Unveiling the bottleneck: Delayed access to Gilead’s CAR T-cell therapy

Pharma News: Minister for Health and Aged Care, The Hon Mark Butler MP, shed light on the funding prospects for Gilead’s CAR T-cell therapy in mantle cell lymphoma, a recommendation put forth by the Medical Services Advisory Committee (MSAC) two years ago.

Up until recently, the administration of CAR T-cell therapy required T cells to be shipped overseas for modification, either to Europe or the US, and then returned to Australia for reinfusion into patients. However, a few weeks ago, Minister Butler marked a turning point by inaugurating the first manufacturing site for CAR T-cell therapy in the Southern Hemisphere at the Peter MacCallum Cancer Centre in Melbourne’s Parkville. This facility will allow Australia to independently modify T cells, ensuring sufficient production to meet national demands and even extend export capabilities to the region.

The delivery of CAR T-cell therapy is orchestrated through public hospitals by state governments, operating under a co-funded 50-50 cost-sharing arrangement pursuant to the Hospital Funding Agreement. Consequently, obtaining state government consent is a pivotal step in funding this advanced therapy.

Minister Butler explained, “The drug manufacturer Gilead, responsible for Tecartus (brexucabtagene autoleucel), submitted an application to MSAC for approval back in 2020 and 2021, advocating for a specific price for the therapy. MSAC approved the therapy as clinically effective but recommended a much lower price, and Gilead refused to act on that recommendation.”

He added “Several months ago, my department engaged Gilead to resubmit their proposal at a reduced cost, which they eventually did. MSAC then, out of session, approved that price and sent that recommendation to me. I accepted this recommendation and, just a few weeks ago, I accepted the recommendation and only a few weeks ago wrote to the state governments asking them to agree for us to act jointly on that. I’m still waiting for a response. They deliver the therapy, and- I must really stress this – they have to agree to it. I’m hoping for urgent action on this.”

Gilead announced pivotal findings from the largest real-world analysis to date of Tecartus (brexucabtagene autoleucel) in patients grappling with relapsed or refractory mantle cell lymphoma (R/R MCL). With a median follow-up of 12 months, the overall response rate (ORR) was 90%, aligning closely with the ZUMA-2 trial outcomes, and a high complete response (CR) rate of 78% was observed in patients administered Tecartus.

Furthermore, at the 12-month mark, the duration of response (DOR), progression-free survival (PFS), and overall survival (OS) rates were recorded at 64%, 61%, and 74%, respectively. Notably, grade 3 or higher cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) incidences were reported at 10% and 28%, respectively. In a noteworthy finding, Tecartus exhibited consistent effectiveness (ORR 92%, CR 83%) and safety outcomes in BTKi-naïve patients when compared to those previously treated with BTK inhibitors.

Data from this real-world registry underscored the potential benefits of early Tecartus treatment for patients facing the challenging mantle cell lymphoma compared to later lines, suggesting promising outcomes that warrant further evaluation in subsequent studies.

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