By Isabell Kang, PharmD; Chelsey Campbell, PharmD, MBA, MS; Josep Darba, PhD
With a population of 7.5 million people, Catalonia is an autonomous region within Spain in charge of its own healthcare, among other things. The region is considered to be a Spanish economic powerhouse, with a GDP of 234.7 billion Euros in 2017. This particularly holds true for the pharmaceutical sector. Catalonia is the leading biotech region in Spain, and in 2016 was responsible for 43.7% of Spanish pharmaceutical exports.
To better understand Catalonia, it is helpful to take a step back and look at the Spanish healthcare system as a whole. Spain has the second highest life expectancy, at 83 years, of all the Organization for Economic Co-operation and Development countries—only Japan ranks higher; additionally, Spanish women live longer than men, with a life expectancy of 85 years compared to 79 years. However, the United Nations projects that Spain will be among one of the world’s oldest countries by 2050, with over 30% of the population aged 60 years or older.
In Spain, all residents are granted universal healthcare by law, which encompasses a wide range of publically covered services and utilizing co-payments for pharmaceutical products. Spain’s Ministry of Health, Social Services, and Equality coordinates broader healthcare priorities and sets pharmaceutical policy (eg, assessment, authorization, and pricing). This tax-funded system is decentralized; Spain is split into 17 different regions that function as autonomous communities within the Spanish National Health Service. Each region is responsible for their own health budget while sharing best practices and HTA information between them. In other words, the government sets targets, guidelines, and actions on what is needed to implement the right to health protection, but is not responsible for the coverage and delivery of services and pharmaceuticals.
Catalonia, one of these 17 regions, is a majority-public healthcare system, but 20% of its population also has supplemental private health insurance. They have their own health model, the Catalan Health Service (CatSalut), which is then integrated into Spain’s national health system. CatSalut was established by the Catalonian government in 1991 as the official entity for planning, assessing, and purchasing health services; it controls all public health resources. Also, all healthcare providers are contracted by CatSalut to provide public health services. Catalonia is the only Spanish autonomous community where purchasing and providing functions are completely separate; CatSalut is responsible for purchasing, but it is the public and private practitioners who are providing services.
Health Technology Assessment in Catalonia
On a national level, the Spanish Agency for Medicines and Healthcare Products (Agencia Española de Medicamentos y Productos Sanitarios [AEMPS]) authorizes and classifies new medicines, and the General Directorate for Pharmacy and Healthcare Products, which is part of AEMPS, assesses drugs and is responsible for setting pharmaceutical policy, evaluating drugs before market entry, and pricing decisions. When a manufacturer requests marketing authorization for a product, they must submit a dossier for AEMPS review. Then, AEMPS will produce therapeutic positioning reports, containing medicinal product assessments; upon publication, report conclusions tend to be adopted by consensus in the 17 regional health authorities. Of note, since regional health services and hospitals may negotiate lower unit prices or risk-sharing agreements, these reports will tend to be more general so that regional decision makers can negotiate their own purchasing requirements. In addition, public hospitals have their own annual budgets set by the health department in each region.
Catalonia’s HTA is the Agency for Health Quality and Assessment of Catalonia (AQuAS). It is a non-profit, public agency of the Catalan Health Ministry and has the goal of generating relevant knowledge to improve the quality, safety, and sustainability of the Catalan healthcare system. It coordinates the Committee for Assessment of Hospital Use of Drugs for drug evaluation, and has various ongoing projects to generate more value for the Catalan Health System. In particular, the Drug Innovation & Support Programme was commissioned to provide information and services to improve drug utilization and safety in Catalonia, as well as maintain the quality of pharmaceutical prescription care. This group creates drug evaluation reports for primary care and hospital drugs, designs information and communication-based support tools for decision making (eg, safety filters for electronic prescriptions), standardizes drugs and healthcare indicators, and implements drug information systems. AQuAS will use reports generated at the national level by AEMPS as part of their drug evaluation reports.
Recently, CatSalut has updated its Pharmacotherapeutic Harmonization Program Evaluation Procedure, for prescriptions either used in the hospital or dispensed in a community pharmacy. Medications, both old and new, will be classified into 4 categories (A, B, C, and D), based on their value and degree of potential therapeutic contributions; the first 3 categories also have criteria for start of use, follow-up, and withdrawal. Category A and B products are those used for first- and second-line treatment, respectively; category B can also be for products with strong evidence for benefit (obtained from published, peer-reviewed sources) in certain patient subgroups. Category C products are for medications prescribed only when other available alternatives have been exhausted, and category D products are medications whose use is not recommended.
Relevant Current Events
In October 2017, Catalonia attempted to declare independence from Spain. Though a referendum was held and as a result Catalonia declared independence, the central Spanish government suspended the region’s autonomy and imposed direct rule from Madrid, ousting the previous Catalan government and calling for new elections.
Currently, Pedro Sanchez, the Spanish prime minister, is in talks with Quim Torra, Catalonia’s new government. What will happen with the separation remains to be seen. Even though Catalonia has been responsible for its healthcare system, independence may have implications regarding budgets and funding, among other things, since the separation would create uncertainty about Catalonia’s future as a European Union member.
Beginning in 2015, Europe has seen a pattern of increased migration from surrounding continents, creating ongoing challenges for individual countries as they attempt to provide services for a growing population. In Catalonia, immigrants are provided one-year renewable medical permits if they provide proof of 3 months of continuous residence in Catalonia and an income below what is required for inclusion. As the immigrant population within Catalonia grows, demand for services and healthcare should increase, putting additional pressure on existing resources.
Key Takeaways for Manufacturers
Given the trend of mounting healthcare costs and a greater global emphasis on value measures to help mitigate ever-rising costs, there will be increasing pressure for Spanish health authorities to measure value as it relates to cost. CatSalut committees are continually evaluating pharmaceuticals and issuing recommendations on a drug’s therapeutic place in clinical practice, defining indications and therapeutic response criteria, and identifying health and efficiency results.
When considering evidence generation and drug commercialization, manufacturers should incorporate their product’s value as well as its safety and quality. In markets where local HTAs play an active role in patient access, manufacturers will benefit from a deep understanding of the market and the drivers of value and access. As a start, showcasing safety and efficacy data via economic models demonstrating value will be a core component for manufacturers trying to expand into this auspicious market.
The article should be referenced as follows:
Kang I, Campbell C, Darba J. Catalonia: Understanding market access within an autonomous region in Spain. HTA Quarterly. Fall 2018. November 2, 2018.