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Bydureon listed after five-year struggle
Posted 15 August 2016
Health Minister Sussan Ley has trumpeted the PBS listing of AstraZeneca's once weekly diabetes medicine Bydureon (exenatide) but failed to mention the five year journey it had to get there.
Bydureon will be listed on 1 September along with changes to listing for other diabetes treatments: Novartis' Galvus (vildagliptin) and Galvumet (vildagliptin/metformin), and Boehringer Ingelheim's Trajenta (linagliptin) and Trajentamet (lindgliptin/metformin),which will be extended to use in triple oral therapy.
Bydureon is a once weekly version of AZ's Byetta (exenatide). Ms Ley described it as "a revolutionary new diabetes treatment" that would see patients "only having to inject themselves once a week, rather than twice a day, meaning they will avoid up to 13 injections per week. Patients will also save over $1600 per year".
Bydureon has been before the PBAC five times. It was first submitted in July 2011 by then owner Eli Lilly but rejected. It was re-submitted in July 2013 by Bristol-Myers Squibb and again rejected. This was followed by a positive recommendation in November 2013 but the drug again changed hands, moving to AZ, which first submitted it in July 2015, seeking a higher price.
That submission was again recommended but price negotiations continued into this year and were still in train when the product was submitted once more by AZ with a new delivery device: dual chamber syringe. Again it was recommended, resulting in the 1 September 2016 listing.
Ms Ley noted that adding the new disbetes medicine to the PBS was expected to be cost-neutral but that other listings due to occur on 1 September would cost the government an extra $70 million.
Most of this is expected to be spent on a new use for Roche's Avastin (bevacizumab), which will be listed for "persistent, recurrent or metastatic cervical cancer where surgery or radiation is not a viable treatment" at an anticipated cost of $60 million over the next five years, the minister said.
Another $10 million is expected to be spent on Novartis' Signifor (pasireotide),which will be listed for acromegaly.
Ms Ley said the Coalition's total investment in listing new medicines since coming to office now amounted to to $4.5 billion.
Nick Lush
nick.lush@lushmedia.com.au
Posted 15 August 2016
Health Minister Sussan Ley has trumpeted the PBS listing of AstraZeneca's once weekly diabetes medicine Bydureon (exenatide) but failed to mention the five year journey it had to get there.
Bydureon will be listed on 1 September along with changes to listing for other diabetes treatments: Novartis' Galvus (vildagliptin) and Galvumet (vildagliptin/metformin), and Boehringer Ingelheim's Trajenta (linagliptin) and Trajentamet (lindgliptin/metformin),which will be extended to use in triple oral therapy.
Bydureon is a once weekly version of AZ's Byetta (exenatide). Ms Ley described it as "a revolutionary new diabetes treatment" that would see patients "only having to inject themselves once a week, rather than twice a day, meaning they will avoid up to 13 injections per week. Patients will also save over $1600 per year".
Bydureon has been before the PBAC five times. It was first submitted in July 2011 by then owner Eli Lilly but rejected. It was re-submitted in July 2013 by Bristol-Myers Squibb and again rejected. This was followed by a positive recommendation in November 2013 but the drug again changed hands, moving to AZ, which first submitted it in July 2015, seeking a higher price.
That submission was again recommended but price negotiations continued into this year and were still in train when the product was submitted once more by AZ with a new delivery device: dual chamber syringe. Again it was recommended, resulting in the 1 September 2016 listing.
Ms Ley noted that adding the new disbetes medicine to the PBS was expected to be cost-neutral but that other listings due to occur on 1 September would cost the government an extra $70 million.
Most of this is expected to be spent on a new use for Roche's Avastin (bevacizumab), which will be listed for "persistent, recurrent or metastatic cervical cancer where surgery or radiation is not a viable treatment" at an anticipated cost of $60 million over the next five years, the minister said.
Another $10 million is expected to be spent on Novartis' Signifor (pasireotide),which will be listed for acromegaly.
Ms Ley said the Coalition's total investment in listing new medicines since coming to office now amounted to to $4.5 billion.
Nick Lush
nick.lush@lushmedia.com.au
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