What is an assessment report?
All applications, including re-applications, need an assessment report. It may be an ADAR or a DCAR. The lodgement of an assessment report starts the assessment phase of the MSAC process.
An assessment report presents the evidence that supports your application. It should:
- align with the MSAC guidelines for preparing assessments
- be consistent with the relevant PICO
- provide updated information on the regulatory status of the service or technology (where required).
View the ADAR template and the DCAR template.
Re-applications
If your assessment report is for a re-application, you should:
- leave out information that is not in dispute
- delete the sections of the template that are not needed
- insert a summary table of the key matters of concern raised about the previous application(s) and how the new assessment report addresses them.
For more detail, see the ADAR template and Technical Guidance 4 in the MSAC guidelines for preparing assessments.
Relevant PICO for an assessment report
If your application is on the standard pathway, the assessment report should be consistent with the ratified PICO confirmation.
If your application is on the expedited pathway or direct pathway, the PICO must be defined as part of the assessment report development process. For more detail, see Technical Guidance 2 in the MSAC guidelines for preparing assessments.
Re-applications
A ratified PICO confirmation may be available from your earlier application. If MSAC did not require a change to the elements of the ratified PICO, it can be used to guide the assessment report for your re-application.
Changing a ratified PICO
If you or the HTA group writing the assessment report want to deviate from the ratified PICO, the assessment report should:
- present both the ratified PICO and the new PICO
- justify the changes.
Deviating from a ratified PICO may affect confidence in the relevance of the evidence or analyses in the report.
Applicant-developed assessment report (ADAR)
An ADAR is an assessment report that an applicant develops, using their own resources. Most applicants develop an ADAR for their application.
After you complete and lodge your ADAR, the next step will be a commentary or an overview paper. These are independent, critical reviews of your ADAR.
Department-contracted assessment report (DCAR)
A DCAR is an assessment report that an HTA group develops, with input from the applicant. Our secretariat manages the contracting process to select an appropriate HTA group.
You may have an opportunity to indicate your interest in a DCAR when you complete the MSAC application form. If no preference is stated in the application form, our secretariat may contact you during the suitability stage to discuss.
You may request a DCAR, but our secretariat will decide whether to contract the DCAR. In considering whether a DCAR is appropriate, our secretariat must comply with the Public Governance, Performance and Accountability Act 2013. This Act requires that, before committing public funds, our secretariat must assess ‘value for money’. That is, the financial delegate must satisfy themselves that contracting a DCAR for an application is:
- an efficient, effective, economical, and ethical use of the relevant funds and
- is not inconsistent with the policies of the Commonwealth.
For further information, see factors our secretariat consider when deciding to contract a DCAR.
If you express an interest in a DCAR, our secretariat will consider this and let you know their decision at the same time they advise suitability. In limited circumstances, our secretariat may defer a decision about a DCAR until after PASC has considered the application (for applications on the standard pathway). Where this occurs, our secretariat will
- when letting you know the outcome of suitability, advise you that a decision regarding contracting of a DCAR will be delayed.
- when giving you the ratified PICO for comment, provide advice about whether a DCAR will be contracted.
Find out how HTA groups develop a DCAR.
Factors our secretariat consider when deciding to contract a DCAR
The MSAC Process Framework (part 4.4) lists elements to consider in determining the type of assessment report. These relate to an applicant’s
- ability to develop the assessment report themselves or to engage an individual or group to develop the assessment report on their behalf.
- understanding of MSAC processes and requirements.
Ability to develop or contract an assessment report
An applicant’s ability to develop (or contract) an assessment report is important in determining ‘value for money’. In assessing this, a key factor that our secretariat will consider is whether the applicant is a not-for-profit or commercial entity.
Not-for-profit entity
Our secretariat will generally conclude that a not-for-profit entity is less likely to have the capacity (e.g., resources, funding, expertise) to develop or contract an ADAR. In determining if an applicant is a not-for-profit, our secretariat may refer to:
- information provided by the Australian Taxation Office
- the charities listing provided by the Australian Charities and Not-for-Profits Commission.
Our secretariat will also consider whether the application involves the direct supply of a product or therapeutic good to a patient or service provider by the applicant. If yes, then further advice may be sought from the applicant. For example, justification for why a DCAR is appropriate given the application contains a commercial element.
Commercial entity
Where the applicant is a commercial entity, our secretariat would expect it to have the capacity (resources, funding, expertise) to either develop an ADAR or contract someone to develop an ADAR on its behalf.
Commercial entities seeking a DCAR would need to provide justification for why a DCAR would represent an efficient, effective, economical, and ethical use of public funds. Factors that our secretariat may consider include:
- The nature of the service or technology and target population groups.
- Would it meet an unmet clinical need? That is, there is no funded alternative available.
- Does it target a health condition(s) with very low prevalence? I.e., fewer than 5 in 10,000 individuals. This may mean that an MSAC application requiring an ADAR is not a financially viable proposition for a commercial entity.
- Does it target populations with high unmet clinical needs? For example, is the service or technology to be used specifically for palliative care; paediatric care; or for medical treatment of Aboriginal and/or Torres Strait Islander peoples?
- Is it necessary for the management of a significant public health event?
- Whether the applicant was encouraged to sponsor the application by the department.
- The quality and quantity of evidence available to underpin the application and who holds the data.
- Whether public funds have previously been allocated for the development of a DCAR for the application. If so, the applicant would need to justify any further investment, including the extent to which there is new evidence or information that could address issues raised by MSAC when it considered the previous application.
Understanding of MSAC processes and requirements
Our secretariat considers factors such as the applicant’s previous experience with MSAC or other HTA processes; whether the applicant has participated in pre-application meetings with the department or sought advice when unsure.
It is anticipated that many commercial entities in the health sphere will have had some experience of HTA processes, either in Australia or internationally. As such, they would be expected to have, or be able to obtain, the necessary expertise to navigate MSAC processes and understand the requirements necessary to develop an ADAR. Commercial applicants that do not have in-house expertise in HTA may engage contractors or consultants to supply the necessary expertise.
Commercial applicants who want to request a DCAR should discuss this with our secretariat in the first instance. A rationale for why a DCAR is appropriate should be provided. This will assist our secretariat to assess whether contracting a DCAR is an efficient, effective, economical, and ethical use of public funds in respect of the application.
When to lodge an assessment report
All applicants must first lodge an MSAC application. If it is found suitable, an assessment report can be lodged after the pre-assessment phase.
New evidence after lodging an assessment report
After an assessment report is lodged, you may become aware of new publications or data analyses relevant to our appraisal of your application. Whether the information supports your claims or not, contact our secretariat.
Our secretariat:
- will consider how the new information may affect your application and how to manage it
- may seek advice from the MSAC Executive on whether:
- we or our ESC should consider the new information
- to defer consideration of your application pending evaluation of the new information.
For Pharmaceutical Benefits Advisory Committee (PBAC) codependent applications, our secretariat will also seek advice from PBAC.
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