Ten things to know about the program: Innovation Adoption in the Catalan Healthcare System

1. Why did the Catalan Ministry of Health set up the Subcommittee on Innovation Adoption in Healthcare in late 2022? 

For two main reasons. In 2023, we have an ecosystem that is much richer in innovations, with a much greater capacity for creating innovative startups and spinoffs, and with record local and international1 investment.  But adoption of this innovation hasn’t progressed at the same pace and the mechanisms and connections needed to explore, filter, identify, interact and incorporate these innovations into the system haven’t been well defined or developed. This is a historic challenge for the ecosystem that particularly affects startups created to address these health needs that, unfortunately, can’t gain access to the system and get reimbursed so, in many cases, decide to leave the country.

At the same time, there are more and more new mechanisms and pathways to get innovation into healthcare systems popping up around the world, for example in Germany, France, England and Belgium.

2. What are the goals of the Subcommittee on Innovation Adoption in Healthcare, coordinated by Biocat?

There are four:

• To create a sustainable innovation adoption program with key stakeholders in the ecosystem
• To coordinate programs and initiatives to accelerate and support existing innovations in the ecosystem and join forces to work towards the shared goal of getting solutions to patients
• To clearly define a recognized fast track to get innovation into the National Health System as quickly and easily as possible
• To define the framework for all innovation in the ecosystem, both technologies (biopharma, medtech and digital health) and processes. 

In order to carry out these tasks, the Subcommittee is made up of a variety of professionals and organizations that represent the whole innovation valorization chain, from concept to use in the healthcare system, with presence in the public and private spheres.

3. Which members are part of the Subcommittee?

The members of the Subcommittee on Innovation Adoption in Healthcare who took part in the Operating Plan are:

• Ramon Maspons, Chief Health Innovation Strategist, Catalan Ministry of Health
• Robert Fabregat, Subcommittee Coordinator and Biocat CEO
• Xavier Aldeguer, Director General for Knowledge Society, Transfer and Territory, Catalan Ministry of Research and Universities
• Elisenda Casanelles, former Director of Operations, CIMTI and recently named Account Manager, GE Healthcare Iberia
• Cristina Casanovas, Head of Projects and Quality of Care Division, Catalan Health Service
• Roser Fernández, CEO, Unió Catalana d’Hospitals
• Òscar Garcia-Esquirol, Chief Medical Officer, Barcelona Health Hub 
• Toni Gilabert, Director of Innovation and Partnership Division, Catalan Health and Social Consortium
• Francesc Iglesias, Head of the Office of Innovation and Research Support, Management Directorate, Catalan Health Institute
• Lluís Juncà, Director General for Innovation and Entrepreneurship, Catalan Ministry of Business and Labor
• Fina Lladós, Farmaindustria board member and CEO for Spain and Portugal, Amgen
• Miquel Martí, CEO, Tech Barcelona
• Glòria Palomar, Director of Management, Institute of Research and Innovation, Parc Taulí
• Marc Pérez, Chair of FENIN Catalonia and Vice-president for Western Europe and Africa, Hartmann Group
• Laura Sampietro, Director of Technical Office for Evaluation of Innovations, Hospital Clinic Barcelona
• Mariona Serra, First Vice-president, CataloniaBio & HealthTech and GoodGut CEO
• Rosa Maria Vivanco, Director of Assessment Division, Catalan Healthcare Assessment and Quality Agency, AQuAS

4. How many pathways into the system will there be?

Two: one standard and one fast track.

As the following diagram shows, there will be a unified gateway for identifying existing innovations in the BioRegion of Catalonia that can potentially be adopted by the healthcare system (1) and a first filter (2) to determine which solutions meet the criteria to be added to the innovation registry (3).

Additionally, CatSalut will establish the system’s priority needs, which will determine the path each innovation takes (4): standard or fast track. This process will take into account criteria that have a direct impact on improving people’s lives.

For top priority innovations that are highly valuable to the system, the solution will take the fast track, getting an “innovation passport” (5) and personalized assessment by the guidance division (6). This division will help them comply with the requirements to be adopted by the healthcare system quickly and efficiently, for a better chance at success.

If, however, the innovation isn’t considered a priority for the system at that time, it will still get initial guidance (7) on the requirements it will have to meet to pass a final assessment according to AQuAS criteria, which is an essential requirement to successfully be adopted into the system. If an innovation doesn’t meet the requirements of any of the preliminary assessments during the process (9), it will be sent to a program, instrument or service that can help it do so successfully (8, 10). This guidance is made possible by identifying and classifying the initiatives available in the ecosystem for valorizing innovation (11).

5. Which actions will Biocat carry out?

• Mapping initiatives available in the ecosystem: a common nexus for all the initiatives and programs available in the BioRegion of Catalonia so that innovation developers can have a unified gateway to programs that address their interests and needs. Additionally, this mapping will lay the groundwork for forging partnerships and collaborations among ecosystem support stakeholders in order to generate synergies and complementarities among their activities, programs and initiatives and ensure that, together, they cover all the needs throughout the value chain.
• Innovation registry: this space aims to act as an antenna for all the healthcare centers, groups/consortia and the Catalan Health Service to identify and potentially incorporate high value innovations in coordination with and complementary to other existing sources of information.
• The guidance division: made up of multidisciplinary professionals from various organizations in the innovation and assessment arena through a collaboration between Biocat and AQuAS to bring in the assessment perspective taking into account the innovation life cycle, offering the right guidance at each stage of development in order to align needs and solutions. It will have the following functions: 
  • Guiding and accompanying early stage innovations through the fast track.
  • Ensuring interaction and collaboration between public and private arenas to optimize and join forces to accelerate innovation towards the market.
     

6. What advantages will the innovation registry have for companies? 

• One point of contact: companies interested in accessing the system currently have to contact and negotiate with each of the centers individually, making the process long and expensive. With this program, companies will have a unified gateway to streamline the process.  
• Visibility: companies get access to a point of reference for healthcare centers, groups/consortia and the Catalan Health System looking for innovations. 
• Ongoing assessment: helping companies perfect and enrich their innovation throughout the process to get the best conditions for valuation, investment, acquisition or scaling up internationally into other markets.
   

7. And the benefits for healthcare centers? 

• Fast access to information: healthcare centers will have one organized point of access to innovative solutions that may meet their needs. 
• Transparency: the centers will know the real status of development of the innovation because this will be validated before being registered and they can also compare it to other solutions in the registry.
• Quality guarantee: the solutions in the registry will have a quality guarantee because they will be assessed along the way, as they meet requirements.
   

8. Is the program for any type of innovation?

Yes, the program concept is designed for biopharma, medtech and digital health companies, as well as for process innovations.

9. When will we see the first results?

It will take some time for the program to reorganize existing structures and adapt them to the new functions and responsibilities. The calendar proposed and agreed on by the organizations involved aims to have all the points laid out by April 2024 in order to start testing the program. That month, we will post a second article explaining the agreements and news on the project.  

10. What models has the Catalan innovation adoption program mirrored?

Mainly the British National Institute for Health and Care Excellence (NICE), which has the Innovative Licensing and Access Pathway (ILAP) to accelerate time to market for new drugs and therapies, with the main aim of benefiting patients.

If certain criteria are met, the developers get an innovation passport that helps them begin the ILAP process. After getting the passport, a multidisciplinary team of experts (regulatory, assessment, healthcare services) helps define the target development profile (TDP), compiling key information on the main pitfalls and creating a roadmap of the requirements throughout development so the innovation can reach the market and get to patients as quickly as possible. 
This innovation passport includes a list of organizations the company/developer can work with in the United Kingdom to get evidence, assessment or commercial and market access considerations. The figure below shows the development stages and processes when ILAP offers innovation developers centralized access to the tools to help them meet all requirements to reach the market as quickly as possible.

Other initiatives that the Catalan program is modeled on:

• Basque Country: the Medtech program seeks public-private partnership within the healthcare system in the Basque Country and helps develop products and/or services by making the healthcare system a test bench for medical technology.
• Germany: the Fast Track Process for Digital Health Applications (DiGA) is a system for early, temporary access for digital technology (class I and IIa) that provides public reimbursement while the technology is being assessed and compiling the most appropriate information on the benefits of the technology (mainly the cost effectiveness of the solution, after the company and regulatory agency have worked together to lay out the procedures for generating evidence).
• Belgium: the mhealthBelgium Initiative and its validation pyramid has three levels to assess safety, quality and data protection compliance (M1), an assessment of the risks, data privacy, therapeutic relationship and interoperability (M2) and finally clinical and economic evidence to show the value within and beyond the healthcare process (M3).
• France: Innovation Package, Early Reimbursability and the recently announced PECAN program give digital health and remote access technologies temporary coverage for one year before being assessed through the standard technology assessment process and becoming permanently reimbursable.
   

For more information, see the Operating Plan for innovation adoption in the Catalan healthcare system.