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Rapid PBS listing for Lilly's Taltz
Posted 27 January 2017
Three new drugs will be listed on the PBS from next week, one within five months of gaining TGA approval.
Novartis' Zykadia (ceritinib) and AstraZeneca's Lynparza (olaparib) will be PBS-listed for the first time from next Wednesday, providing subsidised treatment options for Australians with certain types of lung cancer and ovarian, fallopian tube or primary peritoneal cancer respectively.
Also listing on the PBS in February will be Lilly's Taltz (ixekizumab) for severe plaque psoriasis.
Taltz had the smoothest path to PBS-reimbursement after being approved by the TGA and positively recommended by the PBAC using the parallel pathway. The PBAC positive recommendation was announced following the July meeting, with Taltz being listed on the ARTG in September for moderate to severe plaque psoriasis.
Approved in the US and EU earlier last year for the same indication, Lilly achieved a rare double in gaining TGA approval and PBS listing less than a year after notching up major international approvals.
Zykadia also had a relatively smooth path to reimbursement. Approved by the TGA in March and positively recommended by the PBAC at its November meeting, Zykadia is indicated as a monotherapy for the treatment of ALK-positive locally advanced or metastatic non-small cell lung cancer where the disease has progressed following Pfizer's Xalkori (crizotinib).
Novartis is expected to file Zykadia in the first-line setting for the same indication in the US after revealing top-line results from clinical trials supporting the filing last year.
Lynparza had the longest path to reimbursement after a slightly bumpy road through the PBAC. Approved by the TGA in January last year as a single maintenance treatment for platinum-sensitive relapsed BRCA-mutated high grade serous epithelial ovarian, fallopian tube or primary peritoneal cancer, Lynparza was initially submitted to the March 2016 PBAC meeting for reimbursement but was deferred.
AstraZeneca resubmitted in July only to be rejected on the basis of non cost-effectiveness. A price reduction and risk-sharing agreement helped AstraZeneca get over the line at the November meeting, gaining a positive recommendation.
Notably still missing from the list of PBS additions is Enbrel (etanercept) biosimilar Brenzys. Approved at the July PBAC meeting last year, the government has not yet added it to the PBS leaving Enbrel uncontested in the reimbursement space.
Megan Brodie
megan.brodie@lushmedia.com.au
Posted 27 January 2017
Three new drugs will be listed on the PBS from next week, one within five months of gaining TGA approval.
Novartis' Zykadia (ceritinib) and AstraZeneca's Lynparza (olaparib) will be PBS-listed for the first time from next Wednesday, providing subsidised treatment options for Australians with certain types of lung cancer and ovarian, fallopian tube or primary peritoneal cancer respectively.
Also listing on the PBS in February will be Lilly's Taltz (ixekizumab) for severe plaque psoriasis.
Taltz had the smoothest path to PBS-reimbursement after being approved by the TGA and positively recommended by the PBAC using the parallel pathway. The PBAC positive recommendation was announced following the July meeting, with Taltz being listed on the ARTG in September for moderate to severe plaque psoriasis.
Approved in the US and EU earlier last year for the same indication, Lilly achieved a rare double in gaining TGA approval and PBS listing less than a year after notching up major international approvals.
Zykadia also had a relatively smooth path to reimbursement. Approved by the TGA in March and positively recommended by the PBAC at its November meeting, Zykadia is indicated as a monotherapy for the treatment of ALK-positive locally advanced or metastatic non-small cell lung cancer where the disease has progressed following Pfizer's Xalkori (crizotinib).
Novartis is expected to file Zykadia in the first-line setting for the same indication in the US after revealing top-line results from clinical trials supporting the filing last year.
Lynparza had the longest path to reimbursement after a slightly bumpy road through the PBAC. Approved by the TGA in January last year as a single maintenance treatment for platinum-sensitive relapsed BRCA-mutated high grade serous epithelial ovarian, fallopian tube or primary peritoneal cancer, Lynparza was initially submitted to the March 2016 PBAC meeting for reimbursement but was deferred.
AstraZeneca resubmitted in July only to be rejected on the basis of non cost-effectiveness. A price reduction and risk-sharing agreement helped AstraZeneca get over the line at the November meeting, gaining a positive recommendation.
Notably still missing from the list of PBS additions is Enbrel (etanercept) biosimilar Brenzys. Approved at the July PBAC meeting last year, the government has not yet added it to the PBS leaving Enbrel uncontested in the reimbursement space.
Megan Brodie
megan.brodie@lushmedia.com.au
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