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!
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!
Neil
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Great, at least this is a start on the long road to listing. I just completed the submission and am hoping that many others will do so too.
It's frustrating to know that there are these new therapies, developments all over but that they are totally unaffordable and of no use until listing on the Pbs.
Wondering why only Australians are asked to comment? Americans have been in trials for over 3 years and have amazing results. Would we not be considered reliable sources of data?
Francc, that's an excellent point and already addressed. I've asked a member from the USA to try submitting comments, as the form asks for your contact details and may reject those from outside Australia. You are welcome to try too if you wish.
As a back up plan, if Ibrutinib has to go through the resubmission process and overseas patients on Ibrutinib aren't able to directly respond, I've asked our Leukaemia Foundation if they are prepared to collate responses from members willing to share their experiences, so that the PBAC is provided with a strong patient perspective for Ibrutinib's approval. There's only a handful of Australians with CLL that have had experience with Ibrutinib (and not for very long), so it makes a great deal of sense for others with far more experience to weigh in with their comments. Australians would be very much appreciative of that support too, believe me!
In the unlikely event that the Leukaemia Foundation are unable to assist, I can't see why I couldn't provide a 'care of' address in Australia that overseas members could use...
I indeed just made a submission and suggested that our U.S. input should be of value since we have many more patients using Imbruvica for 3 years now. Hope it has some impact. (P.S. I loved our travels in your fabulous country) ~Fran
I'm in Canada, so I could be wrong, but to my knowledge Ibrutinib is not approved anywhere for first line treatment, with the exception of 17p or TP53 deleted/mutated.
Ibrufinib became available in the UK for 17p patients in March of this year as far as I know .
I applied for the trial. Here in the UK ,was excepted and then it was found I had the 17p so was put on Ibrufinib as a first line treatment .
Regarding the meeting on the 10 th June ,I am having trouble with the site accepting my postal code .I have tried entering this several different ways but it still keeps asking for the code again .What am I dong wrong ?
WWW advised that '-12345' i.e. a '-' in front of the 5 digit USA zip code works; you might try that minus prefix for your UK location code. You'll get an email confirming your response has been accepted in addition to the submission appearing to be successful on the website.
Hi I'd like to add that my husband has been on Ibrutinib in the UK on compassionate grounds, (he had a severe allergic reaction to Ritixumab) for the last 12 months and has almost achieved remission, next check up in 2 weeks so everything crossed. wishing you all the best for getting it approved
Thanks Neil. I've put in my submission. I know there are others in Australia who, like my husband, have had no alternative but to come up with the money to buy Ibrutinib. I hope the decision-makers realise they hold people's lives in their hands at these meetings. My husband goes into hospital for a stem cell transplant this Tuesday. Feeling very nervous about it. We're constantly told how unlucky he was to get CLL at 46 and how unlucky he was to get 17p. So hoping our luck will finally turn and everything will be okay.
Thank you all those that have submitted their response on Ibrutininb. The minutes of the meeting can take upwards of a couple of months to be published and then there's the final decision by the Australian Federal Government. I'll provide updates as I hear them.
The minutes of the PBAC July meeting, at which Ibrutinib was considered for PBS listing have been published with the following PBAC Outcome comments:
"The PBAC did not recommend the listing of ibrutinib for the treatment of relapsed or refractory CLL and SLL. In making its recommendation, the PBAC considered that the patient population and clinical place of ibrutinib were not adequately defined, the size of the comparative clinical benefit could not be quantified and the cost effectiveness and financial implications were underestimated and unacceptably high.
The submission requested PBS listing for ibrutinib therapy for patients with relapsed or refractory CLL or SLL and who were considered unsuitable for treatment or retreatment with a purine analogue*.
In regards to the submission, the PBAC:
- noted that the TGA-approved indication for ibrutinib did not restrict use to patients unsuitable for re-treatment with a purine analogue and also recommended use in first-line patients with CLL with 17p deletion and mantle cell lymphoma. Usage of ibrutinib beyond restriction was a possibility.
- considered that ibrutinib is an effective treatment, but the increased effect over the treatment that would be replaced in Australia was difficult to quantify but may be smaller than proposed in the submission.
- considered that submission could not establish the cost effectiveness of the treatment at the sponsor’s requested price."
* Fludarabine (the F in FCR) would be the purine analog the PBAC is referring to.
So basically, the proposed use of Ibrutinib is not restrictive enough (too many patients would want to use it under the current proposed recommendations), the submission didn't directly compare it with FCR and the price asked for the drug is far too expensive for the anticipated improvement. (Apparently about A$60,000 per year maximum is the most the PBAC is prepared to pay.)
"Sponsor Comment:
Although disappointed that the PBAC were unable to recommend ibrutinib in the requested setting, Janssen are committed to working with the Department and PBAC in order to ensure timely access to ibrutinib. Janssen believe there is an unmet clinical need for an effective and well tolerated treatment for relapsed or refractory CLL and SLL patients who are unsuitable for treatment or retreatment with a purine analogue."
The November PBAC will consider the listing Ibrutinib (again - no doubt with the sponsor addressing what it can of the points raised above for relapsed or refractory CLL and SLL as well as Idelalisib.
Idelalisib is on the agenda for a major submission to list it for the treatment (of) CLL in patients with progressive disease despite previous treatment.
The agenda can be found here, as can the link to the Consumer Comments Submission form:
The deadline for these consumer comments is 7th October 2015.
All CLL patients are encouraged to respond, with the PBAC particularly interested in hearing from CLL patients that have had experience of Ibrutinib or Idelalisib. So particularly if you've had treatment with either of these, please provide the PBAC with your experiences (and compare them with your earlier treatments!!)
Disappointing news Neil. I hope this can be overturned during the November review and the remit focused so that populations with greatest unmet clinical need within the licensed indication can be agreed to reduce the fear of mission creep and cost escalation.
Here in the UK we await the final NICE appraisal decision for Idela plus rituximab for England & Wales (expected 3rd week of September) as the NICE Ibrutinib appraisal commences.
Worrying times
Patient's experiences and perspectives are very important in all this, please share yours if you can within the consumer comments link
1 The PBAC did not recommend the listing of ibrutinib for the treatment of relapsed or refractory chronic lymphocytic leukaemia (CLL) and small lymphocytic lymphoma (SLL). In reaching this conclusion, the PBAC considered that the patient population and clinical place of ibrutinib were not adequately defined, the size of the comparative clinical benefit could not be quantified and the cost effectiveness and financial implications were underestimated and unacceptably high. The PBAC noted the main TGA approval is for second-line treatment of relapsed or refractory CLL and SLL, while the proposed restriction was further limited to patients for whom fludarabine is considered inappropriate. Usage of ibrutinib beyond restriction was a distinct possibility.
2 The PBAC welcomed the input received from consumers, organisations and health care professionals. The comments noted that ibrutinib was better tolerated than standard chemotherapy, prolonged survival and improved quality of life. The PBAC agreed that there was a clinical need for an effective treatment for patients with relapsed or refractory CLL and SLL. The PBAC considered that ibrutinib is an oral drug that provides an additional avenue of therapy for patients with relapsed CLL and SLL and the Committee noted that there is an active research and development program for additional treatments for CLL.
3 The PBAC noted that the TGA approved indication for ibrutnib included first line treatment of patients with CLL with 17p deletion; and patients with mantle cell lymphoma who have received at least one prior therapy. The PBAC noted the clinical need for an effective treatment for these patient populations. "
Many thanks to those that supported this application; I'm sorry I don't have better news...
Neil
- With thanks to Chris Hobson of the Leukaemia Foundation for supplying the above
There are two changes in review for this November's PBAC meeting for which Australians would appreciate anyone with experience of Ibrutinib and Venetoclax informing the PBAC of their experiences and how much they preferred having a non-chemo treatment:
1) Change to recommended listing
(Major Submission)IBRUTINIB/Imbruvica®
To request an Authority Required listing for the first line treatment of patients with CLL or SLL who meet certain criteria.
2) Change to recommended listing (Minor Submission)VENETOCLAX / Venclexta®
To request that the PBAC review the circumstances of listing recommended at its July 2017 meeting for CLL patients.
The On-line submission form (and the process is guided and easy to complete) can be found here: health.gov.au/internet/main...
On behalf of all Australians with CLL and their families/friends, I thank all that take the time to support affordable access to non-chemo treatment options for CLL patients in Australia. When overseas submitters are asked for a their postcode, WWW advised that '-12345' i.e. a '-' in front of the 5 digit USA zip code works and that trick may work for other countries too.
Note: The closing date for consumer comments is 4 October 2017.
Submissions are categorised broadly as major or minor and we have one of each for CLL patients:
•Major: Submissions to list new medicines on the Schedule of Pharmaceutical Benefits or to make substantial changes to current listings are generally classified as major submissions. Major submissions require presentation of an economic evaluation.
•Minor: Submissions that relate to new forms of previously listed products and changes to the conditions of use e.g. change in maximum quantity/repeats or clarifying the wording of a restriction (while not altering the intended use) are considered to be minor submissions. Minor submissions do not usually require the presentation of an economic evaluation.
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