National Methodological Guidelines to Conduct Budget Impact Analysis for Health Technology Assessment in India.

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.