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PBAC flags two-speed system
Posted 16 May 2018
The PBAC is recommending drugs based on early results and with "less than the ultimate information", chair Andrew Wilson says, potentially contributing to concerns Health Minister Greg Hunt is unduly influencing the PBAC process.
Only hours after shadow health minister Catherine King said Labor would be pursuing Hunt in coming weeks for what it perceived as ministerial interference, Wilson says one of the cancer drugs funded in the Budget - presumably Novartis' breast cancer therapy Kisqali - was recommended despite not having full evidence.
"There are circumstances where we accept less than the ultimate information we want to know," Wilson said in a live Facebook Q&A yesterday (Tuesday) with Rare Cancer Australia CEO Richard Vines.
"There have been listings of drugs based on what we've seen in the earlier results. One of the cancer drugs featured in the budget is one where we will not know the overall effects on overall survival of that drug for at least another two to three years until their trials are finished.
"But the results the company presented look very promising in relation to that and we reached an agreement to get a relatively early listing for that drug."
Kisqali will list on the PBS in July after being approved at the PBAC's March meeting, which also recommended its fellow CDK4/6 inhibitor Pfizer's Ibrance. Amgen's Kyprolis was the only other cancer drug in the Budget.
Like Biogen's Spinraza, Kisqali is believed to be one of a number of drugs which Hunt has pushed to get onto the PBS following strong patient group pressure.
PBAC pan-tumour paper due
Hunt is also behind a push for the reimbursement committee to consider immunotherapy drugs across pan-tumour indications, with Wilson saying the PBAC will shortly release a paper on the issue ahead of its August special meeting.
"Minister Hunt has asked us specifically to look at whether there might be a simplified approach that we can take to doing that and we're about to release a paper to seek comments on that particular issue," Wilson said.
"In our August meeting we will look at that and provide advice to the minister as to whether we think we can do it. The challenge at this point in time, from my perspective, is we have relatively limited information provided to us."
However in what seemed to contradict his own comments regarding approving new drugs based on limited evidence, Wilson said pan-tumour submissions needed to provide evidence for cost-effectiveness in each tumour type.
Despite more than 200 checkpoint inhibitor trials being conducted globally, he said, to date the PBAC had only seen submissions for four tumour types - and these submissions ranged across settings and marker requirements.
"So when you divide that among four tumours you can see our experience and understanding of these drugs is still very limited," Wilson said.
Wilson also said the PBAC was looking at how it could share information with similar global jurisdictions as was done with TGA drug registration but this was hampered by companies claiming pricing was commercial-in-confidence, making cost-effectiveness comparisons impossible.
"They don't like to disclose their prices in international markets because they have different prices in different settings," he said, but despite this, the PBAC did consider global evaluations in similar markets to inform the submission process.
Megan Brodie
Posted 16 May 2018
The PBAC is recommending drugs based on early results and with "less than the ultimate information", chair Andrew Wilson says, potentially contributing to concerns Health Minister Greg Hunt is unduly influencing the PBAC process.
Only hours after shadow health minister Catherine King said Labor would be pursuing Hunt in coming weeks for what it perceived as ministerial interference, Wilson says one of the cancer drugs funded in the Budget - presumably Novartis' breast cancer therapy Kisqali - was recommended despite not having full evidence.
"There are circumstances where we accept less than the ultimate information we want to know," Wilson said in a live Facebook Q&A yesterday (Tuesday) with Rare Cancer Australia CEO Richard Vines.
"There have been listings of drugs based on what we've seen in the earlier results. One of the cancer drugs featured in the budget is one where we will not know the overall effects on overall survival of that drug for at least another two to three years until their trials are finished.
"But the results the company presented look very promising in relation to that and we reached an agreement to get a relatively early listing for that drug."
Kisqali will list on the PBS in July after being approved at the PBAC's March meeting, which also recommended its fellow CDK4/6 inhibitor Pfizer's Ibrance. Amgen's Kyprolis was the only other cancer drug in the Budget.
Like Biogen's Spinraza, Kisqali is believed to be one of a number of drugs which Hunt has pushed to get onto the PBS following strong patient group pressure.
PBAC pan-tumour paper due
Hunt is also behind a push for the reimbursement committee to consider immunotherapy drugs across pan-tumour indications, with Wilson saying the PBAC will shortly release a paper on the issue ahead of its August special meeting.
"Minister Hunt has asked us specifically to look at whether there might be a simplified approach that we can take to doing that and we're about to release a paper to seek comments on that particular issue," Wilson said.
"In our August meeting we will look at that and provide advice to the minister as to whether we think we can do it. The challenge at this point in time, from my perspective, is we have relatively limited information provided to us."
However in what seemed to contradict his own comments regarding approving new drugs based on limited evidence, Wilson said pan-tumour submissions needed to provide evidence for cost-effectiveness in each tumour type.
Despite more than 200 checkpoint inhibitor trials being conducted globally, he said, to date the PBAC had only seen submissions for four tumour types - and these submissions ranged across settings and marker requirements.
"So when you divide that among four tumours you can see our experience and understanding of these drugs is still very limited," Wilson said.
Wilson also said the PBAC was looking at how it could share information with similar global jurisdictions as was done with TGA drug registration but this was hampered by companies claiming pricing was commercial-in-confidence, making cost-effectiveness comparisons impossible.
"They don't like to disclose their prices in international markets because they have different prices in different settings," he said, but despite this, the PBAC did consider global evaluations in similar markets to inform the submission process.
Megan Brodie
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