Original Title: Análisis coste-utilidad del cribado neonatal universal de cardiopatías congénitas críticas basado en pulsioximetría en España

Authors' objectives: To assess the efficiency of a universal neonatal screening program for CCHD based on PO in Spain. To estimate the budget impact of the introduction of this screening program among the neonatal systematic screening programs in Spain.

Authors' results and conclusions: RESULTS: The base case results indicate that a PO screening could advance the diagnosis in 70.3% of cases and avoid a 12.4% of deaths due to CCHD in the first year of life in comparison with standard of care. The average cost per child with standard of care is 69.22 € and with PO screening is 67 €. Compared with standard of care, the PO screening obtains an incremental utility of 0.00032 QALY over a lifetime. The PO screening saves costs and obtains greater utility than standard of care, which makes PO screening dominant over standard of care in terms of cost-utility. A 99.3% of the Montecarlo simulations obtained an ICUR below the threshold of 22.000 €/QALY. The results of the univariate deterministic sensitivity analysis indicate that only four of the 21 variables in the model produce relevant changes in the ICUR, although none of the four generates an ICUR above the threshold. The most sensitive variables are those related to the diagnostic accuracy (sensitivity and specificity), the cost of hospital admission for CCHD surgery, and the reduction of costs due to early diagnosis. The annual budgetary impact for the SNHS is greater with the standard of care than with the PO screening. The implementation of the screening would mean an annual saving of 757,299 € for the SNHS. CONCLUSIONS • Carrying out universal screening with PO in the first hours of life for all new-borns who have not been previously diagnosed of CCHD is efficient in Spain compared to the standard of care, in which PO screening is not performed. The PO screening is dominant compared to the standard of care in terms of cost-utility, since PO screening is less expensive and allow QALYs to be gained. • The probability that PO screening is efficient in Spain is greater than 99% for a willingness-to-pay threshold of 22,000 € per QALY. • Compared with the standard of care, the PO screening allows earlier diagnosis in approximately 70% of CCHD cases not previously diagnosed. • PO screening reduces by 12% current deaths in the first year of life among children with CCHD. • The model is robust to variations in the variables, so none of the variables produces relevant changes in the observed cost-utility relationship. • The most sensitive variables in terms of their ability to modify the cost-utility relationship are the reduction of costs due to early diagnosis, those related to the diagnostic accuracy (sensitivity and specificity), and the cost of hospital admission for CCHD surgery. • A universal PO screening to all new-borns who have not been previously diagnosed of CCHD would mean an average annual saving of 757,299 € for the SNHS.

Authors' methods: A de novo decision tree model is built comparing current standard of care in Spain, in which PO screening is not performed, versus universal PO screening performed on all new-borns without a prenatally diagnosed CCHD. The model has a time horizon of one year in which costs, mortality and quality of life are estimated. After the first year of life, mortality and quality of life are estimated. The identification of parameters has been carried out by searching for information in Spanish sources, a bibliographic search and consulting experts. Whenever possible, Spanish sources of information or from neighbouring countries have been used. Costs have been updated to September 2022. A cost-utility analysis is carried out under the SNHS perspective in which the incremental cost-utility ratio (ICUR) is calculated. Univariate deterministic and probabilistic sensitivity analyses are performed for all the variables underlying the model. The willingness-to-pay threshold proposed by RedETS is used, which is between 22,000 and 25,000 € per quality adjusted life year (QALY). The annual budgetary impact of the implementation of universal PO screening for the SNHS is estimated by multiplying the average cost per child obtained with the model for each of the strategies by the number of new-borns in Spain in 2020.

Project Status: Completed

Year Published: 2023

URL for published report: https://repisalud.isciii.es/bitstream/handle/20.500.12105/16703/CostUtilCribNeon_2023.pdf?sequence=1&isAllowed=y

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: Spain

DOI: 10.4321/repisalud.16703

Organisation Name: Agencia de Evaluacion de Tecnologias Sanitarias

Contact Address: Instituto de Salud "Carlos III", Calle Sinesio Delgado 6, Pabellon 4, 28029 Madrid, Spain. Tel: +34 9 1 822 2005; Fax: +34 9 1 387 7841;

Contact Name: Luis M. Sánchez Gómez

Contact Email: luism.sanchez@isciii.es

Copyright: <p>Agencia de Evaluacion</p>