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Aim of this study was to estimate the cost that is borne by the Italian National Health Service, families, and social security due to very low birth weight infants (VLBWIs) without prematurity-related morbidities up to the age of 18 months. We followed up on 150 VLBWIs and 145 comparable full-term infants (FTIs) who were born in one of 25 different neonatal intensive care units upon discharge from the hospital and at six and 18 months of age. The average length of the primary hospitalisation of the VLBWIs was 59.7 days (SD 21.6 days), with a total cost of €20,502 (SD €8409), compared with three days (SD 0.4 days) with a total cost of €907 (SD €304) for the FTIs. The total societal cost of the VLBWIs for the first 18 months of life was €58,098 (SD €21,625), while the corresponding figure for FTIs was €24,209 (SD €15,557). Among VLBWIs, both low birth weight and gestational age were correlated with the length of hospitalisation after birth (r² = 0.61 and r² = 0.57, respectively; p values < 0.0005). Our findings highlight that the existing DRGs and tariffs inadequately reflect the actual costs for Italian National Health Service. [ABSTRACT FROM AUTHOR]

INTRODUCTION:Administrative data (for example, hospital discharge databases, HDDs) can be used as a real world source of clinical and economic evidence for assessing new medical devices (MDs), provided that their use can be identified in the data. In absence of updated classification systems for procedures and diagnoses, which allow to identify the use of new technologies in the data, traceability can still be achieved thanks to authorities coding guidelines (that is, indication on how to combine the existing codes for procedures and/or diagnoses when new technologies are used).In 2009 Italy adopted version 2007 of the International Classification System of Diseases (ICD-9-CM) and version 24 of Diagnosis Related Groups (DRGs), which are still in use. The aim of this work was to investigate the capacity of the classification system currently used in Italy, which is at high risk of obsolescence, to identify innovative MDs.METHODS:To achieve our goal, we performed a systematic search of all the national and regional coding guidelines published from 2009 (that is, the year of introduction of the new classification systems) to 2015. We extracted from each document the list of technologies for which the Ministry of Health and/or the Regional Authorities provided with coding indications.RESULTS:Our results show that only a few recent technological innovations can be identified in the Italian HDDs. This reduces the possibility for decision makers to measure new technologies outcomes and costs in the real world clinical practice.CONCLUSIONS:The traceability of new MDs' can support Heath Technology Assessment (HTA). Indeed, HTA programs should use real world evidence to re-assess MDs 2–3 years after their introduction in clinical practice. The use of routinely collected data, such as HDD, would allow to measure new technologies' “real” effectiveness in “real” world, on “real” patients in “real” hospitals to complement the evidence from Randomized Controlled Trials. [ABSTRACT FROM PUBLISHER]

Technological evolution and the increasing requests of a more qualified health care have challenged politicians to evaluate the economical sustainability of proposed innovations. The objective of government health policies is to guarantee real advances in the quality of care to all citizens. Since 1965, independent research centers have analyzed this issue for the US Congress. In 1973, Congress endorsed the establishment of an Office of Technology Assessment (OTA) to discover the best strategies for evaluating such advances. OTA have proposed the following criteria to identify possible beneficial innovations to be introduced into routine health care: effectiveness, safeness, worth, costs, cost-effectiveness ratio and cost patient-benefit ratio. This review analyzes in detail the pathway that each medical innovation follows in order to identify which technological evolutions might prove to be truly beneficial and sustainable for the community.