Opportunity to support the listing of Acalabru... - CLL Support

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Opportunity to support the listing of Acalabrutinib and Venetoclax for the treatment of Australians with CLL


No matter where you live, you can support the access of Australians with CLL to Acalabrutinib or Venetoclax treatment. Australia's Pharmaceutical Benefits Advisory Committee (PBAC) is soon assessing Acalabrutinib or Venetoclax for listing - which would make them an affordable treatment for Australians with CLL. Given Venetoclax came out of Australian research done at Melbourne's Walter and Eliza Hall Institute of Medical Research, originating from a discovery there of the importance of the BCL-2 regulator protein in haematological malignancies in the late 1980s and supported by Leukaemia Foundation research funding grants, it would be particularly fitting to have Venetoclax approved!

Submissions can be done directly to the PBAC via this form for Australians: www1.health.gov.au/internet... or via Australia's Leukaemia Foundation here: leukaemiafoundation.typefor... The Leukaemia Foundation submission form doesn't require you to provide your address and phone number and also avoids the problems with overseas Zip/Post codes, but does ask for an Australian state. I suggest using ACT (Australian Capital Territory, which is our equivalent to the USA's Washington DC.

As Australia's Leukaemia Foundation says, "Whether you're a person with blood cancer, a friend or family member or a health care professional, we want your voice to be heard. Tell us about you or your loved ones experience with the drugs or blood cancers listed in the feedback form and we'll add that to our submission to the Pharmaceutical Benefits Advisory Committee (PBAC), They are meeting in July 2020 to assesses medicines for listing on the Pharmaceutical Benefits Advisory Scheme (PBS). Feedback closes 5pm (AEST) Monday 1 June 2020."

Having access to non-infusion based treatments is particularly important in our post SARS coronavirus world, reducing the risk of exposure through hospital attendance. Even with Venetoclax, only a proportion of those treated need to be observed in a hospital setting during the ramp-up phase, with the need for such observation further reduced if the tumour burden has been reduced by other drugs. Non-infusion based treatments are also a boon for those of us living a long way from treatment centres.

On behalf of all Australians living with CLL, thank you for your support.

This is an unlocked post for obvious reasons! healthunlocked.com/cllsuppo...


48 Replies

Well spotted Neil.

My submission made.


I filled out the form, and although it does not require an email or street address, it does insist that a Australian state or territory is chosen. How should we answer since a US state or NA is not accepted.


in reply to lankisterguy

Well spotted. I suggest you use ACT (Australian Capital Territory) when using the Leukaemia Foundation form. I'll update my post accordingly.

in reply to AussieNeil

Actually I chose ACT at random since it was first on the list and I had no idea what it stood for. (I'd rather be lucky than smart) Len

I can not only support access to these treatments for Aussies, but for everyone everywhere. Venetoclax is an amazing drug discovered in Australia and it would a travesty if people there couldn’t get access.

Affordable access to life saving drugs should be the same for someone in the US as it is for people in Vietnam, Romania, Peru or Uganda.

It would make me feel better about the 150 k I pay for ibrutinb (16k out of pocket) if I knew the pharma company making a killing on me has a robust program to provide assistance to those who need it.

Ps. Neil, I read somewhere about a study in Australia showing covid can be cured eating vegemite sandwiches with snags and washing it down with Coopers. Do you think this is promising study? :)

in reply to cajunjeff

I'm sure there'd be plenty of Aussie volunteers for that study, but I suspect the vegemite sandwiches might put others off :)

in reply to cajunjeff

The danger of Vegemite would be that the virus would thrive in it, become a supervirus, and say 'Gidday' every time it enters one of your cells. That would be sure to kill you in time.

in reply to cajunjeff

This song brings me back to my college days! Great memories.

Beautiful pic of the bird, what kind is he? If you happen to get one of a red Robin that would be so amazing. I love them😊.

in reply to Sushibruno

It's Australia's kookaburra, the largest member of the kingfisher family. Also called a laughing jackass for obvious reasons per the below. You've probably heard the kookaburra's call in films with jungles/rain forests as part of the canned sound effects.

Robins aren't that common in Australia, unfortunately.

Thank you Neil that was so funny, the sound of their laugh sounds almost like a human laugh😂. I enjoyed the video thank you so much. I've been seeing the same Robin in front of my house every so often now. They such beautiful, BEAUTIFUL CREATURES😊.

I grew up singing:

Kookaburra sits on the old gum tree,

Merry merry king of the bush is he.

Laugh, Kookaburra, laugh, Kookaburra,

Gay your life must be!

Kookaburra sits in the old gum tree

Eating all the gumdrops he can see

Stop, Kookaburra, Stop, Kookaburra

Leave some there for me.

Kookaburra sits in the old gum tree,

Counting all the monkeys he can see

Stop, Kookaburra, Stop, Kookaburra,

That's no monkey, that's me.

No kookaburra's here in Tennessee, but I have a robin nesting in a dogwood tree a few feet from my nose when I'm standing on our upper deck.

in reply to gardening-girl

I also grew up singing the Kookaburra Song in Girl Scouts - one of my favorites, but at 8 I saw a burro in my head. Fond memories!

in reply to gardening-girl

I'm not Australian or American but, as young children, we also sang that song and really enjoyed it.


in reply to gardening-girl

I grew up singing that song too, and it's still very familiar to me. Only knew the first verse though. Interesting to see there were more verses.


Those birds kept us awake the whole night on our trip to Arizona. We had no idea it what it was at the time, but that is exactly what they sounded like.

The form has been filled and sent. It makes sense for Venetoclax to be available for Australians to treat CLL.

Stay safe


Wow interesting to know , Venetoclax was developed in Australia.

Looks like the BTK inhibitors plus Venetoclax have some superb. Synergies in treating CLL

Would. Absolutely love to see this combination approved for CLL all over the World , especially in Canada and the US

looks like there is enough data now from trials to fast track it.


Thanks Neil.

I’ve filled out the form also.

Kind regards,


Hi Neel, sorry but I do not really understand your request. I am on Acalabrutinib, or ACP198 since May 2015 but on a trial as a primary drug and it has been very beneficial to me. Now that I moved back to Germany I found out that this drug is not approved by the European health commission so it is not available. Do you think my appraisal from Germany, where it is still a trial drug, could move your health commission to approve it for first line treatment????

in reply to clemens

Your appraisal will certainly help. Australians. There aren't many Australians with experience of Acalabrutinub or Venetoclax and those that have experience, gained it through clinical trials. Our international community members can provide far more accounts of personal experience to assist the decision makers than are available in Australia.



I have been on it here in Brisbane for 18 mths now. Got it via drug firm on compassionate grounds and they have been supplying it since. I see it is on the PBS scheme already but with many provisos and you have to have it with R as well as having failed a BTK inhibitor.

This at least what I read and the doctor commented on as well.

Be nice to have it or with a combination as a front line choice.

in reply to Peacekeeper

It sure would! Your perspective would be valued input. Thanks!

Thank you Neil, this is particularly pertinent for me

Late March I had a video appointment with my specialist from Peter Mac in Melbourne. He told me that under normal circumstances he would be starting me on treatment. Being 73 years old and with markers 13q mutated, the treatment would have been Chlorambucil and Obinutuzumab .

Due to Covid-19, treatment has been postponed for at least four months and Instead I am on monthly blood tests. His thinking for treatment now is chlorambucil mono therapy or venetoclax but only if the latter has been approved by the PBS.

I really hope Venetoclax and Acalabrutinib become widely available to everyone.

The bird in my circle thingo is a Gang-Gang and is quite a character. There are lots of them in the ACT (Canberra) where I live and their bird call sounds like a creaky door... very distinctive!

Take care everyone


in reply to Lilsa

I’m on this in U.K. it is a brilliant combination hope it gets approved for you and all fellow Australians

All done from Ramsgate UK

Hi Aussie Neil- I have sent off a submission for Veneteclax to the powers that be . I have stated my case as a retired pharmacist working first in community pharmacy then in Vic Health for 43 years firstly giving my qualifications . Then I have stated the case, having CLL myself and having success being on Veneteclax in that for several months now I have been in deep remission, as to why Veneteclax should be available on PBS to anyone who needs and that the criteria for prescribing it needs to be abolished.

in reply to roszika

Thank you Roszilater, for your unique perspective.

Is this just for people already on treatment?

in reply to chrisgrannyUK

Most definitely Not! Per the PBAC statement:

"If you haven't used the new medicine yet, what are your expectations of it?

If you use other currently available therapies or medicines you use to manage your condition (or for prescribers, for your patient’s condition), what are the benefits and/ or the challenges? "

and the Leukaemia Foundation statement "Tell us about you or your loved ones experience with the drugs or blood cancers".

Done - but it feels a bit naughty to have said I live in Australia when I don’t!

Hope it helps.


Thanks! Will do it now.



All done from Canada. It took less than ten minutes.


done. so frustrating for everyone the challenges faced by blood cancer victims to get the meds they need, regardless of where they live. While i support the pharma industry's need to earn a reasonable ROI from research to continue the flow of life saving meds, the manipulation of lawmakers, the government and insurance industry is appalling. I once asked a senior official of a pharma about how the management team determined the pricing of a new anti CLL drug and his answer boiled down to whatever the market will bear. I detected a bit of a smirk as he answered.

in reply to larrymarion


We all share the frustration of eye watering prices, but realistically, "What the market will bear" is the only acceptable answer for a public company. I don't want to get into a political discussion, but the actual price people pay for drugs is generally not those eye watering prices, but a price negotiated by an insurance company or (outside of the USA), a country's government that has arranged a tax payer subsidised access cost. The prices negotiated are commercial in confidence and unfortunately for us take time to negotiate. Realistically, I would expect that a pharmaceutical company will accept a much lower price where there's a guaranteed market, rather than walk away from a deal where they still make a profit. Our community's major issue is those patients with no or inadequate insurance cover, or no affordable access to the drugs where they live.

Completed. Hoping for the best for our brothers and sisters in Australia.

Done. Thanks for asking us to help, Neil. Hope you are getting better by the day!


WE'll Get to it.


Thanks so much Neil for posting this as the Australian regulators do need to hear from our patients. Acalabrutinib has also just received a positive recommendation for eligible patients with relapsed/refractory CLL. This does not mean it is on the PBS yet but very close. Lymphoma Australia supported this submission along with patients and we hope to see the approval announced soon.

As mentioned by Neil the next step is frontline and we have until the 10th of June to make submissions to the PBAC meeting. If can please do this via this link www1.health.gov.au/internet... or if you would like some help we are happy to do this for you. Please email us at enquiries@lymphoma.org.au

How do we get this fast tracked ?

in reply to Canuck901

By advocating for improved treatments through your relevant Patient Advocacy Group. That's the Leukaemia Foundation and Lymphoma Australia in my country and in Canada it's the CLLPAG, cllpag.ca , the Leukemia & Lymphoma Society in the USA lls.org among others, CLL Support UK (the charity of which this is the on line forum, etc.


Thanks for highlighting this Neil ... my submission made!


Thanks for the reminder and link, Neil. Submitted my response this afternoon.

Ok. Bit late but here's mine.

I was diagnosed with CLL (Stage 1A) in 2012 at age 44. While my B-cell counts have, to date, remained relatively stable and I remain in 'watch-and-wait', I have keenly monitored the development of BCL2/BTK inhibitors and a range of other novel drugs for CLL/SLL and other haematological malignancies.

While FCR may remain a suitable and very cost effective, first treatment option for some patients, outcomes for patients are individualised (stratified) according to the wide range of mutations (including 17P) that exist. My understanding is that this medication has been approved in other countries based on the results of phase III randomised trials - ELEVATE-TN and ASCEND - which showed substantial improvements in median progression free survival of CLL/SLL participants and with different side-effect profiles to other BTK inhibitors that are currently available.

As a patient, and someone who participates in a number of CLL/SLL online communities, the prospect of an additional, funded treatment that might improve length and quality of life for sufferers is enormously appealing. I understand that in some instances this drug (in combinations) has induced MRD or lengthy PFS which potentially provides substantial economic and social benefits for Australia.

Economically there is potentially greater opportunity for younger patients, like myself, to continue active participation in the workforce for longer and for all patients to have less impact on the Australian health system. There are also societal benefits of continuity in families; I worry about the care and emotional wellbeing of my young children should I fall unwell or not respond to existing available treatments. This drug is an important addition.

The prospect of friends (and myself) having affordable access to an additional treatment option - with perhaps fewer adverse events such as atrial arrhythmias or less bruising than other drugs - is particularly reassuring and adds to our doctor's options for treatment. It provides hope for those who are unable to take existing drugs due to side-effects or declining/non-response.

I would also encourage the Committee to consider whether evidence and practice now supports a benefit from first-line treatment with BTK/BCL inhibitors, like this drug, and newer drugs more generally. In some countries, newer drug combinations have replaced chemo-immunotherapy regimes such as FCR. Being able to take a tablet is highly desirable and tolerable for both younger patients (who can continue working with minimal interruption) but especially for older patients.

I understand first-line treatment for me (in the absence of 17P) would be FCR and I have concerns about clonal evolution and secondary malignancies that may be induced by chemotherapy. While I would follow my doctor's advice, as a patient a non-chemo, first-line treatment that provides a high response rate with a reduced likelihood of further progression/new malignancies is obviously appealing.

My views have been formed by my primary treating haemotologist (Westmead Hospital), reading and watching relevant presentations from conferences such as ASH, journal articles, information from the Leukaemia Society, and the stories from fellow patients in online forums such as HealthUnlocked and CLL Forum.

in reply to Gondy5

Great! Thanks for sharing. As a matter of interest, which submission option did you use - direct to the PBAC or via the Leukaemia Foundation?

in reply to AussieNeil

I went straight to PBAC - I'd only just seen the March 2020 positive listing recommendation - so am a little confused about the process (see link below - first item). And it will still be a second line treatment! I thought I'd have a shot at highlighting benefits of first line treatment - in hindsight I probably should have emphasised covid and how taking a tablet requires less time in medical facilities than chemo/rituxan. But I fear PBS "drug course/cost" calculations will be the barrier, not advances in practice.


in reply to Gondy5

You'll find that the PBAC process involves continuing negotiations between pharmaceutical companies wishing to gain expanded access for their drugs and the PBAC working to ensure that this only occurs when there is evidence that the proposal is superior to current treatment options. The March Acalabrutinib approval was indeed for second line treatment, but the July meeting will be "To request an Authority Required listing for the treatment of patients (either as monotherapy or in combination with obinutuzumab) with previously untreated CLL or SLL considered unsuitable for treatment with a purine analogue. A second request was for useonly in the subgroup of patients with a 17p deletion." pbs.gov.au/industry/listing... (Page2)

Likewise the Venetoclax "Resubmission to request an Authority Required (telephone/electronic) listing, in combination with obinutuzumab, for the first-line treatment of patients with CLL who have coexisting conditions and are unsuitable for fludarabine based chemotherapy". (Page 25)


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