Description
In this report we describe the Spanish National Health System (SNS) which operates on a decentralised model, where the national Ministerio de Salud (MoH) sets general guidelines, but the 17 Autonomous Communities (ACs) largely control healthcare delivery and funding, leading to regional variability in access to molecular oncology diagnostics. Nationally, the MoH establishes the Common Portfolio of Healthcare Services (Cartera Común de Servicios), which includes the Common Portfolio of Genetic and Genomic Services (CGen), defining biomarkers eligible for public reimbursement but there is no national reimbursement as such. The Interterritorial Council of the SNS (CISNS) approves CGen inclusions, but each AC ultimately decides on funding and implementation, often using local budgets, with national permanent access typically taking 5-7 years.
A common entry point for novel diagnostics is a “bottom-up” approach at the hospital or regional level, where tests can be approved and reimbursed by local hospitals even before CGen inclusion. This is often driven by key opinion leaders (KOLs) and pilot programmes, particularly in regions like Catalonia, Madrid, and Navarra. Inpatient diagnostic procedures are generally bundled within Diagnosis-Related Group (DRG)-based payments, so they are not individually reimbursed. Conversely, Spain lacks a national tariff system for outpatient IVDs; these are reimbursed via decentralised regional budgets and procurement processes, influenced by KOL advocacy and local Health Technology Assessments (HTAs).
HTAs are crucial, conducted by the Spanish Network of Health Technology Assessment Agencies (RedETS), coordinated by the national AETS-ISCIII. HTAs evaluate analytical validity, clinical validity, and, most importantly for reimbursement, clinical utility, which demonstrates how a test improves patient management and outcomes. Economic utility, including cost-effectiveness analysis and budget impact analysis, is also critical, with Spanish HTAs placing significant weight on these aspects, requiring localised Spanish data. Collaboration with pharmaceutical companies is also a key strategy, as they often fund biomarker testing before national reimbursement, accelerating adoption. In summar, this report describes how to navigate the Spanish system, which requires a dual strategy of engaging national bodies for catalogue test inclusion and robust region-specific access strategies.
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