Author: Team

People living with diabetes now have broader access to blood glucose monitoring products in Australia

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Diabetes is considered an epidemic in Australia, with 1.7 million Australians living with the condition and a further 280 people diagnosed each day.

“While pharmacy remains the key access point for products that are reimbursed via the National Diabetes Services Scheme (NDSS) and to seek advice, it is evident that many Australians are simply not managing their diabetes effectively and we want to ensure that access is not a barrier,” said Ms Jane Crowe, General Manager, Roche Diabetes Care Australia.

“We are committed to innovation, not only in our product development, but also in ways in which consumers can access them. Given this range is not reimbursed via the NDSS, no form is required to purchase the products, enabling us to establish the partnership with Woolworths and broaden availability.

“As the market leader in diabetes monitoring, we are passionate about understanding the needs of people with diabetes and offering them broad access to encourage regular self-management,” said Ms Crowe.

Roche Diabetes Care has been pioneering innovative diabetes technologies and services for more than 40 years. Being a global leader in integrated personalised diabetes management, we work every day to support people with diabetes and those at risk to achieve more time in their target range and experience true relief from the daily therapy routines.

Under the brand Accu-Chek and in collaboration with partners, Roche Diabetes Care creates value by providing integrated solutions to enable optimal personalised diabetes management.

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MEDIBANK MANAGEMENT TO BLAME, NOT MEDICAL DEVICES

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[vc_row][vc_column][vc_column_text]Mr Burgess said Medibank’s attempts this week to blame medical device usage for its alleged profit downturn flies in the face of APRA data released Tuesday, showing insurer net profit after tax (NPAT) was up 21 per cent in the Dec 19 Qtr from $1.19 billion to $1.44 billion.

Medibank also failed to declare today the upwards of $400 million in direct medical device savings Health Minister Greg Hunt had already delivered private health insurers since 2017.

“It’s comments like these from Medibank today that are destroying consumer and investor confidence in their own products and performance, as well as the broader sector. No wonder they’re in a self-proclaimed ‘death spiral’,” Mr Burgess said.

“Private health insurers haven’t paid one extra cent for medical devices over the past two premium years, despite raising premiums twice-inflation and banking nearly $1 billion in profits between the big corporate health funds, including Medibank.

“It’s not the role of medical devices to keep propping up Medibank’s managerial inaction and incompetence, while they continue to feather their nest with taxpayer handouts and corporate bailouts.

“Medibank’s management seems to routinely fail to understand that timely access to the best and latest medical devices is exactly why their customers put up with years of premium pain. Reducing access will only reduce customers.

“Medibank’s customers have clearly had enough of their premiums increasing faster than house prices with no matching increase in benefits and are finally cashing in their chips before they’re forced out altogether.

“If Medibank can still afford to pay a dividend to its shareholders, it can afford to drop its prices for its customers.”

Mr Burgess also questioned why there was no mention in Medibank’s statement today of the benefits that were about to flow through from recent price cuts on 1 Feb 2020 to over 7000 medical technologies like pacemakers, insulin pumps, eye lenses, hip and knee replacements and more.

 

“Medical device manufactures have cut their prices upwards of 40 per cent in the past 3 years as a result of the direct lobbying of insurers like Medibank to help reduce premiums and increase access.

“It’s a safe bet that the first private health insurer whose premium increases go below zero will increase their market share overnight.[/vc_column_text][/vc_column][/vc_row]

Impact of MedTech – Anthony’s Story

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[vc_row][vc_column][vc_column_text]Aortic Stenosis (AS), a narrowing of the aortic valve that restricts blood flow, is the one of the most common and serious heart valve disease problems in developed countries. It is an under-recognised phenomenon and a challenging condition to diagnose as it can be silent for a long period of time.

Historically rheumatic disease and congenital conditions were common causes of AS, however with increased longevity, the most common cause of AS today is degenerative calcification of the aortic valve. This causes subtle symptoms such as shortness of breath and the reduced ability for normal activities which many patients and clinicians dismiss as part of the normal aging process or being “out of shape”.

This month HeartKids, the only national charity dedicated to supporting children, teens and adults affected by congenital heart disease all across Australia celebrates Show Your Heart for Little Hearts. Edwards Lifesciences Foundation is a proud supporter of HeartKids. Congenital heart disease is the most common congenital disorder in newborns. The birth rate prevalence of congenital heart disease is understood to be approximately 8 – 10 cases per 1,000 live births.[/vc_column_text][/vc_column][/vc_row]

3D PRINTING – A JOINT SUCCESS STORY FOR BOTH AUSTRALIAN INDUSTRY AND REGULATORS

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[vc_row][vc_column][vc_column_text]Historically, much has been made of Australia’s record of innovation in medical devices and pharmaceuticals. Inventions such as the Cochlear Implant, the vaccine to protect against cervical cancer, spray-on skin and penicillin have long attracted the attention of medical professionals and the public.

Parallel to this, Australia has developed a world-class regulatory regime that facilitates patients’ access to these inventions both here and overseas, while maintaining high standards of public health and safety.

Not long ago, the 3D printing of medical devices – the personalisation of a device to suit an individual’s unique physical characteristics and medical needs – seemed like science fiction. Now it’s a reality, and Australia is leading the way, quietly maybe, but in a manner that is delivering to patients, Australian businesses and the economy.

As ever, this is thanks not only to cutting edge Australian scientific and manufacturing ingenuity, but also regulatory innovation, creating frameworks that help facilitate access to safe high quality products.

Since 2017, the Therapeutic Goods Administration (TGA) has been working towards a modernisation of the regulatory regime to achieve this.  With that process now rapidly heading towards implementation, new classifications of medical devices will provide novel regulatory pathways onto the Australian Register of Therapeutic Goods (ARTG) for mass “personalised” medical devices, which were previously categorised within the much broader “custom medical device” category.

This ground-breaking regulation will support a business environment that encourages innovation and investment, whilst facilitating Australian businesses to export their devices to the markets that need them. The TGA has clearly recognised technological changes in 3D printing and the impact this has had on the market for 3D-printed medical devices.

This is particularly reflected in the harmonisation of definitions relating to personalised medical devices, with the International Medical Device Regulators Forum (IMDRF), agreed in November 2019. This development is extremely important for Australian businesses.  The global leadership demonstrated by the Australian TGA, led in this role by Dr Elizabeth McGrath, cannot be overstated.  In short, it is Australian regulators who have set the gold standard now being implemented by their peers across the world.

For pioneering Australian companies, international harmonisation facilitates access to new markets and broadens existing ones. It supports further innovation by giving greater confidence that new devices will reach sufficient markets to support the investment needed to develop them, as well as local manufacturing facilities to produce them.

This harmonisation of the regulatory approach to 3D printed and personalised medical devices is an achievement of which the Australian Government, the Minister for Health Greg Hunt, and the TGA should all be justly proud. If, as expected, the Australian regime is the first of the IMDRF-harmonised regimes to accept applications for Personalised Medical Devices to enter the ARTG, there is a very real prospect that some of the most sophisticated medical device companies from around the globe will now consider an Australia-first lodgement strategy to facilitate the fastest possible pathway to certifying safety, efficacy and conformity prior to global export.

3DMEDiTech is one Australian company poised to take advantage of the new regulatory pathway onto the ARTG and international equivalents. This Melbourne-based company aims to deliver customised 3D printed devices and manufacturing services to the health sector across the Asia Pacific region and beyond.

Each medical device the 3DMEDiTech develops requires significant research and development to allow it to be rapidly mass personalised according to the prescription of the patients health care provider.  This includes mapping and interpreting the full spectrum of the clinical problems the device aims to address, the development and application of novel algorithms, and finding solutions to significant design, material and engineering problems.

Once all those challenges are addressed, the multidisciplinary collaboration of clinicians, engineers, mathematicians, programmers and technicians needs to ensure that the devices can be produced at scale for thousands of people.  The workflow is entirely digital. This means that they can deliver the fastest and most accurate design and delivery of customised devices to healthcare providers and their patients.

3DMEDiTech has also partnered with world-leading clinical and research partners including Melbourne University, St Vincent’s Health Australia, Orthokids and Ivoclar Vivodent. The company also recently joined as foundation industry partners of the Australian Research Council Training Centre for Medical Implant Technologies “CMIT”, headed by the University of Melbourne’s Professor Peter Lee.

Printed devices developed and manufactured in Australia by 3DMEDiTech include prescription clear aligners for by dental clinicians, orthoses for prescription by orthotists and prosthetists, plagiocephaly helmets (used to help infants’ heads form properly), leg braces and ankle foot orthotics.

While much of 3DMEDiTech’s work is still pre-clinical and not in the public domain, several of their lower risk-class devices are already in market and have been spun out into stand-alone commercial entities.

SmileStyler® www.smilestyler.com.au makes prescription-only clear aligners which has uniquely solved the primary clinical problem that had faced both dental professionals and patients.

Serkel® https://serkel.org/ makes personalised orthoses for prescription by orthotists and prosthetists which include plagiocephaly helmets (used to help infants’ heads form properly), bracing and ankle foot orthotics.

There is enormous demand for these products across Asia Pacific. Australian excellence in the research, development and manufacture of these first-rate devices is evident, and recognised.  So too is the role of the TGA in enhancing the reputation for safety and efficacy of the companies and devices they regulate.

The TGA has recognised the opportunities that exist not just for patients, but for Australian businesses in 3D printing, and has taken a global leadership role in advancing personalised medical devices. However, to fully realise the capabilities and ingenuity of Australian companies like 3DMEDiTech, an effective regulatory system is essential.

3DMEDiTech’s founder, Paul Docherty, said: “Our company operates at the forefront of this rapidly growing sector. But we couldn’t do that if the regulations weren’t being put in place to ensure market access and help achieve a return on the substantial investment necessary. In helping deliver international harmonisation in how to define and regulate these emerging devices, the TGA has helped support Australian businesses and jobs. It’s made it possible for companies like ours to continue leading the way in the research, design and production of outstanding printed, personalised medical devices for patients across Asia Pacific.”

Like all industries, there are rogue operators in 3D printing, but the TGA’s work ensures that unscrupulous companies do not undermine patients’ wellbeing and that companies like 3DMEDiTech thrive, delivering innovation, value and better clinical outcomes both to the Australian economy and health system.

Few people recognise what has been achieved in this field in the last three years.  That is a mistake – it’s an Australian success story in the making, and another triumph in the distinguished history of Australian medical innovation. It deserves to be celebrated.[/vc_column_text][/vc_column][/vc_row]

MEDTRONIC SEEKING PARTNERS IN INNOVATION

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[vc_row][vc_column][vc_column_text]For the first time in Australia, Medtronic Australasia will host Eureka LIVE in collaboration with AusBiotech’s premier medical technology conference AusMedtech 2020 from 20-22 May at the Melbourne Convention Centre. Applications are being called from in-market or ‘launch ready’ medtech companies who are looking for opportunities to scale their product innovations globally.

“Medtronic has the tools and experience to collaborate with inventors across a broad range of innovative ideas,” said Tim Fortin, Vice President and Managing Director, Medtronic Australasia. “We have a proven track record of bringing new products to market, by combining our research, engineering, and commercial competencies to deliver meaningful innovations at the therapeutic, procedural, and healthcare system levels.

“At Medtronic, we believe patient-focused innovation – and strong partnerships – remain key to an even better, more impactful future. We are confident that an approach focused on ANZ, which protects inventors and enhances opportunities to collaborate on innovation development, will yield excellent results and push medical technology forward,” Mr Fortin said.

Following the application process, shortlisted companies will showcase their innovations to delegates attending AusMedtech 2020 – both as part of the main Conference program and through Exhibition space at the event – before moving on to targeted and exclusive deep-dive sessions with global Medtronic executives. Successful companies will then be invited to connect with the Medtronic global network to accelerate and fund appropriate opportunities to market in the pursuit of improving community-wide health.

Eureka LIVE aims to promote innovations that add real value for better patient outcomes at appropriate costs, which are validated by solid clinical and economic evidence:

  • innovation for patients, like device technology or remote sensing and monitoring;
  • innovation for hospitals, like data-driven insights to improve processes and predictive analytics to inform patient selection and management;
  • innovation for health systems, like algorithms and data integration to produce system intelligence and transform system performance.

To apply, please visit: https://www.medtronic.com/au-en/c/eurekalive.html

Hosted by Medtronic Australasia, Eureka LIVE is supported by AusBiotech and the MedTech Actuator. It builds on Medtronic’s commitment to supporting local innovation through its web-based portal Medtronic Eureka, also hosted in collaboration with The Medtech Actuator.[/vc_column_text][/vc_column][/vc_row]

PRIVATE HEALTH PREMIUMS MUST DECLINE IN LINE WITH MEMBERSHIP

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[vc_row][vc_column][vc_column_text]Mr Burgess said over 2 million Australians dumped their private health insurance in the last five years and this week’s December quarter APRA figures confirmed this trend was continuing, with only 44.0% per cent of the country now covered.

At the same time, the APRA data shows private health insurance profits before tax increased 14 per cent over the past 12 months from $1.6 billion to $1.8 billion.

This is despite the price of medical devices paid by private health insurers dropping by up to 38 per cent in the past 3 years thanks to government reforms, including another round of recent price cuts on 1 February 2020 for technology treating heart and lung disease, diabetes, bone cancer, severe arthritis and eye trauma.

“It’s clear private health insurers would rather drop customers than drop their prices and profits,” Mr Burgess said.

“Private health insurance premiums have grown faster than national house prices over the past decade.

“It’s a safe bet that the first private health insurer whose premiums go below zero will increase their market share overnight.

“Surely that’s a better investment than health funds spending more on marketing to squabble over fewer customers?

“Private health insurers haven’t paid one extra cent for medical devices over the past two premium years, despite raising premiums twice-inflation and banking nearly $1 billion in profits between the big corporate health funds.

“The number of Australians dropping out of private health insurance is quickly snowballing into an avalanche and it’s time for government to step in and save private health from itself.”

A recent Alpha Beta report identified $1 billion worth of efficiencies that could reduce private health prices by up to 20 per cent within 3 years if government adopted them now.[/vc_column_text][/vc_column][/vc_row]

$22.3 million funding support for health and medical research

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[vc_row][vc_column][vc_column_text]An initiative of the Medical Research Future Fund (MRFF) and operated by MTPConnect, the BTB program is offering up to $1 million to support development and commercialisation of new biological, pharmaceutical, medical and health technology projects.

MTPConnect will open its next round of funding for the $22.3 million Biomedical Translation Bridge (BTB) program, on Monday, 17 February.

 

This is the second round of the BTB program. Round one, announced in December 2019, saw eight projects selected to share in funding of $5.9 million following a competitive application process.

MTPConnect Managing Director and CEO, Dr Dan Grant, says the BTB program is a unique opportunity for Australian innovators to take their research to the next stage along the translation and commercialisation pathway.

“We’re looking to support SMEs and research organisations conducting research projects that provide innovative solutions in any disease area using any therapeutic modality or medical technology,” Dr Grant adds.

“With applications only open for three weeks, from Monday, the Australian research community needs to move quickly to take advantage of the substantial funding on offer.”

MTPConnect is delivering the BTB program in partnership with BioCurate (Melbourne and Monash Universities), UniQuest (University of Queensland), the Medical Device Partnering Program (led by Flinders University) and the Bridge and BridgeTech programs (Queensland University of Technology).

The BTB program is uniquely positioned to provide applicants with expert mentoring from these partners, that provides scientific expertise and commercial acumen to support projects in their translation to proof of concept.

“The successful projects we invest in through the BTB program will lead to new therapies, technologies and medical devices to improve the health of Australians and deliver real impact to people all over the world,” Dr Grant explains.

Opening Monday 17 February, applications to the BTB program will be open until 5:00PM (AEDT) on Friday, 6 March 2020. Details can be found at the BTB page.[/vc_column_text][/vc_column][/vc_row]

LEADERS JOIN AUSTRALIA’S INNOVATION SUMMIT

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[vc_row][vc_column][vc_column_text]Humanity, Technology and Health Frontiers will be the focus of the Summit, with the program covering topics such as genomics, robotics, 5G technology, private/public partnerships and artificial intelligence.

The GFCC is a global multi-stakeholder organisation represented in more than 30 nations. It promotes innovation, productivity and mutual learning between countries as a way of supporting the ongoing success of a range of sectors, including health.

Noteworthy leaders in the GFCC network Charles Holliday Jr. (Chairman, GFCC and Chairman of Royal Dutch Shell, plc.), Mehmood Kahn (Chairman, U.S. Council on Competitiveness and CEO, Life Biosciences) and Deborah Wince-Smith (President, GFCC and President and CEO, U.S. Council on Competitiveness) will travel to Australia to attend the Summit.

The Morrison Government has committed $300,000 to support the delivery of the Summit.

The Summit will allow Australia to create new partnership opportunities and work with other global leaders to develop innovative health solutions to current and future problems.

Health and innovation are key priorities for the Government, including the recent commitment of $5 billion through the Medical Research Future Fund (MRFF) to support breakthrough medical research into new frontiers of science.

Areas of focus include the transformative platforms of stem cell research and genomics, being able to diagnose, treat, and help people recover with genuine precision medicine.

The Summit agenda will address Australia’s future competitiveness with discussions on navigating the Australian context and opportunities for collaboration between countries.[/vc_column_text][/vc_column][/vc_row]

Reference Pricing – Does It Add Up?

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  • Why does it matter? The private health insurance (PHI) industry has been actively lobbying the government to cut the costs of premiums, which has resulted in benefits and choice being slashed for hard working Australian families. A tactic of the PHI industry is to try to focus as much blame, for the high premiums they charge, onto others, including medical technology innovators.
  • What is their argument? The PHI industry believes the cost of medical devices, as well as keeping vulnerable people who are suffering from a mental health condition in hospital too long, is causing premiums to rise. The PHI industry also wants the government to implement ‘international reference pricing’ to further cut into the prices of medical devices in Australia.

This is where the ‘apple and oranges’ comparison comes into play. Let’s explain: Like any product or service, the price for medical devices can vary from one country to another. Just as the price of a Toyota Sedan in Texas might be different from the price of a Toyota Sedan in Sydney or Adelaide.

  • What causes the difference in price? The price difference can be attributed to several factors, including:
    • Differences in healthcare systems;
    • Differences in purchasing arrangements and market segmentation;
    • Differences in price/benefit determination;
    • Differences in volumes of devices being used;
    • Differences in the level of technical manufacturer support needed;
    • Geographical differences; and
    • Economic difference.

Now despite all these difference that can affect price, the total PHI spend on medical devices is just 10%. Thanks to, what is called, the Prostheses List (PL), Australians can access innovative and leading medical devices, giving them certainty of access and cost (currently nil) to a wide range of prostheses.

KEY INSIGHTS: Comparisons across different markets will result in PL benefit adjustments that could reduce patients’ access to devices recommended by their physicians and force patients to pay more for the same products.

  • The Productivity Commission released a report in 2001 relating to international price comparisons of pharmaceuticals which said: “It’s difficult to identify robust specific explanations for the observed bilateral price differences. Rather, the price differences are probably due to a combination of influences, including systemic differences in health systems…”

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