BERLIN, 21 June (APM) - Six German payers have signed two pay for performance agreements over the two approved CAR-T cell therapies, Novartis's Kymriah (tisagenlecleucel) and Gilead's Yescarta (axicabtagene ciloleucel), APM has learned.
The umbrella organisation vdek, comprising six major statutory health insurers covering 28 million people in Germany, has concluded two separate agreements, according to a payer source on Thursday.
The six payers inclue three large companies - TK (10.4 million insurees), Barmer (9.2 million), DAK-Gesundheit (5.7 million) - and three smaller firms, KKH, HKK and HEK.
Both Novartis and Gilead confirmed to APM that they have signed outcome-based agreements. Asked by APM, vdek refused to comment.
The move comes amid ongoing discussions among German payers on the most appropriate agreements to limit the cost of CAR-T therapy and advanced therapy medicinal products (ATMPs) as a whole (APMHE 63072
) (APMHE 63081
) (APMHE 60749
TK suggested an ATMP-pricing scheme that would need regulatory changes (APMHE 62073
Gilead has signed "an outcome-based discount agreement on Yescarta" with vdek that is "initially valid for two years", the company told APM in an emailed statement on Thursday.
"The success of the therapy is measured by the duration of the patient's survival", the U.S. biotech added.
In another emailed conversation with APM, Novartis said its agreement with vdek for Kymriah "includes patient survival as an outcome parameter".
The Swiss pharma added: "If the patient dies within a defined period after treatment with Kymriah, Novartis reimburses part of the cost of the drug to the health insurance fund."
Kymriah and Yescarta were both approved in August 2018 in the EU for certain forms of lymphoma and leukaemia (APMHE 59438
, APMHE 59444
). They were respectively launched in Germany in September 2018 (APMHE 59716
) and October 2018 (APMHE 60474
Kymriah is priced €320,000 for hospitals and Yescarta €327,000. Kymriah's listed price remains unchanged at €320,000, Novartis told APM.
Each is currently undergoing pricing negotiations with umbrella payer group GKV-Spitzenverband after undergoing health technology assessment (APMHE 62173
, APMHE 62860
Both Gilead and Novartis declined to provide any additional details for reason of confidentiality.
First contract for Yescarta
This deal is the first outcome-based agreement announced so far for Yescarta in Germany, though Novartis has already signed a pay-for-performance agreement with a group of payers (GWQ) covering 12 million people on Kymriah in March (APMHE 62156
According to the DeutschesArztportal website, which monitors discount agreements in Germany, 60 statutory payers covering 41 million insurees have signed a discount agreement on Kymriah.
Apart from payers belonging to GWQ and vdek, also a regional insurer, AOK Rhineland-Hamburg signed an agreement, according to the website.