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.

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-effectiveness analysis of different combination therapies for the treatment of chronic lymphocytic leukaemia in India.

Background: Over the years, there has been introduction of newer drugs, like bendamustine and ibrutinib, for the management of chronic lymphocytic leukaemia (CLL). Though these drugs lead to better survival, they are also associated with higher cost. The existing evidence on cost effectiveness of these drugs is from high-income countries, which has limited generalisability for low-income and middle-income counties. Therefore, the present study was undertaken to assess the cost-effectiveness of three therapeutic regimens, chlorambucil plus prednisolone (CP), bendamustine plus rituximab (BR) and ibrutinib for CLL treatment in India. Methods: A Markov model was developed for estimating lifetime costs and consequences in a hypothetical cohort of 1000 CLL patients following treatment with different therapeutic regimens. The analysis was performed based on a limited societal perspective, 3% discount rate and lifetime horizon. The clinical effectiveness of each regime in the form of progression-free survival and occurrence of adverse events were assessed from various randomised controlled trials. A structured comprehensive review of literature was undertaken for the identification of relevant trials. The data on utility values and out of pocket expenditure was obtained from primary data collected from 242 CLL patients across six large cancer hospitals in India. Findings: As compared to the most affordable regimen comprising of CP as first-line followed by BR as second-line therapy, none of the other therapeutic regimens were cost-effective at one time per capita gross-domestic product of India. However, if the current price of either combination of BR and ibrutinib or even ibrutinib alone could be reduced by more than 80%, regimen comprising of BR as first-line therapy followed by second-line ibrutinib would become cost-effective. Interpretation: At the current market prices, regimen comprising of CP as first-line followed by BR as second-line therapy is the most cost-effective strategy for CLL treatment in India. Funding: Department of Health Research, Government of India.

Cost Effectiveness of Bevacizumab Plus Chemotherapy for the Treatment of Advanced and Metastatic Cervical Cancer in India-A Model-Based Economic Analysis.

PURPOSE: Patients with advanced and metastatic cervical cancer have a poor prognosis with a 1-year survival rate of 10%-15%. Recently, an antiangiogenic humanized monoclonal antibody bevacizumab has shown to improve the survival of these patients. This study was designed to assess the cost effectiveness of incorporating bevacizumab with standard chemotherapy for the treatment of patients with advanced and metastatic cervical cancer in India. METHODS: Using a disaggregated societal perspective and lifetime horizon, a Markov model was developed for estimating the costs and health outcomes in a hypothetical cohort of 1,000 patients with advanced and metastatic cervical cancer treated with either standard chemotherapy alone or in combination with bevacizumab. Effectiveness data for each of the treatment regimen were assessed using estimates from Gynecologic Oncology Group 240 trial. Data on disease-specific mortality in metastatic cervical cancer, health system cost, and out-of-pocket expenditure were derived from Indian literature. Multivariable probabilistic sensitivity analysis was undertaken to account for parameter uncertainty. RESULTS: Over the lifetime of one patient with advanced and metastatic cervical cancer, bevacizumab along with standard chemotherapy results in a gain of 0.275 (0.052-0.469) life-years (LY) and 0.129 (0.032-0.218) quality-adjusted life-years (QALY), at an additional cost of $3,816 US dollars (USD; 2,513-5,571) compared with standard chemotherapy alone. This resulted in an incremental cost of $19,080 USD (7,230-52,434) per LY gained and $34,744 USD (15,782-94,914) per QALY gained with the use of bevacizumab plus standard chemotherapy. CONCLUSION: Addition of bevacizumab to the standard chemotherapy is not cost effective for the treatment of advanced and metastatic cervical cancer in India at a threshold of 1-time per-capita gross domestic product.

Cost-effectiveness of Post-Mastectomy Radiotherapy (PMRT) for breast cancer in India: An economic modelling study.

Background: The role of post-mastectomy radiotherapy (PMRT) for breast cancer is controversial when 3-or-less lymph nodes are metastatic. Apart from local control, survival and toxicity, cost also plays an important role in decision-making. Methods: A Markov model was designed to assess cost, health outcomes and cost-effectiveness of different radiotherapy techniques for management of PMRT patients. Thirty-nine scenarios were modelled based on type of radiotherapy, laterality, pathologic nodal burden, and dose fractionation. We considered a societal perspective, lifetime horizon and a 3% discount rate. The data on quality of life (QoL) was derived using the cancer database on cost and QoL. Published data on cost of services delivered in India were used. Findings: Post-mastectomy radiotherapy results in incremental quality adjusted life years (QALYs) that ranged from -0.1 to 0.38 across different scenarios. The change in cost ranged from estimated median savings of USD 62 (95% confidence intervals: -168 to -47) to incurring an incremental cost of USD 728 (650-811) across different levels of nodal burden, breast laterality and dose fractionation. For women with node-negative disease, disease-specific systemic therapy remains to be the preferred strategy. For women with node-positive disease, two-dimensional radiotherapy (2DRT) with hypofractionation is the most cost-effective strategy. However, a CT based planning is preferred when maximum heart distance (MHD) >1cm, irregular chest wall contour and inter-field separation >18cm. Interpretation: PMRT is cost-effective for all node-positive patients. With similar toxicity and effectiveness profile compared with conventional fractionation, moderate hypofractionation significantly reduces the cost of treatment and should be the standard of care. Conventional techniques for PMRT are cost-effective over newer modalities which provide minimal additional benefit, at high cost. Funding: The funding to collect primary data for study was provided by Department of Health Research, Ministry of Health and Family Welfare, New Delhi, wide letter number F. No. T.11011/02/2017-HR/3100291.

Cost-effectiveness of population-based screening for diabetes and hypertension in India: an economic modelling study.

BACKGROUND: India faces a high burden of diabetes and hypertension. Currently, there is a dearth of economic evidence about screening programmes, affected age groups, and frequency of screening for these diseases in Indian settings. We assessed the cost effectiveness of population-based screening for diabetes and hypertension compared with current practice in India for different scenarios, according to type of screening test, population age group, and pattern of health-care use. METHODS: We used a hybrid decision model (decision tree and Markov model) to estimate the lifetime costs and consequences from a societal perspective. A meta-analysis was done to assess the effectiveness of population-based screening. Primary data were collected from two Indian states (Haryana and Tamil Nadu) to assess the cost of screening. The data from the National Health System Cost Database and the Costing of Health Services in India study were used to determine the health system cost of diagnostic tests and cost of treating diabetes or hypertension and their complications. A total of 962 patients were recruited to assess out-of-pocket expenditure and quality of life. Parameter uncertainty was evaluated using univariate and multivariable probabilistic sensitivity analyses. Finally, we estimated the incremental cost per quality-adjusted life-year (QALY) gained with alternative scenarios of scaling up primary health care through a health and wellness centre programme for the treatment of diabetes and hypertension. FINDINGS: The incremental cost per QALY gained across various strategies for population-based screening for diabetes and hypertension ranged from US$0·02 million to $0·03 million. At the current pattern of health services use, none of the screening strategies of annual screening, screening every 3 years, and screening every 5 years was cost-effective at a threshold of 1-time per capita gross domestic product in India. In the scenario in which health and wellness centres provided primary care to 20% of patients who were newly diagnosed with uncomplicated diabetes or hypertension, screening the group aged between 30 and 65 years every 5 years or 3 years for either diabetes, hypertension, or a comorbid state (both diabetes and hypertension) became cost-effective. If the share of treatment for patients with newly diagnosed uncomplicated diabetes or hypertension at health and wellness centres increases to 70%, from the existing 4% at subcentres and primary health centres, annual population-based screening becomes a cost saving strategy. INTERPRETATION: Population-based screening for diabetes and hypertension in India could potentially reduce time to diagnosis and treatment and be cost-effective if it is linked to comprehensive primary health care through health and wellness centres for provision of treatment to patients who screen positive. FUNDING: Department of Health Research, Government of India.

Impact of COVID-19 on Outcomes for Patients With Cervical Cancer in India.

PURPOSE: The COVID-19 pandemic has placed unprecedented demands on the health system. This led to delays in the initiation and completion of cancer treatment. We assessed the long-term health consequences because of the delay in diagnosis and treatment for cervical cancer due to COVID-19 in India. METHODS: We used a Markov-model-based analysis assessing the lifetime health outcomes of the cohort of women population at risk from cervical cancer in India. The decrease in survival for those with the treatment interruption was calculated based on the number of days the treatment was extended beyond the standard duration. Furthermore, to model the impact of late diagnosis and delayed treatment initiation, the patients were assumed to have upstaged during the delay period, as per natural progression of disease. RESULTS: We estimate 2.52% (n = 795) to 3.80% (n = 2,160) lifetime increase in the deaths caused by cervical cancer with treatment restrictions ranging from 9 weeks to 6 months, respectively, as compared to no delay. On the contrary, 88-238 deaths because of COVID-19 disease are estimated to be saved during this restriction period among the patients with cervical cancer. Overall, the excess mortality because of cervical cancer led to 18,159-53,626 life-years being lost and an increase of 16,808-50,035 disability-adjusted life-years. CONCLUSION: Delays in diagnosis and treatment are likely to lead to more cervical cancer deaths as compared to COVID-19 mortality averted among the patients with cervical cancer. Health systems must reorganize in terms of priority setting for provision of care, starting with prioritizing the treatment of patients with early-stage cervical cancer, increasing use of teleconsultation, and strengthening the role of primary care physicians in provision of cancer care.

Cost of Treatment for Cervical Cancer in India.

INTRODUCTION: Cervical cancer is a major public health problem in India leading to high economic burden, which is disproportionately borne by the patients as out-of-pocket expenditure (OOPE). Several publicly financed health insurance schemes (PFHIs) in India cover the treatment for cervical cancer. However, the provider payment rates for health benefit packages (HBP) under these PFHIs are not based on scientific evidence. We undertook this study to estimate the cost of services provided for treatment of cervical cancer and  cost of the package of care for cervical cancer in India. METHODS: The study was undertaken at a large public tertiary hospital in North India. The health system cost was assessed using a mixed micro-costing approach. The data were collected for all the resources utilized during service delivery for cervical cancer patients. To evaluate the OOPE, randomly selected 248 patients were interviewed following the cost of illness approach. Logistic regression was used to assess the factors associated with catastrophic health expenditure (CHE). RESULTS: Health system cost for different cervical cancer treatment modalities i.e. radiotherapy, brachytherapy, chemotherapy and surgery, ranges from INR 19,494 to 41,388 (USD 291 - 617). Furthermore, patients spent INR 4,042 to 23,453 ( USD 60 - 350) as OOPE. Nearly 62% patients incurred CHE, and 30% reported distress financing. The odds of CHE (OR: 25.39, p-value: <0.001) and distress financing (OR: 15.37, p-value: 0.001) were significantly higher in poorest-income quintile. The HBP cost varies from INR 45,364 to 64,422 (USD 676 - 960) for brachytherapy and radiotherapy respectively. CONCLUSION: Cervical cancer treatment leads to high OOPE in India, which imposes financial hardship, especially for the poorest. The coverage of risk pooling mechanisms like PHFIs should be enhanced. The findings of our study should be used to set the reimbursement rates of providing cervical cancer treatment under PFHI schemes.

Cost-effectiveness of treating head and neck cancer using intensity-modulated radiation therapy: implications for cancer control program in India.

BACKGROUND: The newer cancer treatment technologies hold the potential of providing improved health outcomes at an additional cost. So it becomes obligatory to assess the costs and benefits of a new technology, before defining its clinical value. We assessed the cost-effectiveness of intensity-modulated radiotherapy (IMRT) as compared to 2-dimensional radiotherapy (2-DRT) and 3-dimensional radiotherapy (3D-CRT) for treating head and neck cancers (HNC) in India. The cost-effectiveness of 3-DCRT as compared to 2-DRT was also estimated. METHODS: A probabilistic Markov model was designed. Using a disaggregated societal perspective, lifetime study horizon and 3 percent discount rate, future costs and health outcomes were compared for a cohort of 1000 patients treated with any of the three radiation techniques. Data on health system cost, out of pocket expenditure, and quality of life was assessed through primary data collected from a large tertiary care public sector hospital in India. Data on xerostomia rates following each of the radiation techniques was extracted from the existing randomized controlled trials. RESULTS: IMRT incurs an incremental cost of $7,072 (2,932-13,258) and $5,164 (463-10,954) per quality-adjusted life year (QALY) gained compared to 2-DRT and 3D-CRT, respectively. Further, 3D-CRT as compared to 2-DRT requires an incremental cost of $8,946 (1,996-19,313) per QALY gained. CONCLUSION: Both IMRT and 3D-CRT are not cost-effective at 1 times GDP per capita for treating HNC in India. The costs and benefits of using IMRT for other potential indications (e.g. prostate, lung) require to be assessed before considering its introduction in India.

Cost effectiveness of strategies for cervical cancer prevention in India.

The establishment of link between high-risk human papillomavirus (HPV) infection and occurrence of cervical cancer has resulted in development of various HPV related control strategies for the prevention of cervical cancer. The objective of the present study was to assess the cost effectiveness of various screening strategies for cervical cancer and human papilloma virus (HPV) vaccination in India. A Markov model based on societal perspective was designed to estimate the lifetime costs and consequences of screening (with either visual inspect with acetic acid (VIA), Papanicolaou test or HPV DNA test at various time intervals) in a hypothetical cohort of 30-65 years age women or vaccination among adolescent girls. Diagnostic accuracy of the screening strategies, efficacy of HPV vaccination and data on transition probabilities was based on the results of the existing meta-analyses. Primary data was collected for assessing per person cost of screening, cost of treating cervical cancer and quality of life. We found that introduction of different screening strategies leads to reduction in lifetime occurrence of cervical cancer cases caused by HPV 16/18 from 20% to 61%, and cervical cancer deaths from 28% to 70%, as compared to no screening. Among various screening strategies, screening with both VIA 5 yearly and VIA 10 yearly came out to be cost effective at 1-time per capita GDP, with VIA every 5 years providing greater health benefits as compared to VIA 10 years. Hence, screening with VIA 5 years at an incremental cost of US$ 829 (INR 54,881) per QALY gained is the recommended strategy for India. Further, with regards to HPV vaccination, it leads to 60% reduction in cancer cases and mortality caused by HPV 16/18 as compared to no vaccination. Moreover, when this vaccinated cohort of adolescent girls is also screened later in their life (with VIA every 10 years and VIA 5 years), it leads to 69%-76% reduction in cancer cases and 71%-81% reduction in cancer deaths. As compared to no vaccination and no screening, both HPV vaccination alone and vaccination plus screening (with VIA every 5 yearly and VIA 10 yearly) appears to be cost effective with ICERs in the range of US$ 86 (INR 5,693) to US$ 476 (INR 31,511) per QALY gained. In the long run, when the cohort of adolescent girls, who were immunized for HPV, reach the age of 30 years, the screening frequency using VIA should be determined based on the coverage of HPV vaccination in that cohort.

Health-related quality of life among cervical cancer patients in India.

INTRODUCTION: Estimation of health-related quality of life of cervical cancer patients in India is important in assessing the well-being of patients, monitor treatment outcomes, and conduct health technology assessments. However, health-related quality of life estimates for different stages of cervical cancer are not available for the Indian population. This study aims to generate stage-specific quality of life scores for cervical cancer patients in India. METHODS: A cross-sectional study using the EQ-5D (EuroQol 5-dimensions) instrument, that consists of the EQ-5D-5L descriptive system and the EuroQol Visual Analog Scale (EQ-VAS) was conducted. A total of 159 cervical cancer patients were interviewed. Mean EQ-5D-5L quality of life scores (utility scores) were calculated using the EQ-5D-5L index value calculator across different stages of cervical cancer. The proportion of patients reporting problems in different attributes of EQ-5D-5L was assessed. The impact of socio-economic determinants on health-related quality of life was evaluated using multiple linear regression. RESULTS: The mean EQ-5D-5L and EQ-VAS utility scores among patients of cervical cancer were 0.64 [95% CI=0.61-0.67] and 67.6 [95% CI=65.17-70.03], respectively. The most frequently reported problem among cervical cancer patients was pain/discomfort (61.88%), followed by difficulty in performing usual activities (53.81%), and anxiety/depression (41.26%). CONCLUSION: Cervical cancer significantly impacts the health-related quality of life of the patients in India. Clinical interventions should focus on the control of pain and relief of anxiety. The measurement of health-related quality of life should be an integral component of the effectiveness of interventions as well as health technology assessment.

Estimating the Unit Costs of Healthcare Service Delivery in India: Addressing Information Gaps for Price Setting and Health Technology Assessment.

BACKGROUND: India's flagship National Health insurance programme (AB-PMJAY) requires accurate cost information for evidence-based decision-making, strategic purchasing of health services and setting reimbursement rates. To address the challenge of limited health service cost data, this study used econometric methods to identify determinants of cost and estimate unit costs for each Indian state. METHODS: Using data from 81 facilities in six states, models were developed for inpatient and outpatient services at primary and secondary level public health facilities. A best-fit unit cost function was identified using guided stepwise regression and combined with data on health service infrastructure and utilisation to predict state-level unit costs. RESULTS: Health service utilisation had the greatest influence on unit cost, while number of beds, facility level and the state were also good predictors. For district hospitals, predicted cost per inpatient admission ranged from 1028 (313-3429) Indian Rupees (INR) to 4499 (1451-14,159) INR and cost per outpatient visit ranged from 91 (44-196) INR to 657 (339-1337) INR, across the states. For community healthcare centres and primary healthcare centres, cost per admission ranged from 412 (148-1151) INR to 3677 (1359-10,055) INR and cost per outpatient visit ranged from 96 (50-187) INR to 429 (217-844) INR. CONCLUSION: This is the first time cost estimates for inpatient admissions and outpatient visits for all states have been estimated using standardised data. The model demonstrates the usefulness of such an approach in the Indian context to help inform health technology assessment, budgeting and forecasting, as well as differential pricing, and could be applied to similar country contexts where cost data are limited.

Economic Burden of Head and Neck Cancer Treatment in North India

Background: The rising cost of cancer treatment has imposed a huge financial burden on the affected households, leading to catastrophic outcomes and impoverishment. The present study was designed to estimate the economic burden incurred by households for the treatment of head and neck cancer (HNC) in India. Methods: The present study was undertaken in a large public sector tertiary care hospital of North India. A total of 159 patients were recruited at time of their first registration in the department of Radiation Oncology, and were followed after completion of their treatment. Another 288 were recruited within one month after completion of treatment. Economic burden was assessed in terms of out of pocket (OOP) expenditure incurred, prevalence of catastrophic health expenditure and distress financing (borrowing or selling of assets) related to different modalities of cancer treatment. Results: The average OOP expenditure incurred by a patient of HNC patient was INR 37, 845 (USD 563), which varied from INR 32,379 (USD 482) when a patient undergoes radiotherapy alone to INR 67,480 (USD 1,004) for surgery along with chemo-radiotherapy. Specifically, patients undergoing 2-DRT and IMRT alone had to spend INR 31,487 (USD 469) and INR 42,405 (USD 631) respectively. The prevalence of catastrophic health expenditure (CHE) and distress financing (DF) was 34% and 45% respectively. The odds of incurring both CHE and DF were found to be higher for patients in the lowest income quartile and for those in the younger age groups. Conclusion: Cancer imposes significant economic burden on households. The existing public health system should be strengthened to reduce OOP expenditure incurred by patients. In addition, enhanced coverage of risk pooling mechanisms should be ensured.

Cost of treatment for head and neck cancer in India.

There are no published data on the cost of cancer treatment for guiding reimbursement decisions in India. The present study was designed to estimate the cost of treating head and neck cancer (HNC) with the aim of determining package rates. The present study was undertaken in the Departments of Radiotherapy and Otolaryngology of a large tertiary care hospital in North India. Economic health system costs incurred were assessed using a bottom-up methodology. Data on all resources-capital or recurrent, incurred on the delivery of HNC treatment were collected from April 2014 to March 2015. Following the cost-of-illness approach, patients were interviewed to elicit out-of-pocket (OOP) expenditure. A total of INR 40,993,017 (USD 0.67 million) was spent on radiotherapy care for treating HNC during 1 year. Salaries constituted the major component (42.6%) of this cost, followed by equipment/furniture (29%), space rent (20.7%), overheads and consumables (7.7%). In addition, INR 47,191 (USD 773) per HNC patient was spent on the surgery. Furthermore, patients spent an average amount ranging from INR 12,575 (USD 206) to INR 65,257 (USD 1069) on the different treatment therapies. In terms of package rates, cobalt radiotherapy alone was the cheapest (INR 38,714, USD 634), while intensity modulated radiotherapy (IMRT) was most expensive (INR 192,914, USD 3161). The estimates from the present study could be used for developing package rates under various publicly financed health insurance schemes as well as for the planning for creation of new cancer centres.