ICER releases report on Pierre Fabre’s tab-cel

The Institute for Clinical and Economic Review (ICER) has released a Final Evidence Report assessing the comparative clinical effectiveness of Pierre Fabre’s tabelecleucel (tab-cel) for the treatment of Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD).

The U.S. drug pricing watchdog’s independent appraisal committee voted on the evidence for people with relapsed/refractory EBV+ PTLD who have received at least one prior therapy, unanimously finding that current evidence is adequate to demonstrate a net health benefit for tab-cel when compared to usual care.

EBV+ PTLD is a rare and often fatal cancer that is associated with solid organ transplant and allogeneic hematopoietic stem cell transplant. Approximately half of EBV+ PTLD cases are refractory to initial treatment and/or relapsed; in such cases, additional treatment options are limited and survival is poor.

Because there was no firm estimate of a potential U.S. launch price during the public meeting, the panel did not vote on the treatment’s long-term value for money. However, ICER has calculated a health benefit price benchmark (HBPB) to be between $143,900 to $273,700 per treatment cycle. Tab-cel, an allogeneic T cell immunotherapy, is administered intravenously for three doses per cycle for a minimum of two cycles and can be administered for additional cycles if there is not a complete response to the initial cycles.

In 2021, France-based Pierre Fabre paid Atara Biotherapeutics $45 million upfront with the promise of an additional $320 million in milestones for the rights to commercialize tab-cel Europe, Middle East, Africa, and other select emerging markets. The deal was expanded in December 2023, granting Pierre Fabre the development, manufacturing, and commercialization rights for tab-cel in the U.S. and all remaining markets.

The U.S. FDA accepted the BLA for tab-cel back in July, giving the treatment priority review and assigning a PDUFA date of January 15, 2025. The treatment was granted marketing authorization under the brand name Ebvallo in December 2022 by the European Commission. Marketing authorization was also granted by the Medicines and Healthcare Products Regulatory Agency in the UK in May 2023 and by Swissmedic in Switzerland in May 2024.