Australia's most trusted source of pharma news
When pharma says 'no deal'
Posted 26 October 2018
Negotiations have broken down or pharmas walked away for one in six medicines positively recommended by the PBAC in the past two years, resulting in the listing not proceeding.
The Department of Health has revealed 83 medicines recommended over nine PBAC meetings since July 2016 have not been listed despite being positively recommended.
Of those, 14 are marked as not proceeding, many likely to be due to negotiations between the department and the sponsor breaking down although some were withdrawn for legal or supply issues.
At least 60 are marked as still under negotiation, with talks in some cases underway now for 18 months.
Two drugs on the Department of Health list - Janssen's Simponi and Pfizer's Nimenrix - have both been announced as listing on the PBS, Simponi being expanded from December and Nimenrix from April 2019 for adolescents.
Other products have been held up by red tape, such as Bayer's radium injection for metastatic resistant prostate cancer Xofigo. Recommended in November 2017, Xofigo has been stuck in limbo since awaiting a new S100 program.
With the most products on the waiting list, Pfizer has seven recommended and not yet listed, including Nimenrix.
The pharmaco is also awaiting a PBS berth for its pneumococcal vaccine Prevenar 13, which went back to PBAC three times between July 2016 and March 2018 and is now held up awaiting a cost-effectiveness review requested by PBAC.
Pfizer is still negotiating iron deficiency product Monofer and has withdrawn breast cancer drug Ibrance but is "working towards a co-dependent listing" on the PBS and MBS for its non-small cell lung cancer drug Xalkori and its companion diagnostic, both of which have now been recommended.
In another case, Roche's Mabthera SC, recommended in March 2017 for chronic lymphocytic leukaemia (CLL), has failed to list because the "sponsor currently has no stock available", according to the department.
Gilead is the most patient sponsor, still in negotiations to list its hepatitis B therapy Vemlidy 18 months after it was recommended while more recently commencing negotiations for hepatitis C therapy Vosevi and its newest HIV drug Biktarvy, both recommended in July and awaiting a PBS berth.
AbbVie has ended negotiations without a listing for its hepatitis C combination Technivie, recommended in November 2016, and cancer pill Venclexta, recommended in November 2017 but which goes back to the PBAC next month. A new form of Humira was also recommended in July 2017 but failed to list.
With six products on the recommended but not yet listed list, Novartis was withdrawn only one - Ilaris, recommended last November for cryopyrin associated periodic syndromes. Novartis is still negotiating over Xolair, Sandostatin LAR, Rydapt, Afinitor and Jadenu, according to the department.
The long list of drugs yet to reach the PBS is in contrast to the slightly shorter list of new drugs which have made it in recent years. The department revealed this week 57 new drugs listed in the past three years.
Megan Brodie
Posted 26 October 2018
Negotiations have broken down or pharmas walked away for one in six medicines positively recommended by the PBAC in the past two years, resulting in the listing not proceeding.
The Department of Health has revealed 83 medicines recommended over nine PBAC meetings since July 2016 have not been listed despite being positively recommended.
Of those, 14 are marked as not proceeding, many likely to be due to negotiations between the department and the sponsor breaking down although some were withdrawn for legal or supply issues.
At least 60 are marked as still under negotiation, with talks in some cases underway now for 18 months.
Two drugs on the Department of Health list - Janssen's Simponi and Pfizer's Nimenrix - have both been announced as listing on the PBS, Simponi being expanded from December and Nimenrix from April 2019 for adolescents.
Other products have been held up by red tape, such as Bayer's radium injection for metastatic resistant prostate cancer Xofigo. Recommended in November 2017, Xofigo has been stuck in limbo since awaiting a new S100 program.
With the most products on the waiting list, Pfizer has seven recommended and not yet listed, including Nimenrix.
The pharmaco is also awaiting a PBS berth for its pneumococcal vaccine Prevenar 13, which went back to PBAC three times between July 2016 and March 2018 and is now held up awaiting a cost-effectiveness review requested by PBAC.
Pfizer is still negotiating iron deficiency product Monofer and has withdrawn breast cancer drug Ibrance but is "working towards a co-dependent listing" on the PBS and MBS for its non-small cell lung cancer drug Xalkori and its companion diagnostic, both of which have now been recommended.
In another case, Roche's Mabthera SC, recommended in March 2017 for chronic lymphocytic leukaemia (CLL), has failed to list because the "sponsor currently has no stock available", according to the department.
Gilead is the most patient sponsor, still in negotiations to list its hepatitis B therapy Vemlidy 18 months after it was recommended while more recently commencing negotiations for hepatitis C therapy Vosevi and its newest HIV drug Biktarvy, both recommended in July and awaiting a PBS berth.
AbbVie has ended negotiations without a listing for its hepatitis C combination Technivie, recommended in November 2016, and cancer pill Venclexta, recommended in November 2017 but which goes back to the PBAC next month. A new form of Humira was also recommended in July 2017 but failed to list.
With six products on the recommended but not yet listed list, Novartis was withdrawn only one - Ilaris, recommended last November for cryopyrin associated periodic syndromes. Novartis is still negotiating over Xolair, Sandostatin LAR, Rydapt, Afinitor and Jadenu, according to the department.
The long list of drugs yet to reach the PBS is in contrast to the slightly shorter list of new drugs which have made it in recent years. The department revealed this week 57 new drugs listed in the past three years.
Megan Brodie
Drought, fire and now virus cut chance of PBS relief.
Don't do it for the accolades; do it for your kids.
New forms of rotavirus vaccine Rotarix.