Australian sponsors of implantable medical devices have at times been frustrated by a requirement of two years of clinical evidence for ‘high-risk’ devices. This rule has typically been applied to all Class III product, some class IIb products and active implants. In many cases, this has been a stumbling block for sponsors gaining access to the Australian private market. As the requirement is unique to Australia, sponsors often have difficulty generating the required evidence for such a small segment of the global market.
As part of the MTAA agreement with the Australian Government, the Government undertook to
‘Remove the current requirement for clinical evidence with 2 years of follow up data for some devices, where this is appropriate by 1 August 2018’.
The Department of Health has since followed up with some guidance for sponsors. The guidance, however, while stating that the 2-year rule will no longer be applied, does not actually provide any information as to what sponsors do need to supply. For a device that is claiming clinical equivalence and the same benefit as a comparator (a ‘me too’ device) the department advises:
‘data required will need to demonstrate non-inferiority’
For novel devices and those claiming clinical superiority the department advises
‘the sponsor will need to provide data to demonstrate the clinical benefits of the new device compared with other listed devices and/or treatment options’
While understanding that the Department cannot give specific advice for every possible circumstance, the current advice is not enlightening for sponsors. It is likely that some trends may become apparent as applications are processed for the August 2018 Prostheses List. In the meantime, it is important that sponsors present their available evidence in such a way as to assist the assessors in making decisions.
The Prostheses List is undergoing substantial reform at present as a consequence of the industry agreement. A review is being conducted to ensure that consistent processes are adopted across all of the advisory committees. This is certainly welcome. In addition, the review is intended to improve the quality and timeliness of written information provided to applicants. If this review looks at providing clearer guidance around clinical evidence requirements, then this too will be very welcome.
In the meantime, it is vital that sponsors make every effort to ensure that their evidence is relevant and presented clearly and concisely.
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