Kisqali on PBS, very few will get it.

Rosie_BCNA

Ribociclib has been approved for listing on the PBS forpeople with metastatic breast cancer under specific conditions. The criteria is for hormone receptor positive, HER2 negative metastic breast cancer as first line treatment for Metastatic disease and is used in combination with an aromatise inhibitor (AI) such as letrazole (Femara). The metastatic breast cancer must not have been treated with an AI. @kmakm based on the details you’ve provided and the current eligibility criteria, you would be eligible for treatment with Ribociclib. As always, your oncologist is best placed to explain each person’s situation and likely benefit or risk of any new treatment. Please refer to the link @Riki_BCNA posted above. https://www.bcna.org.au/news/2018/07/ribociclib-now-on-the-pbs-for-people-newly-diagnosed-with-metastatic-breast-cancer/
BCNA is continuing to advocate for this class of drugs (CDK inhibitors) to be made available to people with metastatic breast cancer who have had additional lines of treatments. 

Wildplaces

According to BCNA and a Novartis advisor - my understanding is that -  YES you are, if it is appropriate treament for you and you are prescribed that drug as a first line - ie immediately after diagnosis no other treatment.

BCNA - please correct if that is not correct.

The problem is that is you have been diagnosed with Mets and have been on a AI - you would not be able to access it on PBS. So women with mets on AIs who have waited for it to arrive to PBS and have not prev accessed it through a study or compassionate - can not access it on PBS. If you are a man you can not access it on PBS. If your doctor wants you to have it with Faslodex and not an AI - I think again you can not access it on PBS.

i hope I have that right - BCNA - please let us know if I am incorrect - I am happy to be told the circle is wider than that.

kmakm

Thank you @Rosie_BCNA

iserbrown

Thanks @Rosie_BCNA

Danielle_BCNA

Hi everyone-thanks for the update Wildplaces. At BCNA we continue to seek clarification around any queries people have. We are also being told that men are not restricted as the listing only talks about premenopausal women not being eligible (because the AI drugs don’t work as oestrogen blockers in young women). Men need to have discussions with their doctors about whether a CDK is right for them as there is less evidence around effectiveness in men.

Wildplaces

@Danielle_BCNA - it would be great if men with Metastatic BC could access it - the PBAC recommendation was for women - do you have confirmation from Novartis that men can access Ribociclib under PBS should it be appropriate as management?
If so are there any restrictions around it?

Wildplaces

Hi @Danielle_BCNA ,

Lisa_BCNA said:

Hi  @traveltex, unfortunately the PBS listing for ribociclib is for women only because there is not enough evidence that ribociclib is an effective treatment for men. The first line trials for ribociclib only recruited women. 

However, trials in later lines did include men. As the evidence emerges around benefit for men with breast cancer we will keep everyone updated. We will also continue to advocate for new drugs to treat breast cancer to be available on the PBS. The best advice is to talk to your medical oncologist about options for accessing the drug through compassionate access schemes or clinical trials. 

I knew I had that part of the info from BCNA - can you please correct and tell us - has Novartis confirmed it is available for men on PBS?

I have a good friend with BC who would be very interested.

Giovanna_BCNA

Hello @Wildplaces

Thanks for pointing this out. The post you highlight from Lisa was correct at the time of posting and was based on the application that Novartis submitted for Ribociclib and that BCNA endorsed.

However, when Ribociclib was listed on the PBS on 1st July, the listing was different and the only group excluded are premenopausal women. 

Therefore, men are able to access Ribociclib through the PBS.  We have contacted a number of men privately to make sure that they are aware of this.  It is important however, that men talk to their medical oncologist regarding the suitability of this treatment for them as earlier clinical trials did not include men.  

Wildplaces

That is great news.  
Do you mean the ministry extended the PBS listing outside the Novartis' application ?

wendylou

kmakm   Jul 5     part of  - " now taking AI for ten years , if at some point in the next ten years or beyond it is discovered
I have mets will I be able to take ribociclib on the PBS ?"
Answer from Rosie BCNA  part of -  "you would be eligible for treatment ribociclib"
kmakm  - I am sorry to say Rosie BCNA is incorrect.   Under current eligibility and authority restrictions you would not be
eligible for ribociclib  on the PBS because you have previously taken AI.

wendy55

So complicated, too much information for me, will speak to my oncologist end of July - to see what is best for me, will continue on xeloda for as long as I can, and hope that the whole situation becomes more user friendly in the coming months,DISCRIMINATION - is the term that springs to mind - Treating a person or a particular group of people differently,
especially in a worse way from the way you treat other people - as defined in the Cambridge Dictionary, 
I am so grateful that at least we have got this far,@rosie-bcna,I did send you a pm, did you get it, I think my messages are ending up in cyber space,
Wendy55

Wildplaces

Wendy Lou,
That was my first read of the PBS criteria - posted above .
i have been contacted by BCNA and been told they had consulted a Novartis Medical Advisory - and that is not correct women treated with AI in early disease adjuvant setting are eligible.i have since reposted in bold letters as to not cause undue angst.

i remain sad as who is covered and how the ministry made their decision. From Lisa post Mid June and what I have read from PBAC, men were not covered as the evidence was weaker - it will always be weaker it is harder to get the same numbers for studies. Now according to Giovanna it seems that between mid June and 1st of July - outside PBAC ( because I don't think there was a special meeting reported) men are now covered. If that is correct that would be great.

it still leaves three central questions:
1. What about women with HR positive Metastatic disease who have been on AI but where the oncologist feel they would benefit from a CDK?
2. What about the combination of Faslodex and CDK as a second line - study numbers there are very good? 
3. Why was Ribociclib chosen over Palbociclib - similar side effects esceot for the potential cardiac complications with Ribociclib, and what about Abemaciclib which has been shown to work as monotherapy in heavily pretreated women with Metastic breast cancer.

We don't talk about this enough - and it is difficult for both patients first and foremost but also clinicians - who are forced to make decisions whether to discuss ALL available options knowing that some will be out of affordability - in this group of patients facing chemo and death. 

I think its important to value the effort BCNA continually puts in supporting women with BC - that is their mission - but I would like to see more open conversation about how tough it is to get these treatments in Australia. Be happy about successes but know and admit women have a hell of a fight on their hands to get latest treatments and they are costly on those many grounds. Be respectful of the unthinkably tough process they go through.

On a note of hope trials on CDK 7 and CDK 12 are taking place - albeit phase 1.

kmakm

I remain completely unclear on whether a woman treated for breast cancer, who is then put on an AI, and who then develops a metastasised form of her disease, is eligible for the PBS subsidised Ribociclib. There is complete disagreement here on this point. I think I'll ask my oncologist next time I see her.

Kattykit

I have a number for the people at Novartis, I will give them a call on Monday to see if I can get some answers, we have Ribociclib instead of Palbociclib because they couldn't come to an agreement on pricing.

wendylou

Wildplaces whoever contacted you from BCNA is incorrect, it is very clear.   Novartis DO NOT decide on eligibility
for PBS. Unfortunately the PBAC and the government set the eligibility.
The eligibility rules are on the PBS website or thanks to Arnie the are posted on this discussion for all to read CAREFULLY.