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

Abstract

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. 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. 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. 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.