SDP3 Health Economy

SDP3: Business Models and Health Economics for ATMPs

Lead: RISE – Research Institutes of Sweden

Involved partners: Akademiska sjukhuset, Cell Protect Nordic Pharmaceuticals AB, Idogen AB, IHE – Institutet för Hälso- och sjukvårdsekonomi AB, Karolinska Institutet, Karolinska Universitetssjukhuset, LIF – Läkemedelsindustriföreningens Service Aktiebolag, NextCell Pharma AB, Novartis Sverige AB, Pfizer Innovations AB, Region Skåne, Region Västerbotten, Region Örebro län.

SDP3 focuses on the area of business development and health economics for development of ATMPs. The goal of the project is to pave the way for successful development of ATMP projects so that more products/treatments will reach the market and resolve the needs of the patients. To narrow the scope, the project will build generic cases, representing different types of ATMPs and base the investigation of the “ecosystem” and suggestion of development road maps around these cases.

Examples of tasks and actions:
• Understanding the area; map stakeholders and initiatives and plan for how this project interacts with them.
• Produce generic cases for different types of ATMPs based on Target Product Profiles (TPPs).
• Produce early decision models for the generic cases based on HE models for valuation and payment of ATMPs.
• Investigate the prerequisite for sustainable business models for development and marketing of ATMPs
• Seminars and educational activities.
• Networking and bringing together stakeholders for common dialogue.

Final report and associated resources

The project has now launched their final report describing and exemplifying issues around valuation and payment for ATMPs. The importance of developing, not only a product that works scientifically and clinically, but a product with a well thought out business model and a thorough understanding of competing technologies, is critical to navigating not only market approval and commercialisation but also reimbursement in public health care systems. Resources developed in association with the report can be found in the Commercial aspects of ATMP resource.

Access to advanced therapies and innovative medicines for patients

Interview with Project leader

Hi Anna Ridderstad Wollberg!

What are the primary needs your project addresses?

The project addresses the need of SMEs developing ATMPs to understand when and what type of information must be produced and what are the toll gates for a successful launch. The need to understand the path ahead, onto the market. The project also addresses the need of innovation support system, payers and investors to give the right support and to understand the value of a product.
The area of precision medicine, including ATMPs, is prioritized by the Swedish government and hence there is a need for Sweden to have an infrastructure and system which supports development and treatment with this type of products.

What is your approach to address the need?

I have gathered a highly competent team, representing stakeholders from all different aspects in the ecosystem and we have suggested a process to address these important questions, focusing on generic cases for different types of ATMP products. The knowledge built within the team will be shared, discussed and presented with the identified stakeholder groups.

How will this improve Sweden´s capabilities within ATMPs?

The project will increase the awareness within the ecosystem, on what is needed to take an ATMP all the way to the patient and the market. The project will also identify key hinders and suggest possible solutions for sustainable business models of ATMPs. This will, in the long run, form a basis for improving Sweden´s capabilities within ATMPs.

For more information contact Anna Ridderstad Wollberg