PICO sets
You will be required to complete one or more PICO sets. A document template is available for download which you can use to compile some of your PICO information offline before uploading with your application.
PICO confirmations may be straightforward, with a single population and comparator, or may be more complicated if multiple populations and/or uses of the proposed service/technology are to be assessed. If there are multiple distinct populations or indications, multiple PICO sets may be required to inform the context of the assessments.
Each PICO set will need to contain the following information for the distinct population and intervention:
- Population
- Prior tests (where applicable)
- Intervention
- Comparator
- Outcomes
- Proposed MBS items
- Algorithms
- Claims
- Summary of evidence
- Estimated utilisation
Each of these sections are explained below, but the above links can be used to jump to the relevant section.
Note on multiple PICO sets
Multiple PICO sets may be required if:
- the health technology is proposed to be used across multiple populations
- the health technology is proposed to be used for different purposes.
It is not always clear whether populations or test purposes are sufficiently different to require a separate PICO.
It is often the case that populations included in the same clinical study are sufficiently homogeneous to include in a single PICO. Cascade testing of family members is a clear example of when a separate PICO set is required.
If a test is intended to be used for diagnosis (to determine the presence of a disease) and also for monitoring (to inform adjustments to treatments), these are 2 separate uses (and also describe different populations) and separate PICO sets are required.
If multiple PICO sets are included, cross-reference to other PICO sets when details of PICO components are the same.
For further information, see the MSAC Guidelines.
Adding a PICO set
To add a PICO set, select the ‘Add PICO set’ button.
Provide a name for the population and intervention (PICO set)
Provide a name which describes the population and intervention at a high level, and distinguishes between your distinct PICO sets, where there are multiple.
What is the relevant purpose for this PICO set?
This question is only displayed for investigative health technologies (where ‘Investigative’ has been selected in the ‘Health Technology Type’ field on the Application Details page. You need to select one or more purpose values from the values selected in the ‘Purpose’ field on the Application Details page.
State the purpose(s) of the health technology for this application, and provide a rationale.
The purpose of performing an investigative medical service has implications on the nature of the evidence that needs to be presented to the committee for consideration and each purpose has differing aspects of evidence that needs to be considered. Multiple purpose values can be added, and these will be available to be linked to each PICO set in the ‘PICO Sets’ page. See purposes below.
What additional purpose(s) could the health technology be used for, other than the purposes listed above for this application?
The purpose of performing an investigative medical service has implications on the nature of the evidence that needs to be presented to the committee for consideration and each purpose has differing aspects of evidence that needs to be considered. What additional purpose(s), in addition to those the application is seeking funding for could the health technology be used for. See purposes below.
Describe the population in which the proposed health technology is intended to be used
Provide an overview of the patient population, disease or condition that is targeted by the proposed health technology. Include relevant details of diagnosis, symptoms, prognosis, demographics and other issues relevant to the population targeted by the technology.
If the health technology is proposed for use in a subgroup of a population with a specific condition, describe the characteristics that identify the subgroup and a rationale for targeting the proposed subgroup. Explain which subgroups would be excluded from the target population.
For further information on the Population see section TG2.1 of the MSAC Guidelines.
Specify any characteristics of patients with the medical condition, or suspected of, who are proposed to be eligible for the proposed health technology, describing how a patient would be investigated, managed and referred within the Australian health care system in the lead up to being considered eligible for the technology
Clearly describe characteristics of patients with (or suspected of having) the medical condition, who are proposed to be eligible for the service/technology. Please consider age ranges, severity of medical condition, presence of co-morbidities, and how the patient will be investigated, managed and referred, in order to eligible for the service/technology.
Please also specify other patients who may need to access the service/technology, for example for the purpose of cascade testing (who may form part of MSAC’s evaluation).
Are there any prerequisite tests?
Are there any diagnostic criteria and/or prior tests to determine the target population (eligible patients), including tests required to support any proposed continuation criteria
Are the prerequisite tests MBS funded?
If yes, you will need to select the relevant MBS items from the prerequisite MBS items added on the Application Details Page. These were added in the ‘Related MBS items’ field and have the category of ‘Prerequisite’.
If not, you will need to state how the tests are currently reimbursed (e.g. State and Territory funded) and whether they are universally available in Australia
Search and select the most applicable Medical condition terminology (SNOMED CT)
Optionally, select the most relevant disease or disorder related to your medical service or health technology.
Describe the key components and clinical steps involved in delivering the proposed health technology
Explain the central components pertinent to delivering the service/technology.
Provide details of how the proposed health technology is expected to be used, including frequency of use, mode of delivery, clinical setting, specialist training and provider type. Describe the required infrastructure for use of the technology, and whether the health system is currently able to provide this. State whether the proposed health technology is currently funded (in the public or private setting) in Australia for the same or another clinical indication.
Identify how the proposed technology achieves the intended patient outcomes
Provide details of how the proposed health technology works in order to achieve its intended effect.
Does the proposed health technology include a registered trademark component with characteristics that distinguishes it from other similar health components?
If the proposed medical service includes a registered trademark component, please explain what characteristics distinguish it from others, and will the use of a non-branded term in an item descriptor inadvertently enable other products to be claimed.
Are there any proposed limitations on the provision of the proposed health technology delivered to the patient (For example: accessibility, dosage, quantity, duration or frequency)
If applicable, indicate any limitations of delivering the proposed medical service to the patient, for example, whether it is a once-off or a lifetime intervention, etc.
Will a select type of health professional be needed to provide the proposed health technology?
If applicable, identify the health professionals who will perform the proposed service. Please consider allied health practitioners, nurses, general practitioners, specialists or sub-specialists.
For diagnostic tests, please describe which health professionals will order the test, interpret the test and use the test results.
Can delivery of the proposed health technology be delegated to another professional?
If applicable, specify whether the proposed service should only be rebated by the health professional billing the service or by the health professional performing the service on behalf of another health professional.
Further, please specify whether the proposed medical service could be delegated to be performed by another health professional, for example, a nurse, sonographer, etc.
Are there any proposed limitations on who might provide a referral for the proposed health technology?
Identify whether the proposed service should be restricted and limited to specific specialities or practitioners who have the appropriate training, credentialing or accreditation in performing the service. Please also include if there are referral limitations.
Is there specific training or qualifications required to provide or deliver the proposed service, and/or any accreditation requirements to support delivery of the health technology?
If applicable, describe the training requirements that would be needed to acquire any proposed accreditation, the duration and costs of training, whether training would be one off or ongoing and if credentialing or accreditation is a requirement.
Indicate the proposed setting(s) in which the proposed health technology will be delivered.
This question refers to the setting the patient is in when the health technology or service is delivered. The settings can be one or more of the following:
- Admitted patient to a declared hospital facility
- Admitted patient in the patient's place of residence as a substitute for hospital accommodation*
- Non-admitted patient at a public hospital out-patient clinic; accident and emergency department; private consulting rooms; residential aged care facility; other non-admitted patient, e.g. telehealth
Where the proposed service is performed at a declared hospital facility, please indicate if the service normally requires overnight or same-day hospital accommodation.
Where the proposed service can be performed in more than one setting, describe the rationale for each setting.
For example:
- Describe why it would be considered accepted medical practice for the service to normally be delivered 'out of hospital'.
- Specify exceptions where the medical condition of the patient, or a patient's other special circumstances would make the normal out-of-hospital service contrary to accepted medical practice, requiring the procedure be conducted 'in-hospital'.
If an investigative test or imaging is ordered, the setting is not the lab or imaging centre the analysis may be performed in but rather the status of the patient at the time the test or imaging was ordered.
* In accordance with section 121-5 of the Private Health Insurance Act 2007 Hospital Treatment refers to treatment to manage a disease, injury or condition provided by, or arranged with the direct involvement of, a hospital. It includes admitted patient care provided at the patient's place of residence instead of hospital accommodation.
Is the proposed medical service intended to be entirely rendered in Australia?
Please state if the proposed service is intended to be entirely rendered in Australia, or if a component of the service is provided outside Australia. For example, collection and preparation of a sample may be performed in Australia, however the sample is sent overseas for testing or interpretation and analysis. If a server is used to process and store patient data, please specify if the server is located overseas or in Australia.
Please note, in accordance with the Health Insurance Act 1973, Medicare benefits are only payable for services rendered in Australia. To meet this requirement, the patient and the health professional must be located in Australia.
Select the comparator(s) in the context of the Australian population with the targeted condition, the current health technologies available for that condition in Australia, and the technologies most likely to be replaced (or added to) in clinical practice. A single comparator will be appropriate in most circumstances. The comparator(s) should be selected based on the technology most likely to be replaced or added to in clinical practice, rather than on the availability of evidence. Refer to TG 2.3 of MSAC Guidelines.
If there is a reasonable expectation that another health technology will enter the Australian market for the targeted Australian population, and that it might be considered at the same or an adjacent MSAC meeting, then it would be prudent to regard this other health technology as an additional contingency comparator to inform MSAC consideration across the new competing health technologies. Please clearly indicate that this is a near-market comparator.
MBS number
If the comparator(s) is covered by an existing MBS item, please provide relevant MBS item number(s).
Comparator name
If you are providing a non-MBS comparator, you must supply the name of the comparator
Identifying number (if applicable)
If you are providing a non-MBS comparator, please provide any applicable identifying number (e.g. the entry on the Australian Register of Therapeutic Goods)
Please provide a description of the comparator
Outline the nature of the comparator (e.g. current MBS-listed therapeutic/investigative technology, PBS-listed medicine, medical device etc.) and how it is currently used in the application-specified population.
If the comparator is ‘standard medical management’ or ‘standard of care’, specify what this involves.
Please provide a rationale for why this is a comparator
The comparator should be clearly identifiable in the clinical management algorithm.
If multiple comparators are identified, describe whether different comparators are used for different subpopulations of the overall target population.
Pattern of substitution
Will the proposed health technology wholly replace the proposed comparator, partially replace the proposed comparator, displace the proposed comparator or be used in combination with the proposed comparator?
Identify the patient-relevant health outcomes for the target population, disease or condition. The outcomes that will be most influential for MSAC decision-making are those that are patient relevant and demonstrate the safety and effectiveness of the technology compared to the comparator.
Patient-relevant health outcomes (relevant for both therapeutic and investigative technologies) include:
- outcomes that are directly relevant to the patient, reflecting improvements in quality or length of life – Surrogate or intermediate outcomes are acceptable if they have been validated as being able to predict patient-relevant outcomes.6 If known at the PICO confirmation stage, provide validated examples of transformation from the surrogate to a patient-relevant outcome.
- outcomes that relate to the direct safety of the health technology or comparator (e.g. harms from biopsy or radiation) or the indirect safety (e.g. harms caused by learning curve or insufficient training, lack of equipment maintenance, inappropriate patient selection)
- outcomes that relate to the effectiveness or safety of any downstream interventions
- outcomes that are expected to change if the proposed health technology is publicly funded
- outcomes that are expected to be no different if the proposed health technology is publicly funded (required in the assessment of noninferiority).
Different outcomes may be necessary if the proposed technology is intended to be used across different indications (e.g. diagnosis and predisposition testing) or across subpopulations with different characteristics. Clearly state which outcomes are relevant for each indication or subpopulation. Differences in indications, purpose or populations may require multiple PICO sets.
Outcome type
Outcome name
Outcomes may include survival (mortality), clinical events (e.g. strokes or myocardial infarction), patient-reported outcomes (e.g. symptoms, quality of life), adverse events, burdens (e.g. demands on caregivers, frequency of tests, restrictions on lifestyle) and economic outcomes (e.g. cost and resource use). It is critical that outcomes used to assess health harms (as well as outcomes used to assess health benefits) are among those addressed in an MSAC application.
Outcome description
Please describe the impact of the outcome.
Proposed MBS item details can either be pre-filled from an existing MBS item, or drafted using a blank form. The purpose of pre-filling is to either amend an MBS item descriptor, or use an existing MBS item descriptor as a template for your new item descriptor.
To pre-fill, select the ‘Add proposed item’ button. In the window, enter the relevant MBS item number and click anywhere else in the window. The details of the descriptor will be pre-filled, and you will be able to edit the details as required.
Please search and select the proposed category
To select/change the category for your proposed MBS item, click in the box, and a drop-down menu will appear with all MBS categories.
Please search and select the proposed group
To select/change the group for your proposed MBS item, click in the box, and a drop-down menu will appear with the group values for the category you selected above.
Please draft a proposed item descriptor to define the population and health technology usage characteristics that would define eligibility for funding
Please ensure the descriptor reflects how the MBS item would be billed in practice.
Include first the intervention-based criteria and then the population-based criteria.
Intervention-based criteria: Prerequisites; referral and report; nature, duration and frequency; performed by; manner; venue; includes/excludes; related services.
Population-based criteria: eligibility criteria for the person; prerequisites (e.g. symptoms, age).
Compare descriptor with template
If you have pre-filled your proposed item, you can change the descriptor text, and select ‘Compare descriptor with template’ to view any changes made as tracked changes.
Proposed MBS fee
Enter the fee, in dollars and cents.
How is the technology/service funded at present?
For example: research funding; State-based funding; self-funded by patients; no funding or payments.
Overall cost per patient of providing the proposed health technology
Includes MBS fee plus additional costs not captured within the PBS fee
Anticipated out of pocket costs
Specify whether there is likely to be a ‘gap’ amount the patient is likely to have to pay above and beyond the MBS fee claimed by the service provider.
Cost breakdown attachment
Explain how the proposed MBS fee has been derived. In circumstances where the health technology is proposed to be covered by an existing or amended MBS item, explain why its fee is appropriate. A comparison of MBS item fees of similar services may provide some context for the proposed fee. However, greater justification for a fee will usually be required. Typically, the health technology should be costed with reference to relevant input costs. These may include the costs of the time taken for the provider to perform the service (before, during and after the service), and direct service costs such as costs of the time taken for identified ‘non-rebated employees’ to be involved in providing the service, costs of identified consumables, and costs of shared use of identified reusable equipment. Any consumables (such as sterile sheaths and IV giving sets) that must be used by a practitioner to conduct a procedure are generally included within the MBS item fee. There is also precedent that wet laboratory consumables may be included in MBS fees for pathology services.
Algorithms must be consistent with the population, intervention and comparator.
Preparation for using the health technology
Define and summarise the clinical management algorithm, including any required tests or healthcare resources, before patients would be eligible for the proposed health technology
This refers to management or investigations, plus management of the disease or condition in the Australian target population in the lead-up to the proposed health technology being used.
Is there any expectation that the clinical management algorithm before the health technology is used will change due to the introduction of the proposed health technology?
If yes, describe and explain any differences in the clinical management algorithm prior to the use of the proposed health technology vs. the comparator health technology.
Use of health technology
Explain what other healthcare resources are used in conjunction with delivering the proposed health technology
This may include medicines, procedures, tests, hospital admission etc.
Explain what other healthcare resources are used in conjunction with the comparator health technology
This may include medicines, procedures, tests, hospital admission etc.
Describe and explain any differences in the healthcare resources used in conjunction with the proposed health technology vs. the comparator health technology
Why have the healthcare resources changed as a result of the proposed health technology? For example, the proposed health technology may use non-invasive methods and the comparator may require surgical intervention.
Clinical management after the use of health technology
Define and summarise the clinical management algorithm, including any required tests or healthcare resources, after the use of the proposed health technology
What will happen to the management of the patient following the intervention.
Define and summarise the clinical management algorithm, including any required tests or healthcare resources, after the use of the comparator health technology
What happens to the management of the patient currently, following use of the comparator.
Describe and explain any differences in the healthcare resources used after the proposed health technology vs. the comparator health technology:
Summarise the differences to the management of the patient following use of the proposed health technology (intervention) vs comparator and explain what the differences attributed to.
In terms of health outcomes (comparative benefits and harms), is the proposed technology claimed to be superior, non-inferior or inferior to the comparator(s).
Briefly outline specific clinical claim in this section, whether the proposed service/technology is, in terms of relative safety and clinical effectiveness:
- Superior: The use of the proposed technology results in superior health outcomes and safety compared to the comparator/standard practice (i.e. does it have a positive impact on health and safety compared to the comparator)
- Non-inferior: The use of the proposed technology results in noninferior health outcomes and safety compared to the comparator/standard practice (i.e. does it have a neutral impact on health and safety compared to the comparator)
- Inferior: The use of the proposed technology results in inferior health outcomes and safety compared to the comparator/standard practice (i.e. does it have a negative impact on health and safety compared to the comparator)
This will inform the type of economic evaluation that is conducted during the ‘evaluation’ stage of the MSAC process. Please refer to TG 1.2 – Defining clinical claim in the MSAC Guidelines.
In terms of the immediate costs of the proposed technology (and immediate cost consequences, such as procedural costs, testing costs etc.), is the proposed technology claimed to be more costly, the same cost or less costly than the comparator?
Select the appropriate option.
Summary of evidence
Provide one or more recent, high quality clinical studies that support the use of the proposed health technology.
Provide a summary of key journal articles/research projects most likely to be relevant to MSAC’s assessment of the merits of the proposed service/technology.
Providing this summary enables the Applicant to signal the likely evidence base for the subsequent Assessment Report (as long as this evidence remains relevant, following finalisation of the Ratified PICO).
Two of the most frequently-used databases to undertake a search are Medline and Embase.
Please state the specific type of study design, title of the study, short summary of the study, website link to the study, and date the study was published. A table has been provided in the Application Form to capture this information.
The provision of information on evidence is simply to provide a snapshot of the evidentiary landscape. This will enable Departmental HTA and medical advisers to assess broad availability (and status) of the body of evidence/trials. This has implications for timing of the assessment through MSAC.
At Application Form lodgement, Applicants are not expected to provide a detailed analysis of the body of evidence (i.e. what it is saying or likely to say).
Estimate the prevalence and/or incidence of the proposed population
Communicate this in terms of prevalence in the broader Australian population.
Provide the percentage uptake of the proposed health technology by the proposed population
Communicate this in terms of percentage of patients with the condition who would use the proposed service/technology.
If your service or health technology is new, please consider the timeframe for implementation. If your health technology is displacing or replacing another health technology, please take this into consideration.
Estimate the number of patients who will utilise the proposed technology for the first full year
If the proposed health technology were to become available, how many patients would be expected to access it in the first year?
Will the technology be needed more than once per patient?
Select if the technology is required multiple times or only once. If ‘Yes, multiple times is selected:
- Over what duration will the health technology or service be provided for a patient? (preferably a number of years).
For example: over ten years, once per lifetime, duration of lifetime etc.
- What frequency will the health technology or service be required by the patient over the duration? (range, preferably on an annual basis)
For example: twice a year
Provide references to support these calculations.
The two duration and frequency should come together to describe how much the proposed health technology will be used, e.g. twice a year for two years. Provide justification for this.
Need further support?
If you have any questions or feedback, please contact hpp.support@health.gov.au.