Commercial aspects of ATMPs
Learn more about the Health Technology Assessment related issues of your ATMP development!
The goal of the following resources is to increase the likelihood that ATMPs developed or marketed in Sweden will actually be accessible to patients. Risks around commercial considerations during development and at market approval are discussed as well as the importance of healthcare/industry partnerships for implementation and early health economy considerations.
Product developers, healthcare and industry are encouraged to use these resources to increase their understanding of the similarities and differences of ATMP drug development compared to traditional pharmaceuticals and to understand the critical aspects they can contribute to in order to expedite ATMP generation, delivery and reimbursement in Sweden.
The final report Final rapport dec 2020;
The main target group for the report are SMEs. The report acts as a support resource for development of ATMPs highlighting what needs to be done early to make sure products not only make it to market approval but to reimbursement, the best access for patients. As a tool the report investigates Health Economy questions around certain types of ATMPs and proposes solutions that could scale to the National level and to a variety of products.
Appendix documents to this report;
- ATMP Health Technology Assessment checklist to better prepare you (Bilaga A) (Guide to using the checklist – Bilaga B)
- A generic TPP template for ATMP (in English) (Bilaga C)
- An explanation of value-based pricing for drug reimbursement (Bilaga D)
- Commercial issues regarding regulations in ATMP development (Bilaga E)
- A presentation of Health Economics, Pricing & Reimbursement models for ATMPs in other countries (in English) (Bilaga F)
- Initial results of global market analysis of ATMP for China, Japan and South Korea (in English) (Bilaga G)
- An introduction to the sakigake fast-track review system (in English) (Bilaga H)
- European benchmark analysis of ATMP market entry from an HTA perspective (in English) (Bilaga I)
- A high level road map of the pharmaceutical development process for ATMPs (image below – yellow boxes covered in this report) (enlargeable version)