Funding and local manufacturing for Novartis' CAR-T therapy

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The wait is over for funded access to Novartis' CAR-T therapy with KYMRIAH (tisagenlecleucel) to be reimbursed for paediatric and young adult patients up to 25 years old with B-cell precursor acute lymphoblastic leukaemia (ALL).

Confirmation of the funding follows recent approval by the Medical Services Advisory Committee. The government has previously confirmed CAR-T will be funded and administered via the public hospital system.

"Novartis is delighted about today’s announcement and the difference this therapy will make to patients in Australia," said Lauren Carey, general manager Oncology and country president, Novartis Australia and New Zealand.

"I am also delighted that Novartis Global Group has entered into negotiations of a manufacturing agreement and, subject to future volume expansion, to complete the technical transfer of the manufacturing process for Kymriah to Cell Therapies at Peter MacCallum Cancer Centre.”

"CAR-T therapy is paradigm-changing and we welcome this announcement which will ensure young ALL patients will now have affordable access to this transformative treatment,” said Associate Professor Simon Harrison, director of Centre of Excellence in Cellular Immunotherapy and Director of Apheresis, Peter MacCallum Cancer Centre.

"We are proud that we can offer these state-of-the-art therapies as a government-funded standard-of-care to Australian patients who need them.”

"CAR-T therapy is a one-time treatment manufactured for each individual patient using their own cells and now that we can treat very sick Australian children is wonderful news," said Richard Vines, founder and chairman, Rare Cancers Australia.

"This development is further amplified by the manufacturing capabilities at Peter MacCallum Cancer Centre that will position Australia as a leader in the Asia-Pacific region."

“Medical Services Advisory Committee is still evaluating KYMRIAH for the treatment of adult patients with relapsed or refractory diffuse large B cell lymphoma (DLBCL) after two or more lines of systemic therapy," added Ms Carey. “We are committed to working closely with the Medical Services Advisory Committee and the Department of Health to enable access to all eligible patients.”