by Sabine Ohlenbusch
LEIPZIG, 31 Aug (APM) - Novartis Germany said it is in talks with German payers for outcome-based contracts for CAR-T therapy Kymriah (tisagenlecleucel).
Novartis is "basically willing" to a pay-for-performance scheme, Markus Karmasin, head of cell and gene therapy at Novartis oncology Germany told reporters in a roundtable discussion in Leipzig on Thursday.
Karmasin said that the launch of Kymriah was "imminent" following its EU approval on Monday (APMMA 59504). Negotiations about the commercial use of Kymriah in university clinics Frankfurt and Cologne are being run "on the final metres".
Kymriah will be listed in the pharmacists' data base Lauer-Taxe at a retail price of €320,000, which is consistent with the manufacturer price since Kymriah will be distributed solely via hospital pharmacies of specialised centres, he said.
However, pharmaceutical companies have the option of negotiating contracts on alternative pricing schemes directly with individual health insurance companies.
"We are in discussion with payers, we have to make sure that this leads to a practicable construct," Karmasin added.
An important point is to agree on parameters that qualify to measure success, Karmasin said.
Furthermore, Karmasin pointed out that such a scheme had to be manageable on the administrative side: "We have to make sure this eases the access to therapy for patients," he added.
Germany is the first EU market in which the drug will be launched. Under pricing law AMNOG, the launch price of a new drug is freely determined by the manufacturer. The price is maintained for one year while health technology assessment (HTA) procedures are completed and the manufacturer and umbrella payer group GKV-Spitzenverband (GKV-SV) negotiate a new reimbursed price.
In the U.S. where Kymriah was approved in its first indication in August 2017, Novartis set its price at $475,000 for children and young adults’ acute lymphoblastic leukaemia (ALL) (APMMA 54486) and at $373,000 for large B-cell lymphoma (APMMA 57941).
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