Gilead seeks funding of CAR T-cell therapy in follicular lymphoma

Pharma News: Gilead has applied to the Medical Services Advisory Committee (MSAC) for funding of its cutting-edge CAR T-cell therapy, Yescarta (axicabtagene ciloleucel), to combat relapsed or refractory Follicular Lymphoma (FL), the second most prevalent lymphoma diagnosed in the Western hemisphere.

Gilead’s application is underpinned by claims of superior efficacy and non-inferior safety in comparison to Standard of Care (SoC) and a ‘basket’ of anti-CD20 monotherapy, anti-CD20 therapy in combination with chemotherapy regimens. This evaluation draws from the data of the ZUMA-5 study and an external cohort, the SCHOLAR-5 study.

Recent findings from the four-year follow-up of the ZUMA-5 trial are promising. At a median follow-up of 52.5 months, the overall response rate (ORR) held steady at an impressive 90%, with a 75% complete response rate. The median progression-free survival (PFS) reached 57.3 months, while the 48-month overall survival (OS) rate stood at an encouraging 72%.

Starting January, another Gilead CAR T-cell therapy, Tecartus (brexucabtagene autoleucel), has been publicly funded for patients with mantle cell lymphoma, a rare subtype of non-Hodgkin lymphoma. This includes those who have relapsed or are refractory to at least two lines of therapy. Access to this treatment is available at The Alfred (Melbourne), Royal Prince Alfred (Sydney), Peter MacCallum Cancer Centre (Melbourne), and Westmead Hospital (Western Sydney), with additional centres anticipated to join the initiative.

Also, Gilead’s re-application for Tecartus (brexucabtagene autoleucel) has resulted in its recent recommendation by the MSAC for funding in adults facing relapsed or refractory B-precursor acute lymphoblastic leukaemia.

However, the path to making these highly specialised therapies accessible to patients is not without challenges. These therapies are jointly funded by the Commonwealth Government and State & Territory Governments, currently on a 50/50 basis as per the National Health Reform Agreement (NHRA). There are differences across jurisdictions in funding of CAR T-cell therapy, preferred implementation approaches and support to patients. Limited funding allocation, coupled with the misalignment of jurisdictional budget cycles to the timing of the MSAC announcement, further complicates the situation.

Recently, the MSAC rejected Janssen’s CAR T therapy, Carvykti (cilta-cel), for multiple myeloma, citing the necessity for a ‘substantial price reduction’ despite its clinical superiority. This decision underscores the delicate balance between innovation and affordability in the rapidly advancing field of CAR T-cell therapies.

Unfortunately, the differences in access, approach and timing of approvals by the Commonwealth Government and State & Territory Governments is not optimal, and it occurs at a detriment to patients.

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