Battle lines drawn in mission for EU CAR-T reimbursement

With both therapies already approved in the USA and backed by strong data sets, getting European health technology assessment (HTA) bodies on board over Yescarta (axicabtagene ciloleucel) and Kymriah (tisagenlecleucel) was always going to be a bigger battle than getting regulatory approval.

As if to confirm that, over the weekend that both were approved by the European Medicines Agency, one of the major cost watchdogs published guidance not recommending routine funding for Yescarta, a therapy from Gilead Sciences (Nasdaq: GILD) that is indicated for relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and primary mediastinal large B-cell lymphoma (PMBCL), after two or more lines of systemic therapy.

"All the cost-effectiveness estimates are above the range normally considered to be a cost-effective use of NHS resource"