At the March meeting of the Australian Pharmaceutial Benefits Advisory Committee (PBAC), approval for the two new CLL treatments, obinutuzimab (Gazyva®) and Idelalisib (Zydelig®) will be decided, namely:
1) To request Authority Required (STREAMLINED) listing of Idelalisib for the treatment of CLL in patients with progressive disease despite previous treatment.
2) To request Section 100 (Efficient Funding of Chemotherapy) listing of Obinutuzimab for the treatment of CLL.
If you have had prior therapy for CLL and you need treatment again fairly soon, then it is unlikely that you will benefit from a repeat of your earlier treatment. You really need access to an alternative treatment (such as Idelalisib) to gain any benefit.
As the PBAC site says:
"Your comments are welcome whether you are a patient, carer, member of the public, health professional or member of a consumer interest group."
You can support these submissions via on line comment to the PBAC.
On line submission - must be provided by 11th February:
I have submitted my "ten cents" of input per the online submission form. Here's hoping and praying for a successful outcome.
Diagnosed in 2012, I had chemo (FC) in 2013 and have had a partial remission. While currently feeling fit and well, on my last visit to my haematologist in Nov 2013, , he indicated that I may need further treatment towards the end of 2015. It would be great to have these alternatives to chemo!
I know I'm 12,000 miles away but I would just like to offer my "experience" to this exciting Aussie Opportunity!
You may recall I have been on a Gilead Clinical Trial - Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Idelalisib (GS-1101) in Combination with Bendamustine and Rituximab for Previously Treated CLL.
Prior to treatment - June '13 my WBC and Lymphocytes were both climbing above 85.
Whilst there was threefold initially (Expected with Idelalisib.) after eighteen months (Dec '14) these figures are nearly below 10 !!
I know that everybody is DX & body is different -- but Idelalisib (Zydelig®) daily tablets - have worked so far for me.
I just pray that the evidence from Clinical Trials like mine -- will negate the funding issue!
Thanks Marty! I can see why you are so pleased to have had the opportunity to joint an Idelalisib trial. Anyone interested in how important it is to have newly approved drugs for those previously treated need look no further than Marty's profile.
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