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CDK Inhibitors approved by PBAC 20 April 2018

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  • Giovanna_BCNA
    Giovanna_BCNA Member Posts: 1,839 ✭
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    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.
  • Giovanna_BCNA
    Giovanna_BCNA Member Posts: 1,839 ✭
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    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.


  • Wildplaces
    Wildplaces Member Posts: 81 ✭
    edited April 2018
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    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. 
  • Wildplaces
    Wildplaces Member Posts: 81 ✭
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    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

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