PROSTHESES LIST ADVISORY COMMITTEE

COMMUNIQUE No. 13

The PLAC met for the thirteenth time on 15 February 2018 at the Pullman Sydney Airport Hotel.

Chair’s Update

The Chair briefed the Committee on the progress of the reform work set out in the Government’s Agreement with the Medical Technology Association of Australia (MTAA).

The Governance Group overseeing the Agreement met for the first time on 6February 2018 to agree on Terms of Reference and membership of the Industry Working Groups (IWGs).

The Governance Group discussed the commitment to remove the requirement for clinical evidence with 2 years of follow-up data for some devices where this is appropriate by 1 August 2018. The Chair explained that the “2 year rule” no longer exists; however the PLAC still needs outcome data to assess comparative clinical performance of devices for setting benefits. Where a device is comparable to a listed device, data required will depend on the risk associated with the device and what is needed to demonstrate non-inferiority. For devices claimed to be clinically superior or new technology, data will be needed to demonstrate the clinical benefits compared with other listed devices or treatment options to justify a benefit increase. The PLAC will continue to work with the Clinical Advisory Groups and Panel of Clinical Experts to define the outcomes data needed to support applications.

The Chair advised he is now a member of the Advisory Committee on Medical Devices that advises the Therapeutic Goods Administration (TGA). This will provide an opportunity to improve communications and liaison between the PLAC and the TGA.

Department Update

The Prostheses Section in the Department is undergoing staffing changes, with a few staff moving on and new staff coming on board.

The Department will look at the guidelines for declarations of interest and managing potential conflicts to support the integrity of the prostheses listing arrangements.

Prostheses listings

The Committee considered 95 applications to list new devices and 116 applications to amend listings on the Prostheses List and made recommendations to the Minister’s delegate.

PLAC Reform

The Committee considered a high level workplan encapsulating the deliverables in the Government’s Agreement with the MTAA and agreed to publish it on the Department’s website.

TGA Update

The Committee was updated on activities in the TGA, including implementation of priority review designations for medical devices from January 2018, upclassification of surgical mesh (including urogynaecological mesh) from Class IIb to Class III, the Senate Inquiry into transvaginal meshes, recent alerts and recall notices for implantable devices, findings from the 2017 Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) Annual Report and policy projects for 2018. Information on the TGA’s activities is available at

Next Meeting

The next meeting is scheduled for 5 April2018 in Sydney.