Kisqali on PBS, very few will get it.

wendylou

those of us who were waiting to get Ibrance or Kisqali on PBS we will not get either.  Only newly the diagnosed who have NOT had an
Aromatose drug.  ( there would be very few of them )  BCNA failed to include this in their news item. 
Those who were on a trial or compassionate grounds will get Kisqali on the PBS.   Go to the PBS website, put in Ribociclib and
click on ' Authority required ' then read the sorry tale.   BCNA applauded the health minister for his decision deliberately ignoring
all of us who have stage 4.   BCNA should be condemned for there reaction.      Good luck every one.       wendylou 

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Kattykit

I know that I just made the cut as I had only been on letrozole for 27 days, otherwise I wouldn't have been given the Ribociclib, my oncologist was panicking a bit because the hospital stuffed up and lost my records between hospitals when I needed the nail put in my leg.

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Tennille

If a drug is added to the PBS is should be for anyone who needs it. So sick of hearing you can't have this or that or be added to a clinical trial because you had that drug first. Well excuse me for getting metastatic bc and needing treatment. I believe all Stage 4 should be prioritised or those with aggressive early bc regardless. 

FYONA1

I agree even though I'm on this particular drug initially I wanted to have it down the track because of potentialsid effects but I was told no I had to take it there and then otherwise may not have had the opportunity to have it down the track who knows 

and yes@ Tennille I agree with you we metastatic women need to put basically put first and heard 200%

arpie

A bit harsh there, I think Wendylou  .... I wouldn't think BCNA would deliberately falsify information re treatment/medication.  I am sure there will be a response shortly.

That's disgusting.  No 'conditions' were mentioned in the interview that I saw on TV .... 

If it is available for one BC patient - it should be available for ALL

I think a heap more lobbying is needed @Giovanna_BCNA    @Marianne_BCNA  @Rosie_BCNA    to bring back some fairness in this decision.

Looking forward to your response on this complex issue!   

arpie

From the PBS Website:  http://www.pbs.gov.au/medicine/item/11385F

It looks like you need to be a lawyer to understand the 'conditions' attached to the access to this drug!  

They appear to contradict themselves, saying: Patient must not have previously been treated with an aromatase inhibitor,

 - then further down say: The treatment must be in combination with anastrozole or letrozole

Hmmm ... so you only qualify if you start AIs AFTER starting Ribociclib?

How many are given AIs BEFORE starting Ribociclib?

Personally, I don't understand all the terms  ..... like 'grandfather patients'??  Please explain?  

There appears to be different criteria for 3 different 'Met BC & Phases/' .... 

1) Locally advanced or metastatic breast cancer

    Treatment Phase: Initial Treatment

2) Locally advanced or metastatic breast cancer

    Treatment Phase: Continuing treatment

3) Locally advanced or metastatic breast cancer

    Treatment Phase: Initial treatment - Grandfather patients

Direct PBS QUOTE:

Locally advanced or metastatic breast cancer

Treatment Phase: Initial treatment

Clinical criteria:

• Patient must not have previously been treated with an aromatase inhibitor,

AND

• The condition must be hormone receptor positive,

AND

• The condition must be human epidermal growth factor receptor 2 (HER2) negative,

AND

• The condition must be inoperable,

AND

• Patient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less,

AND

• The treatment must be in combination with anastrozole or letrozole,

AND

• Patient must require dosage reduction requiring a pack of 21 tablets.

Population criteria:

• Patient must not be premenopausal.

Authority Required

Locally advanced or metastatic breast cancer

Treatment Phase: Continuing treatment

Clinical criteria:

• Patient must have previously received PBS-subsidised treatment with this drug for this condition,

AND

• Patient must not develop disease progression while receiving treatment with this drug for this condition,

AND

• Patient must have stable or responding disease,

AND

• The treatment must be in combination with anastrozole or letrozole,

AND

• Patient must require dosage reduction requiring a pack of 21 tablets.

Population criteria:

• Patient must not be premenopausal.

A patient who has progressive disease when treated with this drug is no longer eligible for PBS-subsidised treatment with this drug. 

Authority Required

Locally advanced or metastatic breast cancer

Treatment Phase: Initial treatment - Grandfather patients

Clinical criteria:

• Patient must have previously received non-PBS-subsidised treatment with this drug for this condition prior to 1 July 2018,

AND

• Patient must not have previously been treated with an aromatase inhibitor prior to initiating treatment with this drug for this condition,

AND

• The condition must be hormone receptor positive,

AND

• The condition must be human epidermal growth factor receptor 2 (HER2) negative,

AND

• The condition must be inoperable,

AND

• Patient must have had a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less prior to initiating treatment with this drug for this condition,

AND

• The treatment must be in combination with anastrozole or letrozole,

AND

• Patient must not develop disease progression while receiving treatment with this drug for this condition,

AND

• Patient must have stable or responding disease,

AND

• Patient must require dosage reduction requiring a pack of 21 tablets.

Population criteria:

• Patient must not be premenopausal.

A patient may qualify for PBS-subsidised treatment under this restriction once only.

For continuing PBS-subsidised treatment, a Grandfathered patient must qualify under the Continuing treatment criteria.

UNQUOTE

Ellamary98

I was diagnosed with bone mets in May and my onc deliberately avoided putting me straight onto an AI, so that I could have access to ribociclib once it came onto the PBS. I don't know the reasoning behind it, but I certainly agree that it is unfair and the reports have been misleading.

brightspace

Hi All for those mets patients who have been following the submissions for
Palbociclib and then ribociclib
to pbs listing which occured last year and again this year 
It was known then that the drug would only be available to those of us who are
hormone positive her negative  first time diagnosed  mets
This being patients who had not been on an AI drug for more than one month
This has not changed
Yes we are disappointed
However I feel that BC NA has not misrepresented this
I cannot comment on the info from media sources

YES bcna can now lobby on our behalf for these drugs to be made avaible to those who have been on AI 
Bright in hope

Riki_BCNA

Hello everyone, thank you for raising concerns with the listing of ribociclib on the PBS. Please see the link below to BCNAs recent statement on our website explaining the PBS listing for people newly diagnosed with metastatic breast cancer

https://www.bcna.org.au/news/2018/07/ribociclib-now-on-the-pbs-for-people-newly-diagnosed-with-metastatic-breast-cancer/

As always we advise you speak with your medical oncologist about your individual situation. If you have any further questions please do not hesitate to contact BCNA on 1800 500 258 or email policy@bcna.org.au 

arpie

Many thanks for that @Riki_BCNA

Good to know that people can make requests thru their oncologist on 'compassionate grounds' to be included in the cheaper treatment.

Those not covered on the current criteria - get your onc to give it a go.

Patti J

But...it is NOT suitable for everyone with stage 4 breast cancer.

Wildplaces

1 in 8 women in Australia gets breast cancer.
Of those diagnosed with breast cancer 20-30% will have a recurrence during their life span.
For those living with Metastatic Breast Cancer there is no cure.
Metastatic Breast Cancer women will die of their disease. Two thirds of these women will die of their disease within 5 years.

CDK 4/6 drugs offer women with HR breast cancer the opportunity to at the very least delay the onset of chemotherapy drugs. Palbociclib is the most known and certainly the drug on which we have the most data.

It was approved by the FDA in February 2015 by accelerated approval.
Canada and the European Union followed suite.

More than 3 years later this drug still NOT available in Australia on PBS.

Ribociclib has potential cardiac side effects that have not been the reported with Palbociclib.

The choice over which drug came down to money - the cheaper of the CDK4/6 has been granted PBS approval. Furthermore it is limited to women who have not been on AI - so what about all the postmenopausal women on AIs who develop metastasis? BC peak incidence is mid 50s through 60s. It is also not on PBS for men who have Metastatic breast cancer. 

And yes, while they are compassionate programs - these women are going through enough not to be put through one more loop, one more jump, one more reminder of how vulnerable they are. 

I agree that BCNA has not been entirely open about the ongoing fight and the political scene behind trying to bring CDK inhibitors to Australian women who are dying from Mestatstic Breast Cancer. 

Wildplaces

I have been contacted by BCNA - thank you for clarifying and following this up -  I stand corrected. 
According to Novartis - (so yes Arpie it is indeed strange that on the " initial treatment - one of the conditions states " patient must not have been treated with AIs" but then for Continuing or Grandfather patients the phrase " patients must have not been treated with AIS for this condition" is used) still I am happy to write.

Ribociclib is available on PBS for women with early disease who use AIs in the adjuvant setting and go on to progress to advanced disease provided they fulfill the time criteria of accessing the drug. 

Arpie posted the PBS criteria for all to look at. Thank you!! 

So the restriction to my understanding involves women who have Metastatic Breast Cancer and have been on AIs. And again my understanding is that men with Metastatic Breast Cancer can not access it on PBS. BCNA please weigh on this. 

My statement about the time lag between FDA approval in the States PBS authority is correct - it took us three years to bring the drugs to PBS. My understanding is Palbociclib is not available because a satisfactory financial deal could not be reach between the ministry and Pfizer. Ribociclib does have potential cardiac side effects, albeit rare -  not reported with Palbociclib - women who take Ribociclib have regular cardiac monitoring. 

Finally BCNA - Is Ribociclib available with Faslodex on PBS?

Its time to fight hard for solid options for Metastatic Breast Cancer.
Time for Beyond Pink!

kmakm

I am confused. I have completed active treatment for breast cancer and am now taking an AI, for ten years. If at some point in the next ten years, or beyond, it's discovered I have mets, will I be able to take Ribociclib on the PBS?