Mildly interesting - especially the last paragraph - that indirectly points to recycling of therapies in some patients.

https://www.onclive.com/web-exclusives/cdk46-inhibition-refined-in-hr-breast-cancer-as-novel-combos-emerge?p=2

Giovanna,
Thank you for that piece of the access puzzle on Pfizer.

Lesleyb - you are right - it's a little bit of a pickle for PBS ...not so little.

This is from late 2017 following Asco -  published as Pfizer news.

http://press.pfizer.com/press-release/updated-data-phase-3-trial-ibrance-palbociclib-plus-letrozole-er-her2-metastatic-breas

I draw attention to the paragraph that says 

In the U.S., IBRANCE is indicated for the treatment of HR+, HER2- advanced or metastatic breast cancer in combination with an aromatase inhibitor as initial endocrine based therapy in postmenopausal women, or fulvestrant in women with disease progression following endocrine therapy.Dec 6, 2017

There is a catch - fulvestrant ( Faslodex ) is not PBS approved in Australia, despite being an effective hormonal therapy and being around for more then 5 years. As far as I can tell Astra Zeneca DID NOT submit to PBAC thus fulvestrant is only available at around $800 a month or a start up compassionate access. 

The question remains what do the women who need Faslodex/Ibrance as a line of therapy do??

Giovanna - is absolutely right WE should ALWAYS check all information with your treating oncologist to work out how it pertains to our treatment plan. 

Hello all,

Here is the response from our policy team.

Thanks for your comments and questions about CDK inhibitor drugs.

The proposed listing of the CDK inhibitors on the PBS is only for first line treatment at this time. BCNA is continuing to advocate for these drugs to be made available at a reasonable price for all who need it, including those who are using them, or might benefit from them, as a later line treatment. However @wendy55, it is a great idea to speak with your oncologist about what options are open to you.

@leapfrog, the Ibrance (palbociclib) access program currently offered by Pfizer means that eligible women will be able to access Ibrance for a one-off cost of $50, paid at the pharmacy when the first script is filled. All scripts after that will be filled free of charge. Eligibility for the program will be similar to the proposed PBS listing – that is for people newly diagnosed with hormone receptor positive, HER2-negative metastatic breast cancer, as a combination treatment with an aromatase inhibitor (anastrazole or letrizole).

The government and the pharmaceutical companies are currently in negotiations on the cost of the drugs. It is a good idea to keep an eye on the BCNA website for updates – we will be posting there once we have an update.

Some more information about the access programs is available on our website: https://www.bcna.org.au/news/2018/03/cdk-inhibitor-update/ . For more specific information, it is best to talk to your medical oncologist.

Hello,
Thanks for the posts, I have asked our policy team to provide further information regarding special access schemes for Palbociclib and Ribociclib.  Stay tuned.

I just made it on by 3 days because I  had been on Letrozole for 27 days and 1 month was the cutoff time.

I am really disappointed.  My onco has told me I am not eligible for Ibrance because it is not the first line treatment for me even though all I have had is 2 aromatose inhibitors and that is during the 5 years I was dx with MBC.  He is trying to get it for me on compassionate grounds once again

I am on the compassionate access program for Ribociclib and it is at no cost to me until they decide on a price for the PBS, then , as I am on a disability pension I  will pay $6.40 per script.

Wendy55

This is the FDA ( States ) approval from 2015
https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm549978.htm

 - and how Pfizer phrased it in relation to the body of evidence - the reality is that if clinically appropriate most women can access it in the States ( they have odd insurance policies that complicate things ...) . There is sometimes a pattern where resistance to hormone therapy develops and using chemo resensitizes one to hormone therapy ( not always but it can happen) so I think in this context one goes with what the clinical oncologist decides is best, not just first line.

PBAC approved what Pfizer asked for and it is listed as initial not first line - iffy I know- so it may be opened to interpretation, firngers crossed.


Definetely check with your oncologist - and also maybe keep an eye out Pfizer may put out a compassionate access program for "others" once the deal with PBS happens.

Leapfrog,
You are ahead of me on this - I did not think there is an access program for Palbo - last I checked with Pfizer was couple of months ago... can you please share what do you know about this or can anyone/Giovanna add. Would be thrilled to know that is not correct.

My understanding is that Novartis offers a compassionate access programme for Ribociclib -  I don't know the cost to the patient.

I am positive - Keytruda has gone through for lymphoma - immunotherapy trials do include it in some mets BC work - so the door is open on that too, I hope the government will not delay too much the CDKs.

I posted this on the General Discussion board by mistake.  This would have been more appropriate.

Can someone tell me how the Palbociclib Access Program works?  I'm asking out of interest for women who already have metastatic breast cancer and will be taking it for the rest of their life.  It doesn't affect me personally as I'm on a trial and receive Palbociclib free.  I'm curious about the eligibility.  I believe newly diagnosed women will pay $50 upfront and then receive all scripts for free after that.  Does this mean until the drug is listed on the PBS or for life?  If newly diagnosed women can receive it for $50 for life, why would those who are already diagnosed have to pay for each script when it is listed?  Or am I missing something?