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This page will contain different fields depending on the answer to the question Which list/schedule will the other health technologies be listed on? on the Application details page.
In the context of the Medical Services Advisory Committee (MSAC), a codependent technology is a medical technology/service that relies on another technology to achieve its intended purpose or enhance its effect.
An important feature of all codependent technologies is that it is the combined use of different services/technologies that leads to, or enhances, their intended clinical effect. Therefore, the benefits of both technologies should be assessed together (rather than assessing each technology in isolation). There are a number of different scenarios for possible codependencies that involve medical services:
- An investigative medical service and a therapeutic medical service. For example, a diagnostic imaging service that identifies patients who may benefit from a specialised treatment, such as targeted radiotherapy.
- An investigative medical service and a medicine. For example, a test that identifies which patients may benefit from a particular medicine.
- A therapeutic medical service and a medicine. For example, a medical procedure to administer a medicine in a targeted or specialised way, improving the performance/effectiveness of the medicine.
- A therapeutic medical service and a medical device. For example, a surgical procedure and an implantable device such as an artificial joint.
In addition, hybrid technologies are a type of codependent technology that combine characteristics of different health technologies within a single product. For example, a drug eluting stent combines a medical device and a medication, by coating a small mesh tube designed to support an artery wall, with a time-release medication that assists to prevent further blockages.
Applications for Health Technology Assessment are deemed materially codependent if the Minister for Health requires advice from two different expert advisory committees, with the different components funded from separate reimbursement schemes. For example, the Minister for Health would require advice from MSAC regarding the listing or amendment of an investigative medical service on the MBS and from PBAC regarding the listing or amendment of the medicine on the Pharmaceutical Benefits Scheme.
In some cases, this occurs automatically because MSAC is responsible for assessing both components. For example, where both the therapeutic and investigative technologies require listing (or amendment) on the MBS, MSAC is responsible for conducting the health technology assessment on both components.
Pharmaceutical Benefits Scheme (PBS)
Applications for materially codependent technologies are managed by MSAC and PBAC as either integrated or streamlined.
When a completed MSAC Application Form is received, the application is assessed by the Department to determine if it is suitable for consideration by MSAC and, if so, the most appropriate assessment pathway, taking into account the nature of the service and/or technology, its novelty and complexity, the availability of supporting evidence, available subsidy programs, and the technologies involved.
If an application is allocated to the integrated codependent pathway, the Applicant is required to prepare and lodge a combined submission-based assessment report (referred to in MSAC as an Applicant Developed Assessment Report or 'ADAR') addressing both technologies. The submission is lodged via PBAC through the Health Products Portal.
If an application is allocated to the streamlined codependent pathway, the Applicant is required to lodge separate submission-based assessment reports to PBAC and MSAC. These separate submissions are prepared and lodged with the relevant committees concurrently, to ensure timely alignment of advice. MSAC and PBAC will consider the submissions in parallel. Given it is a streamlined submission, the major component of the request (e.g. funding of drug) will require a submission-based assessment report be prepared for the relevant committee (in this case PBAC), while the minor component of the request (e.g. amendment of MBS item to include another drug to the list of available drugs) will require a less substantive submission to the relevant committee (in this case MSAC).
Further information is provided to applicants by the Department once a pathway has been determined.
Applicants are encouraged to review the guidelines for preparing assessment reports and other associated templates on this website before lodging a submission-based assessment report to MSAC. Some core information about the co-dependent therapy will need to be provided in order to link the clinical conclusion of the investigative medical service to an economic analysis.
Will a submission be made to the Pharmaceutical Benefits Advisory Committee (PBAC)?
If your application is a MSAC/PBAC codependent application, your submission will need to be made to the PBAC. If you are not lodging a PBAC submission, please provide comments in the below rationale field.
Please select the PBAC meeting date relevant for this codependent application
PBAC meetings occur three times per year. Please select the most likely PBAC meeting date for your application.
Please provide a rationale for the codependency
Please outline why the application requires consideration by both PBAC and MSAC.
The most common example of a codependent technology is a medicine-test combination where a new medicine seeking listing on the PBS has a related pathology test that may help to determine the population group eligible for that medicine. The Medical Services Advisory Committee (MSAC) classifies such tests as ‘investigative medical services’.
An investigative medical service can have several purposes, of which the following are most likely to be relevant to codependent technologies:
- establishing a predisposition or estimating a prognosis
- identifying a patient as suitable for a therapeutic medical service by predicting a variation in the effect of the therapeutic medical service
- measuring an early treatment effect on a surrogate outcome as the basis for predicting the extent of a later treatment effect on more patient-relevant outcomes
- monitoring a patient over time after an initial investigation to guide subsequent treatment decisions if the service needs to be repeated.
To achieve an improvement in health outcomes, the investigative information from the test must result in a change in the management of a subsequent therapeutic service. In this sense, the test can only indirectly improve health outcomes and any improvement also needs to be balanced against any harm that the service might cause. This purpose defines the need for a codependent technology to be assessed.
For further information on making an application to MSAC to list or amend an MBS item (to support a new or revised PBS listing), please refer to:
The Medical Devices and Human Tissue Advisory Committee's (MDHTAC) role is to determine a reimbursement price for devices funded by private health insurers (consequently, the application processes are separate). Devices will not be listed on the Prescribed List until there is a corresponding MBS item for the associated medical service.
Will a submission be made to the Medical Devices and Human Tissue Advisory Committee (MDHTAC)?
If your application is a MSAC/PL codependent application, a separate Prescribed List application will need to be lodged. If you are not lodging a Prescribed List application, please provide comments in the below rationale field.
Please select the MDHTAC meeting date relevant for this codependent application
Please select the most likely MDHTAC meeting date for your application.
Please provide a rationale for the codependency
Please outline why the application requires consideration by both MDHTAC and MSAC.
- Is a new MBS item or amendment to a current MBS item required for a medical service associated with the medical device? (e.g. implantation or removal of the prosthesis)
- Has MDHTAC referred your application to MSAC? If so, please provide relevant details of MDHTAC’s advice and consideration.
Are there any other sponsor(s) and / or manufacturer(s) that have similar prosthesis or device component in the Australian market place which this application is relevant to?
Please provide names of all commercial suppliers with similar prostheses or devices (technologies).
It should be noted that the Government funds professional services, rather than individual technologies or brands through the MBS.
The Department of Health and Aged Care consider that MBS items should generally describe the professional service, without specifying a particular brand of device delivered as part of the service. This is so other ‘equivalent’ devices may not necessarily need separate MSAC assessment or MBS listing and to avoid issues with patient access to testing. While some items are restricted to accommodate use of a particular brand or device and not others, this is by exception only and must be supported by evidence, on grounds of safety, clinical effectiveness, cost-effectiveness or total cost impacts.
The suitability of your application may be affected if you do not include sufficient evidence and justification to restrict a medical service to a particular technology or brand.
When an application is subject to a broader assessment across multiple device options, MSAC observes procedural fairness and commercial-in-confidence issues.
After receipt of an MSAC Application Form, the Department assesses the broader clinical landscape. This ensures other relevant sponsor(s) and/or manufacturer(s) with a similar prosthesis or implantable device have been identified in the Australian market.
Are there any single and/or multi-use consumables delivered as part of the service or health technology?
Please list any single and/or multi-use consumables used as part of the proposed service (e.g. catheters, electrodes, syringes and needles, bandages and dressings etc.). Medical consumables tend to be non-durable and/or disposable in nature, and are often restricted to single use per patient. In some circumstances, these consumables can be expensive.
Be sure to note if any consumables are specialised for use with the prosthesis and an essential part of service delivery (e.g. specialised catheter for insertion of the prosthesis).
Need further support?
If you have any questions or feedback, please contact hpp.support@health.gov.au.