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.

Development and Economic Evaluation of a Patient-Centered Care Model for Children With Duchenne Muscular Dystrophy: Protocol for a Quasi-Experimental Study.

BACKGROUND: Duchenne muscular dystrophy (DMD) is a rare progressive muscular disease that primarily affects boys. A lack of comprehensive care for patients living with DMD is directly associated with a compromised quality of life (QoL) for those affected and their caregivers. This disease also has a huge economic impact on families as its treatment requires substantial direct, indirect, and informal care costs. OBJECTIVE: This study presents a protocol developed to evaluate the feasibility and efficacy of a patient-centered care (PCC) model for children with DMD. The care model was designed with the aim to empower families, improve QoL, and reduce economic burden on their families. METHODS: This study is planned as a quasi-experimental study that will enroll 70 consecutive families with boys (aged 5-15 years) with DMD visiting a tertiary care center. The study is being conducted in 2 phases (preintervention and postintervention phases, referred to as phase 1 and phase 2, respectively). During phase 1, the patients received routine care. The study is now in phase 2, with the intervention currently being administered. The intervention is based on the PCC model individualized by the intervention team. The model has a comprehensive DMD telecare component that includes teleconsultation as one of its key components to reduce in-person physician visits at the health facility. Teleconsultation is especially beneficial for late-ambulatory and nonambulatory patients. Data on economic burden are being collected for out-of-pocket expenses for both phases during in-person visits via telephone or messaging apps on a monthly basis. QoL data for patients and their primary caregivers are being collected at 3 time points (ie, time of enrollment, end of phase 1, and end of phase 2). Outcome measures are being assessed as changes in economic burden on families and changes in QoL scores. RESULTS: Participant recruitment began in July 2021. The study is ongoing and expected to be completed by March 2023. The findings based on baseline data are expected to be submitted for publication in 2023. CONCLUSIONS: This paper outlines a research proposal developed to study the impact of a PCC model for patients with DMD in low- and middle-income countries (LMICs). This study is expected to provide evidence of whether a multicomponent, patient-centric intervention could reduce economic burdens on families and improve their QoL. The results of this study could guide policy makers and health professionals in India and other LMICs to facilitate a comprehensive care program for patients living with DMD. The economic impact of a rare disease is an important consideration to formulate or evaluate any health policy or intervention related to new treatments and financial support schemes. TRIAL REGISTRATION: Clinical Trials Registry India (ICMR-NIMS) CTRI/2021/06/034274; https://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=56650. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/42491.

Cost of hospital services in India: a multi-site study to inform provider payment rates and Health Technology Assessment.

The 'Cost of Health Services in India (CHSI)' is the first large scale multi-site facility costing study to incorporate evidence from a national sample of both private and public sectors at different levels of the health system in India. This paper provides an overview of the extent of heterogeneity in costs caused by various supply-side factors.A total of 38 public (11 tertiary care and 27 secondary care) and 16 private hospitals were sampled from 11 states of India. From the sampled facilities, a total of 327 specialties were included, with 48, 79 and 200 specialties covered in tertiary, private and district hospitals respectively. A mixed methodology consisting of both bottom-up and top-down costing was used for data collection. Unit costs per service output were calculated at the cost centre level (outpatient, inpatient, operating theatre, and ICU) and compared across provider type and geographical location.The unadjusted cost per admission was highest for tertiary facilities (₹ 5690, 75 USD) followed by private facilities (₹ 4839, 64 USD) and district hospitals (₹ 3447, 45 USD). Differences in unit costs were found across types of providers, resulting from both variations in capacity utilisation, length of stay and the scale of activity. In addition, significant differences in costs were found associated with geographical location (city classification).The reliance on cost information from single sites or small samples ignores the issue of heterogeneity driven by both demand and supply-side factors. The CHSI cost data set provides a unique insight into cost variability across different types of providers in India. The present analysis shows that both geographical location and the scale of activity are important determinants for deriving the cost of a health service and should be accounted for in healthcare decision making from budgeting to economic evaluation and price-setting.

Cost of National Vector Borne Disease Control Programme in North India.

Background & objectives: Despite significant resources being spent on National Vector Borne Disease Control Programme (NVBDCP), there are meagre published data on health system cost upon its implementation. Hence, the present study estimated the annual and unit cost of different services delivered under NVBDCP in North India. Methodology: Economic cost of implementing NVBDCP was estimated based on data collected from three North Indian States, i.e. Punjab, Haryana and Himachal Pradesh. Multistage stratified random sampling was used for selecting health facilities across each level [i.e. subcentres (SCs), Primary Health Centres (PHCs), community health centres (CHCs) and district malaria office (DMO)] from the selected States. Data on annual consumption of both capital and recurrent resources were assessed from each of the selected facilities following bottom-up costing approach. Capital items (equipment, vehicles and furniture) were annualized over average life span using a discount rate of 3 per cent. The mean annual cost of implementation of NVBDCP was estimated for each level along with unit cost. Results: The mean annual cost of implementing NVBDCP at the level of SC, PHC and CHC and DMO was ₹ 230,420 (199,523-264,901), 686,962 (482,637-886,313), 1.2 million (0.9-1.5 million) and 9.1 million (4.6-13.5 million), respectively. Per capita cost for the provision of complete package of services under NVBDCP was ₹ 45 (37-54), 48 (29-73), 10 (6-14) and 47 (31-62) at the level of SC, PHC, CHC and DMO level, respectively. The per capita cost was higher in Himachal Pradesh (HP) at SC [₹ 69 (52-85)] and CHC [₹ 20.8 (20.7-20.8)] level and in Punjab at PHC level [₹ 89 (49-132)] as compared to other States. Interpretation & conclusions: The evidence on cost of NVBDCP can be used to undertake future economic evaluations which could serve as a basis for allocating resources efficiently, policy development as well as future planning for scale up of services.

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 of delivering primary healthcare services through public sector in India.

Background & objectives: Public health spending on primary healthcare has increased by four times (in real terms) over the last decade and continues to constitute more than half of the total public health expenditure. The present study estimated the cost of providing healthcare services at sub centre (SC) and primary health centre (PHC) level in four selected States of India. Methods: A total of 51 SCs and 33 PHCs were selected across the four States (Himachal Pradesh, Odisha, Kerala and Tamil Nadu) of India. The economic cost of delivering health services at these facilities was assessed using bottom-up costing methodology during the reference year of 2014-2015. The cost of capital items was annualized and allocation of shared resources was based on appropriate apportioning statistics. Results: The mean annual cost of providing health services at SC and PHC was ₹ 0.69 million (US$ 11,392) and ₹ 5.1 million (US$ 83,837), respectively. Nearly 3/4th and 2/3rd of this cost at the level of SC (74%) and PHC (63%) were spent on salaries. In terms of unit cost, the costs per antenatal care and postnatal care visit were ₹ 221 (173-276) and ₹ 333 (244-461), respectively, at SCs. Similarly, the costs of per patient outpatient consultation and per bed day hospitalization at PHC level were ₹ 121 (91-155) and ₹ 1168 (955-1468), respectively. Interpretation & conclusions: The cost estimates from the present study can be used in economic evaluations, assessing technical efficiency and also for providing valuable information during scale-up of health facilities.

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.

Adherence to country-specific guidelines among economic evaluations undertaken in three high-income and middle-income countries: a systematic review.

OBJECTIVE: To assess the adherence of economic evaluations to the recommendations on principles of economic evaluation as stated in the country-specific guidelines for three countries across different income groups, namely, Canada, South Africa, and Egypt. METHODS: Searches were undertaken in three databases to identify economic evaluations meeting predefined inclusion criteria. Methodological and reporting standards listed in the country-specific guidelines were converted into discrete binary variables to calculate mean adherence scores. Quality appraisal was done using Drummond's checklist. Stratified analysis was undertaken to identify independent variables affecting adherence. RESULTS: We identified forty-four, seventy-nine, and sixteen economic evaluations for Canada, South Africa, and Egypt, respectively. The mean adherence score was the highest for Canada (71%), followed by South Africa (65%) and Egypt (60%). Adherence to guidelines was positively correlated with quality of studies, r = .72. Furthermore, the mean adherence score was significantly (p < .05) higher for studies using a cost-utility analysis design (72%), having local/national funding aid (72%), undertaken by a health economist (71%) and for pharmacoeconomic evaluations (70%). CONCLUSION: The quality of economic evaluations improves with adherence to country-specific guidelines. Locally funded and health-economist led health technology assessments (HTAs) should be encouraged for greater adherence to the guidelines. The HTA researchers and the HTA bodies should lay emphasis on adherence to the country-specific guidelines for improving the quality of HTA evidence.

Cost effectiveness of typhoid vaccination in India.

INTRODUCTION: World Health Organization has prequalified the use of typhoid conjugate vaccine (TCV) in children over six months of age in typhoid endemic countries. We assessed the cost-effectiveness of introducing TCV separately for urban and rural areas of India. METHODS: A decision analytic model was developed, using a societal perspective, to compare long-term costs and outcomes (3% discount rate) in a new-born cohort of 100,000 children immunized with or without TCV. Three vaccination scenarios were modelled, assuming the protective efficacy of TCV to last for 5, 10 and 15 years following immunization. Incidence of typhoid infection estimated under 'National Surveillance System for Enteric Fever' (NSSEFI)' was used. The prices of vaccine and cost of service delivery were included for vaccination arm. Both health system cost and out-of-pocket expenditures for treatment of typhoid illness and its complications was included. RESULTS: TCV introduction in urban areas would result in prevention of 17% to 36% typhoid cases and deaths. With exclusion of indirect costs, the incremental cost per QALY gained was ₹ 151,346 (54,730-307,975), ₹ 61,710 (-5250 to 163,283) and ₹ 45,188 (-17,069 to 141,093) for scenario 1, 2 and 3 respectively. While, with inclusion of indirect costs, all 3 scenarios were cost saving. Further, in rural areas, TCV is estimated to reduce the typhoid cases and deaths by 19% to 36%, with ICER (incremental cost per QALY gained) ranging from ₹ 2340 (1316-4370) to ₹ 3574 (2057 - 6691) thousand (inclusive of indirect costs) among the 3 vaccination scenarios. CONCLUSION: From a societal perspective, introduction of TCV is a cost saving strategy in urban India. Further, due to low incidence of typhoid infection, introduction of TCV is not cost-effective in rural settings 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 scaling-up comprehensive primary health care in India: Implications for universal health coverage.

India has announced the ambitious program to transform the current primary healthcare facilities to health and wellness centres (HWCs) for provision of comprehensive primary health care (CPHC). We undertook this study to assess the cost of this scale-up to inform decisions on budgetary allocation, as well as to set the norms for capitation-based payments. The scale-up cost was assessed from both a financial and an economic perspective. Primary data on resources used to provide services in 93 sub-health centres (SHCs) and 38 primary health care centres (PHCs) were obtained from the National Health System Cost Database. The cost of additional infrastructure and human resources was assessed against the normative guidelines of Indian Public Health Standards and the HWC. The cost of other inputs (drugs, consumables, etc.) was determined by undertaking the need estimation based on disease burden or programme guidelines, standard treatment guidelines and extent and pattern of care utilization from nationally representative sample surveys. The financial cost is reported in terms of the annual incremental cost at health facility level, as well as its implications at national level, given the planned scale-up path. Secondly, economic cost is assessed as the total annual as well as annual per capita cost of services at HWC level. Bootstrapping technique was undertaken to estimate 95% confidence intervals for cost estimations. Scaling to CPHC through HWC would require an additional ₹ 721 509 (US$10 178) million allocation of funds for primary healthcare >5 years from 2019 to 2023. The scale-up would imply an addition to Government of India's health budget of 2.5% in 2019 to 12.1% in 2023. Our findings suggest a scale-up cost of 0.15% of gross domestic product (GDP) for full provision of CPHC which compares with current public health spending of 1.28% of GDP and a commitment of 2.5% of GDP by 2025 in the National Health Policy. If a capitation-based payment system was used to pay providers, provision of CPHC would need to be paid at between ₹ 333 (US$4.70) and ₹ 253 (US$3.57) per person covered for SHC and PHC, respectively.

Cost of Illness Due to Severe Enteric Fever in India.

BACKGROUND: Lack of robust data on economic burden due to enteric fever in India has made decision making on typhoid vaccination a challenge. Surveillance for Enteric Fever network was established to address gaps in typhoid disease and economic burden. METHODS: Patients hospitalized with blood culture-confirmed enteric fever and nontraumatic ileal perforation were identified at 14 hospitals. These sites represent urban referral hospitals (tier 3) and smaller hospitals in urban slums, remote rural, and tribal settings (tier 2). Cost of illness and productivity loss data from onset to 28 days after discharge from hospital were collected using a structured questionnaire. The direct and indirect costs of an illness episode were analyzed by type of setting. RESULTS: In total, 274 patients from tier 2 surveillance, 891 patients from tier 3 surveillance, and 110 ileal perforation patients provided the cost of illness data. The mean direct cost of severe enteric fever was US$119.1 (95% confidence interval [CI], US$85.8-152.4) in tier 2 and US$405.7 (95% CI, 366.9-444.4) in tier 3; 16.9% of patients in tier 3 experienced catastrophic expenditure. CONCLUSIONS: The cost of treating enteric fever is considerable and likely to increase with emerging antimicrobial resistance. Equitable preventive strategies are urgently needed.

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 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 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.

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

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

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.