Budgeting for a billion: applying health technology assessment (HTA) for universal health coverage in India.

BACKGROUND: India recently launched the largest universal health coverage scheme in the world to address the gaps in providing healthcare to its population. Health technology assessment (HTA) has been recognised as a tool for setting priorities as the government seeks to increase public health expenditure. This study aims to understand the current situation for healthcare decision-making in India and deliberate on the opportunities for introducing HTA in the country. METHODS: A paper-based questionnaire, adapted from a survey developed by the International Decision Support Initiative (iDSI), was administered on the second day of the Topic Selection Workshop that was conducted as part of the HTA Awareness Raising Workshop held in New Delhi on 25-27 July, 2016. Participants were invited to respond to questions covering the need, demand and supply for HTA in their context as well as the role of their organisation vis-à-vis HTA. The response rate for the survey was about 68% with 41 participants having completed the survey. RESULTS: Three quarters of the respondents (71%) stated that the government allocated healthcare resources on the basis of expert opinion. Most respondents indicated reimbursement of individual health technologies and designing a basic health benefit package (93% each) were important health policy areas while medical devices and screening programmes were cited as important technologies (98% and 92%, respectively). More than half of the respondents noted that relevant local data was either not available or was limited. Finally, technical capacity was seen as a strength and a constraint facing organisations. CONCLUSION: The findings from this study shed light on the current situation, the opportunities, including potential topics, and challenges in conducting HTA in India. There are limitations to the study and further studies may need to be conducted to inform the role that HTA will play in the design or implementation of universal health coverage in India.

Cost-effectiveness of emicizumab prophylaxis for haemophilia A with inhibitors: an adaptive health technology assessment for the Indian setting.

OBJECTIVE: To assess the cost-effectiveness of emicizumab prophylaxis for patients having haemophilia A with inhibitors in the Indian context using an adaptive health technology assessment (aHTA) methodology. DESIGN: Economic evaluation using multiple approaches aimed at adjusting previously generated cost-effectiveness results based on (1) price differences only ('simple') and (2) differences in cost and expected treatment duration ('moderate') and differences in cost, inflation and life expectancy ('complex'). SETTING: Typical haemophilia care in India. PARTICIPANTS: Patients with haemophilia A and inhibitors. INTERVENTION: Emicizumab prophylaxis using two vial strengths (30 or 150 mg/mL) in comparison to no prophylaxis. MAIN OUTCOME MEASURES: Adjusted incremental cost-effectiveness ratio (ICERa), incremental costs and incremental quality-adjusted life years associated with emicizumab prophylaxis from both the health system and societal perspectives. RESULTS: Using the simple ICER adjustment method, emicizumab prophylaxis resulted in potential cost savings from the payers' perspective for both vial strengths in patients aged ≥12 and <12 years. However, from a societal perspective, emicizumab prophylaxis was not cost-effective. Using the moderate adjustment method, emicizumab prophylaxis showed potential cost saving from the health system perspective. The complex adjustment method also revealed cost savings for emicizumab prophylaxis from the health system and societal perspectives across different age groups. CONCLUSION: We found that implementing emicizumab prophylaxis for patients with haemophilia A and inhibitors in India has the potential to result in cost savings. This study highlights the feasibility of using the expanded aHTA methodology for rapid evidence generation in the Indian context. However, it is crucial to address certain research gaps, including data limitations, challenges in translating international evidence to Indian context and associated uncertainties. Additionally, conducting a comprehensive budget impact analysis is necessary. These findings hold significant implications for decision-making regarding the potential provision of emicizumab prophylaxis through federal or/and state government-funded programmes and institutions in India.

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.

Health care cost accounting in the Indian hospital sector.

Setting reimbursement rates in national insurance schemes requires robust cost data. Collecting provider-generated cost accounting information is a potential mechanism for improving the cost evidence. To inform strategies for obtaining cost data to set reimbursement rates, this analysis aims to describe the role of cost accounting in public and private health sectors in India and describe the importance, perceived barriers and facilitators to improving cost accounting systems. In-depth interviews were conducted with 11 key informants. The interview tool guide was informed by a review of published and grey literature and government websites. The interviews were recorded as both audio and video and transcribed. A thematic coding framework was developed for the analysis. Multiple discussions were held to add, delete, classify or merge the themes. The themes identified were as follows: the status of cost accounting in the Indian hospital sector, legal and regulatory requirements for cost reporting, challenges to implementing cost accounting and recommendations for improving cost reporting by health care providers. The findings indicate that the sector lacks maturity in cost accounting due to a lack of understanding of its benefits, limited capacity and weak enforcement of cost reporting regulations. Providers recognize the value of cost analysis for investment decisions but have mixed opinions on the willingness to gather and report cost information, citing resource constraints and a lack of trust in payers. Additionally, heterogeneity among providers will require tailored approaches in developing cost accounting reporting frameworks and regulations. Health care cost accounting systems in India are rudimentary with a few exceptions, raising questions about how to source these data sustainably. Strengthening cost accounting systems in India will require standardized data formats, integrated into existing data management systems, that both meet the needs of policy makers and are acceptable to hospital providers.

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

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

Harnessing Health Technology Assessment in Latin America and the Caribbean: Keeping the Region on Course.

Latin America and the Caribbean has made significant progress toward universal health coverage (UHC), but health spending efficiency, equity, and sustainability remain major challenges-and progress is hindered by the difficult macroeconomic context. Health technology assessment (HTA) can make resource allocation more efficient and equitable when systematically used to inform coverage decisions. We highlight five considerations that need to be taken into account to realize the full potential of HTA in the LAC region: i) explicitly link HTA to decision-making and anchor it in legal frameworks, ii) systematically incorporate the opportunity cost as a core principle into HTA activities informing coverage decisions, iii) make the internationally available evidence more fit for purpose for low- and middle-income countries (LMICs), iv) incorporate pragmatism as a key principle of HTA activities in the region, and v) institutionalize the monitoring of HTA processes and results.

Cost-effectiveness of implementing risk-based cardiovascular disease (CVD) management using updated WHO CVD risk prediction charts in India.

INTRODUCTION: The World Health Organization (WHO) has released the updated cardiovascular disease (CVD) risk prediction charts in 2019 for each of the 21 Global Burden of Disease regions. The WHO advocates countries to implement population-based CVD risk assessment and management using these updated charts for preventing and controlling CVDs. OBJECTIVE: To assess the cost-effectiveness of implementing risk-based CVD management using updated WHO CVD risk prediction charts in India. METHODS: We developed a decision tree combined with Markov Model to simulate implementing two community-based CVD risk screening strategies (interventions) compared with the current no-screening scenario. In the first strategy, the whole population is initially screened using the WHO non-lab-based CVD risk assessment method, and those with ≥10% CVD risk are subjected to WHO lab-based CVD risk assessment (two-stage screening). In the second strategy, the whole population is subjected only to the lab-based CVD risk assessment (single-stage screening). A mathematical cohort of those aged ≥40 years with no history of CVD events was simulated over a lifetime horizon with three months of cycle length. Data for the model were derived from a primary study and secondary sources. Incremental cost-effectiveness ratios (ICERs) were determined for the screening strategies and sensitivity analyses. RESULTS: The discounted Incremental cost-effectiveness ratio per QALY gained for both the two-stage (US$ 105; ₹ 8,656) and single-stage (US$ 1073; ₹ 88,588) screening strategies were cost-effective at an implementation effect of 40% when compared with no screening scenario. Implementing CVD screening strategies are estimated to cause substantial reduction in the number of CVD events in the population compared to the no screening scenario. CONCLUSION: In India, both CVD screening strategies would be cost-effective, and implementing the two-staged screening would be more cost-effective. Our findings support implementing population-based CVD screening in India. Future studies shall assess the budget impact of these strategies at different implementation coverage levels.

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.

Organizational Formation for Priority Setting: Historical Perspectives and Thematic Analysis of India's Health Technology Assessment Agency.

Countries pursuing universal health coverage must set priorities to determine which benefits to add to a national health program, but the roles that organizations play are less understood. This article investigates the case of the formation of an organization with a mandate for choice of technology for public health interventions and priorities, the Health Technology Assessment India. First, we narrate a chronology of agenda setting and adoption of national policy for organizational formation drawing on historical documentation, publicly available literature, and lived experiences from coauthors. Next, we conduct a thematic analysis that examines windows of opportunity, enabling factors, barriers and conditions, roles of stakeholders, messaging and framing, and specific administrative and bureaucratic tools that facilitated organization formation. This case study shows that organizational formation relied on the identification of multiple champions with sufficient seniority and political authority across a wide group of organizations, forming a coalition of broad base support, who were keen to advance health technology assessment policy development and organizational placement or formation. The champions in turn could use their roles for policy decisions that used private and public events to raise priority and commitment to the decisions, carefully considered organizational placement and formation, and developed the network of organizations for the generation of technical evidence and capacity building for health technology assessment, strengthened by international networks and organizations with financing, expertise, and policymaker relationships.

International Partnerships to Develop Evidence-informed Priority Setting Institutions: Ten Years of Experience from the International Decision Support Initiative (iDSI).

All health systems must set priorities. Evidence-informed priority-setting (EIPS) is a specific form of systematic priority-setting which involves explicit consideration of evidence to determine the healthcare interventions to be provided. The international Decision Support Initiative (iDSI) was established in 2013 as a collaborative platform to catalyze faster progress on EIPS, particularly in low- and middle-income countries. This article summarizes the successes, challenges, and lessons learned from ten years of iDSI partnering with countries to develop EIPS institutions and processes. This is a thematic documentary analysis, structured by iDSI's theory of change, extracting successes, challenges, and lessons from three external evaluations and 19 internal reports to funders. We identified three phases of iDSI's work-inception (2013-15), scale-up (2016-2019), and focus on Africa (2019-2023). iDSI has established a global platform for coordinating EIPS, advanced the field, and supported regional networks in Asia and Africa. It has facilitated progress in securing high-level commitment to EIPS, strengthened EIPS institutions, and developed capacity for health technology assessments. This has resulted in improved decisions on service provision, procurement, and clinical care. Major lessons learned include the importance of sustained political will to develop EIPS; a clear EIPS mandate; inclusive governance structures appropriate to health financing context; politically sensitive and country-led support to EIPS, taking advantage of policy windows for EIPS reforms; regional networks for peer support and long-term sustainability; utilization of context appropriate methods such as adaptive HTA; and crucially, donor-funded global health initiatives supporting and integrating with national EIPS systems, not undermining them.

A new tool for evaluating health equity in academic journals; the Diversity Factor.

Current methods to evaluate a journal's impact rely on the downstream citation mapping used to generate the Impact Factor. This approach is a fragile metric prone to being skewed by outlier values and does not speak to a researcher's contribution to furthering health outcomes for all populations. Therefore, we propose the implementation of a Diversity Factor to fulfill this need and supplement the current metrics. It is composed of four key elements: dataset properties, author country, author gender and departmental affiliation. Due to the significance of each individual element, they should be assessed independently of each other as opposed to being combined into a simplified score to be optimized. Herein, we discuss the necessity of such metrics, provide a framework to build upon, evaluate the current landscape through the lens of each key element and publish the findings on a freely available website that enables further evaluation. The OpenAlex database was used to extract the metadata of all papers published from 2000 until August 2022, and Natural language processing was used to identify individual elements. Features were then displayed individually on a static dashboard developed using TableauPublic, which is available at www.equitablescience.com. In total, 130,721 papers were identified from 7,462 journals where significant underrepresentation of LMIC and Female authors was demonstrated. These findings are pervasive and show no positive correlation with the Journal's Impact Factor. The systematic collection of the Diversity Factor concept would allow for more detailed analysis, highlight gaps in knowledge, and reflect confidence in the translation of related research. Conversion of this metric to an active pipeline would account for the fact that how we define those most at risk will change over time and quantify responses to particular initiatives. Therefore, continuous measurement of outcomes across groups and those investigating those outcomes will never lose importance. Moving forward, we encourage further revision and improvement by diverse author groups in order to better refine this concept.

Role of healthcare cost accounting in pricing and reimbursement in low-income and middle-income countries: a scoping review.

OBJECTIVES: Progress towards universal health coverage (UHC) requires evidence-based policy including good quality cost data systems. Establishing these systems can be complex, resource-intensive and take time. This study synthesises evidence on the experiences of low-income and middle-income countries (LMICs) in the institutionalisation of cost data systems to derive lessons for the technical process of price-setting in the context of UHC. DESIGN: A scoping review and narrative synthesis of publicly available information. DATA SOURCES: PubMed, MEDLINE, EconLit, the Web of Science and grey literature searched from January 2000 to April 2021. ELIGIBILITY CRITERIA: English-language papers published since 2000 that identified and/or described development of and/or methods used to estimate or inform national tariffs for hospital reimbursement in LMICs. Papers were screened by two independent reviewers. DATA EXTRACTION AND SYNTHESIS: Extraction was performed by one reviewer and checked by the second reviewer on: the method and outputs of cost data collection; commentary on the use of cost data; description of the technical process of tariff setting; and strengths and challenges of the approach. Evidence was summarised using narrative review. RESULTS: Thirty of 484 papers identified were eligible. Fourteen papers reported on primary cost data collection; 18 papers explained how cost evidence informs tariff-setting. Experience was focused in Asia (n=22) with countries at different stages of developing cost systems. Experiences on cost accounting tend to showcase country costing experiences, methods and implementation. There is little documentation how data have been incorporated into decision making and price setting. Where cost information or cost systems have been used, there is improved transparency in decision making alongside increased efficiency. CONCLUSIONS: There are widely used and accepted methods for generating cost information. Countries need to build sustainable cost systems appropriate to their settings and budgets and adopt transparent processes and methodologies for translating costs into prices.

Ensuring quality in contextualised cancer management guidelines for resource-constraint settings: using a systematic approach.

To address the wide variation in access to cancer care in India requires strengthening of infrastructure, trained oncology workforce, and minimisation of out-of-pocket expenditures. However, even with major investments, it is unlikely to achieve the same level of infrastructure and expertise across the country. Therefore, a resource stratified approach driven by evidence-based and contextualised clinical guidelines is the need of the hour. The National Cancer Grid has been at the forefront of delivery of standardised cancer care through several of its initiatives, including the resource-stratified guidelines. Development of new guidelines is resource and time intensive, which may not be feasible and can delay the implementation. Adaptation of the existing standard guidelines using the transparent and well-documented methodology with involvement of all stakeholders can be one of the most reasonable pathways. However, the adaptation should be done keeping in mind the context, resource availability, budget impact, investment needed for implementation and acceptability by clinicians, patients, policymakers, and other stakeholders. The present paper provides the framework for systematically developing guidelines through adaptation and contextualisation. The process can be used for other health conditions in resource-constraint settings.

Increasing identification of foot at risk of complications in patients with diabetes: a quality improvement project in an urban primary health centre in India.

The majority of foot amputations are preventable in people with diabetes. Guidelines recommend that people with diabetes should receive a foot examination for risk assessment, at least annually. In an audit at a primary health centre (PHC) in Mumbai, India, no patient with diabetes was offered preventive foot assessment in preceding 12 months. Problem analysis identified a lack of clinic policy, training and equipment for foot assessment. There was no standardised referral pathway for patients identified with foot at risk of diabetes complications. Furthermore, limited data review, high patient volumes and little time available with healthcare providers were important constraints. A quality improvement project was carried out at the PHC from January to September 2017. The project aimed at increasing compliance to standardised foot assessment in patients with diabetes presenting to the PHC from a baseline of 0% to 100% over 6 months. This would help identify patients having a foot at risk of complications due to diabetes. The Quality Standard on foot assessment was adopted from the Ministry of Health and Family Welfare Diabetic Foot Guideline. The electronic medical record (EMR) was standardised, health providers were trained, PHC processes and referral pathways were redesigned. Plan-Do-Study-Act was used to address barriers with weekly data review. 88.2% (848) of patients with diabetes visiting the PHC during the study period received a foot examination. Out of these, 11% (95) were identified to have a foot at risk and referred to a specialist foot centre. 57% of referred patients followed with specialised foot protection services. Training of healthcare providers, standardisation of processes and regular data feedback can improve diabetic foot care. Integrating quality indicators in the EMR helps monitor compliance. The inability to use doctor's time efficiently was the biggest challenge and sustaining the change will require organisational changes with suitable task shifting.

Institutionalising health technology assessment: establishing the Medical Technology Assessment Board in India.

India is at crossroads with a commitment by the government to universal health coverage (UHC), driving efficiency and tackling waste across the public healthcare sector. Health technology assessment (HTA) is an important policy reform that can assist policy-makers to tackle inequities and inefficiencies by improving the way in which health resources are allocated towards cost-effective, appropriate and feasible interventions. The equitable and efficient distribution of health budget resources, as well as timely uptake of good value technologies, are critical to strengthen the Indian healthcare system. The government of India is set to establish a Medical Technology Assessment Board to evaluate existing and new health technologies in India, assist choices between comparable technologies for adoption by the healthcare system and improve the way in which priorities for health are set. This initiative aims to introduce a more transparent, inclusive, fair and evidence-based process by which decisions regarding the allocation of health resources are made in India towards the ultimate goal of UHC. In this analysis article, we report on plans and progress of the government of India for the institutionalisation of HTA in the country. Where India is home to one-sixth of the global population, improving the health services that the population receives will have a resounding impact not only for India but also for global health.