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Cancer drugs struggle at PBAC
Posted 20 December 2016
Rejections outnumbered approvals in the swathe of oncology submissions that dominated the November 2016 PBAC meeting, with only 10 of the 27 decisions coming down in favour of reimbursement.
One in three submissions being considered by the PBAC last month were for cancer drugs, yet only a third of these were approved.
Twelve of the submissions were rejected with half of these being first-time rejections. These were: Janssen's Imbruvica (ibrutinib) for mantle cell lymphoma, Amgen's Kyprolis (carfilzomib) for multiple myeloma, Roche's Gazyva (obinutuzumab) for Non-Hodgkin's lymphoma, Baxalta's Onivyde (irinotecan) for metastatic pancreatic cancer, Rare Cancers'Istodax (romidepsin) for peripheral T-cell lymphoma and BMS' Opdivo (nivolumab) for renal cell carcinoma.
MSD was successful in scoring a positive recommendation for its initial submission for Emend IV (fosaprepitant) in chemotherapy induced nausea and vomiting but was knocked back for Keytruda (pembrolizumab) in unresectable or metastatic melanoma.
It could still score a win with a third product before the PBAC in Zolinza (vorinostat) for relapsed/refractory cutaneous T-cell lymphoma and for Keytruda (pembrolizumab) in PD-L1 positive non-small cell lung cancer, which is still awaiting TGA approval.
Zolinza was rejected for reimbursement when it went before the PBAC in March 2011 on the basis of unacceptably high and uncertain cost-effectiveness ratios. The resubmission, including "a substantial price reduction", was made by Rare Cancers Australia (RCA) with funding support from MSD.
The PBAC deferred its decision pending further negotiations.
Novartis achieved success first time around with ALK-positive non-small cell lung cancer drug Zykadia (ceritinib) in the second-line setting while AstraZeneca was successful second time around with its submission for Lynparza (olaparib) in BRCA-mutated platinum-sensitive relapsed ovarian, fallopian tube and primary peritoneal cancer.
Other new products which appeared before the PBAC included Servier's Lonsurf (trifluridine/tipiracil) for colorectal cancer. Approved in Europe and the US in recent months, the PBAC withheld its decision on Lonsurf awaiting the outcome of the TGA registration process.
Megan Brodie
megan.brodie@lushmedia.com.au
Posted 20 December 2016
Rejections outnumbered approvals in the swathe of oncology submissions that dominated the November 2016 PBAC meeting, with only 10 of the 27 decisions coming down in favour of reimbursement.
One in three submissions being considered by the PBAC last month were for cancer drugs, yet only a third of these were approved.
Twelve of the submissions were rejected with half of these being first-time rejections. These were: Janssen's Imbruvica (ibrutinib) for mantle cell lymphoma, Amgen's Kyprolis (carfilzomib) for multiple myeloma, Roche's Gazyva (obinutuzumab) for Non-Hodgkin's lymphoma, Baxalta's Onivyde (irinotecan) for metastatic pancreatic cancer, Rare Cancers'Istodax (romidepsin) for peripheral T-cell lymphoma and BMS' Opdivo (nivolumab) for renal cell carcinoma.
MSD was successful in scoring a positive recommendation for its initial submission for Emend IV (fosaprepitant) in chemotherapy induced nausea and vomiting but was knocked back for Keytruda (pembrolizumab) in unresectable or metastatic melanoma.
It could still score a win with a third product before the PBAC in Zolinza (vorinostat) for relapsed/refractory cutaneous T-cell lymphoma and for Keytruda (pembrolizumab) in PD-L1 positive non-small cell lung cancer, which is still awaiting TGA approval.
Zolinza was rejected for reimbursement when it went before the PBAC in March 2011 on the basis of unacceptably high and uncertain cost-effectiveness ratios. The resubmission, including "a substantial price reduction", was made by Rare Cancers Australia (RCA) with funding support from MSD.
The PBAC deferred its decision pending further negotiations.
Novartis achieved success first time around with ALK-positive non-small cell lung cancer drug Zykadia (ceritinib) in the second-line setting while AstraZeneca was successful second time around with its submission for Lynparza (olaparib) in BRCA-mutated platinum-sensitive relapsed ovarian, fallopian tube and primary peritoneal cancer.
Other new products which appeared before the PBAC included Servier's Lonsurf (trifluridine/tipiracil) for colorectal cancer. Approved in Europe and the US in recent months, the PBAC withheld its decision on Lonsurf awaiting the outcome of the TGA registration process.
Megan Brodie
megan.brodie@lushmedia.com.au
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