At the time of launch in the German market, pharmaceutical companies are free to set the price for their product with a new chemical entity (NCE). This price is then valid for the first 12 months from the day of launch.
After the G-BA published its final resolution on the additional benefit of the product, price negotiations between the pharmaceutical company and the GKV-SV, i.e., representatives of the SHI funds, will commence. There is one exception: if the G-BA concludes “No additional benefit (proven)” and the product falls into an existing reference price group, then the price is determined by the reference pricing system instead of negotiation.
The pharmaceutical company and the GKV- SV are now expected to agree on a reimbursement price within 6 months. These price negotiations are confidential.
Main factors considered in the price negotiations
If both parties cannot agree on a price, a final decision on the price will be made by an arbitration board.
Throughout the process, both, the pharmaceutical company or the GKV-SV, have the right to commission the IQWiG to conduct a formal evaluation of the costs and benefits of the product.
The final negotiated price is published in the Lauer Taxe database (publicly available, for a subscription fee).
