When planning global medical device clinical trials and early commercialization, a growing number of manufacturers are conducting clinical trials in Australia. Access to innovative medical services, an established healthcare infrastructure, and an ability to conduct business “off the radar” make the region advantageous for clinical research.

While the country’s public health insurance program — Medicare — does not offer reimbursement for medical device clinical trials, it does allow for the reimbursement of certain medical devices approved for sale in Australia. If obtaining commercial approval in Australia is a goal, data from clinical trials conducted in Australia may offer at least an efficiency advantage when submitting information to the Australian government’s Therapeutic Goods Administration (TGA), which regulates medical devices.

Why Australia?

Aside from beautiful beaches and good wine, Australia boasts a robust clinical research sector supported by government.

Conducting clinical trials in Australia offers several financial, clinical, and operational advantages:

  • One of the best healthcare systems in the world. The Commonwealth Fund ranked Australia’s public-private system third in the world, and many of its clinical practices resemble those of the U.S. and the U.K.
  • Top-tier research facilities. Australia is internationally known as a clinical research center. The country adheres to good clinical practice (GCP) standards, which means its data are accepted by most regulatory agencies, including the FDA. International Conference on Harmonisation (ICH) and International Organization for Standardization (ISO) GCP standards are mandatory for all clinical trials conducted in Australia.
  • Significant tax incentives. The Australian government provides a research and development tax incentive to businesses investing in R&D activities, including clinical trials. Businesses with annual revenues of less than $20 million AUS receive a 45% tax offset, while businesses with higher revenue receive a 40% tax offset. Medical device manufacturers based outside of Australia should consider creating a business entity or subsidiary in Australia to take advantage of this benefit.

Reimbursement for Regulated Medical Devices

Procedures and associated devices must be included on the Medicare Benefits Schedule (MBS) to receive reimbursement from Australia’s Medicare as well as private health insurers. Ideally, a device will fall under a procedure already included on the MBS, as applying to include a new procedure is a long and arduous process. However, Avania has extensive experience in the Australian market and can assist with both MBS item number selection and application.

For more information on conducting medical device clinical trials in Australia, read the article in MassDevice: “Australia Medical Device Reimbursement: Incentives From the Land Down Under.”

Reimbursement for Implantable Devices

Companies bringing implantable devices into the Australian market can apply for inclusion on the prostheses list, which is governed by the Prostheses List Advisory Committee (PLAC), to receive reimbursement. Regulatory approval must be obtained either before or in parallel with a Prostheses List application.

How it works: Private health insurers pay a specific benefit for devices on this list. The list currently includes more than 11,000 joint replacement devices, cardiac implantable devices, stents, infusion pumps, catheters, and cardiac remote monitoring systems.

Upon receipt of application, the clinical effectiveness and other characteristics of the device are reviewed by a Clinical Advisory Group (CAG), another panel of clinical experts, the PLAC, and the Australian government’s Minister of Health. The entire process takes about four to six months.

Application process algorithm courtesy of Australia Department of Health, Office of Health Technology Assessment.

How to Increase Your Odds of Reimbursement Approval

As with U.S. clinical trials, manufacturers must factor reimbursement into the clinical trial planning process as early as possible. When designing the protocol and determining what data to gather, consider the following:

  • Optimize clinical trial design. Design your clinical trial so it produces as much valuable information as possible for regulatory and payer organizations.
  • Focus less on price, more on value. While your product may deserve premium pricing, know that Australia prioritizes value. Demonstrate how your product reduces healthcare costs and consider these metrics when planning clinical trials.
  • Don’t plan to negotiate. Australia’s payer system offers a fixed price for medical devices. Hospital systems have a set budget to work with, which leaves little to no room for negotiation.

With its generous tax incentives, an excellent healthcare system, and a relatively smooth regulatory process, be sure to keep Australia on the map when planning your next global trial.

Need help conducting clinical trials or obtaining reimbursement in Australia? Let’s talk.

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