In Spain, getting in vitro diagnostics (IVDs) reimbursed involves navigating distinct pathways, each with its focus and requirements. The three primary systems are theSpanish Catalogue of Health Products, the Common Portfolio (Cartera Común), andRegional Complementary Portfolios (Cartera Complementaria). Each system offers unique advantages depending on the diagnostic tool and its impact on healthcare services. Here is a breakdown of how these systems work, why they exist, and when an IVD might be better suited for one over the others.
1. The Spanish Catalogue of Health Products: National Access for Medical Devices
The Spanish Catalogue of Health Products is the primary pathway for medical devices, including IVDs, that require national access. Managed by AEMPS (Agencia Española de Medicamentos y Productos Sanitarios), this catalogue is designed to ensure medical devices meet strict health economic criteria and are available for nationwide reimbursement.
The Spanish Catalogue is focused specifically on medical devices. Once an IVD is listed here, it becomes eligible for national reimbursement, meaning it can be accessed consistently across Spain’s regions under a unified pricing model. This system is ideal for devices that need to be deployed across the entire healthcare network without the need for separate pricing discussions in each region.
Health Economic Requirements:
- Cost-effective analysis (CEA): The device must demonstrate that it provides valuable health outcomes relative to the cost, improving both patient outcomes and the efficiency of the healthcare system.
- Budget impact analysis (BIA): It must be clear how widespread use of the device will affect the overall healthcare budget, factoring in savings from better diagnostics or reduced hospital stays.
- Pricing: Once the health economic evaluations are passed, the device’s price is set by the Interministerial Commission on Prices for Medicines and Medical Devices. This single price applies nationwide, ensuring consistent access.
Real-World Example: Roche Diagnostics’ Cobas 6800/8800
During the COVID-19 pandemic, Roche’s Cobas 6800/8800 systems were included in the Spanish Catalogue to handle high-throughput molecular testing for SARS-CoV-2. This ensured the systems could be deployed swiftly across the country’s regions, supporting Spain’s efforts to control the pandemic. The Cobas systems required broad, national access to respond to an urgent public health crisis. The Spanish Catalogue allowed Roche to avoid delays associated with region-by-region negotiations and ensured uniform pricing and availability in hospitals across the country. This was crucial for an issue like COVID-19, where timely and consistent diagnostics were needed nationwide.
2. The Common Portfolio (Cartera Común): Routine Services and National Programmes
The Common Portfolio (Cartera Común) focuses on health services and procedures that are essential and must be available uniformly across all of Spain. This portfolio is ideal for IVDs that are part of routine clinical procedures or preventive health programmes, ensuring that everyone has equal access to these services regardless of their region.
While the Spanish Catalogue is device-specific, the Common Portfolio is focused on the services and procedures that make up standard care. If an IVD is part of a larger national programme—like a screening or monitoring service—it is likely to be included here to ensure equal access to that service across the country.
Health Economic Requirements:
- Economic evaluations for the Common Portfolio focus on the entire service, looking at the clinical and financial benefits of providing the service to the population. The device itself is just one component within the broader health service.
- The aim is to ensure that the service is cost-effective and accessible to all regions equally, with the focus on improving health outcomes across the country.
Real-World Example: Mammography for Breast Cancer Screening
Mammography is included in Spain’s national breast cancer screening programme, ensuring that all women within specific age groups receive regular screenings to detect early signs of breast cancer. Mammography is a routine service essential for detecting early-stage breast cancer. Its inclusion in the Common Portfolio ensures nationwide access to this screening programme, guaranteeing equal access for all women in Spain. The focus is on the service provided, not just the device, making the Common Portfolio the ideal pathway for this type of public health initiative.
3. Regional Complementary Portfolios: Regional Flexibility and Innovation
Spain’s decentralised healthcare system allows each of the 17 Autonomous Communities to manage certain healthcare services independently. The Regional Complementary Portfolios enable these regions to introduce innovative services or devices that address specific local needs before they are adopted nationally. This system offers regional flexibility, allowing certain regions to pilot and adopt new healthcare technologies that may not yet be available at the national level. If an IVD addresses a specific regional issue or if a region is more willing to invest in new diagnostics, the Complementary Portfolios provide a way to introduce and test these technologies on a smaller scale.
Health Economic Requirements:
- The focus is on how the IVD can address regional health challenges and deliver cost-effective solutions locally.
- Often, these portfolios allow regions to gather real-world data to support broader adoption later, enabling a pilot programme approach to innovation.
Real-World Example: Genomic Testing in Catalonia
Catalonia was an early adopter of genomic testing for hereditary cancers, including BRCA1/2 mutations for breast and ovarian cancer risk. The tests were included in Catalonia’s Complementary Portfolio before being considered for wider adoption. Genomic testing was new and required time to demonstrate its cost-effectiveness and clinical value. By including it in the Complementary Portfolio, Catalonia was able to pilot the technology and collect data to support its case for future national adoption. This regional approach allowed for innovation while managing financial risk at the local level.
Each of these systems serves a different purpose and is designed for specific types of health services or devices:
- Spanish Catalogue of Health Products: Ideal for medical devices like IVDs that need broad, national adoption. If your device, such as the Cobas systems, addresses a national healthcare priority, the Catalogue ensures consistent pricing and availability across all regions.
- Common Portfolio (Cartera Común): Best for IVDs that are part of routine healthcare services. If your device is involved in a national screening programme, such as mammography, the Common Portfolio guarantees that the service will be provided uniformly across the country.
- Regional Complementary Portfolios: Perfect for innovative technologies that need to be tested or adopted regionally before a national rollout. If your IVD requires time to gather real-world data, like genomic testing in Catalonia, this pathway allows for regional flexibility and localised innovation.
Choosing the right reimbursement pathway in Spain depends on the type of IVD, its clinical role, and how it fits into the broader healthcare system. For devices that need national access and standardised pricing, the Spanish Catalogue of Health Products is the most appropriate. The Common Portfolio is ideal for services that need to be consistently available across all regions, while the Regional Complementary Portfolios provide an opportunity for regional innovation and pilot programmes. Understanding these distinctions is key to navigating the Spanish healthcare market and securing the right reimbursement for your IVD.