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Prostheses List Advisory Committee (PLAC) Bulletin 3

Bulletin number 3, April 2011

Printable version of Prostheses List Advisory Committee (PLAC) Bulletin 3 (PDF 68 KB)

The role of the Prostheses List Advisory Committee (PLAC) is to provide recommendations to the Minister for Health and Ageing on the listing of products on Part A of the Prostheses List and the benefits payable for them.

The purpose of the PLAC bulletin is to provide stakeholders to the prostheses arrangements with information relevant to current and future Prostheses Lists. The Bulletin is posted on the Prostheses page of the Department of Health and Ageing’s website and can be found at the following address: http://www.health.gov.au/internet/main/publishing.nsf/Content/privatehealth-pdc-bulletin.htm

Conflicts of Interest

Purpose

To provide an update on the approach that the Prostheses List Advisory Committee (PLAC) has recently agreed for future consideration of potential conflicts of interest arising in respect of Clinical Advisory Group (CAG), Panel of Clinical Experts (PoCE), or PLAC members.

Issues

The PLAC has noted that there is an increasing trend for medical device sponsors to engage clinicians to assist in horizon scanning, design of clinical trials, identification of gaps in the market place, and review of existing product lines to identify cost effective enhancements.

The Prostheses Secretariat and PLAC greatly value the expertise of experienced clinicians, and consequently we are developing guidelines that will allow us to assess risks and actively manage potential conflicts of interest.

The aim is to ensure that the depth of expertise available to consider new CAG and PoCE prostheses applications, and provide expert advice on issues at Prostheses meetings, is maintained, without actual or perceived conflicts of interest compromising the results.

The PLAC has agreed to implement some risk management based procedures to assess risks, and actively manage potential conflicts.

Risk assessment	Low	Medium	High
Examples	Travel grants to attend training or present at conferences	Sponsor Advisory Board Clinical trials Product development	Share holdings Direct financial interest (held by member or their spouse/partner)
Strategy	Record disclosure Monitor	Assess risk Develop mgt plan	PLAC to assess impact on CAG/PoCE work. In event direct conflict agreed by PLAC, member invited to divest shares or withdraw

Concurrently, the Department is revising Conflict of Interest Guidelines as a part of the Health Technology Assessment Review to improve consistency between the TGA, PBAC, MSAC and PLAC processes. The guidelines will be presented to PLAC once finalised, and then circulated to all Prostheses Committees and other key stakeholders.

Background

On 20 December 2010, the PLAC Chair wrote to all PoCE and CAG clinicians seeking an updated Disclosure of Interest form, with a higher level of detail than previously sought.

The Prostheses Secretariat is continuing to review these disclosures as they are received, and they will undertake a preliminary risk evaluation against the matrix above.

The PLAC has requested that the Secretariat present this assessment at the PLAC meeting on 12 May 2011 to facilitate discussion and agreement on the level of risk associated with potential conflicts; and agree an intervention strategy where it is warranted. As new members are appointed and current members are re-appointed, updated declarations will be reviewed in the same manner.

Any enquiries from members or stakeholders about these interim arrangements should be directed to the Chair of the PLAC for consideration.

Restructure of the Prostheses Section

The Prostheses Section, Private Health Insurance Branch, has been restructured. Roles and responsibilities are as follows:

Prostheses List Management Team – Director: Samantha Harris (02) 6289 4998

• PLAC secretariat
• Consultative Committee secretariat
• Database management and development

Clinical Assessment and Panel Team – Director: Kylie Boland (02) 6289 9420

• CAG secretariat: Vascular, Ophthalmic, Cardiac, Urogenital, Vascular
• Panel of Clinical Experts Secretariat: Neurosurgical, General and Miscellaneous, Plastic and Reconstructive and ENT
• HTA Review implementation

Clinical Assessment Team – Director: David O’Neill (02) 6289 1270

• CAG secretariat: Hip, Knee, Specialist Orthopaedic, Cardiothoracic, Spinal
• Part B – Human Tissue
• HTA Review implementation

Prostheses List Benefits – Director: Alan Stevens (02) 6289 9406

Implementation of Recommendation 12 b – e of the Health Technology Assessment Review will be completed by the Clinical Assessment Teams.

Application Assessment Process Timeline

The attached application timeline (Diagram 1) has been developed to improve the transparency of the Prostheses Listing arrangements and to assist stakeholders with their understanding and management of the continuous application process.

The key dates provided (Table 1) relate to new applications for the February 2012 Prostheses List.

The timeline and key dates will also be included on the Department’s website.

Attachments

• Diagram 1: Clinical Advisory Groups (CAG) and Panel of Clinical Advisory Experts (PoCE) Clinical Evaluation (PDF 66 KB)
• Table 1: Cut-off dates for clinical assessment for the February 2012 Prostheses List (PDF 152 KB)