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March PBAC sees rush of new drugs
Posted 20 December 2017
The PBAC will consider 15 major new drug submissions when it meets for the first time in 2018 including Gilead's latest pan-genotypic Hepatitis C triple combination pill Vosevi (sofosbuvir/velpatasvir/voxilaprevir).
Fourteen of the major new submissions will be first-time appearances on the PBAC agenda with only Alexion's Strensiq (asfotase alfa) returning after being rejected at the July PBAC meeting this year for reimbursement in juvenile onset hypophosphatasia.
Pfizer's meningococcal conjugate vaccine Nimenrix, which targets four strains of the fatal virus, is seeking listing on the National Immunisation Program (NIP) for infants, teenagers in Year 10 and a catch-up program for adolescents up to 19. It's chances of success are high, particularly given Health Minister Greg Hunt's comments in September that he was "optimistic we'll have it well in time for next year' season".
Gilead and AstraZeneca are the only sponsors with two major new submissions apiece, with Gilead also looking for a recommendation for its as yet unbranded HIV combination tenofovir/emtricitabine/bictegravir. Filed in Europe and the US mid-2017 and as yet unapproved globally, its appearance on the PBAC agenda indicates it is also under consideration by the TGA and likely to win ARTG registration around the same time as the FDA delivers its verdict.
AZ is looking to start the new year strongly with PBAC submissions for its asthma biologic Fasenra (benralizumab) and a first-line listing in ovarian, fallopian tube and primary peritoneal cancer for listed therapy Lynparza (olaparib). Just approved in the US and still under consideration in Europe, Fasenra was recently tipped by Pharma in Focus as one of a number of new drugs that would appear on the ARTG in 2018.
The type two diabetes market will become even more competitive in 2018 should MSD and Sanofi be successful with their new submission for drugs to treat this area.
Sanofi's Soliqua (insulin glargine/lixisenatide) and MSD's Steglatro (ertugliflozin) and Segluromet (ertugliflozin/metformin) dual oral combination therapy are both seeking positive recommendations at March PBAC next year.
MSD has developed the ertugliflozin products jointly with Pfizer along with a third combination or ertugliflozin and sitagliptin called Segluromet which has not been submitted to PBAC. Approved in the US today, the SGLT2 latecomers' appearance on the ARTG suggests they were filed with the TGA in Australia around the same time as in Europe - March 2017.
Three other sponsors are looking for PBS access for their latest therapies in cancer, although all only as either second or third line therapies following already approved treatments.
Lilly's biologic Cymraza (ramicirumab) is looking at reimbursement in advanced or metastatic, gastric or gastro-oesophageal junction adenocarcinoma following platinum and fluoropyrimidine chemotherapy while Bayer's Stirvaga (regorafenib) is looking at second-line unresectable hepatocellular carcinoma.
Shire's Onivyde (irinotecan (nanoliposomal)) rounds out the cancer trifecta, seeking PBS access in second-line metastatic pancreatic cancer.
Janssen's Tremfya (guselkumab) is the only major new submission in the autoimmune area, looking for access in severe chronic plaque psoriasis while Otsuka's Jinarc (tolvaptan) will be assess in autosomal dominant polycystic kidney disease (ADPKD).
Emerge Health's Diacomit (stiripentol) has been submitted for Dravet Syndrome seizures while Aspen's Zaldiar (tramadol/paracetamol) has a major new submission to go before the PBAC in pain.
Megan Brodie
megan.brodie@lushmedia.com.au
Posted 20 December 2017
The PBAC will consider 15 major new drug submissions when it meets for the first time in 2018 including Gilead's latest pan-genotypic Hepatitis C triple combination pill Vosevi (sofosbuvir/velpatasvir/voxilaprevir).
Fourteen of the major new submissions will be first-time appearances on the PBAC agenda with only Alexion's Strensiq (asfotase alfa) returning after being rejected at the July PBAC meeting this year for reimbursement in juvenile onset hypophosphatasia.
Pfizer's meningococcal conjugate vaccine Nimenrix, which targets four strains of the fatal virus, is seeking listing on the National Immunisation Program (NIP) for infants, teenagers in Year 10 and a catch-up program for adolescents up to 19. It's chances of success are high, particularly given Health Minister Greg Hunt's comments in September that he was "optimistic we'll have it well in time for next year' season".
Gilead and AstraZeneca are the only sponsors with two major new submissions apiece, with Gilead also looking for a recommendation for its as yet unbranded HIV combination tenofovir/emtricitabine/bictegravir. Filed in Europe and the US mid-2017 and as yet unapproved globally, its appearance on the PBAC agenda indicates it is also under consideration by the TGA and likely to win ARTG registration around the same time as the FDA delivers its verdict.
AZ is looking to start the new year strongly with PBAC submissions for its asthma biologic Fasenra (benralizumab) and a first-line listing in ovarian, fallopian tube and primary peritoneal cancer for listed therapy Lynparza (olaparib). Just approved in the US and still under consideration in Europe, Fasenra was recently tipped by Pharma in Focus as one of a number of new drugs that would appear on the ARTG in 2018.
The type two diabetes market will become even more competitive in 2018 should MSD and Sanofi be successful with their new submission for drugs to treat this area.
Sanofi's Soliqua (insulin glargine/lixisenatide) and MSD's Steglatro (ertugliflozin) and Segluromet (ertugliflozin/metformin) dual oral combination therapy are both seeking positive recommendations at March PBAC next year.
MSD has developed the ertugliflozin products jointly with Pfizer along with a third combination or ertugliflozin and sitagliptin called Segluromet which has not been submitted to PBAC. Approved in the US today, the SGLT2 latecomers' appearance on the ARTG suggests they were filed with the TGA in Australia around the same time as in Europe - March 2017.
Three other sponsors are looking for PBS access for their latest therapies in cancer, although all only as either second or third line therapies following already approved treatments.
Lilly's biologic Cymraza (ramicirumab) is looking at reimbursement in advanced or metastatic, gastric or gastro-oesophageal junction adenocarcinoma following platinum and fluoropyrimidine chemotherapy while Bayer's Stirvaga (regorafenib) is looking at second-line unresectable hepatocellular carcinoma.
Shire's Onivyde (irinotecan (nanoliposomal)) rounds out the cancer trifecta, seeking PBS access in second-line metastatic pancreatic cancer.
Janssen's Tremfya (guselkumab) is the only major new submission in the autoimmune area, looking for access in severe chronic plaque psoriasis while Otsuka's Jinarc (tolvaptan) will be assess in autosomal dominant polycystic kidney disease (ADPKD).
Emerge Health's Diacomit (stiripentol) has been submitted for Dravet Syndrome seizures while Aspen's Zaldiar (tramadol/paracetamol) has a major new submission to go before the PBAC in pain.
Megan Brodie
megan.brodie@lushmedia.com.au
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