High cost, highly specialised therapy (HST) applications

If your application meets the definition of an HST under the National Health Reform Agreement, the Medical Services Advisory Committee (MSAC) process will be a little different.

About HST applications

The Australian and state and territory governments fund HSTs under the National Health Reform Agreement (NHRA).

HST applications go through the MSAC process as usual. But some things will be a little different, in line with the framework for assessing, funding and implementing HSTs.

How and why we involve states and territories in the MSAC process

Aside from contributing to funding, the state and territory governments also decide where and when HSTs will be delivered.

Our secretariat will liaise with state and territory health officials throughout the MSAC process. This includes:

This is important because they can provide:

  • insight into implementation, service provision and costings
  • feedback on the proposed clinical cohort
  • real-world experience with similar treatments.

Before you apply

Pre-application meeting (optional)

If you think your application is for a potential HST, you may find a pre-application meeting with our secretariat helpful. They will:

  • explain how they manage HST applications
  • give you advice on your application, including if they think it is likely the application is for a potential HST.

Find out how to request a pre-application meeting.

Briefing for health officials (mandatory)

If your application is for a potential HST, you must provide a briefing to Australian and state and territory health officials. This helps them to provide input to the NHRA Joint Chairs' Group.

Our secretariat will organise the meeting and provide you with the details. It should occur at least 4 to 8 weeks before you lodge your application.

The briefing will be at a non-binding and informal meeting to encourage open communication. You should:

  • provide a description or overview of the proposed therapy
  • outline the purpose of the proposed therapy and expected clinical outcomes
  • define the target population – disease, clinical features, diagnostic and therapeutic requirements
  • outline administration needs – such as setting, specialist equipment, level of specialisation and training, ongoing monitoring, expected duration of hospital stay
  • estimate the possible number of patients
  • indicate the price of the therapy.

If you do not want a pre-application meeting, you should still get in touch to flag that you will be lodging an application for a potential HST. If our secretariat think your application may be for a potential HST, they will organise the briefing.

How the MSAC process differs

Stage or stepDifferencesNotes
Suitability stage
  • Our secretariat will share an unredacted copy of your application form with state and territory health officials.
  • The NHRA Joint Chairs' Group will confirm which committee should assess the application. This occurs at the same time as the check suitability step.
If your application is not directed to us, our secretariat will advise on possible next steps.
PICO confirmation development and 
PASC consideration

Our secretariat will share with state and territory health officials:

  • an unredacted copy of the draft and ratified PICO confirmations
  • your pre-PASC comments
  • any consultation input (redacted) on the PICO.

Our secretariat will also invite state and territory health officials to submit input on the draft PICO confirmation and consultation comments.

Some HSTs may bypass PASC.
Assessment report development

After you lodge your applicant-developed assessment report (ADAR), our secretariat will:

  • share an unredacted copy of your ADAR with state and territory health officials
  • invite them to submit input on your ADAR.
None.
ESC consideration

Our secretariat will share with state and territory health officials an unredacted copy of:

  • the ADAR commentary
  • your pre-ESC response
  • the Evaluation Subcommittee (ESC) report (if applicable).
You will have an opportunity to comment on input from state and territory governments as part of your pre-ESC response.
MSAC consideration

Our secretariat will share with state and territory health officials:

  • an unredacted copy of your  pre-MSAC response
  • any consultation input (redacted) on your application
  • an unredacted copy of the ratified public summary document, following the meeting.

State and territory health officials may attend as observers at the MSAC meeting when we consider your application.

Our secretariat will also share an unredacted copy of the public summary document with the:

None

Applying

There is no difference to how you apply – you must lodge an application form.

If we support your application

If we support your application, the next step is to negotiate the conditions of public funding. The negotiation will be between:

  • you (the applicant)
  • the Australian Government
  • 2 state and territory representatives.

To find out more about implementation, see the framework for assessing, funding and implementing HSTs.

Contact

General enquiries

Contact us for general enquiries or to find out more about the MSAC process before applying.
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