However, it should also be noted that as part of its regulatory reforms, the Department of Health and Aged Care is revising product groups. The current groupings are available here, but they still refer to the Prostheses List.

Australia’s Prescribed List Application Tiers

As mentioned in our previous article, three types of applications may be submitted under the PL Scheme, after the inclusion of the device on the ARTG or submission of an application for device inclusion on the ARTG, including:

Tier 1 – Department Assessment Pathway

Applications submitted under this pathway are assessed only by the Department of Health and Aged and Care. The baseline requirements for this pathway are that the medical devices are:

• • Class IIb or lower
  • Well-established technology (with relatively simple, well-understood, and stable designs and limited variations, and with proven records of satisfactory safety and performance)

Furthermore, it is expected that devices assessed under this pathway will be interchangeable with the comparator devices listed in the same PL grouping, i.e.

• • Similar characteristics
  • Intended for use in the established patient population with the same indications
  • It is unlikely that the device will cause an increase in the PL expenditure within the group

All claims of interchangeability with the comparator stated in the application must be justified. Sponsors may only apply for listing the device in one of the existing PL groupings and do not ask to change the groupings for the billing codes in the amendment applications.

This pathway does not apply to the following types of devices:

• • Class III devices
  • Devices within scope of Part C of the PL
  • Devices subject to PL Part A applications for which the comparators are currently listed on the PL with conditions applied (as indicated in Part A of the PL)

Manufacturers must be aware that there is only a single opportunity under this pathway to provide sufficient information if the Department determines that the application is incomplete, has incomplete information, or the subject device is ineligible. If the manufacturer is unable to address the Department’s concerns in this single response, they will need to wait until at least the next cycle to submit another application (the PL is updated 3 times a year, in March, July, and November) and the device is no longer eligible for the Tier 1 pathway.

Tier 2 Clinical/Focused HTA Pathway

This tier pathway is for devices not suitable for assessment via the Tier 1 Pathway and require clinical assessment by the respective Expert Clinical Advisory Group (ECAG), and in some cases HTA consulting group. Specifically, devices within the scope of this pathway include:

• • Class III devices
  • Devices within scope of Part C of the PL
  • Devices within scope of Part A of the PL of any risk classification that is not well-established technology, i.e. Devices which:
  • Are reasonably new/do not have a long history
  • Have known issues with performance/safety problems
  • Have high variability in design and characteristics
  • Have novel features, characteristics, or functionality

Additionally, the following types of applications are subject to the Tier 2 pathway:

• • Requests for a new or amended grouping
  • Applications rejected under the Tier 1 pathway, including where the sponsor was unable to provide the required information in the format required by the Department.

The pathway has two routes dependent upon the level of assessment required:

• • Tier 2a – Clinical assessment only
  • Tier 2b – Clinical assessment + Economic assessment to establish cost-effectiveness

Under the Tier 2b route, an HTA may be undertaken by a HTA Group assigned by the Department which will typically take the form of a focused commentary (appraisal) of the clinical and/or economic claims made by the sponsor in the application. Sponsors are provided the opportunity to provide feedback on the assessment reports before them being provided to MDHTAC.

Tier 3 – Full HTA Pathway

This pathway is for devices requiring assessment by the MSAC to establish the comparative clinical effectiveness and cost-effectiveness and, in some cases, assessment of the device is conducted as part of the assessment of the related Medicare service (NOTE: Medicare is the Australian public healthcare system). The PL application may be submitted concurrently with or after the MSAC application. Applications and the respective correspondence must identify and explain the link between the PL application and the MSAC application.

Examples of applications that are subject to the Tier 3 pathway include:

• • Devices for which there is no relevant MBS item associated with the use of the device (a new or amended MBS item is necessary)
  • Novel devices or first-in-class technology and/or there are no appropriate comparators on the PL
  • Listing the device on the PL will likely cause a significant financial impact on the overall PL expenditure, thereby warranting a detailed financial assessment.

Specific Clinical Data Requirements

The drafted Australia Prescribed List Guide that was published to assist Sponsors in preparing their applications for the July 2024 Prescribed List is available here. This includes guidance on specific clinical data requirements where such data is necessary (Tier 2 and 3 applications). For example, this guidance includes the following requirements for knee and hip devices:

• • For hip and knee joint replacement devices used in primary or in both primary and revision procedures, the clinical data is required on a minimum of 250 procedures with at least 2 years of adequate follow-up
  • For hip and knee joint replacement devices, used in revision or special circumstances or unusual situation devices (e.g. constrained acetabular cup designed for use in high risk of  dislocation patients) procedures, the clinical data is expected on a minimum of 50 hip or knee joint replacement devices implanted with at least 2 years follow-up
  • For the tumor devices, a minimum of 20 devices implanted with at least 2 years of follow-up may be accepted, although these devices may have variability in the data requirements depending on circumstances.

While this guidance is still in draft, it provides highly specific detailed clinical data requirements that manufacturers should consider when designing their clinical investigations.

Learn More about Australia’s Prescribed List with MedEnvoy

This article provides an overview of updates to medical device reimbursement under the Australia’s Prescribed List scheme. Should you have any questions regarding Australian medical device regulatory requirements, or require an Australian Sponsor, get in touch.