Response 603225309

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Consultation questions

4. Do you support introduction of a priority pathway for biologicals?

Please select one item
Yes
No
Unsure
Please explain your answer
As a patient advocacy group/consumer organisation for rare, chronic and life impacting diseases, we support the introduction of a priority pathway for biologicals. Biologics offer new hope for individuals and families for seriously debilitating conditions that have a significant impact on quality of life as they can address unmet medical needs for certain, often complex patients when prescription medicines have not been able to provide the relief required to substantially improve patient outcomes and wellbeing.

5. Is there any expected impact if the proposed Priority Review pathway was to be implemented?

Please select one item
Yes
No
Unsure
Please explain your answer
An expedited pathway is crucial to facilitate important timely access to biologic treatments and whilst we are obviously not in a position to comment on the logistics or impact for industry, from a patient perspective we support this proposal and thank you for your consideration.

6. Do you agree that the 4 proposed criteria for Priority Review of biologicals address the objectives of an expedited pathway?

Please select one item
Yes
No
Unsure

7. Do you believe any eligibility criteria should be added, amended or removed from the proposed Priority Review pathway?

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Yes
No
Unsure

8. Do you agree that the proposed determination process and timing of the steps is appropriate?

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Yes
No
Unsure

9. Do you agree that there should be a 6 month limit on the duration for the determination for Priority Review of biologicals?

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Yes
No
Unsure

10. Do you agree that we should publish the outcomes of approved applications for Priority Review determination of biologicals?

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Yes
No
Unsure

11. Do you agree that Decision Summaries and/or Australian Public Assessment Reports (AusPARs) should be published for applications approved through the Priority Review pathway?

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Yes
No
Unsure

12. Does the proposed application fee for a Priority Review determination and the expectation that a higher evaluation fee for an application through the Priority Review pathway seem reasonable?

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Yes
No
Unsure

13. Do you anticipate utilising the Priority Review process for your products in the future?

Please select one item
Yes
No
Unsure
Please explain your answer
not applicable as we are not from industry

Publishing your response

16. I consent to the submission made by me being published on the Department’s website, and accessible to the public, including persons overseas, in accordance with the following preference:

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(Required)
Publish response with my name and organisation's name
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