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 (APMMA 63072) (APMMA 63081) (APMMA 60749).
TK suggested an ATMP-pricing scheme that would need regulatory changes (APMMA 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 (APMMA 59438, APMMA 59444). They were respectively launched in Germany in September 2018 (APMMA 59716) and October 2018 (APMMA 60474).
Kymriah is priced €320,000 for hospitals and Yescarta €327,000. Kymriah's listed price remains unchanged at €320,000, Novartis told APM.
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 (APMMA 62173, APMMA 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 (APMMA 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.
hm/nm
TRY APM Market Access AND GET ACCESS TO THE FULL CONTENT
Interviews with KOLs/senior executives amongst the Regulators, Payers, Health, Medical & Pharmaceutical organisations
Events coverage with a unique focus on Market Access & sustainability of healthcare systems
6 European bureaus : Berlin, Brussels, London, Madrid, Milan & Paris
Ask for a Free trial and get access to the latest stories
Our coverage includes:
- Health Care
- Market Access
- HTA – policies & practices
- European medicine regulations
- Drug safety issues
- Pricing & Reimbursement
- International medicines agencies
If you are a Payer, Pharmaceutical or Consulting professional our premium data will keep you informed on the regulatory, pricing, market access and cost-effectiveness issues that impact all stakeholders.
REQUEST
an initial 10 day temporary access of APM Market Access.
