Strengthening the National Sickle Cell Elimination Mission through universal access to point-of-care screening test.

OBJECTIVE: The study aims to identify the most affordable point-of-care tests and their financial implications for the implementation of the universal screening of sickle cell disease in India. METHOD: This study is a rapid health technology assessment from Indian public health system's perspective using decision tree model for a hypothetical tribal population cohort of 0-40 years in six endemic states. Point-of-care (POC) tests (Hemotype Sc, Sickle Scan, Sickle CERT and Gazelle) were compared with the existing standard of care (SOC) - solubility test with confirmation using high-performance liquid chromatography, for universal screening and early detection of sickle cell disease/traits. The health system cost per case screened and detected were estimated along with budget impact for implementing the screening programs. RESULTS: The health system cost were higher for all the evaluated POC tests than SOC. The POC screening cost ranged from US$2.38 - US$3.85 per case and US$146.17 - US$230.73 per case detected, compared with US$0.67 and US$42.53 for SOC. However, POC test detected substantially more sickle cell disease cases, incrementally detecting 21,125-41,458 cases. Based on these findings, the National Health Mission directed states to publicly procure POC tests. The price negotiation resulting from the public tendering and competitive bidding resulted in-house manufacturing and validation of these kits lowering their prices substantially which enabled states procuring these POC tests at less than US$ 1.21 per test, potentially yielding US$37.86 million in savings with full coverage. CONCLUSION: The rapid HTA provided the state governments with evidence-based guidance to negotiate procurement prices for the POCs which facilitated efficient budget allocation to implement sickle cell screening strategy effectively.