Oncopeptides announces successful price negotiations for Pepaxti in Germany
Stockholm – September 26, 2023 – Oncopeptides AB (publ), a biotech company focused on difficult-to-treat cancers, today announces that following negotiations between Oncopeptides and the German Federal Joint Committee National Association of Statutory Health Insurance Funds (GKV-Spitzenverband), a reimbursed price for Pepaxti has been agreed on in Germany. The negotiated reimbursed price in Germany, which will also guide negotiations in other European markets, is reflective of the innovation Pepaxti brings to the market, and in line with the company´s financial projections.
“Germany’s system for setting reimbursed prices is designed to balance the need for patient access to innovative medicines, ensure the financial sustainability of the healthcare system, and provide fair returns to pharmaceutical manufacturers for their innovations. We are happy that we have been able to agree on a price that we believe reflect the innovative nature of Pepaxti and is fair,” says Sofia Heigis, CEO of Oncopeptides. “Given the complexities of commercializing a drug within the EU, achieving a fair price cannot be taken for granted, and we see this step as a confirmation of the already strong belief we have in our product, and it allows us to continue our ambitious commercialization effort across Europe.”
Several factors decide the reimbursed price of a new drug, including the innovation the drug adds and the existence of existing treatments (comparators) for the same condition in the same line of treatment. The negotiated price is valid for Pepaxti in its current indication.
How are price negotiations in Germany conducted?
After a drug receives marketing approval from the European Medicines Agency (EMA), individual European Union member states decide the pricing and reimbursement of that drug within their legislation. In Germany, this is an established system of additional benefit evaluation (AMNOG) and reimbursed price negotiation based on the AMNOG rating.
Are you able to communicate the price?
The reimbursed price will be made public later this fall by publication in Lauer Taxe, a database of all pharmaceuticals approved on the German market, before then we are not able to communicate it publicly due to ongoing price negotiations in other markets.
What price have you used this far when selling in Germany?
We have a current list price of €10,900 per month (€5,450 per vial), however we have accrued for a discounted price in line with the now confirmed price since April 1. It is common procedure to receive a lower price following negotiations in different markets.
How can the negotiated price in Germany affect price negotiations in other EU markets?
The price of a drug negotiated in Germany can influence its pricing in other European countries due to External Price Referencing (EPR), where countries compare drug prices with those in other markets. Given Germany’s status as a key reference country in many EPR systems, a price change there can set a benchmark for other nations. However, individual countries also weigh other factors like health system priorities and economic conditions when setting drug prices.
How would this affect the price of Pepaxti in potential earlier lines of treatment?
Pepaxti is currently approved as a treatment for multiple myeloma in later lines of treatment, where there currently is a high unmet need. Should Oncopeptides decide to extend its indication to earlier lines of treatment, something that was made possible through the recently received CHMP opinion, new price negotiations would take place.