Gene therapy in Germany – Innovation vs. Reimbursement
Gene therapies as well as somatic stem cell therapy medicinal products and Tissue Engineered Products pertain to the group of ATMP (advanced therapy medicinal products). The central approval is granted by the EMA. Prior this decision, the CHMP as well as the expert committee CAT make their recommendations based on a benefit-risk assessment. However, the approval is only the first hurdle on the way to a successful gene therapy, since the reimbursement must be realized in every single European country. For instance, in Germany the pathway to reimbursement follows the same rationale as for other drugs. In case of an approval the pharmaceutical company must submit a dossier. On that basis, the Federal Joint Committee (G-BA) assesses the additional benefit of the drug and decides about the relevant patient population and annual therapy costs. The resolution of the G-BA is legally binding and together with the costs of comparable drugs and other European prices sets the basis for the subsequent price negotiations between the pharmaceutical company and the umbrella organization of the statutory health insurance. As a result, a price for the therapy is determined that will be paid by every statutory health insurance in the future.
For gene therapies, the model did not seem to be adequate. A gene therapy induces extremely high but only one-time treatment costs caused by its singular administration. The foregoing stands in opposition to the currently available therapy options, which focused on long-term treatments that must be paid over the whole period especially for chronic diseases. The therapy can be switched or stopped, if the efficacy is no longer present or decreasing. Therefore, the drug will only be reimbursed if the treatment is ongoing and the efficacy is proven. This principle is not possible for gene therapies due to the single administration, so that the total treatment cost will apply without special knowledge about the individual duration and effect of the treatment. This uncertainty in conjunction with the high costs encounter the innovative possibility to cure diseases with a single treatment. This may lead to critical attitudes towards the pricing system of gene therapies not only in Germany but also elsewhere.
To address this dilemma in the future and pave the way for gene therapies in Europe and Germany, the article “gene therapy ante portas – Appropriate solutions for the reimbursement dilemma” discusses alternatives to the current reimbursement systems. The article can be found in the new issue of “Welt der Krankenversicherung” (http://www.welt-der-krankenversicherung.de/).
To read the full article for free in English please click here.