Develop an applicant-developed assessment report (ADAR)

What you need to know

An ADAR is a type of assessment report. You can lodge an ADAR after the pre-assessment phase if:

• your application was found suitable for the MSAC process
• you have a ratified PICO confirmation (if your application is on the standard pathway)
• you have notified your intent to lodge for your preferred meeting.

You can include new evidence or clinical trial outcomes that have become available since you lodged your application form. But we generally do not accept new evidence after you have lodged your assessment report.

• Two-stage option – for feedback before starting the economic evaluation

  With this option, you can submit the clinical evaluation section of your assessment report before starting the economic evaluation section.

  This allows you to receive feedback from us and our Evaluation Subcommittee (ESC) on both the:

  • clinical evidence
  • proposed structure of the economic model.

  This option extends the time it will take for your application to go through the MSAC process.

  To find out more, contact our secretariat.

• Integrated codependent applications – extra PBAC requirements

  If your application is integrated codependent, your assessment report must also meet the requirements of the Pharmaceutical Benefits Advisory Committee (PBAC).

  You should refer to both the:

  • guidelines for preparing assessments for MSAC
  • PBAC guidelines for preparing a submission – in particular, see product type 4 codependent technologies.

  You can use the ADAR template, as long as you provide the information that PBAC requires.

What you need to do

1. Be aware of the deadline

To confirm the lodgement deadline, go to key dates for applicants and refer to the meeting date you want your ADAR to be considered at.

2. Follow our guidance

When you develop your ADAR, you should:

• use our ADAR template
• refer to the guidelines for preparing assessments
• align the ADAR with the relevant PICO (for applications on the standard pathway, this will be the ratified PICO confirmation)
• comply with our document standards.

Next steps

The next step is to notify your intent to lodge your ADAR.

Contact

Contact your application manager or our secretariat if you have any questions.