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Patient body issues challenge to PBAC
Posted 12 May 2016
In an unusual turn of events, Rare Cancers Australia (RCA) has revealed that it will be making a PBAC submission to list MSD's Zolinza (vorinostat) and Celgene's Istodax (romidepsin) with funding support for the companies.
"The government has so many reviews ... the Senate [cancer] inquiry, the PBAC guidelines, the TGA review ... which it hasn't responded to. And nothing is changing. Doing this means there is a real-life example ... They have to respond to this," says Richard Vines, RCA's director.
"If they have to deal with a live example driven by a patient group ... there would be something real to discuss. Then industry, patients, the department will be talking about something real."
The medicines are histone deacetylases (HDACs) inhibitors, with Zolinza indicated for the treatment of cutaneous T-cell lymphoma and Istodax for treatment of peripheral T-cell lymphoma.
Zolinza was TGA registered in 2009 and MSD had made a PBAC submission in March 2011 for the indication only to have it rejected for reimbursement on the basis of unacceptably high and uncertain cost-effectiveness ratios. MSD has not since made a resubmission. Istodax has never been before the PBAC.
The challenge with these drugs is that there is no phase III data that would be normally considered by the PBAC, Mr Vines explains. And while they are being prescribed on the private market, or available in compassionate access programs, the challenge is gathering data in the post-market situation.
"These medicines are available ... we just need to find a mechanism to get them listed ... to make them available to patients in a safe, reliable way."
THEMA Consulting has been chosen to prepare the submission and Mr Vines confirms that it is on track for the November PBAC meeting. He says RCA received funding from MSD and Celgene to cover the out-of-pocket costs of making the submission.
Whatever the outcome, he says there will be lessons to learn and RCA would be "better informed and more knowledgeable advocates" for the experience.
Mr Vines admits that it was his frustration with the current system that was the genesis of the idea.
The Department of Health often says that it cannot force companies to bring drugs to Australia - to register indications or list them on the PBS - but the current system means it is not realistic for the company to do anything, he points out.
In rare cancers, the situation is that the environment is not practical to produce the data the PBAC wants. "So the system creates all these barriers then they criticise the companies ... someone has to call them on it," he says. "The companies have been brave enough to let us do this. It's our idea - we want to sit in the room and say this is the best we can do ... It's affirmative action for the funding of medicines for rare cancer patients."
Michelle Lam
michelle.lam@lushmedia.com.au
Posted 12 May 2016
In an unusual turn of events, Rare Cancers Australia (RCA) has revealed that it will be making a PBAC submission to list MSD's Zolinza (vorinostat) and Celgene's Istodax (romidepsin) with funding support for the companies.
"The government has so many reviews ... the Senate [cancer] inquiry, the PBAC guidelines, the TGA review ... which it hasn't responded to. And nothing is changing. Doing this means there is a real-life example ... They have to respond to this," says Richard Vines, RCA's director.
"If they have to deal with a live example driven by a patient group ... there would be something real to discuss. Then industry, patients, the department will be talking about something real."
The medicines are histone deacetylases (HDACs) inhibitors, with Zolinza indicated for the treatment of cutaneous T-cell lymphoma and Istodax for treatment of peripheral T-cell lymphoma.
Zolinza was TGA registered in 2009 and MSD had made a PBAC submission in March 2011 for the indication only to have it rejected for reimbursement on the basis of unacceptably high and uncertain cost-effectiveness ratios. MSD has not since made a resubmission. Istodax has never been before the PBAC.
The challenge with these drugs is that there is no phase III data that would be normally considered by the PBAC, Mr Vines explains. And while they are being prescribed on the private market, or available in compassionate access programs, the challenge is gathering data in the post-market situation.
"These medicines are available ... we just need to find a mechanism to get them listed ... to make them available to patients in a safe, reliable way."
THEMA Consulting has been chosen to prepare the submission and Mr Vines confirms that it is on track for the November PBAC meeting. He says RCA received funding from MSD and Celgene to cover the out-of-pocket costs of making the submission.
Whatever the outcome, he says there will be lessons to learn and RCA would be "better informed and more knowledgeable advocates" for the experience.
Mr Vines admits that it was his frustration with the current system that was the genesis of the idea.
The Department of Health often says that it cannot force companies to bring drugs to Australia - to register indications or list them on the PBS - but the current system means it is not realistic for the company to do anything, he points out.
In rare cancers, the situation is that the environment is not practical to produce the data the PBAC wants. "So the system creates all these barriers then they criticise the companies ... someone has to call them on it," he says. "The companies have been brave enough to let us do this. It's our idea - we want to sit in the room and say this is the best we can do ... It's affirmative action for the funding of medicines for rare cancer patients."
Michelle Lam
michelle.lam@lushmedia.com.au
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