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.

🎧 Listen: Navigating European Healthcare – Diagnostics, Funding, and Policy

In this report we describe the German healthcare system which operates as a complex, multi-payer model, providing universal coverage through a dual public-private structure. Its governance is centralized by federal law, with implementation responsibilities shared between federal and state authorities. The system is primarily funded through Statutory Health Insurance (SHI), known as Gesetzliche Krankenversicherung (GKV), which covers approximately 89% of the population via numerous sickness funds (Krankenkassen), financed by income-based contributions from employees and employers. Around 11% of the population, including high-income earners, self-employed individuals, and civil servants, opt for Private Health Insurance (PKV). Navigating this system, particularly for novel molecular in vitro diagnostic (IVD) tools in oncology, requires a tailored approach involving several key institutions and processes. The Federal Ministry of Health (Bundesministerium für Gesundheit, BMG) sets the overall legal framework and national health policy. The Federal Joint Committee (Gemeinsamer Bundesausschuss, G-BA) is the highest decision-making authority on SHI-covered services, evaluating new IVDs for medical benefit, necessity, and efficiency to decide on their reimbursement. The Institute for Quality and Efficiency in Health Care (Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen, IQWiG) supports the G-BA by conducting evidence-based Health Technology Assessments (HTAs), evaluating clinical utility, economic impact, and system benefit.

For outpatient settings, manufacturers submit reimbursement requests via the Evaluation Committee (Bewertungsausschuss, BeWa), supported by the Institute of the Evaluation Committee (Institut des Bewertungsausschusses, InBA). The BeWa decides on inclusion and reimbursement rates within the Einheitlicher Bewertungsmaßstab (EBM) catalogue. Due to potentially lengthy EBM inclusion timelines (up to 3 years), manufacturers may pursue individual contracts directly with sickness funds (Krankenkassen).

In inpatient settings, diagnostics are reimbursed through Diagnosis-Related Group (DRG) codes, with the Institute for Hospital Remuneration Systems (Institut für das Entgeltsystem im Krankenhaus, InEK) managing DRG assignment and evaluating applications for code inclusion or adjustment. Hospitals can also apply annually to InEK for temporary reimbursement for innovative diagnostics not yet priced within the DRG system via the Neue Untersuchungs- und Behandlungsmethoden (NUB) pathway, though these often face high rejection rates. To address these challenges and promote innovation, Germany launched the §64e SGB V Model Project in 2023 with €700 million in federal investment, providing a temporary, nationally coordinated reimbursement framework for advanced oncology diagnostics through 2027, aiming for early access and evidence generation. This initiative is part of the National Strategy for Genomic Medicine, genomDE initiative, launched in 2019 to integrate whole-genome sequencing into clinical care. Other key institutions include the Paul-Ehrlich-Institut (PEI) for regulatory oversight and test validation, especially for Companion Diagnostics (CDx), and medical professional societies like the German Society for Hematology and Oncology (DGHO) and the German Society of Pathology (DGP), which define clinical standards and guide biomarker integration. Comprehensive Cancer Centers (CCCs), certified by the German Cancer Society (Deutsche Krebsgesellschaft, DKG), also play a vital role in local adoption and standardizing cancer care. Ultimately, securing reimbursement for new diagnostics in Germany requires a robust demonstration of both clinical utility and cost-effectiveness, along with early engagement with key stakeholders, all of which we describe comprehensively in this report.

🎧 Listen: Navigating German Oncology – Access and Reimbursement for Diagnostics

This comprehensive report outlines how to successfully navigate the Italian healthcare system for molecular oncology diagnostics. Italy’s decentralized public healthcare system features a multi-tiered structure involving national, regional, and local stakeholders who collectively shape access and reimbursement for in vitro diagnostics (IVDs). At the national level, the Ministry of Health (Ministero della Salute) defines health priorities and the Essential Levels of Care (LEA), while the National Programme for Health Technology Assessment of Medical Devices (PNHTADM) serves as the central body for evaluating the clinical and economic value of new diagnostics. AGENAS (Agenzia Nazionale per i Servizi Sanitari Regionali) provides technical guidance and coordinates HTA activities with the MoH and regional authorities. AIFA (Agenzia Italiana del Farmaco), although primarily focused on pharmaceuticals, also contributes to companion diagnostic (CDx) evaluations and co-manages HTA processes under PNHTADM. At the regional and local levels, the Regioni (Regional Governments) are responsible for planning, financing, and delivering healthcare services, while the Local Health Authorities (ASL) manage funding decisions and service implementation. IRCCSs (Scientific Institutes for Research, Hospitalisation and Healthcare) are key centers for innovation, generating clinical evidence and piloting early access to novel diagnostics. Molecular Tumor Boards (MTBs), now mandatory, act as gatekeepers for NGS reimbursement and access to targeted therapies. Among non-governmental stakeholders, the Italian Association of Medical Oncology (AIOM) influences clinical guideline development, and patient advocacy groups such as AIMaC (Associazione Italiana Malati di Cancro, Parenti e Amici) are increasingly involved in access policy and innovation equity. The report also addresses system-wide challenges like fragmentation and delays, and provides strategic recommendations for diagnostic manufacturers, emphasizing the importance of evidence generation and collaborative engagement. Additionally, it contextualizes the Italian model within broader European healthcare frameworks and reflects on the growing cancer burden and related EU policy initiatives.

🎧 Listen: Navigating Italian Oncology – Access and Reimbursement for Diagnostics

Here we describe the French healthcare system which is a centralised system with universal and mandatory coverage provided through Statutory Health Insurance (SHI), financed primarily through compulsory health insurance contributions (salary deductions and taxes) supplemented by government funding. The system features centralised policy setting and involves multiple institutional actors at both national and regional levels. At the national level, the Ministère de la Santé (MoH) oversees national health priorities, allocates budgets, and defines strategies for public healthcare, allocating funds to Regional Health Agencies (ARS) through its Directorate-General of Health (DGS). The Haute Autorité de Santé (HAS) is the main independent health authority, playing a central role in HTA and the evaluation of medical devices, including IVDs. Under HAS, three key committees lead HTA: the Commission de la Transparence (CT) assesses pharmaceuticals, the Commission nationale d’évaluation des dispositifs médicaux et des technologies de santé (CNEDiMTS) evaluates medical devices and health technologies for inclusion in the List of Reimbursable Products and Services (LPPR), and the Commission d’Évaluation des actes Diagnostiques (CEDiag), created in 2023, reviews diagnostic tests for inclusion in the NABM and CCAM coding systems and is dedicated to evaluating IVDs.

The Union Nationale des Caisses d’Assurance Maladie (UNCAM) coordinates France’s three main public health insurance schemes (Caisse Nationale d’Assurance Maladie (CNAM), Mutualité Sociale Agricole (MSA), and Régime Social des Indépendants/Sécurité Sociale des Indépendants (RSI/SSI)), setting reimbursement rates, negotiating national agreements with healthcare professionals, and representing SHI in discussions with HAS and CEPS. As the primary public health insurance fund, Caisse Nationale d’Assurance Maladie (CNAM) manages the régime général, covering the majority of residents. The Comité Économique des Produits de Santé (CEPS) negotiates the prices of reimbursed pharmaceuticals, diagnostics, and medical devices based on HAS evaluations. The Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM) regulates the safety, efficacy, and market access of medicines and IVDs. The Santé publique France (French Public Health Agency) is crucial for public health surveillance, epidemiology, prevention, and crisis preparedness. At the regional level, Agences Régionales de Santé (ARS) implement national health policy, plan and organise care delivery, allocate resources to providers, oversee public health initiatives, and monitor service quality. The Institut National du Cancer (INCa) coordinates national cancer strategies and supports research, prevention, and diagnostics policy. It plays a pivotal role in coordinating funding through national cancer plans and establishing networks of excellence to strengthen cancer care and research infrastructure across France. INSERM (Institut National de la Santé et de la Recherche Médicale) complements this mission by advancing medical research and innovation. While INSERM contributes significantly to the scientific evidence base that may support reimbursement applications. Reimbursement for diagnostic tests in France is structured around the Nomenclature des Actes de Biologie Médicale (NABM) for laboratory tests, the Classification Commune des Actes Médicaux (CCAM) for technical procedures, and the Liste des Produits et Prestations Remboursables (LPPR) for medical devices, reagents, and test kits, particularly for ambulatory care. Innovative diagnostics may access temporary reimbursement via the Référentiel des Innovations Hors Nomenclature (RIHN 2.0) framework, which facilitates early access and interim funding while real-world evidence (RWE) is collected, typically for a limited period of 3 years. For inpatient settings, reimbursement operates through Tarification à l’Activité (T2A), based on Diagnosis-Related Groups (DRGs) known as Groupes Homogènes de Séjours (GHS), where hospitals receive a fixed bundled payment per patient stay covering all services, including diagnostics.

🎧 Listen: Navigating French Oncology – Access and Reimbursement for Diagnostics