Have you lodged an MSAC application for this service or health technology previously?
If you have previously lodged an MSAC application for this service, you will need to provide the application number and details of the previous application.
If you have resubmitted your application through the HPP, using the ‘Resubmit’ option available on the ‘Lodged Applications’ view, the previous application details will be pre-filled for you.
Please provide an application title
The title of the application should describe the proposed medical service, and include the intervention, population, and specific indications (where applicable).
Examples of the general format application titles should follow are provide below:
Investigative technology to inform eligibility for treatment
Testing for [patient attribute/disease attribute] in [patient population/disease] to determine eligibility for [treatment option]
Investigative technology for diagnosis
[test/device/service] for the detection/diagnosis of [disease/illness/injury] in [patient population]
Investigative technology for monitoring of treatment response
[test/device/service] for the monitoring of [patient population/disease status/disease progression]
[device/treatment/service] for the treatment/prevention of [disease/injury/patient attribute]
No trade names should be included in the title (i.e. the title should be brand-agnostic). If specific technology components/parameters of technology function/performance forms part of MSAC’s advice, these would be included in the eventual listing/funding description (if necessary). Examples of application titles can be found on individual application webpages on the MSAC website.
When suitability of the application for MSAC consideration has been determined, the title will be published on the MSAC website. The Department retains the right to alter/finesse wording, but will consult with the Applicant about this. The Department retains the right to refuse to publish information provided by the Applicant, if the Department considers the information to be inaccurate, misleading or advertorial in nature.
Has the Department notified you that your application will bypass the PICO Advisory Sub‑committee (PASC)?
In some instances, the Department will notify you that your application does not need to go to PASC. This could be due to the application being a resubmission, or due to the intensity of the process required due to the nature of the item i.e. an amendment vs. a new item.
If you are bypassing PASC, you will need to select the relevant MSAC meeting for your application, and provide details of the type of assessment report which will be developed for your application.
If your application will go to PASC, you will need to select the relevant PASC meeting for your application.
Please select the MSAC meeting relevant to this application
If the Department has determined that your application will bypass the PASC, it will still need to be submitted to the Medical Services Advisory Committee (MSAC) for consideration.
The MSAC committee each meets three times per year. The link below contains a list of future meeting dates, including timeframes for lodgement for each meeting: http://www.msac.gov.au/internet/msac/publishing.nsf/Content/pasc-calendar-key-dates
Applications should be lodged prior to the cut-off in order for there to be sufficient time for consultation and to give the MSAC sufficient time for consideration. If you wish for your application to be considered at an MSAC meeting for which the meeting cut-off has lapsed, you will need to seek prior agreement from the Department and provide a rationale.
Please select the PASC meeting relevant to this application
The PICO Advisory Sub-committee (PASC) meets three times per year. The link below contains a list of future meeting dates, including timeframes for lodgement for each meeting: http://www.msac.gov.au/internet/msac/publishing.nsf/Content/pasc-calendar-key-dates
Applications should be lodged prior to the meeting cut-off in order to give sufficient time for consultation, PICO development and PASC consideration. If you wish for your application to be considered at a PASC meeting for which the meeting cut-off has lapsed, you will need to seek prior agreement from the Department and provide a rationale.
Will a full assessment report be required for your application?
A health technology assessment (HTA) is done to establish that the health technology is safe, effective and good value for money compared with what is already used. The assessment report is reviewed and discussed by the Evaluation Sub-Committee (ESC) prior to consideration by MSAC.
Assessment reports are developed either:
by the applicant (called applicant-developed assessment reports, or ADARs)
by an assessment group that is contracted by the Department on behalf of the applicant (called Department-contracted assessment reports, or DCARs).
Both types of assessment reports follow the same process. The templates for the main body of the assessment report are identical.
In certain circumstances, a full assessment report may not be required for your application, particularly if your application is bypassing ESC (e.g. streamlined codependent MSAC-PBAC submission). If you are unsure, please select the ‘unsure’ option.
Will this be developed by the applicant?
Some applicants will develop the assessment report (ADAR) themselves. If you will be developing an ADAR, please select ‘Yes’ to this questions.
If you are unsure what is involved in developing an assessment report the MSAC Guidelines and ADAR template is available on the MSAC website.
Does the implementation of your service or health technology rely on a new listing on the Pharmaceutical Benefits Scheme (PBS) or the Prostheses List?
The purpose of this question is to determine if your application is for a codependent technology.
A codependent technology occurs where use of one health technology (to directly improve health outcomes) – e.g. a medicine, medical device or procedure - is improved by use of another health technology - e.g. a pathology or imaging technology - and where both technologies require consideration for public funding. Additional guidance on codependent technologies can be found in the MSAC Guidelines.
Which list/schedule will the other health technologies be listed on?
For more information on the PBS, see the PBS website.
For more information on the Prescribed List, see the Prescribed List website.
This question will determine which questions you need to answer on the ‘Codependent Details’ page.
Is the application for a new service or health technology, or an amendment to an existing listed service or health technology?
If an application is an amendment to an existing MBS item, it is important to determine how it will be classified to establish the most appropriate MSAC pathway. Additionally, information provided about an amendment can guide alternative options if MSAC is not appropriate.
Depending on degree of the amendment, some applications will not require a full health technology assessment (HTA). If suitable, they may even need an alternative (non-HTA) pathway. The nature of the amendment also influences intensity of the process (i.e. is PASC required), if an HTA is to be conducted.
What is the nature of the amendment?
An amendment to the way the service/technology is clinically delivered under existing item(s)
this may reflect a change to the duration of consultation, details of the service being provided under the existing item, or consultation setting.
An amendment to the patient population under the existing item(s)
broadens intended use of an existing item within a medical condition to a new or altered subgroup of patients (in addition to the subgroup of patients already covered by the item/funding).
For example, expanding eligibility for the service, based on when the service is used (i.e. in addition to the service being used as ‘third line’ treatment in management of a particular medical condition, the amendment seeks use of the service for ‘second line’ treatment).
An amendment to the medical condition under the existing item(s)
intended use of an existing item/funding would be expanded to include a new medical condition (that is completely different to the medical condition currently eligible under existing item(s)/funding).
An amendment to the schedule fee of the existing item(s)
The clinical service essentially remains the same.
An amendment to the time and complexity of an existing item(s)
There is nothing to compare clinically (because the clinical service essentially remains the same) – e.g. time-tiered initial and subsequent-attendance MBS items.
Access to an existing item(s) by a different health practitioner group
The amendment is solely based on a request to provide the same clinical service already provided by other types of health professionals.
Minor amendments to MBS item descriptor that do not affect or change how the service is delivered.
Examples of this type of amendment include:
- administrative amendments, such as clarification of wording in an existing item descriptor, without altering its intended use, or changing a service description that corrects terminology that is not technically correct or is ambiguous;
- a change that addresses a typographical error, or aligns an item descriptor with regulations (e.g. inclusion of a missing word, to correct an error).
An amendment to an existing ‘consultation’ item
A single model of care is proposed to be the only clinical encounter covered by that service (e.g. one type of clinical encounter is included in the item descriptor).
An amendment to an existing ‘global’ (broadly-based) consultation item
Items which are professional attendance items on the MBS that accommodate a range of clinical encounters under one MBS item – e.g. health practitioner groups requesting increased funding for their existing general professional attendance items.
Please describe (specify) any option that is not outlined above.
Please select any relevant MBS items
Please add all relevant MBS items. When adding an MBS item, you must also select one of the following Reasons:
- Co-claimed item
- Expansion or amendment to existing item
- Prerequisite item
- Other - only select 'Other' when none of the other reasons are applicable. Upon selection of Other, you will be required to supply a reason.
What is the type of service or health technology?
If this is a codependent application, please select the type relevant to the MBS component.
A service that impacts on health outcomes directly (i.e. no other intermediate medical service needs to be provided to achieve improvement in health outcomes). Examples include novel surgical techniques, insertion of a stent or other therapeutic device(s), and most blood products.
Identifying whether a medical service is therapeutic has implications on the nature of evidence that needs to be presented to MSAC. This is expanded on in Section 2A – Assessment of therapeutic technologies, in the MSAC Guidelines.
A service that generates clinically-relevant information about the individual to whom the service is rendered. To achieve an impact in health outcomes, the investigative information would usually result in a change in management of an intermediate therapeutic service (i.e. it can only indirectly impact on health outcomes).
Identifying whether a medical service is investigative has implications on the nature of evidence that needs to be presented to MSAC. This is expanded on in Section 2B – Assessment of investigative technologies, in the MSAC Guidelines.
Services that tend to combine an investigative component (e.g. clinical history, examination, and requesting investigations) and a therapeutic component (e.g. execution of a management plan) for the patient. Taking a history and examining a patient is essential for a medical consultation, with information (that is clarified by this clinical assessment) assisting the health practitioner to determine what should happen next (in terms of investigations and patient management/treatment).
Please select the type of investigative health technology
For investigative health technologies, further information is required on the type of health technology.
There are several types of investigative health technologies including:
Molecular diagnostic tests
Please select the type of molecular diagnostics health technology
The drop down list include both genetic and genomic tests.
- Single variant assay: The test detects a single genetic variant, including qualitative and quantitative tests. (Note: this is the typical test method for cascade testing of blood-relatives of an affected individual).
- Single gene assay: The test detects more than one genetic variant, up to and including all variants within a single gene. (Note: this is the typical test method for reproductive partner testing).
- Small panel gene assay: The test detects more than one variant in each of a selected number of genes that are seen in a particular condition
- Other genetic test: For example: karyotyping, FISH, multiplex ligation-dependent probe amplification
- Multigene/biomarker panel assay
- The test detects variants in a panel of genes, including amplicon-specific panel test methods and virtual panels on an exome/genome background.
- If this option is selected, further information is required on the number of genes/biomarkers in the panel assay, and whether it is possible to vary or select the genes/biomarkers requested within the panel.
- Whole genome sequencing: the test includes analysis of all genes in the patient’s exome/genome. Whole genome sequencing may also encompass the mitochondrial genome Other genomic test: exome/genome data re-analysis, pathogen genomes.
- Other genomic test
Histopathology and cytology
The examination of body organ and tissue samples. Anatomical pathology includes histopathology (examination of whole tissues), for example examination of tumour tissue for the purpose of cancer staging; and cytopathology (examination of single cells), for example examination of a cervical smear performed for the purpose of cervical screening. Immunodiagnostics is another diagnostic method that relies on antigen-antibody reaction for detection of the disease, or biomarker of disease
Analysis of cells, blood and other body fluids for their chemical, biochemical and hormonal components. Biochemical tests are most often applied to samples of serum, plasma and urine where levels of specific chemicals are measured and the results compared with those representative of a healthy individual.
Clinical and laboratory haematology
The diagnosis of diseases of blood and blood forming tissues.
‘Diagnostic microbiology’ is used to detect and accurately identify implicated microorganisms in test specimens through a variety of techniques.
Computed tomography scans
Computed tomography (CT) scans use radiation for the diagnosis and treatment of disease.
Positron emission tomography scans
Positron emission tomography (PET) scans use radiation for the diagnosis and treatment of disease.
X-rays (including mammography, fluoroscopy, angiography, and orthopantomography) use use radiation for the diagnosis and treatment of disease.
Magnetic resonance imaging scans
Magnetic resonance imaging (MRI) scans use magnetic fields and radio waves to generate images of the body.
Ultrasounds use high-frequency sound waves to create visual images of the body.
‘Diagnostic audiology’ involves the assessment and diagnosis of hearing loss, ear disease or related disorders
Endoscopy is used to visualise body cavities for a variety of diagnostic purposes. This can include for example procedures of the upper or lower gastrointestinal tract, urinary tract or joints.
Lung function tests assess how well a person’s lungs work. This can include measuring lung volume and airflow using spirometry, or measurement of how well gases such as oxygen get in and out of the blood through oximetry and arterial blood gas tests.
Echocardiography uses soundwaves to create moving images of the heart. It can be used to diagnose issues with the heart’s chambers and valves, pinpoint areas of heart muscle that aren’t contracting well because of poor blood flow or injury, blood clots, fluid build up in the pericardium and problems with the aorta.
Any technology that does not fit into one of the purposes above. You will be required to provide details.
Please note: Applications for investigative health technologies require input from each of the requestor of the service, the provider of the service, and as necessary, the manufacturer of any device components.
Can you confirm that the application reflects their perspectives on the use of the proposed health technology or service?
Select ‘Yes’ if you have sought and incorporated input from the requestor, provider and the manufacturer where there is a related device component, and provide a summary of how you obtained and used this input.
Need further support?
If you have any questions or feedback, please contact hpp.support@health.gov.au.
