You Have Made a Difference! The Australian Government is Working on a New Policy!

Your voice has been heard! The PBAC is working on a new policy where not all aHUS patients will have to stop treatment. And it appears that the doctors will have input. I have been asked by aPSGA to close this petition (or at least pause it) while final negotiations go on with the PBAC which would NOT require all aHUS patients to come of Soliris. This is to show good faith to the PBAC as they are listening to our concerns. Rest assured that if we are not happy with what the PBAC comes back with I will either re-open or start a new petition and we will fight even harder. But I am encouraged that they are working on a plan. The following describes what the PBAC is working on as per Greg O'Toole from the PBAC. *************************************** I'm writing to provide an update on this situation. As you're aware, there are discussions ongoing between the Commonwealth and Alexion to ensure that the PBS listing for eculizumab is appropriately managed going forward. As you are aware, the current restriction criteria specify that the patient must have ongoing damage to their organs (brain, heart, gastrointestinal tract or kidneys) in order to qualify for ongoing treatment. As per amendments recently recommended by the Pharmaceutical Benefits Advisory Committee (PBAC), an additional criterion will be added: "The patient must have a high risk of aHUS recurrence in the short term in the absence of continued treatment with eculizumab" Prescribers intending to apply for continued treatment for their patient are being requested to provide a cover letter outlining the objective evidence of high risk of critical organ damage if aHUS recurs, including the following information: a) Results of testing for genetic mutations (if available), whether or not a mutation has been identified; b) Any past history of active and progressive TMA due to aHUS, prior to the episode that led to current use of eculizumab; c) Any family history of aHUS; d) Any history of renal or other organ transplant (if any), including any history of aHUS episodes following renal transplant; e) Any other clinical matters considered relevant by the prescriber. It should be noted that in the event that a patient does not wish to continue PBS-subsidised treatment with eculizumab, treatment may be recommenced in future in the event of another episode of aHUS. The PBS restrictions for eculizumab are designed to facilitate rapid recommencement for patients who have already received the drug on the PBS. The Department of Health is working to give effect to the PBAC's recommendations, however it will not be possible to implement the PBAC's recommendations for 1 December 2016. Therefore, arrangements are being made for additional doses of eculizumab to provide uninterrupted treatment where needed, until the new restrictions are in place. Prescribers with patients in this situation are being contacted directly to make suitable arrangements. The exact wording of the updated restriction will be shared in the near future with you organisation, as well as with the professional organisations that represent medical specialists that treat patients with aHUS. *********************************** We will not stop fighting for those on dialysis who don't get Soliris and therefore cannot get a kidney transplant. Please sign the petition for those patients as the PBAC is still leaving them behind. https://www.change.org/p/make-soliris-eculizumab-available-for-dialysis-patients-with-ahus-in-australia