Germany’s first outcomes deal for CAR-T-cell therapy

By Ciaran Cassidy, Analyst

Email: [email protected]

Novartis recently announced an innovative reimbursement scheme with the GWQ –  (a body representing a small number of insurance funds in Germany) –  for its CAR-T cell therapy, Kymriah (tisagenlecleucel).

Since September 2018, Kymriah has been used to treat patients up to the age of 25 with refractory and acute lymphocytic B-cell leukaemia and adult patients with relapsed or refractory diffuse large B-cell lymphoma.

Under this agreement,  Novartis will partly reimburse the cost of their €320,000 per patient (pending negotiations) drug Kymriah, in the event a patient dies due to their blood cancer within an agreed time frame.

This model is a first in Germany for CAR-T therapies and while the price and time-frame are set to be negotiated both parties praise the risk sharing effort and support further such agreements to increase patient access in future.

According to Markus Karmasin, a Business unit manager for Cell and Gene Therapy at Novartis Oncology, the move is believed to be “forward-looking especially for gene therapies….”

An outcomes based deal which falls under pay-for-performance type deals involving pharmaceuticals is not entirely a new trend in Europe. But it has been increasingly considered as a pathway to ensure the viability of new products that have a distinct or complex set of pricing requirements for eg: high upfront costs for gene therapies.

In November 2018, GWQ entered into an outcomes deal with Merck in a bid to provide access to latter’s multiple sclerosis drug Mavenclad (cladribine).

Further support for this trend can be seen with the largest health insurance fund in Germany (Techniker Krankenkasse) implementing a system for dynamic pricing. Within this system, the initial market entry price is retained for two years and then evaluated based on treatment results .

Among other European countries, Italy has pioneered centrally managed outcomes-based agreements since 2006  and France’s agreement with Celgene on myeloma drug Imnovid (pomalidomide) suggests further interest in using outcome based deals.

This trend is expected to continue, providing impetus to research and development efforts in rare diseases where increasingly premium therapy costs affect treatment access.

Indeed, another CAR-T therapy Gilead Sciences’ Yescarta (axicabtagene ciloleucel) with costs nearly £300,000 per patient was able to strike a discount based deal with NHS England in October 2018  to initiate access. With innovative and flexible reimbursement agreements payers can derisk their large upfront investments in these new forms of patient care.

The steps were taken by Novartis and GWQ look not only to increase the patient access to the most innovative therapies but may also be part of a larger trend which aids both innovators, patients, and payers across Europe.

Partners4Access is an expert global consultancy specializing in access for orphan drugs, cell and gene therapy. If you would like support in your product candidate commercialization journey, please contact the team on [email protected].





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