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Novartis' CAR-T steps closer
Posted 12 September 2018
Novartis' CAR-T therapy Kymriah is on track to be considered by the MSAC at its November meeting after appearing to be rushed through the system.
Listed for consideration by the MSAC's evaluation sub-committee (ESC) in early October, Kymriah appears to have been ushered swiftly through the evaluation process.
Given the novelty and complexity of the new therapy, it would not have been unusual for it to go through two rounds of PICO advisory sub-committee (PASC) review.
However, it has moved to the ESC and MSAC meetings after being considered by the PASC only once at its April meeting.
The appearance of Kymriah on the October ESC agenda and its consideration in November is good news for Novartis, providing strong hope it will be launched in Australia in the first half of 2019.
It will be a second big win for Novartis in a head-to-head battle should it successfully navigate MSAC and emerge with a recommendation. The company beat rival Pfizer to the PBS for its breast cancer therapy Kisqali.
It appears Novartis is also set to win the CAR-T race with still no sign of Gilead and Kites' CAR-T offering Yescarta.
While it has not yet appeared in Australia, the pair lost round one in the UK with reimbursement body NICE moving to reject their submission for Yescarta last month, labelling it too expensive to justify.
"Unfortunately, in this case, we are not able to recommend axicabtagene ciloleucel for use in the NHS in England at the cost per patient set by Kite Pharma," NICE director Meindert Boysen said.
While Yescarta has a list price of USD375,000 and Kymriah USD475,000, the UK regulator approved Kymriah, saying Novartis had set a "fair and affordable" price for its CAR-T therapy.
NICE has called for comments and further evidence on Yescarta, setting a deadline of next Tuesday while Gilead responded that it was continuing discussions with the UK body.
Megan Brodie
Posted 12 September 2018
Novartis' CAR-T therapy Kymriah is on track to be considered by the MSAC at its November meeting after appearing to be rushed through the system.
Listed for consideration by the MSAC's evaluation sub-committee (ESC) in early October, Kymriah appears to have been ushered swiftly through the evaluation process.
Given the novelty and complexity of the new therapy, it would not have been unusual for it to go through two rounds of PICO advisory sub-committee (PASC) review.
However, it has moved to the ESC and MSAC meetings after being considered by the PASC only once at its April meeting.
The appearance of Kymriah on the October ESC agenda and its consideration in November is good news for Novartis, providing strong hope it will be launched in Australia in the first half of 2019.
It will be a second big win for Novartis in a head-to-head battle should it successfully navigate MSAC and emerge with a recommendation. The company beat rival Pfizer to the PBS for its breast cancer therapy Kisqali.
It appears Novartis is also set to win the CAR-T race with still no sign of Gilead and Kites' CAR-T offering Yescarta.
While it has not yet appeared in Australia, the pair lost round one in the UK with reimbursement body NICE moving to reject their submission for Yescarta last month, labelling it too expensive to justify.
"Unfortunately, in this case, we are not able to recommend axicabtagene ciloleucel for use in the NHS in England at the cost per patient set by Kite Pharma," NICE director Meindert Boysen said.
While Yescarta has a list price of USD375,000 and Kymriah USD475,000, the UK regulator approved Kymriah, saying Novartis had set a "fair and affordable" price for its CAR-T therapy.
NICE has called for comments and further evidence on Yescarta, setting a deadline of next Tuesday while Gilead responded that it was continuing discussions with the UK body.
Megan Brodie
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