What you need to know
Your response to the commentary on your ADAR is your pre-ESC response.
ESC will consider your response along with the commentary, your ADAR and any consultation input.
This step is for applications on the standard pathway or expedited pathway.
Applications on the direct pathway do not need ESC consideration. For these applications, you respond to the ADAR overview paper in your pre-MSAC response.
Timeframes and length of response
Most applicants will have 10 business days to respond (see the exceptions below). Your response can include up to:
- 5 A4 pages of text in Microsoft Word
- 2 pages of diagrams, graphs and tables.
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You will have 5 business days to respond to the ADAR commentary.
Your response can include up to:
- 10 A4 pages of text in Microsoft Word
- 4 pages of diagrams, graphs and tables.
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If your application is for a high cost, highly specialised therapy, you will also receive a copy of any submissions from state and territory governments.
You will have 10 business days to respond to the commentary and any submissions.
Your response can include up to:
- 7 A4 pages of text in Microsoft Word
- 2 pages of diagrams, graphs and tables.
What you need to do
1. Access the commentary
In the Health Products Portal, you will receive:
- the ADAR commentary
- the timeframe for your response.
See key dates for applicants for the date you can expect to receive these.
2. Review the commentary
You can clarify, explain or reanalyse information in your ADAR.
You should not include extra clinical trial information or substantially amended economic or financial models in your response. Our secretariat will seek the appropriate advice if you provide new evidence in your response.
3. Provide your response
Send your response to our secretariat through the Health Products Portal by the due date. To find out how to do this, see uploading your pre-committee response.
Next steps
In the next step, ESC will consider your assessment report at an ESC meeting.
Contact
Contact your application manager or our secretariat if you have any questions.
