Cost-effectiveness of population-based screening for microalbuminuria in people with type 2 diabetes mellitus in India.

OBJECTIVES: Patients with diabetes have a higher risk of developing chronic kidney disease (CKD). Early detection of CKD through microalbuminuria screening, followed by treatment, delays the progression of CKD. We evaluated the cost-effectiveness of population-based screening of microalbuminuria among normotensive type 2 diabetes mellitus patients aged >40 years compared with no screening scenario using a decision tree combined with the Markov model. METHODS: We considered two scenarios: Scenario I - dipstick microalbuminuria followed by spot-urine albumin-creatinine ratio (ACR) and serum creatinine in sequence; Scenario II - spot urine ACR plus serum creatinine. A mathematical cohort of the target population was simulated over a lifetime horizon with an annual cycle. Data for the model were obtained from secondary resources. The incremental cost-effectiveness ratios (ICERs) were estimated for screening scenarios compared to nonscreening scenario, along with sensitivity analyses. RESULTS: The discounted ICER per quality-adjusted life years gained for annual microalbuminuria screening in the normotensive diabetic population in India were ₹ 24,114 (US$ 308) and ₹ 13,790 (US$ 176) for scenarios I and II, respectively. Annual screening by scenarios I and II resulted in a reduction of 180 and 193 end-stage renal disease (ESRD) cases per 100,000 population, respectively, resulting in a cost saving of ₹ 12.3 and 13.3 Crore spent on ESRD management over 10 years. Both scenarios were also cost-effective even at the screening frequencies of 5 and 10 yearly. CONCLUSION: Microalbuminuria screening was cost-effective at the threshold of one-time GDP per capita in India.

Universal health coverage in India and health technology assessment: current status and the way forward.

In India, there is a renewed emphasis on Universal Health Coverage (UHC). Alongside this, Health Technology Assessment (HTA) is an important tool for advancing UHC. The development and application of HTA in India, including capacity building and establishing institutional mechanisms. We emphasized using the HTA approach within two components of the Ayushman Bharat programme, and the section concludes with lessons learned and the next steps. The UHC has increased the importance of selecting and implementing effective technologies and interventions within national health systems, particularly in the context of limited resources. To maximize the use of limited resources and produce reliable scientific assessments, developing and enhancing national capacity must be based on established best practices, information exchange between different sectors, and collaborative approaches. A more potent mechanism and capacity for HTA in India would accelerate the country's progress toward UHC.

Use of Portable Automated Auditory Brainstem Responses in Universal Neonatal Hearing Screening: A Mixed-Method Study in Odisha, India.

Hearing loss in children affects cognitive development, so early detection is crucial. It is because of the lack of portable technology that the majority of hearing problems go undetected. The authors conducted a mixed-method study in India to examine the concurrent validity and operational feasibility of portable automated brainstem response (P-AABR) and otoacoustic emissions (OAE) in universal neonatal hearing screening. They screened 198 children's ears using ABR and OAE devices. Additionally, 60 observations were recorded during the 'portable automated ABR' screening process. The hearing screening could be performed with P-AABR by any health care staff with basic skill-based training. However, the interpretation of the graphical wave required an audiologist. If the baby was quiet, the test could be performed in 20 min, including electrode implantation, impediment setting, earphone installation, and swipe counts. The P-AABR device can be used in the universal health coverage of hearing screening among infants in outreach areas due to its portability and minimal infrastructural requirements.

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 Effectiveness of Ribociclib and Palbociclib in the Second-Line Treatment of Hormone Receptor-Positive, HER2-Negative Metastatic Breast Cancer in Post-Menopausal Indian Women.

BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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.

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.

Stakeholders' Perspective for Improved Universal Newborn Hearing Screening Uptake in Odisha, India.

Universal Newborn Hearing Screening (UNHS) is a significant public health initiative as early diagnosis and intervention are critical for children's cognitive development. In India, priority for UNHS has been provided since 2013; however, there are various operational challenges associated with it. There is a lack of multi-stakeholders perspective on UNHS, which is crucial for improving the service intake. Therefore, this study attempted to understand the perspective of various stakeholders to explore the practices, processes and technologies used in the existing UNHS landscape in Odisha, India. The qualitative in-depth interviews were conducted among various stakeholders including 15 mothers, 5 service providers (audiologists), 10 districts and state-level programme managers. Data were analysed using content analysis approaches. Two major themes emerged were 'social-shaping of technology for UNHS' and 'mothers' understanding and experience on UNHS'. Employee retention, equipment limitations, facilities maintenance and little knowledge among mothers about hearing screening have been described as major operational challenges. The study revealed that to increase universal coverage 'screening technology should be socially shaped'. There seems to be a need for 'portable technology with ease to use and better diagnostic accuracy' for first-stage screening at various levels of healthcare facilities along with community literacy on UNHS.

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

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

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

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

Cost-Effectiveness Analysis and Decision Modelling: A Tutorial for Clinicians.

Cost-effectiveness analysis (CEA) provides information on how much extra do we need to spend per unit gain in health outcomes with introduction of any new healthcare intervention or treatment as compared to the alternative. This information is crucial to make decision regarding funding any new drug, diagnostic test or determining standard treatment protocol. It becomes even more important to consider this evidence in resource constrained low-income and middle-income country settings. Generating evidence on costs and consequences of a treatment or intervention could be performed in the setting of a randomized controlled trial, which is the perfect platform to evaluate efficacy or effectiveness. However, we argue that randomized controlled trial (RCT) offers an incomplete setting to generate comprehensive data on all costs and consequences for the purpose of a CEA. Hence, it is needed to use a decision model, either in combination with the evidence from RCT or alone. In this article, we demonstrate the application of decision model-based economic evaluation using 2 separate techniques - a decision tree and a Markov model. We argue that application of a decision model allows computation of health benefits in terms of utility-based measure such as a quality-adjusted life year or disability-adjusted life year which is preferred for a CEA, measure distal costs and consequences which are much more downstream to the application of intervention, allows comparison with multiple intervention and comparators, and provides opportunity of making use of evidence from multiple sources rather than a single RCT which may have limited generalizability. This makes the use of such evidence much more acceptable for clinical use and policy relevant.