MSAC to consider funding for first TGA-approved TTVR device

In an evaluation that could open access to the first approved transcatheter tricuspid valve replacement (TTVR) device on the Australian Register of Therapeutic Goods (ARTG), the Edwards Lifesciences’ Evoque system is set to go before the Medical Services Advisory Committee (MSAC) in November.

Tricuspid regurgitation (TR) – a condition where the heart’s tricuspid valve fails to close properly, allowing blood to flow backward into the right atrium – carries a grim prognosis for patients with severe disease. With a reported 1-year mortality rate of 20%, TR also leads to poor quality of life and frequent hospitalisations. For most affected patients, open heart surgery is either too risky or not feasible.

TTVR using the Evoque system is superior in efficacy and non-inferior with respect to safety compared to optimal medical therapy alone, based on results from the Triscend II pivotal trial.

The trial will continue to follow participants for five years, with final completion expected in December 2029. Currently, 1-year safety and efficacy data have been published, and 2-year outcomes were presented at the 2024 Transcatheter Cardiovascular Therapeutics (TCT) conference.

Although other orthotopic valve replacement devices – such as Medtronic’s Intrepid, Jenscare Biotechnology’s LuX-Valve and LuX-Valve Plus, and NaviGate Cardiac Structures’ Navi-Gate – are in development, none are yet approved by the TGA, placing Evoque at the forefront of TTVR devices.

Input on the MSAC application was provided by Hearts4heart, Medtronic, and Private Healthcare Australia (PHA), revealing contrasting views. PHA objected on economic grounds, arguing that the procedure cost, estimated at over $125,000, far exceeded that of “almost zero-cost diuretics” under current optimal medical therapy – despite the superior outcomes shown with the Evoque system.

Medtronic advocated for a device-agnostic item descriptor, suggesting the proposed MBS item should not reference a specific brand. However, precedent supports naming devices in item listings, with MitraClip previously included in the original item for transcatheter edge-to-edge mitral valve repair (TEER).

Patient advocacy group Hearts4heart expressed strong support for the submission, citing the transformative impact in relation to health and quality of life for patients ineligible for surgery.

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