The ability to provide appropriate clinical evidence in order to gain reimbursement for either a device or a procedure can often be difficult for innovators wishing to bring medical devices to market in Australia. At times the requirements in Australia may appear to be out of step with that required in other markets which can be frustrating for sponsors of new technology.
It is important to remember that ‘clinical’ evidence focuses on outcomes that matter to patients and that patients are aware of. This can include pain, disability, quality of life, survival, walking distance, shortness of breath or other measures. Other types of information such as engineering data, bench testing and design rationales that may be required to include some devices on the register on the Australian Register of Therapeutic Goods are not usually considered ‘clinical’ evidence.
There are two Health Technology Assessment (HTA) agencies that you are likely to encounter when bringing new medical devices to Australia. These are the Medical Services Advisory Committee (MSAC) and the Prostheses List Advisory Committee (PLAC).
MSAC advises the Minister of Health as to which medical services and technologies should be included on the Medical Benefits Schedule (MBS). Inclusion on the MBS is necessary for physician reimbursement for a procedure.
An application to MSAC is a major undertaking. MSAC’s preference is for randomised controlled trials, appropriately powered with adequate follow up and comparators. An economic model is built based on this trial evidence. Although lower levels of evidence will be considered they will be thought to bring greater uncertainty to the conclusions and will therefore be considered less reliable. This is a very simplified description of the requirements and MSAC has extremely detailed guidelines that must be adhered to.
MSAC assesses clinical evidence rigorously and it is important to assess the quality of available clinical evidence for your medical device carefully before embarking on an application.
A successful application to the PLAC will result in inclusion on the Australian government’s ‘Prostheses List’ and ensures that an implantable medical device will be reimbursed in the Australian private hospital system. However evidence requirements for some devices can be quite out of step with other similar health markets.
There are generally two clinical evidence pathways to inclusion on the Prostheses List.
‘Substantial Clinical Equivalence’. In this case it is only necessary to prove that your device is similar enough in design and function to a device that is already included that similar outcomes and complications can be expected. Similar performance to this device may be assumed in the absence of clinical trials.
However devices that are considered ‘high risk’ or require long term durability or are considered novel in design require clinical evidence with a minimum of two years follow up.