register

News & Trends - Pharmaceuticals

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

Health Industry Hub | July 8, 2024 |

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.

In reimagining healthcare, Health Industry HubTM is the ONLY one-stop-hub uniting the diversity of Pharma, MedTech, Diagnostics & Biotech sectors to inspire meaningful change. The exclusive leadership and influencer podcasts and vodcasts offer unparalleled insights and add immense value to our breaking news coverage.

The Health Industry HubTM content is copyright protected. Access is available under individual user licenses. Please click here to subscribe and visit T&Cs here.


News & Trends - Pharmaceuticals

Lilly's drug cuts diabetes risk by 94%, so why is it still not on the PBS?

Lilly’s drug cuts diabetes risk by 94%, so why is it still not on the PBS?

Health Industry Hub | November 14, 2024 |

On World Diabetes Day (14 November), new data reveals that three years of treatment with a GIP/GLP-1 receptor agonist significantly […]

More


News & Trends - Biotechnology

Depaz Oration to celebrate an 'enduring' legacy in the biotech sector

Depaz Oration to celebrate an ‘enduring’ legacy in the biotech sector

Health Industry Hub | November 14, 2024 |

AusBiotech announced the establishment of the Depaz Oration, an annual keynote event that will debut at the AusBiotech Conference in […]

More


News & Trends - Pharmaceuticals

Government calls for public input on genomic-led cancer care

Government calls for public input on genomic-led cancer care

Health Industry Hub | November 14, 2024 |

The Australian Government has launched a public consultation on a draft policy framework aimed at enhancing genomics-informed cancer care nationwide. […]

More


News & Trends - MedTech & Diagnostics

Can the patient voice reduce low-value care? Australia’s first large-scale hospital initiative seeks answers

Can the patient voice reduce low-value care? Australia’s first large-scale hospital initiative seeks answers

Health Industry Hub | November 14, 2024 |

In an Australian-first, a not-for-profit private health insurer will ask hospital patients to rate not only their clinical care but […]

More


This content is copyright protected. Please subscribe to gain access.