In March 2025, Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) will consider an extension to the existing listing of Ruxolitinib (known as Jakavi®) onto the Pharmaceutical Benefits Scheme (PBS). The extension sought will be for the treatment of adult patients with PV who are resistant to or intolerant of hydroxycarbamide (hydroxyurea).

NOTE: CLOSING DATE FOR PATIENT INPUT – 29 JANUARY 2025

To help the Government in its considerations, PBAC is taking consumer comments until 29 January 2025.
* See below for advice on making a submission.

The MPN AA is supportive of ruxolitinib being available on the PBS for PV patients. It would provide another treatment option when first line therapy fails. Thanks to the MAJIC-PV trial conducted in the UK, Ruxolitinib has now been established as a viable second line treatment option for PV.

For more information please see our News post about the Majic-PV trial.

*Next steps if you’d like to make a submission

Making a submission to the PBAC is a way for PV patients to have a voice by explaining how having access to this treatment could impact on their own quality of life.

If you follow the instructions below you will be able to make your comments via a simple process.

1. To comment for the  2025 PBAC meeting, start by clicking on this LINK.
2. On Page 2, enter your name and contact details and select the category that best describes your reason for input, ie:
   – Individual who would like to access the medicine to treat own health condition
   The drug you are commenting on is ‘Ruxolitinib Jakavi®.
   You will see that this is a ‘Resubmission to request a General Schedule Authority Required (STREAMLINED) listing for the treatment of adult patients with polycythemia vera (PV) who are resistant to or intolerant of hydroxycarbamide (hydroxyurea).’ This is because the drug company unsuccessfully sought approval in 2019. However as more results are now available from the MAJIC study, the pharmaceutical company is resubmitting its application.
3. On Page 3, provide your input by answering the questions in the free text boxes OR by attaching a PDF or Word file at the bottom of the page.
4. On Page 4, please declare any conflicts of interest relevant to the responses provided in Pages 2 or 3.
5. When you have completed the form, select ‘Submit Response’ on Page 5. You will be sent a confirmation receipt and link to a PDF copy of your response to the email address you provided on Page 2.

If you’d like any support in making your submission, you can contact the Department of Health at HTAconsumerengagement@health.gov.au or watch one of their facebook Q&A recordings HERE.