Category: Patients

WORLD’S FIRST HEART DEVICE FOR BABIES APPROVED

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[vc_row][vc_column][vc_column_text]An invention of medical device company Abbott, the pea-sized self-expanding device, called the Amplatzer Piccolo Occluder, now offers hope to premature infants and newborns who need corrective treatment, may be non-responsive to medical management or high-risk to undergo corrective surgery.

The device is inserted through a small incision in the leg and guided through vessels to the heart, where it is placed to seal the opening in the heart. The minimally invasive procedure to insert the device means many of the premature babies who are critically ill in the neonatal intensive care unit are able to be weaned from artificial respirator support soon after the procedure.

Born at 27 weeks, twin babies Irie and Judah Felkner of Columbus, Ohio, were both fighting for their lives in the neonatal intensive care unit when an echocardiogram revealed Irie had a patent ductus arteriosus (PDA) – a potentially life-threatening opening between two blood vessels leading from the heart – that required immediate treatment.

Irie’s mother, Crissa Felkner said “The doctor thought Abbott’s Amplatzer Piccolo device was the best solution for Irie, and after learning more about the procedure we decided to move forward”.

“You have to live it to fully appreciate what that device did for our daughter. Three days after the procedure, she was making great progress and is now a normal toddler with no limitations. The Abbott device was truly lifesaving for our daughter,” Mrs Felkner said.

Vice President of Abbott’s structural heart business, Michael Dale, said “Piccolo is a critical advancement in the standard of care for the most vulnerable of premature babies who may not be able to undergo surgery to repair their hearts.”

“Our mission is to develop life-changing technology to help people live better lives through improved health. This approval is another important step toward achieving our mission for the patients and physicians we serve,” Mr Dale said.

Amplatzer Piccolo Occulder is not yet available for Australian consumers.[/vc_column_text][/vc_column][/vc_row]

Better Data Demands for Aussies

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[vc_row][vc_column][vc_column_text]A collaboration between the Digital Health Cooperative Research Centre, the Capital Markets CRC and Research Australia, the report – Flying Blind 2:  Australian Researchers and Digital Health – found that better access to health data for researchers could save the economy $3 billion and improve health outcomes for all Australians, over 15 years.

In spite of the abundance of digital data that Australia holds, health and medical researchers are continually forced to assemble data-sets for their research themselves – a process which can take months, if not years. These delays can also drain funding and resources, forcing researchers to abandon linked data studies or seek support from other countries’ data-banks.

The report also told of a University of Melbourne researcher having to pay spend $60,000 of her research funding in order to access Victoria’s registry of births, deaths and marriages. This is made even more absurd when it was discovered that the research was government funded, meaning the funds went from the government to the researchers and back to the government.

Fragmentation of Australian health data also proves immensely troublesome, with various State and Federal laws and regulations creating a maze of bureaucracy researchers must navigate.

The Flying Blind report has proposed a series of recommendations for enhanced medical research in Australia, including the creation of Accredited Release Agencies to build data collections suitable for research, and a single national data-rich access point for researchers. The report also suggests creating publicly accessible protocols for all Australians to see how health data is used and how it is making a difference.[/vc_column_text][/vc_column][/vc_row]

More Than $500 Million Research Boost To Improve Lives

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[vc_row][vc_column][vc_column_text]A total of 682 grants will be funded, totalling more than $526 million, through the National Health and Medical Research Council (NHMRC).

The funding announced today includes:

    • $61 million for cardiovascular disease research
    • $86 million for cancer research, including cancers where treatment options are limited and early detection is critical
    • $41 million for mental health research projects
    • $29 million for diabetes research
    • $28 million for obesity research
    • $25 million for research focused primarily on improving the health of Indigenous Australians

As the highest recipient of funding of any university or institute, Monash University will receive almost $76 million to support excellent medical research.

The funding includes over $5 million to a team lead by Professor Sophia Zoungas of Monash University for her important cardiovascular disease research.

Professor Zoungas and her team will lead a trial to understand whether statins prolong independent living and reduce cardiovascular events in older adults without established vascular disease or diabetes.

This impressive research project is only one of 682 projects that will continue the proud Australian tradition of ground-breaking discovery and translation into better health for all.

This funding will ensure sustained support for our internationally-competitive health and medical research sector.

Projects announced today support cutting edge ideas from researchers at all careers stages and included research on vaccine development and tackling antimicrobial resistance.

These grants will support our health and medical research workforce, providing greater opportunities for more life-changing medical breakthroughs.

Health and medical research is one of the four pillars of the Government’s Long-Term National Health Plan. Our Government is committed to strengthening health and medical research.

The 2018–19 Budget we provided a record total of $6 billion to Australia’s health and medical research sector, including $1.3 billion for a health and medical industry growth plan to drive a new era of better health care and fuel jobs and growth.

A full list of grant recipients is available on NHMRC’s website[/vc_column_text][/vc_column][/vc_row]

PRICE DISPARITY BLAMED FOR HIGHER PREMIUMS

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[vc_row][vc_column][vc_column_text]Just last month, the Guardian reported that the Australian competition watchdog’s review of the private health insurance industry found Australians were forced to cough up $23.9 billion in premiums last financial year – that’s $834 million more than they had to pay in 2016/17.

The Guardian also reported that “the number of people with hospital-only or combined health cover fell 0.9 percentage points to 45.1%, while the proposition of policyholders with extras-only cover rose to 9.2% from 8.9%”.

The association representing Australia’s private health insurance industry, Private Healthcare Australia (PHA), has continued to assert that private health funds are delivering record health benefits for Australians, despite their decision to increase premiums for their customers.

PHA has points to a number of factors for the price hikes, including blaming medical technology (MedTech) innovators for the prices they charge for medical devices. However, PHA appears to have conveniently ignored the Agreement MedTech innovators reached with the Commonwealth Government to deliver $1.1 billion in savings, over four years. This enabled MedTech innovators to singlehandedly deliver, for Australians, the lowest increase to their private health insurance premiums in 17 years.

Another tried and tested argument rolled out by the PHI industry is that Australians are charged up to three times more for medical devices than their British and New Zealand counterparts. MedTech innovators, however, argue that the variations in prices for medical devices reflects the differing market environments, supply chains, economies of scale and contrasting reimbursement systems from country to country.

So do Australians really pay more for the same devices? Let’s take a look:

In 2016, one of Australia’s largest PHI companies, Bupa, acknowledged the difficulty in comparing the prices of devices in one country to another. When asked why Australians are having to pay up to $400 more a month for private health insurance than consumers in countries like Britain, Bupa said the “private health market in Britain was ‘very different’ (than Australia’s market), with insurers able to pick and choose customers and force patients to seek their approval before being referred to a specialist.”

The structure of healthcare systems in individual countries, the split between private and public healthcare and the source of funding impacts the price of prostheses, making it impossible for prices to be the same across different countries.

A simple example of these difference can be found when comparing the incentives for the public hospital sector and the private hospital sector and the services they provide. Public hospitals are incentivised to provide necessary and efficient care at the lowest possible cost through, what is called, Activity Based Funding (ABF). As a result, purchasing of prostheses occurs through centralised tenders which trade off prostheses choice against prostheses volume (either directly or indirectly), with control about what is available to the hospital being made by hospital administrators.

The private hospital sector, however, is not constrained by ABF and clinicians rather than hospital administrators make the decisions about services and care provided, including the types of prostheses they would like to use. These different incentives influence the different patterns of use and the economies of scale that are possible.

So, while some countries may appear to have comparable healthcare systems to Australia, but when they are analysed in a greater depth, they can actually be completely different.[/vc_column_text][/vc_column][/vc_row]

$240 MILLION FOR RESEARCH INTO THE NEXT BIG MEDICAL BREAKTHROUGH

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[vc_row][vc_column][vc_column_text]Applications for the Frontier Health and Medical Research program have now opened, allowing researchers to push the boundaries to develop tomorrow’s health and medical breakthroughs.

The Frontiers program is filling a gap in the research sector by providing government funding for early innovative projects and ideas that traditionally would not have received funding at this stage.

The Australian-first program has a unique, two-stage structure and was developed in consultation with Australian and international leaders in health and medical research including Research Australia.

In stage one, up to ten selected applicants will receive funding of up to $1 million each over one year to develop detailed planning for their cutting-edge research projects.

In stage two, a number of research plans developed under stage one will be chosen to receive funding to develop their ideas into new technological advances or approaches to revolutionise healthcare.

Stage two grants could be $50 million or more depending on the project and can extend over five years.

This program will confirm Australia as a leading source of innovation and discovery and will help bring about the next big medical breakthrough.

Frontiers is an initiative under the $1.3 billion National Health and Medical Industry Growth Plan, announced in the 2018 Budget. This game changing program is funded by the Government’s Medical Research Future Fund (MRFF).

Minister Hunt said the investment has the potential to transform healthcare and stimulate growth in the Australian medical technologies, biomedical and pharmaceutical (MTP) sector, a vital part of the innovation economy.

“The Government is able to provide unprecedented levels of support to health and medical research because of our strong economic management,” Mr Hunt said.

The MRFF is an endowment fund, which will mature at $20 billion, providing a sustainable source of funding for vital medical research. It is the single largest boost in health and medical research funding in Australia’s history.[/vc_column_text][/vc_column][/vc_row]

A Finite Resource With Infinite Demands

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[vc_row][vc_column][vc_column_text]The Medical Services Advisory Committee (MSAC) plays an important role in determining which medical services Australians have access to through Medicare.  It may be stating the obvious, but funding for healthcare is a finite resource, and there are infinite demands for healthcare.  It follows that healthcare dollars must be spent judiciously.

MSAC is charged with deciding whether a new medical service should be publicly funded based on an ‘assessment of its comparative safety, clinical effectiveness, cost-effectiveness and total cost’.  Innovations in medical technology often require the development of new medical procedures to ensure that the technology can be utilised for its best possible performance.  MSAC decides whether a medical professional can be paid for performing the procedure. If the application is successful, the procedure will be included on the Medical Benefits Schedule (MBS). If the technology is implantable then the device will likely to be eligible to be included on the Prostheses List.

Some new technologies allow patients to be treated outside of a hospital.  Treatment for varicose veins has previously involved invasive procedures to be carried out solely in the care of hospitals.  Innovation in technologies such as radio-frequency ablation hasenabled patients to access these procedures in alternative, more office based environments.  The MBS covers payment to the doctor for performing the procedure but does not, in most cases, make an allowance for any single-use technologies.  This can result in significant out of pockets for patients.  MSAC has acknowledged this structural issue on a number of occasions in their assessments of new technologies.

This problem is compounded by our strange system of private health insurance (PHI). PHI covers hospital admissions but does not cover office-based therapies, therefore hospital-based treatments may be less expensive for patients, while overall costing more.  Looking at this from an economic perspective, we can see that the least costly options of out-patient based innovations are not being incentivised by the payment system.

There is certainly an opportunity for Government to have a more flexible approach to what may be included in an MBS fee. Realistic coverage for the actual cost of delivering a service, including device cost, would be of real benefit to patients and is likely to reduce the cost to the health system overall.  Alternatively, at a time when the value of PHI is certainly being questioned, mechanisms whereby PHI could cover out of hospital procedures – that the MSAC has previously considered to represent good value, should also be considered.[/vc_column_text][vc_zigzag][/vc_column][/vc_row][vc_row][vc_column width=”1/4″][vc_single_image image=”2606″ img_size=”full”][/vc_column][vc_column width=”3/4″][vc_column_text]

About The Author

Sarah Griffin B.App.Sc (Physio), GradDIp Health Ec & Policy
Principal Medtechnique Consulting.

Sarah Griffin is the founder of Medtechnique Consulting and has more than 25 years experience in medical technology, both in Australia and the United States. Sarah expertise includes health economics, health insurance, health policy and legislation, reimbursement systems and government relations. Sarah also serves as Chair of the AusMedtech Health Economics Expert Panel and as an independent expert to the Australian Government’s Industry Working Group on Prostheses List Benefit Reform.[/vc_column_text][/vc_column][/vc_row]

HOW ROBUST ARE AUSTRALIA’S REGULATIONS?

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[vc_row][vc_column][vc_column_text]When questions about safety are raised it’s understandable that people, by their nature, might assume the worst is true. But is it? PulseLine wanted to go to the source and find out just how robust Australia’s system is when it comes to medical devices.

In Australia MedTech companies are represented by a national association called the Medical Technology Association of Australia (MTAA). The aim of MTAA is to ensure the benefits of modern, innovative and reliable MedTech are delivered effectively to provide Australians with better health outcomes and an improved quality of life.

MTAA CEO, Ian Burgess, believes millions of Australians’ lives have been transformed by having a medical device thanks to the Australian MedTech industry making safety as its highest priority.

“MedTech has improved the lives of millions of people right across Australia, thanks primarily to the efforts made by MedTech companies, government and medical practitioners placing such a high priority on the safety of medical devices being used in Australia,” Mr Burgess said.

“When it comes to ensuring we have a robust and thorough process for approving medical devices for the Australian market, MTAA are the first to advocate for a consistent and evidence-based approach to regulations.”

In Australia, the regulatory process is governed by a risk-based system of classification that determines the level of scrutiny a medical device will be subjected to before it is included in the Australian Register of Therapeutic Goods (ARTG). A medical device must be on the ARTG before it can be lawfully supplied in or imported into Australia.

The regulator responsible for overseeing this process in Australia is the Therapeutic Goods Administration (TGA) which assesses medical devices in line with a device’s intended purpose and risk-based classification. This includes:

  • A pre-market assessment – called a conformity assessment;
  • Market authorisation – so the device can be included on the ARTG; and
  • Post-market monitoring – which ensures the device continues to comply with all of the regulatory, safety and performance requirements and standards.

We all know how fast technology changes in today’s world. So, when it comes to regulations keeping up with that change, we wanted to know what the MedTech industry and government were doing to keep pace.

It turns out that in 2016 the Australian Government announced a series of reforms and projects to improve the regulatory process. These include moving towards global harmonisation, achieving appropriate classification for classes of medical devices based on risk, and working with sponsors and manufacturers to manage emerging issues in the post-market space.

Department of Health Deputy Secretary, Adjunct Professor John Skerritt, highlighted to PulseLine that TGA uses a number of sources of information to monitor the ongoing safety of medical devices included in the ARTG.

When it comes to monitoring the safety of post-market devices, the TGA receives “signals from multiple sources including notifications and information from other regulators, compulsory reporting from manufacturers and sponsors, competitors and whistle-blowers, media and government,” Professor Skerritt said.

“Reporting of adverse events and issues associated with the use of medical devices plays a vital role in identifying emerging issues that may require regulatory action or legislation change.”

Medical devices in Australia are subjected to a robust regulatory approval and legal framework, which requires device companies to report adverse events to the TGA.

So, when you consider the millions of medical devices Australians have successfully implanted, or interact with each year, it’s clear the regulatory process has a strong track record for ensuring safety for all Australians.[/vc_column_text][/vc_column][/vc_row]

RECORD DATE CHANGED AT 11th HOUR

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[vc_row][vc_column][vc_column_text]In an eleventh-hour reprieve, the Australian Senate voted to extend the opt-out period for a second time, meaning Australians will now have until January 31, 2019 to decide whether they want a My Health Record or not. Those that choose not to opt-out will have a record automatically created in the Government-run online database.

Minister for Health, Greg Hunt, who welcomed the Senate’s extension, has previously said the online health records provide “many benefits to patients, including reduced duplication of tests, better co-ordination of care for people with chronic and complex conditions, and better-informed treatment decisions.”

Speaking on the benefits of the My Health Record scheme, Consumer Health Forum CEO, Leanne Wells, had previously said the clinical benefits of My Health Record for patients are significant and compelling, including hospital admissions avoided, fewer adverse drug events, and better-informed treatment decision.

“For too long, healthcare has lagged behind in exploiting the clear benefits of information technology,” Ms Wells said.

Under the My Health Record framework, data can be linked to other datasets such as the Pharmaceutical Benefits Scheme (PBS) or the Medicare Benefits Scheme (MBS) creating an easy to access overview of a user’s profile.

Other industries, including the Medical Technology industry have welcomed the My Health Record. Medical Technology Association of Australia CEO, Ian Burgess, said the development of My Health Record will “provide tremendous opportunity to improve data collection across the whole health system and across the patient journey”.

Ultimately, Australians will be the biggest beneficiaries of the My Health Record system.[/vc_column_text][/vc_column][/vc_row]

New Report: Australia Poised For Global Success In Regenerative Medicine

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[vc_row][vc_column][vc_column_text]The report by MTPConnect, the Medical Technologies and Pharmaceuticals Industry Growth Centre, provides a roadmap for elevating the sector so it can successfully compete at a global level.

“We have a bold vision for regenerative medicine – to create an end-to-end world-leading value chain, from discovery to delivery, that gives Australian patients access to world-class therapies, creates high paying jobs and exports Australian therapies to the world,” MTPConnect CEO Dr Dan Grant said in launching the report.

“Australia has already demonstrated many successes in this relatively new field – the opportunity now is to build on that foundation, capitalise on our depth of talent in research, clinical trials and advanced manufacturing and elevate the sector to a new level.

If we get this right, ongoing success in regenerative medicine could be worth $6 billion in annual revenue and 6,000 new jobs for Australia by 2035, Dr Grant said.

Regenerative medicine harnesses cells and tissues, often in combination with gene therapy and devices, to enable the body to regenerate and heal itself. MTPConnect’s report, ‘Regenerative Medicine: Opportunities for Australia’, was produced in collaboration with the AusBiotech Regenerative Medicine Advisory Group and other key stakeholders including the Centre for Commercialization of Regenerative Medicine (CCRM) Australia.

“The report examines Australia’s strengths and weaknesses in regenerative medicine, as well as what our major competitors like the US and Japan are doing,” said Advisory Group chair and CCRM Australia CEO Silvio Tiziani.

“By taking stock of the local and international regenerative medicine landscape, we’ve been able to outline a five- point plan for delivering on our vision for the sector.”

The report’s five-point plan includes:

  • Prioritise skills development by attracting, building and retaining world-class talent
  • Improve collaboration across the value chain to accelerate commercialisation
  • Secure long-term investment by expanding the diversity of the pool of funders and venture capitalists
  • Create a clear market access pathway through regulatory reform and alignment with key globalmarkets
  • Enhance manufacturing capacity and capability to support commercial-scalemanufacturing

To guide implementation of the five-point plan, establishment of a central coordination group is recommended.

“Realising Australia’s enormous potential in regenerative medicine will require focus, persistence and the entire sector working together,” said AusBiotech CEO Lorraine Chiroiu.

“We can achieve this with a central catalyst group to coordinate and connect stakeholders. With MTPConnect leading the way, AusBiotech and the Regenerative Medicine Advisory Group will work to support establishment of this national body.”[/vc_column_text][/vc_column][/vc_row]

Digital Boost For NSW Royal Flying Doctor Service Set To Saves Lives

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[vc_row][vc_column][vc_column_text]According to Dr William Ibbotson, Medical Officer and Anaesthetist for the Royal Flying Doctors Service, Australia, the new system is set to take the organisation into the digital age, which could be the difference between NSW residents receiving the right care or not. Prior to the introduction of electronic medical records, all clinical record keeping was paper based. A new study, conducted by the QLD RFDS, suggests that digital medical records could help reduce data interpretation inaccuracies vs. manual data recording by up to 30 per cent.

“Across Australia, the RFDS cared for more than 335,000 Australians in 2017. Like many other healthcare services, until now, the majority of medical records have been hand-written, which has significant limitations,” said Dr Ibbotson.

“By digitising our medical records, we can set a gold standard for data recording, and have a wealth of medical history at our fingertips when making treatment decisions. Ultimately, this will help us provide higher quality, safer, and more integrated care that will save more lives.”

The RFDS provides aeromedical retrieval of critical care patients across New South Wales. This differs from many other pre-hospital care and retrieval services because patients are at an early, unstable stage, and often have prolonged transfer times in excess of 2 hours. This presents unique challenges in the provision of safe and effective medical care. Therefore, understanding each patient’s medical history is crucial to decide factors, such as whether air transport is appropriate in the first place, and if so which specialist doctors and nurses and what equipment are needed. The new system has been custom-designed for the NSW RFDS to meet the unique needs of the service.

“The RFDS is almost unique around the world in that we essentially bring an intensive care unit (ICU) across vast distances, directly to the patient,” Dr Ibbotson said.

“While there are other ambulance or airborne medical units in Australia and countries, such as the flying doctors in the U.S. and Canada, and metro helicopter services in the UK and Sydney, remote and rural Australia has exceptional challenges in connecting patients with specialist care providers. This means that the new system is bespoke to the NSW RFDS.”

Beyond improving clinical care, there are three other benefits expected to result from implementing an electronic medical record system. These include:

  • Governance and assurance – using digital records the service expects to improve consistency in data and show the true value of the service in terms of patient outcomes. This will help Government and key health bodies, such as NSW Health, evaluate the service and allocate resources where appropriate.
  • Education – data analyses will support providing specialised training for medical doctors of the future, including tailoring training for individuals and establishing new procedures. Partner organisations, such as the University of Sydney School of Rural Health, will be supported by data-driven case studies.
  • Organisational improvement – modelling and analytics will help to optimise the service to improve efficiencies, such as what equipment is needed, where staff are required and when key services may be required.

John Daniels, Global Vice President of HIMSS Analytics, said that RFDS of Australia was a global centre of excellence in digital transformation.

“Electronic medical records have been shown to improve quality, safety, cost-effectiveness, and access to healthcare around the world,” Mr Daniels said.

“Australia has been a real hot spot for adopting digital health innovations, and it’s great that these advancements can help those in rural and remote areas, where access to world-class technology can be limited.”

Dr Ibbotson concluded, “The HIMSS AsiaPac 18 conference is a great opportunity to collaborate with global leaders in digital healthcare. I’m really excited to have the opportunity to learn from the likes of military healthcare and trauma leaders. In the future, I hope that we can help roll out these advancements across the whole South East Australia RFDS.”[/vc_column_text][/vc_column][/vc_row]