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Off-agenda decisions mark March results
Posted 21 April 2017
The PBAC has made two cancer drug recommendations for submissions that were not published in its original agenda for March.
BMS' submission for reimbursement of Opdivo (nivolumab) in lung cancer was given a positive recommendation after being deferred at the November meeting.
BMS told Pharma in Focus that the November submission had been resubmitted to the committee's March meeting after some further work with the Health Department.
The company was in celebratory mood following the positive recommendation.
Brent Pfeiffenberger, general manager for Australia and New Zealand, welcomed it as a significant milestone for the treatment of lung cancer in Australia but stressed there is still more to be done to ensure Australian patients can have subsidised access to treatment.
"Whilst the PBAC recommendation is an important step forward, there is further work to be done to ensure patients have affordable access to Opdivo through the PBS as soon as possible. Advanced lung cancer patients don't have time to wait," he said.
Also given a positive recommendation from the March meeting but absent from the agenda was MSD's Zolinza (vorinostat) for relapsed or refractory cutaneous T-cell lymphoma.
This was also a rapid resubmission from the November meeting to which it had been presented by Rare Cancers Australia.
The PBAC said it had deferred its decision in November "to seek further clarification from the sponsor of vorinostat (Merck Sharp & Dohme (Australia) Pty Ltd) regarding the financial impact of a listing on the PBS, specifically, the patient numbers and an agreement for a Risk Sharing Arrangement".
It recommended a General Schedule Authority Required listing for cutaneous T-cell lymphoma, saying "The PBAC recommendation for listing was based on, among other matters, its assessment that the cost-effectiveness of vorinostat would be acceptable at the price proposed in the resubmission."
But the off-agenda cancer items did not stop there.
The PBAC also gave a out-of-session positive recommendations on two Janssen cancer drugs.
It recommended General Schedule Authority Required listing of Imbruvica (ibrutinib), on the basis that it be available "only for use as monotherapy in patients who meet certain conditions" for relapsed or refractory chronic lymphocytic leukaemia and relapsed or refractory small lymphocytic lymphoma.
It also recommended an amendment to the listing for Janssen's Zytiga (abiraterone) in metastatic castration resistant prostate cancer requested by the Medical Oncology Group of Australia.
The clinicians had asked for Zytiga to be administered with a corticosteroid such as prednisolone instead of administration with prednisolone alone.
For a complete rundown on March outcomes, see Monday morning's Pharma in Focus.
Nick Lush
nick.lush@lushmedia.com.au
Posted 21 April 2017
The PBAC has made two cancer drug recommendations for submissions that were not published in its original agenda for March.
BMS' submission for reimbursement of Opdivo (nivolumab) in lung cancer was given a positive recommendation after being deferred at the November meeting.
BMS told Pharma in Focus that the November submission had been resubmitted to the committee's March meeting after some further work with the Health Department.
The company was in celebratory mood following the positive recommendation.
Brent Pfeiffenberger, general manager for Australia and New Zealand, welcomed it as a significant milestone for the treatment of lung cancer in Australia but stressed there is still more to be done to ensure Australian patients can have subsidised access to treatment.
"Whilst the PBAC recommendation is an important step forward, there is further work to be done to ensure patients have affordable access to Opdivo through the PBS as soon as possible. Advanced lung cancer patients don't have time to wait," he said.
Also given a positive recommendation from the March meeting but absent from the agenda was MSD's Zolinza (vorinostat) for relapsed or refractory cutaneous T-cell lymphoma.
This was also a rapid resubmission from the November meeting to which it had been presented by Rare Cancers Australia.
The PBAC said it had deferred its decision in November "to seek further clarification from the sponsor of vorinostat (Merck Sharp & Dohme (Australia) Pty Ltd) regarding the financial impact of a listing on the PBS, specifically, the patient numbers and an agreement for a Risk Sharing Arrangement".
It recommended a General Schedule Authority Required listing for cutaneous T-cell lymphoma, saying "The PBAC recommendation for listing was based on, among other matters, its assessment that the cost-effectiveness of vorinostat would be acceptable at the price proposed in the resubmission."
But the off-agenda cancer items did not stop there.
The PBAC also gave a out-of-session positive recommendations on two Janssen cancer drugs.
It recommended General Schedule Authority Required listing of Imbruvica (ibrutinib), on the basis that it be available "only for use as monotherapy in patients who meet certain conditions" for relapsed or refractory chronic lymphocytic leukaemia and relapsed or refractory small lymphocytic lymphoma.
It also recommended an amendment to the listing for Janssen's Zytiga (abiraterone) in metastatic castration resistant prostate cancer requested by the Medical Oncology Group of Australia.
The clinicians had asked for Zytiga to be administered with a corticosteroid such as prednisolone instead of administration with prednisolone alone.
For a complete rundown on March outcomes, see Monday morning's Pharma in Focus.
Nick Lush
nick.lush@lushmedia.com.au
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