Kisqali on PBS, very few will get it.

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.

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

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.

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

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.  

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. 

@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?

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.

Thanks @Rosie_BCNA

Thank you @Rosie_BCNA