Commercial Aspects
This page provides resources on Health Technology Assessment (HTA) related aspects of ATMP development.
Purpose
The goal of these 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 and industry partnerships for implementation and early health economy considerations.
Product developers, healthcare professionals, and industry representatives 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 development, delivery, and reimbursement in Sweden.
Final Report
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 reach market approval, but also reimbursement – ensuring the best possible patient access. 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.
The report and some of its appendices have been translated from the Swedish versions to English, as requested by stakeholders when the report was circulated for review in 2020. Appendices A and B were translated by IHE – The Swedish Institute for Health Economics, the report and appendix D were reviewed and translated by Svensk Språkservice. The translation of the report and appendix D have been edited and corrected in terms of terminology, by members of the project team, into version 3.
Report Appendices
- ATMP Health Technology Assessment checklist (Bilaga A English, Swedish)
- Guide to using the ATMP HTA checklist (Bilaga B English, Swedish)
- A generic TPP template for ATMP (Bilaga C English)
- An explanation of value-based pricing for drug reimbursement (Bilaga D English, Swedish)
- Commercial issues regarding regulations in ATMP development (Bilaga E Swedish)
- A presentation of Health Economics, Pricing & Reimbursement models for ATMPs in other countries (Bilaga F English)
- An introduction to the Sakigake fast-track review system (Bilaga H English)
- European benchmark analysis of ATMP market entry from an HTA perspective (Bilaga I English)
