Background: Congenital hypothyroidism (CH) is one of the most common preventable causes of mental retardation. Implementing newborn screening (NBS) in >52 countries enabled early detection and to initiate treatment of neonates with CH. India is yet to implement a national NBS program even though an estimated 5-15% of sick newborns suffer from genetic and metabolic disorders. Recent pilot studies confirm that the CH incidence rates range from 1 in 500 to 1 in 3,400 live births. Our objective was to estimate overall incidence rates of congenital hypothyroidism and to evaluate the costs and benefits of implementing universal NBS for CH in India.
Methods: We used the best available epidemiological and cost data to synthesize incidence rates and screening costs for CH in India. We conducted a meta-analysis of country-specific published literature and included 14 studies to calculate baseline CH incidence rates. We used two models to estimate intellectual disability in unscreened cohorts. Disability-adjusted life years (DALY) were calculated to quantify burden of disease utilizing disability weights. Direct costs including screening, confirmatory tests, and treatment costs were obtained from public and private market sources. Economic benefits were calculated from lost DALY using human capital approach and value of statistical life methods, utilizing gross national income (GNI) per capita data and value of statistical life year (VSLY), respectively. Cost discounting was used to estimate the present value of future benefits over lifetime of affected newborns.
Results: The incidence rate of CH in India is 72 (95% CI: 58, 85) cases per 100,000 live births. Based on this data, 1 in 1,388 (95% CI: 1166, 1714) infants were diagnosed with CH in India for the year 2018. The estimated annual incidence ranged from 14,000 to 20,730 cases, and those at risk for intellectual disability ranged from 5,397 to 13,929 cases. Estimated discounted and undiscounted lost DALYs were 57,640 and 410,000, respectively. Direct annual costs for universal screening for CH in India is around USD187 million. Based on current incidence and expected severity of sequelae, economic losses ranged from USD 159 million to 1.1 billion. Benefit-cost ratios ranged from 1.8 to 6.
Conclusions: Universal NBS for CH is one of the healthcare interventions that is beneficial to prevent morbidity and cost saving. The cumulative economic benefits, derived from prevention of intellectual disability, assuming cost effectiveness threshold of three times of gross domestic product per capita, far outweigh the direct and indirect costs of screening, treatment, and surveillance throughout the life of the affected individuals. Our analysis strongly supports the argument for investing in NBS that provides good value for money and would yield substantial financial gains for the country.
Keywords: Benefit-Cost Analysis; India; congenital hypothyroidism; disability adjusted life year; economic evaluation; newborn; newborn screening; value of statistical life.
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