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We aim to develop a comprehensive checklist for evaluating Health Technology Assessment (HTA) studies commissioned in India. The primary objective of this work is to capture all vital aspects of an HTA study in terms of conduct, reporting and quality.The development of a quality appraisal checklist included 3 steps. First, a targeted review of the literature was done to gather information on existing HTA checklists. After reviewing these checklists, an initial draft of the HTA quality appraisal checklist (HTA-QAC) for India was prepared with discussion amongst the authors. Second, the draft checklist was reviewed by the members of the Technical Appraisal Committee (TAC) and their feedback was incorporated. Subsequently, the revised checklist was presented at a virtual meeting of the TAC. Finally, a pilot phase was undertaken to apply HTA-QAC for the approved HTA study reports. Three rounds of virtual discussions were held with the researchers who were involved in the conduct of these HTA studies to resolve any discordance in opinion or develop solutions for the problems in the use of the HTA-QAC followed by a further revision of the checklist.The HTA-QAC is divided into two parts: a self-reporting section to be completed by the author, and the other to be completed by the reviewer. The reviewer checklist has two sections: one to review the report and the other to review the model. The author section is in a self-reporting format, which includes details of basic study information, the rationale for the study, policy relevance, study description, study methods, reporting of model parameters, and results. The reviewer section of the checklist focuses on the quality aspect of the conducted study. The domains included in the report review include details on study methodology, results, discussion, and conclusion. The second part of the reviewer section of HTA-QAC constitutes a review of the model in terms of model assumptions, functionality, model inputs, calculations, uncertainty analysis, model output, and model validation.We recommend a standardised process of quality appraisal to ensure the high quality of HTA evidence for policy use in the Indian context. The proposed HTA-QAC will help authors to ensure standardised reporting, as well as allow reviewers to assess the quality of analysis.

Objective Our paper aims to present Budget Impact Analysis (BIA) guidelines for health technology assessment (HTA) in India. Methodology A Systematic Literature Review (SLR) was conducted to retrieve information on existing BIA guidelines internationally. The initial set of principles for India were put together based on an interactive process between authors, taking into consideration the existing evidence on BIA and features of Indian healthcare system. These were reviewed by Technical Appraisal Committee (TAC) of Health Technology Assessment in India (HTAIn) for their inputs. Three rounds of consultations were held before finalising the guidelines. Finally, user feedback on the draft guidelines was obtained from the policy makers and programme managers involved in the budgeting decisions. Results We recommend a payer’s perspective, which will include both a multi-payer (depicting the current situation in India) and a single-payer scenario (which reflects a futuristic universal health care situation). A time horizon of 1–4 years is recommended. For estimation of eligible population, a top-down approach is considered appropriate. The future and current mix of interventions should be analysed for different utilisation and coverage patterns. We do not recommend discounting; however, inflation adjustments should be performed. The presentation of results should include total and disaggregated results, segregated year-wise throughout the chosen time horizon, as well as segregated by the type of resources. Deterministic sensitivity analysis and scenario analysis are recommended to address uncertainty. Conclusion Our recommendations, which are tailored for the Indian healthcare and financing context, aim to promote consistency and transparency in the conduct as well as reporting of the BIA. BIA should be used along with evidence from economic evaluation for decision making, and not as a substitute to evidence on value for money.

The objective of this systematic review was to review the recommendations for the conduct of a budget impact analysis in national or organisational guidelines globally. We searched several databases including MELDINE, EMBASE, The Cochrane Library, National Guideline Clearinghouse, HTA Database (International Network of Agencies for Health Technology Assessment), Econlit and IDEAS Database (RePEc, Research Papers in Economics). The OVID platform was used to run the search in all databases simultaneously. In addition, a search of the grey literature was also conducted. The timeframe was set from 2000 to 2020 with language of publication restricted to English. A total of 13 publications were selected. All the countries where financing of health is predominantly tax funded with public provisioning recommend a healthcare payer (government) perspective. However, countries where a healthcare payer includes a mix of federal government, communities, hospital authorities and patient communities recommend a complementary analysis with a wider societal perspective. While four guidelines prefer a simple cost calculator for costing, the rest rely on a decision modelling approach. None of the guidelines recommend discounting except the Polish guidelines, which recommend discounting at 5%. Only two countries, Belgium and Poland, mention that indirect costs, if significant, should be included in addition to direct costs. The comparative cross-country analysis shows that a standard set of recommendations cannot be directly useful for all as there are contextual differences. Thus, budget impact analysis guidelines must be carefully contextualised in the policy environment of a country so as to reflect the dynamics of health systems.