Post-market Review Products Used in the Management of Diabetes Report to Government Stage 2: Insulin Pumps February 2015

2.8 Access to insulin pumps via private health insurance

2.8.1 Prostheses List

Under the Private Health Insurance Act 2007, private health insurers are required to pay mandatory benefits for a range of products on the Prostheses List that are provided as part of an episode of hospital treatment (or hospital substitute treatment) where a Medicare benefit is payable for the associated professional service. There are more than 9,000 products on the Prostheses List including cardiac pacemakers, hip and knee replacements, and intraocular lenses; as well as human tissues, such as human heart valves and corneas.

In order to obtain an insulin pump through private health insurance, patients usually have a 12month waiting period before they are eligible to apply for a benefit from their health insurance provider. Insulin pumps are listed under Schedule C of the Prostheses List and have a minimum benefit amount listed. The minimum benefit amount listed on the Prostheses List dictates the minimum benefit insurers are required to pay for a specific insulin pump where the pump is provided as part of an episode of hospital or hospital-substitute treatment during a professional attendance by a consultant physician for which a Medicare benefit is payable (i.e. a certified Type C procedure). Insurers may not pay benefits less than this amount, such as a percentage of the minimum benefit. However, the hospital may charge more for the insulin pump than the minimum benefit and in this case, the remainder would need to be covered by either the insurer or the patient.

Insulin pumps fitted in a clinic are considered part of general rather than hospital treatment, and the insurer is not required to pay the minimum benefit for the pump. Some insurers provide cover for insulin pumps as part of general treatment, but the amount covered and level of cover required varies. Some insurers require patients to maintain their cover at a certain level in the intervening years between receiving one insulin pump and the next.

The benefit amount is negotiated between the insurer and manufacturer of the product, mediated by the Department. Appendix A contains information on insulin pumps available under the Prostheses List as at February 2014 and Appendix B provides information on insulin pumps that have been discontinued or are no longer available on the Prostheses List.

2.8.2 Prostheses List Advisory Committee (PLAC)

The Prostheses List Advisory Committee (PLAC) was established on 4 October 2010, replacing the Prostheses and Devices Committee. Its primary role is to advise the Minister for Health about the listing of prostheses and their appropriate benefits on the Prostheses List. In making recommendations, the PLAC considers advice from Clinical Advisory Groups, members of the Panel of Clinical Experts and the Negotiating Oversight Committee (Department of Health 2010).

In order to provide advice to the Minister, when considering a new prosthesis listing, the PLAC considers the cost, clinical function, effectiveness and safety of the prosthesis in comparison to other products included on the Prostheses List intended to treat similar clinical conditions. For the item to be listed it must also fit within the classification criteria of a prosthesis as defined in the Department’s Guide to listing and setting benefits for prostheses (Department of Health 2010).

The Prostheses List arrangements and the PLAC were established to control inflation in private health insurance benefits paid for prostheses. The Prostheses List plays an important role in ensuring the sustainability of the Australian private health insurance system, and helps to achieve the Government’s policy objective of ensuring private health insurance remains affordable and accessible.

The PLAC is comprised of an independent Chair, with members having expertise in clinical practice, health insurance, consumer health, health economics, health policy, private hospitals, and the medical device industry (Department of Health 2010).

Since the establishment of PLAC in 2010, there has been an increasing focus on the comparative effectiveness for new listings on the Prostheses List, which includes the clinical advantages over the already listed comparators in the therapeutic group.

2.9 Regulation of insulin pumps in Australia

The TGA is Australia's regulatory authority for therapeutic goods. Medical devices must be included on the Australian Register of Therapeutic Goods (ARTG) before they may be supplied in, or exported from, Australia.

There are currently six insulin pump listings included on the ARTG (Table 1). Each ARTG entry covers all models of ambulatory insulin infusion pumps made by that manufacturer and supplied by that sponsor.

Table 1. Insulin pumps on the ARTG as of 1 November 2013.

ARTG No.	Sponsor	Manufacturer	Classification	Global Medical Device Nomenclature Term
98469	Medical Specialties Australia Pty Ltd	Smiths Medical ASD Incorporated	Class IIb	Infusion pump, insulin, ambulatory
96120	Australasian Medical & Scientific Ltd	Animas Corporation	Class IIb	Infusion pump, insulin, ambulatory
169095	Closing the Loop Pty Ltd	Insulet Corporation	Class IIb	Infusion pump, insulin, ambulatory
95763	Medtronic Australasia Pty Ltd	Medtronic Minimed	Class IIb	Infusion pump, insulin, ambulatory
212526	Roche Diagnostics Australia Pty Limited	Roche Diagnostics GmbH Diabetes Care	Class IIb	Infusion pump, insulin, ambulatory
99868	Managing Diabetes Pty Ltd	SOOIL Development Co Ltd	Class IIb	Infusion administration set, insulin pump

Class IIb devices such as insulin pumps are required to meet certain criteria to be included on the ARTG. This requires the manufacturer to implement and have assessed a Quality Management System in accordance with the ISO 13485:2003 standard for the design, production, packaging, labelling, and final inspection of the devices. The manufacturer must make a declaration of conformity, which includes a statement that the insulin pump complies with the provisions of the Essential Principles. This includes the requirement that the device is fit for purpose, designed considering the current 'state-of-the-art', and that sufficient clinical evidence exists for the device. A full list of the Essential Principles can be found in Schedule 1 of the Therapeutic Goods (Medical Devices) Regulations 2002.

Generally, the TGA would not conduct any specific reviews of an insulin pump prior to inclusion of the device on the ARTG. This type of device is not required to undergo a pre-market application audit of product or technical information by the TGA.

The TGA's website contains the Database of Adverse Event Notifications (DAEN) and the System for Australian Recall Actions (SARA), which contains information on adverse events and recall actions, respectively, for medical devices in Australia since 1 July 2012.

Information regarding adverse events or recalls of insulin pumps is included in Appendix A.