On July 28, 2021 EVERSANA reported After reassessing Gilead/Kite’s CAR-T therapy Yescarta (axicabtagene ciloleucel) following the collection of three-year survival data, the Zorginstituut (ZIN) has determined the treatment to be effective but necessitating a 5% price cut, as its budget impact will most likely exceed €44.9 million (Press release, EVERSANA, JUL 28, 2021, View Source [SID1234585280]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
In the Netherlands, Yescarta is cleared for use in the treatment of adult patients with 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.
Yescarta was initially placed in the lock for expensive medicines but following price negotiations between the Minister for Medical Care and the manufacture, the CAR-T therapy secured reimbursement through the basic care package from May 1, 2020 until December 1, 2021. However, Gilead/Kite’s CAR-T was made available only to patients with high disease burden because there is no other effective treatment available for this subgroup.
Amidst price negotiations, ZIN recommended Yescarta be made available to patients, considering the curative property of the therapy. Initially, ZIN recommended against inclusion of Yescarta in the basic care package unless a price reduction could be agreed; by how much was indeterminable at the time. Due to uncertainty in the long-term efficacy of Yescarta, ZIN advised a "pay for performance" agreement for the therapy and agreed to follow up on its decision by 2022.
The long-term efficacy of the CAR-T therapy has since been monitored, with three-year survival data now available. As such, ZIN concluded that Yescarta "meets the state of science and practice after a median follow-up time of 51 months," meaning that the drug is effective. Given the potential for Yescarta to have actual budget impact exceeding €44.9 million, ZIN called for a price reduction of 5%.