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Background: The inflammatory state that characterizes COVID-19 may contribute to depression, anxiety, other morbidities, and mortality. Interleukin-6 blocker tocilizumab has been used as a treatment modality in COVID-19 as an anti-inflammatory agent. Tocilizumab has also been studied for its potential use in preventing depression in other patient groups, with mixed results. This study was designed to study subsequent depression, anxiety, and quality of life (QOL) in patients treated with tocilizumab plus standard care versus standard care alone, for moderate to severe COVID-19 pneumonia. Methods: Patients admitted with moderate to severe COVID pneumonia, treated with tocilizumab plus standard treatment, and discharged from the hospital were identified. Age- and gender-matched controls who had received standard treatment alone for COVID-19 pneumonia during the same time frame were identified. After obtaining consent, these patients were followed up and assessed at 3 and 6 months on measures of depression (PHQ-9), anxiety (GAD-7), and QOL (EQ-5D-5L). Results: 39 patients in the tocilizumab group and 41 in the control group were followed up at 3 and 6 months. Patients in both groups were comparable in sociodemographic and clinical parameters. The prevalence of clinically significant depression in the tocilizumab group at 3 and 6 months was 33.33% and 5.12%, respectively, whereas in control group it was 31.7% and 4.87%, respectively. Analysis of EQ-5D health profiles revealed that the maximum problems were reported in the dimension of mobility: 43.7% at 3 months and 35% at 6 months. Conclusions: Depressive and anxiety symptoms and impairment in QOL were reported more frequently and with greater severity in patients in the tocilizumab group at three months but not at six months. Psychological morbidity and impairment in QOL were modest and improved from 3 to 6 months.

Summary 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.

Dimple Butani,1 Nidhi Gupta,2 Gaurav Jyani,1 Pankaj Bahuguna,1 Rakesh Kapoor,3 Shankar Prinja1 1Department of Community Medicine and School of Public Health, Postgraduate Institute of Medical Education and Research, Chandigarh, India; 2Department of Radiation Oncology, Government Medical College and Hospital, Chandigarh, India; 3Department of Radiation Oncology, Postgraduate Institute of Medical Education and Research, Chandigarh, IndiaCorrespondence: Shankar PrinjaDepartment of Community Medicine and School of Public Health, Postgraduate Institute of Medical Education and Research, Chandigarh, IndiaTel +91 9872871978Email shankarprinja@gmail.comBackground: Breast cancer is the leading cause of cancer among women in India. Treatment with hormone therapy reduces recurrence. We undertook this cost-effectiveness study to ascertain the treatment option offering the best value for money.Methods: The lifetime costs and health outcomes of using tamoxifen, AI and switch therapy were measured in a cohort of 50-year-old women with HR-positive early stage breast cancer. A Markov model of disease was developed using a societal perspective with a lifetime study horizon. Local, contralateral, and distant recurrence were modelled along with treatment related adverse effects. Primary data collected to obtain estimates of out-of-pocket expenditure (OOPE) and utility weights. Both health system cost and OOPE were included. The future costs and consequences were discounted at 3%. A probabilistic sensitivity analysis was used.Results: The lifetime cost of hormone therapy with tamoxifen, AI and switch therapy was to be ₹1,472,037 (I$ 68,947), ₹1,306,794 (I$ 61,208) and ₹1,281,811 (I$ 60,038). The QALYs lived per patient receiving tamoxifen, AI and switch were 13.12, 13.42 and 13.32. tamoxifen was found to be more expensive and less effective. As compared to switch therapy, AI for five years incurred an incremental cost of ₹259,792 (I$12,168) per QALY gained. At the willingness to pay equals to per capita GDP of India, there is 55% probability of AI therapy to be cost-effective compared to switch therapy.Conclusion: In postmenopausal women with HR-positive early-stage breast cancer, switch therapy is recommended for use on the basis of cost-effectiveness.Keywords: cost-effectiveness, aromatase inhibitor, tamoxifen, endocrine therapy, breast cancer

Objectives This study aims to assess the impact of raising the price of sugar and/or sugar-sweetened beverages (SSBs) on caries incidence in the Indian population. Methods A tooth-level decision-analytic model was developed to evaluate a change in caries increment after increasing the price of Sugar and SSBs. The transition of a tooth from a caries-free state to the state of tooth loss in both scenarios was modelled with the help of a Markov model for a time horizon of 63 years, ranging from 2021 to 2083 for the 12-year-old population cohort of India. A conceptual framework was designed to implicate the possible effects of an increase in sugar prices on the reduction of caries incidence. Health effects were estimated in terms of the number of carious lesions and tooth-loss in both the scenarios and modelled as a product of the dose-response relationship between sugar intake and caries incidence. The model was thus used to establish the number of caries lesions prevented, and tooth-loss avoided. Uncertainties in the parameters were assessed using probabilistic sensitivity analysis. The Monte Carlo method was used for simulating the results 1000 times. Results A 20% rise in the price of sugar is expected to result in the prevention of an average of 1.32 teeth in a lifetime of an individual and prevent 27.96 million tooth-loss incidents among the population cohort of India that will eventually lead to a saving of INR (₹) 3116.32 billion (US$ 42.69 billion) on account of dental caries treatment. Similarly, increasing-price of SSBs by 20% will lead to a 0.86% reduction in carious teeth incidence in an individual's lifetime. Conclusion Increasing the cost of sugar and/or SSBs will reduce the daily intake of sugar, which will reduce caries incidence and subsequent progression, thereby preventing caries-attributed tooth-loss and saving treatment costs.

Background The increasing burden of kidney failure (KF) in India necessitates provision of cost-effective kidney replacement therapy (KRT). We assessed the comparative cost-effectiveness of initiating KRT with peritoneal dialysis (PD) or haemodialysis (HD) in the Indian context. Methods The cost and clinical effectiveness of starting KRT with either PD or HD were measured in terms of life years (LYs) and quality-adjusted life years (QALYs) using a mathematical Markov model. Complications such as peritonitis, vascular access–related complications and blood-borne infections were considered. Health system costs, out-of-pocket expenditures borne by patients and indirect costs were included. Two scenarios were considered: Scenario 1 (real-world scenario)—as per the current cost and utilization patterns; Scenario 2 (public programme scenario)—use in the public sector as per Pradhan Mantri National Dialysis Programme (PMNDP) guidelines. The lifetime costs and health outcomes among KF patients were assessed. Results The mean QALYs lived per KF person with PD and HD were estimated to be 3.3 and 1.6, respectively. From a societal perspective, a PD-first policy is cost-saving as compared with an HD-first policy in both Scenarios 1 and 2. If only the costs directly attributable to patient care (direct costs) are considered, the PD-first treatment policy is estimated to be cost-effective only if the price of PD consumables can be brought down to INR70/U. Conclusions PD as initial treatment is a cost-saving option for management of KF in India as compared with HD first. The government should negotiate the price of PD consumables under the PMNDP.

Heterogeneity in methods of economic evaluation makes the use of health technology assessment (HTA) evidence difficult. Thereby, several countries including India have developed their own standard guidelines for conducting HTAs. However, diverse HTA studies involving drugs, medical devices, health programs, and platforms require an adaptation of the standard methods.This review presents the specific characteristics of HTAs involving medical devices and health programs requiring adaptation of the standard guidelines. We use recent HTA studies in India to illustrate specific issues. These considerations involve the nature of decision-making problems, multiple scenarios in case of health programs, and specific attention to costing and the valuation of consequences. In case of medical devices, we discuss the issue of costing application of devices, multiple usage, learning curve for achieving effects, long causal path for health outcomes, and the issue of valuing false positives.While standard guidelines are essential, specific features of health programs and medical devices need to be considered while undertaking HTAs. Additionally, the context in which the HTA is being undertaken, characteristics of the health system, methods of financing healthcare, and demand-side characteristics of healthcare utilization should be reflected in the HTA for health programs and medical devices.

In this study, we evaluate the cost and outcomes of cyclin-dependent kinase 4/6 inhibitors (CDK4/6i) plus fulvestrant, fulvestrant alone, and conventional chemotherapy as the second-line therapy for hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer (MBC) in India.Using a Markov model, the clinical effectiveness of managing HR+, HER2- MBC in postmenopausal women with either a CDK4/6i (either ribociclib or palbociclib) and fulvestrant, fulvestrant alone, and chemotherapy (single-agent paclitaxel or capecitabine) was measured in terms of quality-adjusted life-years (QALYs). The costs were estimated from two different points of view: scenario I, as per the prevailing market prices of the drugs; and scenario II, as per the reimbursement rates set up by the publicly financed national health insurance scheme. Incremental cost per QALY gained with a given treatment option was compared against the next best alternative and was assessed for cost effectiveness using a threshold of 1-time the per capita gross domestic product (GDP) in India from a societal perspective.In scenario I, an MBC patient was found to incur a lifetime cost of Indian Rupees (₹) 2.54 million ($34,644), ₹2.53 million ($34,496), ₹512,598 ($6,984), ₹326,026 ($4,442) and ₹237,115 ($3,230) for the ribociclib and palbociclib combination arms, fulvestrant monotherapy, single-agent paclitaxel and the single-agent capecitabine treatment arms, respectively. The lifetime cost for CDK4/6i (ribociclib and palbociclib) combination therapy, fulvestrant monotherapy, paclitaxel, and capecitabine arms was estimated to be ₹1.94 million ($26,459), ₹1.92 million ($26,220), ₹315,387 ($4,296), ₹187,392 ($2,553) and ₹153,263 ($2,088), respectively, in scenario II. The mean QALYs lived per MBC patient with CDK4/6i (either ribociclib or palbociclib) combination therapy, fulvestrant, paclitaxel and capecitabine were estimated to be 1.4, 1.0, 0.9 and 0.7, respectively. None of the treatment arms are cost effective at current prices and reimbursement rates at a threshold of 1-time the per capita GDP of India. However, a 78% reduction in the current market price or a 72% reduction in the reimbursement rate of fulvestrant in the government-funded insurance program will make it a cost-effective treatment option for HR+, HER2- MBC patients in India.CDK4/6i (ribociclib and palbociclib) therapy is not a cost-effective treatment option for MBC patients. A 72% reduction in the reimbursement rate for fulvestrant monotherapy will make it a cost-effective treatment option in the Indian context.

IntroductionTo ensure that the evidence generated by health technology assessment (HTA) is translated to policy, it is important to generate a threshold value against which the outcomes of HTA studies can be compared. In this context, the present study delineates the methods that will be deployed to estimate such a value for India.Methods and analysisThe proposed study will deploy a multistage sampling approach considering economic and health status for selection of states, followed by selection of districts based on Multidimensional Poverty Index (MPI) and identification of primary sampling units (PSUs) using the 30-cluster approach. Further, households within PSU will be identified using systematic random sampling and block randomisation based on gender will be done to select respondent from the household. A total of 5410 respondents will be interviewed for the study. The interview schedule will comprise of three sections including background questionnaire to elicit socioeconomic and demographic characteristics, followed by assessment of health gains, and willingness to pay (WTP). To assess the health gains and corresponding WTP, the respondent will be presented with hypothetical health states. Using time trade off method, the respondent will indicate the amount of time he/she is willing to give up at the end of life to avoid morbidities in the hypothetical health condition. Further, respondents will be interviewed about their WTP for treatment of respective hypothetical conditions using contingent valuation technique. These estimates of health gains and corresponding WTP will then be combined to ascertain the value of WTP per quality-adjusted life year.Ethics and disseminationThe ethical approval has been obtained from the Institutional Ethics Committee (IEC) of Postgraduate Institute of Medical Education and Research, Chandigarh, India. The study outcomes will be made available for general use and interpretation of HTA studies commissioned by India’s central HTA Agency.

Background The health and economic consequences of alcohol consumption have been assessed mainly in developed countries. This study aims to estimate health impact and economic burden attributable to alcohol use in India. Methods A combination of decision tree and mathematical markov model was parameterized to assess the health effects and economic cost attributable to alcohol consumption. Health effect of alcohol was modelled for a time period of 2011 to 2050 on three sets of conditions – liver disease, cancers and road traffic accidents. Estimates of illness, death, life years lost and quality adjusted life years (QALYs) gained were estimated as a result of alcohol consumption. Both direct and indirect costs were estimated to determine economic burden. Future costs and consequences were discounted at 3% for time preferences of cost and utility. Uncertainties in parameters were assessed using probabilistic sensitivity analysis. Results Between 2011 and 2050, alcohol attributable deaths would lead to a loss of 258 million life years. In contrast, 552 million QALYs would be gained by eliminating alcohol consumption. Treatment of these conditions will impose an economic burden of INR 3127 billion (US$ 48.11 billion) on the health system. Societal burden of alcohol, inclusive of health system cost, out of pocket expenditure and productivity losses will be INR 121,364 billion (US$ 1867 billion). Even after adjusting for tax receipts from sale of alcohol, alcohol poses a net economic loss of INR 97,895 billion (US$ 1506 billion). This amounts to an average loss of 1.45% of the gross domestic product (GDP) per year to the Indian economy. Conclusion Alcohol causes significant negative health impact and economic burden on Indian society and evidence informed policy interventions are needed to control alcohol attributable harm.

This study aimed to develop the Indian 5-level version EQ-5D (EQ-5D-5L) value set, which is a key input in health technology assessment for resource allocation in healthcare.A cross-sectional survey using the EuroQol Group's Valuation Technology was undertaken in a representative sample of 3548 adult respondents, selected from 5 different states of India using a multistage stratified random sampling technique. The participants were interviewed using a computer-assisted personal interviewing technique. This study adopted a novel extended EuroQol Group's Valuation Technology design that included 18 blocks of 10 composite time trade-off (c-TTO) tasks, comprising 150 unique health states, and 36 blocks of 7 discrete choice experiment (DCE) tasks, comprising 252 DCE pairs. Different models were explored for their predictive performance. Hybrid modeling approach using both c-TTO and DCE data was used to estimate the value set.A total of 2409 interviews were included in the analysis. The hybrid heteroscedastic model with censoring at -1 combining c-TTO and DCE data yielded the most consistent results and was used for the generation of the value set. The predicted values for all 3125 health states ranged from -0.923 to 1. The preference values were most affected by the pain/discomfort dimension.This is the largest EQ-5D-5L valuation study conducted so far in the world. The Indian EQ-5D-5L value set will promote the effective conduct of health technology assessment studies in India, thereby generating credible evidence for efficient resource use in healthcare.

IntroductionEstimation 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.MethodsA 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.ResultsThe 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%).ConclusionCervical 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.

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.

BACKGROUND Introduction of human papillomavirus (HPV) vaccination for adolescent girls is being considered in the Punjab state of India. However, evidence regarding cost-effectiveness is sought by policy makers when making this decision. The current study was undertaken to evaluate the incremental cost per quality-adjusted life-years (QALYs) gained with introduction of the HPV vaccine compared with a no-vaccination scenario. METHODS A static progression model, using a combination of decision tree and Markov models, was populated using epidemiological, cost, coverage, and effectiveness data to determine the cost-effectiveness of HPV vaccination. Using a societal perspective, lifetime costs and consequences (in terms of QALYs) among a cohort of 11-year-old adolescent girls in Punjab state were modeled in 2 alternate scenarios with and without vaccination. All costs and consequences were discounted at a rate of 3%. RESULTS Although immunizing 1 year's cohort of 11-year-old girls in Punjab state costs Indian National Rupees (INR) 135 million (US dollars [USD] 2.08 million and International dollars [Int$] 6.25 million) on an absolute basis, its net cost after accounting for treatment savings is INR 38 million (USD 0.58 million and Int$ 1.76 million). Incremental cost per QALY gained for HPV vaccination was found to be INR 73 (USD 1.12 and Int$ 3.38). Given all the data uncertainties, there is a 90% probability for the vaccination strategy to be cost-effective in Punjab state at a willingness-to-pay threshold of INR 10,000, which is less than one-tenth of the per capita gross domestic product. CONCLUSIONS HPV vaccination appears to be a very cost-effective strategy for Punjab state, and is likely to be cost-effective for other Indian states. Cancer 2017;123:3253-60. © 2017 American Cancer Society.

Recent innovations in treatment of multiple myeloma include autologous stem cell transplantation (ASCT) along with high dose chemotherapy (HDC). We undertook this study to estimate incremental cost per quality adjusted life year gained (QALY) with use of ASCT along with HDC as compared to conventional chemotherapy (CC) alone in treatment of multiple myeloma. A combination of decision tree and markov model was used to undertake the analysis. Incremental costs and effects of ASCT were compared against the baseline scenario of CC (based on Melphalan and Prednisolone regimen) in the patients of multiple myeloma. A lifetime study horizon was used and future costs and consequences were discounted at 5%. Consequences were valued in terms of QALYs. Incremental cost per QALY gained using ASCT as against CC for treatment of multiple myeloma was estimated using both a health system and societal perspective. The cost of providing ASCT (with HDC) for multiple myeloma patients was INR 500,631, while the cost of CC alone was INR 159,775. In the long run, cost per patient per year for ASCT and CC arms was estimated to be INR 119,740 and INR 111,565 respectively. The number of QALYs lived per patient in case of ASCT and HDC alone were found to be 4.1 and 3.5 years respectively. From a societal perspective, ASCT was found to incur an incremental cost of INR 334,433 per QALY gained. If the ASCT is initiated early to patients, the incremental cost for ASCT was found to be INR 180,434 per QALY gained. With current mix of patients, stem cell treatment for multiple myeloma is not cost effective at a threshold of GDP per capita. It becomes marginally cost-effective at 3-times the GDP per capita threshold. However, accounting for the model uncertainties, the probability of ASCT to be cost effective is 59%. Cost effectiveness of ASCT can be improved with early detection and initiation of treatment.

Hematopoietic stem cell transplantation (HSCT) is the only cure for thalassemia major (TM), which inflicts a significant 1-time cost. Hence, it is important to explore the cost effectiveness of HSCT versus lifelong regular transfusion-chelation (TC) therapy. This study was undertaken to estimate incremental cost per quality-adjusted life-year (QALY) gained with the intervention group HSCT, and the comparator group TC, in TM patients. A combination of decision tree and Markov model was used for analysis. A hospital database, supplemented with a review of published literature, was used to derive input parameters for the model. A lifetime study horizon was used and future costs and consequences were discounted at 3%. Results are presented using societal perspective. Incremental cost per QALY gained with use of HSCT as compared with TC was Image 1764,096 (US$986) in case of matched related donor (MRD) and Image 181,67,657 (US$2579) in case of a matched unrelated donor transplantation. The probability of MRD transplant to be cost effective at the willingness to pay threshold of Indian per capita gross domestic product is 94%. HSCT is a long-term value for money intervention that is highly cost effective and its long-term clinical and economic benefits outweigh those of TC.