About PBAC codependent applications
Your codependent application will need consideration by both our committee and PBAC if it seeks to add or amend an item on both the:
- Medicare Benefits Schedule (MBS) – for a therapeutic or investigative service
- Pharmaceutical Benefits Scheme (PBS) – for a medicine or vaccine.
If your application needs MSAC and PBAC consideration, it will go through the MSAC process as usual. But some things will be different so we can coordinate our assessment with PBAC.
Costs
Find out about the PBAC cost-recovery fees that may apply.
Before you apply
Before you apply, you can request:
- an MSAC pre-application meeting if you have questions about the application or assessment process – there is currently no charge for this
- a PBAC pre-submission meeting if your questions are more focused on the medicine or vaccine, technical or about the assessment report – you will need to pay a PBAC cost-recovery fee for the meeting.
Both our secretariat and the PBAC secretariat will ensure they have representatives at these meetings.
These meetings are optional. If you are not sure which meeting to request, please get in touch.
How the MSAC process differs
Integrated or streamlined
During the suitability phase, PBAC codependent applications will need an extra decision about how to manage your application. As well as deciding the MSAC assessment pathway, our secretariat will work with the PBAC secretariat to decide to manage your application as either:
- integrated:
- you will need to lodge a combined assessment report for both the service and the medicine or vaccine
- the committees will work together to appraise your application
- streamlined:
- you will need to lodge 2 assessment reports (one for the service and one for the medicine or vaccine)
- the committees will maintain their separate processes but coordinate timings.
For more detail about how the secretariats make this decision, see the integrated or streamlined flowchart on the PBAC website.
We require an applicant-developed assessment report (ADAR) for codependent applications. PBAC calls these submissions.
Integrated applications
Your application will generally be managed as integrated if one of the following applies:
- You need a new listing or a substantial change to an existing listing for both the service and the medicine or vaccine.
- Both committees were not satisfied with a previous application or submission.
- The medicine or vaccine is of a different class to one that PBAC has previously considered.
In these cases, both committees will generally require a comprehensive health technology assessment (HTA). A combined assessment report will allow the committees to appraise your application together.
| Stage or step | Differences | Notes |
|---|---|---|
| Suitability stage | An extra decision on how to manage your application – integrated or streamlined. This occurs at the same time as the assessment pathway decision. | The standard and expedited pathways are the most common assessment pathways for integrated applications. |
| PICO confirmation development and PASC consideration | None | If your application is on the standard pathway, it goes through these stages as usual. |
| Assessment report development | Lodge a single ADAR that meets both our and PBAC requirements. | In the Health Products Portal, select PBAC and MSAC (codependent submission) when you notify your intent to lodge. |
| ESC consideration |
| Our secretariat will contract one commentary for both ESC and PBAC ESC to consider at their joint meeting. |
| MSAC consideration |
| We will coordinate the timing of our advice with PBAC. |
| Consultation | Our secretariat will share any relevant consultation input with PBAC. | None |
Streamlined applications
Your application will generally be managed as streamlined if one of the following applies:
- Only one committee requires a comprehensive HTA – usually PBAC.
- Neither committee requires a comprehensive HTA.
In these cases, one or both committees can streamline the assessment of your application using their usual processes.
| Stage or step | Differences | Notes |
|---|---|---|
| Suitability stage | An extra decision on how to manage your application – integrated or streamlined. This occurs at the same time as the assessment pathway decision. | The direct pathway is the most common assessment pathway for streamlined applications. |
| PICO confirmation development and PASC consideration | None | If your application is on the standard pathway, it goes through these stages as usual. |
| Assessment report development | You must also lodge a submission to PBAC. | Use the usual processes to lodge your ADAR and submission. Unless you have been given other advice by our secretariat, follow the timeframes for your allocated MSAC pathway for both the ADAR and the . See key dates for applicants for the relevant deadlines. |
| ESC consideration | None | None |
| MSAC consideration | Our secretariat will redact the public summary document in line with the PBAC redaction criteria. | We will coordinate the timing of our advice with PBAC. |
| Consultation | Our secretariat will share any relevant consultation input with PBAC. | None |
Applying
You will first need to lodge an MSAC application form for the service. The form asks whether the service relies on a PBS listing. This lets us know your application is a PBAC codependent application.
Our secretariat will discuss your application with the PBAC secretariat. If your application is found suitable, the secretariats will progress it as either integrated or streamlined.
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