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Bayer's Xofigo stuck in limbo
Posted 21 May 2018
Bayer and the government are remaining tight-lipped regarding progress of a new program through which to list nuclear medicine therapies.
Bayer's radiopharmaceutical prostate cancer drug Xofigo is waiting in the wings for the new program after being recommended by the PBAC in November. It is unable to progress until the new Section 100 program is created for it and other radiopharmaceutical drugs.
Registered in Australia in May 2014 and four years later still only available on private script, Bayer's nuclear hopeful has walked a long and frustrating road to reimbursement.
MSAC recommended Xofigo on a cost-minimisation basis against other prostate therapies in 2014 but Bayer did not pursue the MBS listing as it was unable to include a Special Pricing Arrangement (SPA) to hide its effective price.
At the time, MSAC forecast Xofigo would earn $13.4 million in MBS benefits in 2018-19 with "a corresponding saving to the PBS" as Xofigo was used instead of other treatments.
Last year Xofigo appeared on the PBAC's November agenda seeking a cost-minimisation listing on the PBS in line with its MBS recommendation and again requesting a SPA, this time receiving both a positive recommendation and a green light for the SPA.
The PSD for Xofigo calculates it would save the PBS money as it would be used instead of Janssen's Zytiga and at a lower cost. Zytiga made $42 million in pre-rebate benefits in the year to January.
"The PBAC noted advice from the department that there were numerous steps involved in developing a new Section 100 program for radiopharmaceuticals," Xofigo's PSD released earlier this year noted.
Requests by Pharma in Focus for information on progress regarding the new program to both Bayer and the Department of Health went unanswered.
Xofigo's listing looked to be near in March when Bayer appointed a speciality prostate cancer brand manager.
Bayer is not the only company keen to list the new class of drugs on the PBS. Australia's Telix Pharmaceuticals is also developing a portfolio of radiopharma drugs to treat prostate, renal and glioblastoma cancer.
Globally, the radiopharmaceutical medicine market is expected to reach USD13.8 billion by 2024, according to Grand View Research, driven up by the rising incidence of cancer and awareness about nuclear medicine.
Megan Brodie
Posted 21 May 2018
Bayer and the government are remaining tight-lipped regarding progress of a new program through which to list nuclear medicine therapies.
Bayer's radiopharmaceutical prostate cancer drug Xofigo is waiting in the wings for the new program after being recommended by the PBAC in November. It is unable to progress until the new Section 100 program is created for it and other radiopharmaceutical drugs.
Registered in Australia in May 2014 and four years later still only available on private script, Bayer's nuclear hopeful has walked a long and frustrating road to reimbursement.
MSAC recommended Xofigo on a cost-minimisation basis against other prostate therapies in 2014 but Bayer did not pursue the MBS listing as it was unable to include a Special Pricing Arrangement (SPA) to hide its effective price.
At the time, MSAC forecast Xofigo would earn $13.4 million in MBS benefits in 2018-19 with "a corresponding saving to the PBS" as Xofigo was used instead of other treatments.
Last year Xofigo appeared on the PBAC's November agenda seeking a cost-minimisation listing on the PBS in line with its MBS recommendation and again requesting a SPA, this time receiving both a positive recommendation and a green light for the SPA.
The PSD for Xofigo calculates it would save the PBS money as it would be used instead of Janssen's Zytiga and at a lower cost. Zytiga made $42 million in pre-rebate benefits in the year to January.
"The PBAC noted advice from the department that there were numerous steps involved in developing a new Section 100 program for radiopharmaceuticals," Xofigo's PSD released earlier this year noted.
Requests by Pharma in Focus for information on progress regarding the new program to both Bayer and the Department of Health went unanswered.
Xofigo's listing looked to be near in March when Bayer appointed a speciality prostate cancer brand manager.
Bayer is not the only company keen to list the new class of drugs on the PBS. Australia's Telix Pharmaceuticals is also developing a portfolio of radiopharma drugs to treat prostate, renal and glioblastoma cancer.
Globally, the radiopharmaceutical medicine market is expected to reach USD13.8 billion by 2024, according to Grand View Research, driven up by the rising incidence of cancer and awareness about nuclear medicine.
Megan Brodie
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