Authors: Ina Berger, Thomas Frankl, Dr. rer. nat. Ingo Hantke, Dr. nat. med. Alexandra Martyniszyn-Eiben, Dr. rer. nat. Dominik Müller, PD Dr. rer. nat. Sabrina Schlie-Wolter, Heike Kielhorn-Schönermark, Prof. Matthias P. Schönermark, M.D., Ph.D. (2023)
In recent years, the number of gene and cell therapies on the German market has steadily increased. By the beginning of 2023, more than 20 products have been launched and many more are in development, offering the hope of revolutionizing healthcare even further.
Many of the challenges to market access for gene therapies such as manufacturing problems and generation of high-quality clinical evidence are general in nature. Reimbursement problems, on the other hand, are country-specific. Especially in Germany, an optimal market access strategy needs to take multiple layers and prerequisites into account in order to eventually reach the overall goal: treating as many patients in need with an adequately reimbursed price.
In 2020, SKC had analyzed the gene therapy landscape and published a whitepaper on the strategic challenges and potential solutions in Germany. Since then, new laws substantially changed the German benefit assessment and price negotiation landscape, new (methodological) requirements were implemented, additional options to close evidence gaps were introduced, an EU-wide HTA is on the horizon, and several new gene therapies became learning cases: they made it into the market – or failed.
Therefore, we have prepared a comprehensive analysis to derive key considerations for the strategic challenges for gene therapies in Germany, with a focus on pricing and reimbursement. Both, the holistic view as well as individual case examples reinforce the need for early engagement, strategic positioning, and continuous monitoring and learning.
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