J&J secures nod for CAR-T therapy amidst MSAC criticism

Pharma News: The CAR-T therapy Carvykti (cilta-cel) has been recommended by the Medical Services Advisory Committee (MSAC) as a fifth-line treatment for relapsed or refractory multiple myeloma. This decision comes after a third application from Johnson & Johnson Innovative Medicine, formerly known as Janssen.

Criticism has been directed at the company, with the MSAC stating, “the applicant’s unwillingness to negotiate on the unit price of cilta-cel since its initial application in July 2022 and failure to address the MSAC’s concerns was delaying access to publicly funded treatment for Australian patients.”

Payment to J&J Innovative Medicine will be made in instalments over a four-year period, contingent on evidence that the patient shows no signs of myeloma progression. An independent registry will collect the necessary data to support this. However, the details are yet to be negotiated.

The next step involves finalising a deed of agreement between the Federal Government and J&J Innovative Medicine for 50% of the funding. Based on previous CAR-T therapies from Gilead, this process could take a lengthy 18 to 30 months. Following this, negotiations with State Governments for the remaining 50% of funding will commence.

Mark Henderson, CEO of Myeloma Australia, told Health Industry Hub, “We welcome this step forward in providing access to CAR T cell therapy for Australians with myeloma. We hope the next phase of obtaining State and Territory agreements progresses quickly, so eligible patients can access this life saving treatment option.

“Therapies in Australia have not kept pace with the rate of innovation in other countries and we look forward to a time where myeloma patients in Australia are able to access the best possible treatment options that are already being utilised in other parts of the world.”

Urs Voegeli, Managing Director, Johnson & Johnson Innovative Medicine, Australia & New Zealand, said “Johnson & Johnson will work through the further negotiations with Federal and State Governments which are necessary to navigate the complexities of bringing this highly specialised therapy to Australian patients.”

Earlier this month, J&J announced the “statistically significant and clinically meaningful” overall survival results from the phase 3 CARTITUDE-4 trial, which compared Carvykti with standard combination therapies in myeloma patients who had tried one to three prior lines of therapy.

Carvykti has already received FDA approval as a second-line therapy for multiple myeloma based on CARTITUDE-4 data, showing that the BCMA-targeted CAR-T can lower the risk of disease progression or death by 59% compared to standard therapies. This overall survival advantage may place Carvykti ahead of BMS’ rival CAR-T, Abecma (idecabtagene vicleucel).

An analysis of CARTITUDE-4 will be submitted to regulatory authorities worldwide, according to the company.

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