Australia's Pharmaceutical Benefits Advisory Committee (PBAC) - the body that recommends what should be on the PBS, will consider the submission of Ibruitinib for approval in Australia at their July meeting. You can provide a supporting submission on line to the PBAC and it is a well structured process that shouldn't take you too long to complete. Comments must be submitted by next Wednesday the 10th of June. PBAC will review all submissions and make a decision next month. (They only meet three times a year.)
Fran (see below) has kindly checked that overseas responses are accepted. Given there are very few Australians with experience of Ibrutinib, if you'd like to help your falling behind the times Aussies with CLL, please go ahead and say your piece!
On line submission form:
PBAC's role, Meeting Agenda and Consumer Comments
Dr Anna Williamson, Head of Research and Advocacy, Australian Leukaemia Foundation has responded to my query about the submission of Ibruitinib for approval in Australia as follows: "Australia's July PBAC meeting is the first time that Ibrutinib will be considered by the PBAC. The PBAC is required by legislation to make an evidenced-based recommendation to the Minister (and in case of very expensive drugs, to Federal Cabinet). The PBAC makes its assessment of the new therapy compared with existing therapies available in Australia and considers the cost effectiveness of the new therapy. A model of cost effectiveness is prepared by the sponsor (Pharma company) using the trial and any other evidence that they have collected. It must also consider negative effects – side effects etc. This data is not publically available (Pharma choice not to release).
The best thing Australians can do is make a personal submission to the PBAC. Submissions from people with personal experience of CLL are very useful for the PBAC. The Consumer Rep on the panel receives all the Consumer submissions and analyses them to gather patient experience of impact of CLL on their everyday life, what symptoms people with CLL experience, what treatments they have already had, impact of treatments on CLL, side effects of treatment on their health and life, and if they have been involved in an Ibrutinib trial – personal experience of this new therapy compared with other therapies, impact of side effects of new treatment on their health and life (both negatives and positives of the new therapy). One of the first checks PBAC makes is to see if the sponsor understands and recognises the impact of CLL on the patient and have they gathered evidence in their trials of benefits and negative side effects (both clinical and broader quality of life)? (my emphasis - Neil)
One of the problems everyone faces is obtaining accurate information so that we can make up our own minds about drug access, PBAC processes etc. It is a very complicated and rigorous process because it involves payments of huge amounts of taxpayers funds."
So don't be surprised if Ibrutinib isn't approved on this first submission. It's quite likely that the PBAC will identify gaps in the proposal that will need to be addressed in a subsequent submission.
Thanks for your support!