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considered in depth and early on in the decision-making process. This is due to variations in treatment
costs, hospital-billing policy, the requisite infrastructure (at all stages) and personnel cost of running the
programme, as well as additional expertise and follow-up systems for surveillance. All of these aspects will
affect the viability and sustainability of the NBS programme [6,30-33] . Aside from costs, additional unexplored
variations in value judgments, driven by technological availability, social or professional pressure, or
[34]
political opportunity, usually not explicitly stated, could play a differential role in policy decision-making .
There is no evidence to show that those populations who receive NBS for fewer disorders, such as in the
UK, France, several Spanish regions, and Finland, are at a higher risk of poorer health outcomes than the
populations of Austria, Italy, or Iceland, where NBS programmes cover more than 25 different conditions .
[3]
Moreover, governments are committed to ensuring the value of all health care provided to the population,
as well as the long-term sustainability of the health care system per se. This commitment has recently been
exacerbated by the double impact of the 2008 economic and financial crisis and the direct and collateral
pandemic effects of COVID-19 .
[35]

EVIDENCE-BASED HEALTH POLICY INITIATIVES TO ENHANCE EQUITY AND
EFFICIENCY FOR THE NBS PROGRAMME IN SPAIN
The Spanish National Health Service (SNHS) is a decentralized public health insurance system with
universal coverage, which provides free health care to every resident in all of the country’s Autonomous
Regions (ARs). The SNHS is managed at a regional level and fully financed by national insurance
contributions and taxes, though some regional governments allocate local budgets to provide additional
funding. The national government established three health policy instruments to support the
decentralization of health planning and management competencies in each ARs: (1) the Spanish
General Health Care Act, guaranteeing free and universal healthcare access to all Spanish
residents ; (2) the National Benefits Catalogue to ensure equity in the supply of healthcare
[36]
services ; (3) the Inter-territorial Board of the SNHS (made up of central and regional public health
[37]
authorities). However, even though these health-policy instruments were established early to ensure
equity, homogeneity, and efficiency in a decentralized SNHS, variations have since occurred in the supply
[26]
of healthcare services, including NBS programmes .

Universal NBS, introduced in 1968 in Spain, is a well-established programme funded by every AR. It is
currently organized through a network of 20 regional laboratories with an overall coverage of over 98% of
the neonatal population. By 2000, the AR of Galicia had implemented a pioneering expanded NBS
programme based on MS/MS for more than 40 conditions , at a time when the country’s remaining ARs
[23]
were mainly screening for phenylketonuria (PKU) and hypothyroidism. Despite the fact that the Galician
programme was not expressly developed as a research initiative, it has nonetheless generated new
knowledge about the true prevalence of a wide spectrum of disorders and relationships between biomarkers
and disease expression in that region of Spain . Subsequently, the SNHS Cohesion and Quality was
[38]
operationalized by means of Quality Plans supported by the Spanish Network for Health Technology
Assessment (RedETS), with the aim of bolstering evidence-based health policies and limiting variations in
the supply of healthcare services among ARs . As a result, there has been a growing demand for evidence
[39]
and justification of value in the context of innovation and health technology assessment (HTA), whether to
endorse funding, coverage, and reimbursement decisions or, alternatively, to support price negotiations .
[40]

To standardize the offer of NBS and reduce inequalities in the SNHS, the Spanish Ministry of Health
prompted the creation of (1) a Framework Document to guide NBS decisions approved by the Public
Health Commission of the SNHS Inter-territorial Board; (2) an expert group to develop
recommendations on (i) a uniform screening panel; (ii) minimal standards for NBS in all ARs;