A gene that rescues children with a hereditary eye disease before Blindness. A cancer therapy, which can cure with genetically modified immune cells dying of blood cancer patients. A gene therapy for Haemophiliacs save the constant spraying of expensive blood-clotting agent and a normal life. It is a great success, that such medical innovations are currently or soon in the clinical application. For the health system, the associated costs are, however, a great challenge.
Who should pay?
Luxturna, gene therapy for blindness, has been priced in in the USA with 850 000 dollars per treatment. The CAR-T cancer therapy Kymriah is 380 000 euros – dozens more waiting in the approval pipeline. And the gene therapy for hemophilia could cost the technician health insurance (TK), after the approval of 2023 is estimated at one Million Euro per Patient. The treatment heals the blood disease is most likely to replace annual therapy costs of about 120 000 euros per Patient. But at 4000 hemophiliacs-patients in the Federal Republic, the expenditure of the Statutory health insurance of currently € 480 million per year, could rise to four billion.
“That would be about ten percent of the current total expenditure of the GKV for medicines,” said Jens Baas, Chairman of the Board of TK. And it will not stay at these few examples, the refund problem is growing. On Wednesday, the TK price presented a “new model for a rapid market access and a fair price determination of such therapies”, “dynamic Evidence”.
The idea is to come up with more meaningful data and more reasonable rates
The concept is mainly a collection of data, the success or failure of novel therapies measured. However, this data provides for flow in the Register, the “to be financed by producers and funds independently,” and – contrary to the draft of the Federal Ministry of health, for the amendment of the “act for the security of the drug supply” (GSAV). Ideally, should assume the Joint Federal Committee G-BA this task, said Baas on demand the daily mirror.
So, the technicians health insurance Fund before the reimbursement procedure for Gene and cancer therapies. This is a concept that the…negotiate graphics: techniker Krankenkasse
After a period of two years, manufacturers and health insurers will then use this data to map the performance of the therapy is more realistic than at the time of admission, for the first time on the reimbursement prices. “These price negotiations are to be repeated thereafter at 12-month intervals on the Basis of the current data object”, – stated in the “Drug Future Report” of the TK (pdf here). It should have an impact on the price positive, if the manufacturer, research in Germany, or produce. In the two years of “data collection” should the manufacturer of the prices “up to a limit, which is based on the average European prices, free to choose”.
More about
The best science of the year, A gene therapy, the doomed children to save
Sascha Karberg
After a long debate behind the Scenes about better payment models, the TK is now the first Fund, presenting a concept and demands Changes. The impartial Chairman of the G-BA, Josef Hecken, has shown “positive interest,” says Baas. Ultimately, the legislature is required to define new pricing rules.
