by Sabine Ohlenbusch
BERLIN, 12 Apr (APM) - Novartis Germany is seeking more "innovative payment models" for its CAR-T cell therapy Kymriah (tisagenlecleucel), the company has told APM.
"Novartis is in discussions with more payers," the company told APM in a Wednesday emailed exchange.
Novartis signed the first outcomes-based contract for a CAR-T cell therapy in Germany for Kymriah at the beginning of March with payer purchasing body GWQ. The contract is set to last until Novartis and umbrella payer group GKV-Spitzenverband (GKV-SV) have found a reimbursed price but could be renewed or updated later (APMHE 62156
Kymriah was approved in the EU in August 2018 for a one-off treatment of B-cell acute lymphoblastic leukaemia (ALL) in children and young adults and in relapsed or refractory diffuse large B-cell lymphoma (DLBCL) in adults (APMHE 59438
). The orphan drug was launched in Germany in September 2018 at a price of €320,000 (APMHE 59716
Novartis is in pricing negotiations with GKV-SV under the AMNOG pricing law, the company confirmed. These started on the basis of the 'unquantifiable added benefit' rating given by higher health technology assessment (HTA) body G-BA in March (APMHE 62173
"The result of the pricing negotiations will be the reimbursed price, which will take effect on 15 September," Novartis added.
Under Germany's drug pricing law AMNOG, the launch price of a new drug is freely determined by the manufacturer and is maintained for one year while HTA procedures are completed and the manufacturer and GKV-SV negotiate a new reimbursed price.
New treatment option in hospitals
From this spring, single hospitals can negotiate individual remuneration with payers for Kymriah's therapy costs as a new treatment option under the framework of the so-called 'NUB system', Novartis also told APM.
For 2019, Kymriah received a 'NUB status 1', which means that the therapy meets the criteria for hospital-individual NUB agreements, it added.
In October 2018, GKV-SV said that patients' access in hospitals would simplify in 2019 when CAR-T cell therapies would have received NUB status (APMHE 60292
The NUB status is valid for one year and must be renewed annually. The NUB phase usually lasts up to three years.
Novartis said that, in general, the reimbursed sum covers the cost of the drug, whereas services provided by hospitals are usually paid for by case rates determined by diagnosis-related groups (DRGs) or by so-called supplementary charges.
Receiving NUB status is the condition for later inclusion in DRGs as part of a regular hospital reimbursement scheme for a treatment.