakeholder consultations. The use of health economic evidence increased with each additional revision with consideration of health technology assessment (HTA) evidence for some packages and reimbursement rates based on empirical cost evidence in the most recent update. The establishment of the Health Financing and Technology Assessment unit further signifies the use of evidence-based policymaking within PM-JAY. However, challenges persist, notably with regard to staff capacity and understanding of HTA principles, necessitating ongoing education and training initiatives. CONCLUSION: While substantial progress has been made in transitioning towards evidence-based practices within PM-JAY, sustained efforts and political commitment are required for the ongoing systematisation of processes.

Assessing the WHO-UNICEF primary health-care measurement framework; Bangladesh, India, Nepal, Pakistan and Sri Lanka.

Objective: To assess the availability of information on indicators of the World Health Organization and United Nations Children's Fund primary health-care measurement framework in Bangladesh, India, Nepal, Pakistan and Sri Lanka and to outline the opportunities for and challenges to using the framework in these countries. Methods: We reviewed global and national data repositories for quantitative indicators of the framework and conducted a desk review of country documents for qualitative indicators in February-April 2023. We assessed data sources and cross-sectional survey tools to suggest possible sources of information on framework indicators that were not currently reported in the countries. We also identified specific indicators outside the framework on which information is collected in the countries and which could be used to measure primary health-care performance. Findings: Data on 54% (32/59) of the quantitative indicators were partially or completely available for the countries, ranging from 41% (24/59) in Pakistan to 64% (38/59) in Nepal. Information on 41% (66/163) of the qualitative subindicators could be acquired through desk reviews of country-specific documents. Information on input indicators was more readily available than on process and output indicators. The feasibility of acquiring information on the unreported indicators was moderate to high through adaptation of data collection instruments. Conclusion: The primary health-care measurement framework provides a platform to readily assess and track the performance of primary health care. Countries should improve the completeness, quality and use of existing data for strengthening of primary health care.

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.

Health care 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 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 as 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 as follows: 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 health care 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. Health care cost accounting systems in India are rudimentary with a few exceptions, raising questions about how to source these data sustainably. Strengthening cost accounting systems in India will require standardized data formats, integrated into existing data management systems, that both meet the needs of policy makers and are acceptable to hospital providers.

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.

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.

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 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.

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.

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.