The company has submitted the AMNOG dossier to “The Federal Joint Committee” (G-BA) in Germany.
This initiates the commercial launch of Pepaxti (melphalan flufenamide) and thus Germany will be the first market in Europe where the drug is launched, states the company in a press release.
“The launch of Pepaxti in Germany is an important milestone for Oncopeptides and very good news for patients with triple class refractory disease,” says Jakob Lindberg, CEO of Oncopeptides. “Multiple myeloma is an incurable disease, and despite the recent introduction of several novel therapies, there is a high unmet medical need that Pepaxti may satisfy, in particular in the large population of elderly patients with relapsed refractory multiple myeloma.”
Marketing Authorization in Europe
On August 18, the European Commission granted Pepaxti, in combination with dexamethasone, Marketing Authorization in the European Union and countries in the European Economic Area, for the treatment of adult patients with multiple myeloma who have received at least three prior lines of therapies, whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one anti-CD38 monoclonal antibody, and who have demonstrated disease progression on or after the last therapy. For patients with a prior autologous stem cell transplantation, the time to progression should be at least 3 years from transplantation.
An average price of 10.900 EUR per cycle/month
The ex-manufacturer price amounts to 5.450 EUR per vial, concluding an average price of 10.900 EUR per cycle/month. The price reflects the clinical benefit for patients in the approved indication. The price is valid for one year and will be subject to negotiations with the National Association of Statutory Health Insurance Funds to set a reimbursed price for German sick funds.
According to data from more than 60 sick funds in Germany in 2020, the prevalence of multiple myeloma is estimated to 59.000 patients and the annual incidence of diagnosed patients is approximately 9.200 cases. The indicated population for Pepaxti in Germany amounts to around 2.500 patients.
Photo of Jakob Lindberg: Oncopeptides