SKYCLARYS to be Assessed by PBAC

The Pharmaceutical Benefits Advisory Committee has today published the Agenda for their March 2025 meeting. FA Treatment Skyclarys is listed on that Agenda.

What Does This Mean?

The Pharmaceutical Benefits Scheme (PBS) ensures that all Australian residents have access to necessary and lifesaving medicines at an affordable price.

The Pharmaceutical Benefits Advisory Committee (PBAC) assesses applications for listing of medicines on the PBS.

The meeting is scheduled to be held on 12 -14th March 2025.

Please note that Skyclarys is still under review for registration by the Therapeutic Goods Administration who are considering the quality, safety and efficacy of the treatment.

With both the TGA & PBAC, the listing is under the name, Omaveloxolone.

What You Can Do?

This is an exciting phase in the multi-stage Australian Regulatory & Reimbursement process as it is now that individuals and organisations can submit Consumer Comments to the PBAC.

Consumer Comments opened today and will close on Wednesday 29th January 2025.

Whilst the PBAC considers robust facts on what the new medicine is, which patient population it is for and what the evidence is for its clinical and cost-effectiveness, patients’ and caregivers’ lived experiences, preferences and needs can be invaluable when making sense of this evidence.

Preparing For & Making Your Comments

The Consumer Comment process is one many individuals and organisations have undertaken before us for other treatments.

A summary of the process and how to prepare for your comments based on this collective experience can be found on the Patient Voice Initiative Website.

It is an excellent guide covering how the PBAC works and how to ensure your input can have the greatest impact. It includes clear “Do’s” and “Don’ts” to help you i.e. Don’t explain the condition, explain the reality of living with the condition.

We strongly urge you to read and understand this material before making your Comments.

When you believe you are ready, Consumer Comments to the PBAC can be lodged on this Link. Please note you will need to search for Omaveloxolone.

A simple Tip Sheet for submitting Consumer Comment to the PBAC can also be downloaded here.

Timeline

Summarised below are some key dates for the March 2025 PBAC Meeting:

·      Publication of main Agenda                                      Thursday 28th November 2024

·      Consumer Comments open                                      Thursday 28th November 2024

·      Publication of updated Agenda                                           Friday 10th January 2025

·      Consumer Comment close                                        Wednesday 29th January 2025

·      PBAC Meeting                                          Wednesday 12th – Friday 14th March 2025

·      Posting of Outcomes                                                            Thursday 24th April 2025

As more information becomes available, we will continue to share it with our community.

If you require further support making your Consumer Comments, please contact us on info@fara.org.au