What affects the timelines?
We have set timeframes for some steps. But the total time it takes for your application to go through the MSAC process can vary. It depends on things like:
- the completeness of the application form – the suitability stage will take longer if:
- some sections of the form are not complete or clear
- your application is to list or amend a Medicare Benefits Schedule item, but you did not include a statement of clinical relevance
- the assessment pathway – applications on the expedited and direct pathways generally progress more quickly than those on the standard pathway
- the assessment report:
- if you take longer to develop an applicant-developed assessment report (ADAR) or choose the 2-stage option, this will extend the timeline
- a department-contracted assessment report (DCAR) will generally take longer than an ADAR to develop
- your responsiveness – if you do not respond to requests for information or comments by the relevant deadlines, this will extend the timeline
- regulatory approvals – if you have not started the regulatory process for an approval your service or technology needs, this may extend the timeline
- committee meeting dates – we and our subcommittees usually meet 3 times a year. If you miss the relevant deadlines for consideration at a meeting, you may need to wait about 4 months for the next one.
Example timelines
If you applied by the July 2024 deadline, these are the earliest potential dates for consideration.
| Pathway | Earliest potential consideration |
|---|---|
| Standard pathway – ADAR |
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| Expedited pathway – ADAR |
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| Direct pathway |
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Applications with special requirements
Some applications have special requirements and go through the MSAC process with extra or slightly different steps. This may affect the timeline for your application. Find out about the differences in the process for:
- high cost, highly specialised therapy (HST) applications
- codependent applications PBAC also considers.
Regulatory processes
The process to seek regulatory approvals (if needed) can happen at the same time as an MSAC application. But some things must happen before certain points of the MSAC process. Any delays in providing regulatory information may extend the timeline for your application.
See below for more detail about the most common regulatory approvals.
Approval of therapeutic goods for supply in Australia
If your service or technology involves the use of a therapeutic good, it cannot receive public funding until the therapeutic good has market authorisation (unless it is exempt). Market authorisation usually means a listing on the Australian Register of Therapeutic Goods (ARTG).
If your service or technology includes the use of a therapeutic good that is already listed in the ARTG, ensure that your application form includes the ARTG ID, and the Therapeutic Goods Administration (TGA) approved indication(s) and purposes(s).
If the therapeutic good is exempt, provide evidence with your application confirming its exempt status.
Our secretariat will work with you so that you know what is required at each stage of the process. A summary of requirements is provided below.
Application form
For new applications, your product is not required to have market authorisation at the time of application form lodgement. However, it is recommended that you are positioned to seek market authorisation in the short term.
If the therapeutic good does not already have market authorisation and it is not exempt, you must indicate this in your application form and provide a timeline for the market authorisation steps, as appropriate.
If your application is for a pathology-related service that is not provided in Australia by a National Association of Testing Authorities (NATA) accredited laboratory, you must include a plan to provide this service in Australia with your application form.
ADARs and DCARs
You must apply for market authorisation before you notify your intent to lodge an ADAR or work on a DCAR can begin.
You must upload evidence that market authorisation has commenced at the same time as (or before) you notify your intent to lodge an ADAR. For example, a relevant notification letter issued by the TGA.
For in-vitro diagnostic (IVD) medical devices, this may include evidence that an active IVD application is with the TGA (TGA application ID) or, if it is intended as an in-house IVD, evidence that an application for changes to the scope of accreditation has been submitted to NATA.
If evidence of application to NATA is not available, explain why and provide evidence of a partnership agreement with a laboratory provider who is seeking accreditation to supply the in-house IVD.
You must confirm market authorisation and/or NATA accreditation has been granted before we can finalise our advice on funding. You should provide the relevant documents from the Therapeutic Goods Administration (TGA) and/or NATA to our secretariat, such as:
- ARTG registration confirmation
- updated ARTG product listing information.
- NATA accreditation confirmation
The TGA and NATA websites provide additional information.
Accreditation of providers for pathology-related services
Where applicable, laboratories and other investigative service providers must be accredited by NATA. The scope of NATA accreditation must capture the service for which reimbursement is being sought.
Services to be rendered in Australia
To meet eligibility for MBS funding, in accordance with the Health Insurance Act 1973 Medicare benefits are only payable for a professional service rendered in Australia. For avoidance of doubt, in respect of a pathology service, this includes any necessary interpretation, analysis or reporting components of the service.
Regulation of radiopharmaceuticals
If your application is for a radiopharmaceutical, you must refer to the framework for the MSAC assessment of radiopharmaceuticals. Depending on the regulatory status of the radiopharmaceutical, you may need to provide extra information with your application form.
If you do not provide the information we need about the composition and supply of the radiopharmaceutical, it may delay your application.
Contact
If you have any questions about timelines or regulatory processes, please get in touch.
