Opposition’s $26 Million For Clinical Trials

[vc_row][vc_column][vc_column_text]In a follow-on announcement from Labor’s signature Medicare Cancer Plan, is an investment of $26 million for clinical trials over four years. With the aim to ensure as many Australians as possible can access trials that can improve patient lives.

The funding will be broken down into three main segments and will be invested in the work of the Australian Clinical Trials Alliance, they include:

  • $12 million to support two research projects – one cancer related
  • $10 million to provide more support for existing Clinical Trial Coordinating Centres
  • $4 million to help ensure that results from clinical trials are quickly implemented

Clinical trials however don’t just benefit patients and the advancement of medical knowledge there are also estimated to be worth around $1 billion to the Australian economy each year.

The environment in which clinical trials are conducted is complex, often occurring across multiple jurisdictions and with every study needing ethics and governance approvals before it can commence.[/vc_column_text][/vc_column][/vc_row]

Increased funding a boon MedTech in Victoria

[vc_row][vc_column][vc_column_text]The Victorian Minister for Health Jenny Mikakos has announced Victorian hospitals will receive $60 million in the latest round of the Medical Equipment Replacement Program and Engineering Infrastructure Replacement Program grants.

Both these programs are aiming to replace existing end-of-life, critical, high-risk assets that are deemed essential to maintaining life and safety in the state’s health care sector. Whilst maintaining ongoing continuity for acute services in public hospitals.

Jenny Mikakos stated “New state-of-the-art medical equipment and better hospital infrastructure will make sure more Victorians can get the world-class care they need, when they need it, closer to home.”

The grant funds will be focused on purchasing updated and new cutting-edge medical equipment such as mammography units, fluoroscopy units, digital X-ray machines and gamma cameras. In what would may be that start of a funding windfall for the states MedTech sector.

The State of Victorian is coming off several years of budget surplus thanks to a booming population and property market and is currently delivering the biggest pipeline of infrastructure projects in the state’s history. Having invested $3.2 billion on infrastructure in a first term Government, with another $3.8 billion to be delivered over the next four years.[/vc_column_text][/vc_column][/vc_row]

A Pandora’s Box of Possibilities for World First Trial

[vc_row][vc_column][vc_column_text]The Royal Melbourne Hospital will begin an early feasibility study for the safety of the Stentrode™ device. The Stentrode™ is a device that is placed inside a blood vessel of the brain located in the area that controls movement, the motor cortex.

Once implanted, the Stentrode™ picks up signals and transmits them to artificial intelligence software that can allow a person to communicate or control a computer.

It is the only investigational technology of its kind that does not require open brain surgery.

Five participants with loss of motor function due to paralysis from spinal cord injury, motor neuron disease, stroke, muscular dystrophy and loss of limbs were chon to take place in the ground-breaking trial. The research will be the first of its kind to be performed in humans and will attempt to find safer, more effective ways to implant electrical sensors in patients’ brains.

Testing is supported by Synchron (formerly known as SmartStent) that spun out of the University of Melbourne. A company that was founded in 2012 after a cold-call pitch to the Pentagon with a new concept for a Brain-Computer Interface by CEO and founder Thomas Oxley.

Synchron claims this technology has the potential to enable patients with paralysis to take back digital control of their world, without having to move a muscle.[/vc_column_text][/vc_column][/vc_row]

Government to Spend $2 million Reviewing Effectiveness of Natural Therapies

[vc_row][vc_column][vc_column_text]The last review was conducted in 2014-2015 and concluded 17 natural therapies offered through health insurance hadn’t been proven to work on patients. The therapies found unproven to work were:

  • Alexander technique
  • Aromatherapy
  • Bowen therapy
  • Buteyko
  • Feldenkrais
  • Western herbalism
  • Homeopathy
  • Iridology
  • Kinesiology
  • Naturopathy
  • Pilates
  • Reflexology
  • Rolfing
  • Shiatsu
  • Tai chi
  • Yoga

The updated review will be led by the Commonwealth Chief Medical Officer, Professor Brendan Murphy and will be supported by an advisory panel of experts including Associate Professor of Public Health Jon Wardle from the University of Technology Sydney. In addition to Associate Professor Wardle the advisory panel will include other experts in natural therapies, consumer representatives, and experts in private health insurance, medicine, and allied health.

The private health insurance rebate is an amount the government contributes towards the cost of private health insurance premiums. The rebate can be claimed for premiums paid for a private health insurance policy that provides private patient hospital cover or general cover, commonly known as ‘extras’, or combined hospital and general cover.[/vc_column_text][/vc_column][/vc_row]

Labor Guarantees Affordable Medicines

[vc_row][vc_column][vc_column_text]Shadow Minister for Health Catherine King has stated that there are currently 18 drugs recommended by the Pharmaceutical Benefits Advisory Committee that the current Government have saidthey will never list. King also claimed, that at last count, there were more than 40 drugs that had been recommended by PBAC that were not listed.

King’s statement comes in response to the Government announcing an investment of more than $200 million to list four new breakthrough cancer treatments on the Pharmaceutical Benefits Scheme, saving patients up to a quarter of a million dollars a year. Almost 1,800 eligible patients with leukemia, advanced kidney cancer, bladder cancer and liver cancer will have new be able to access to scheme for the medicine.

The PBS was first introduced 65 years ago by the Chifley Labor Government and ensures all Australian citizens that listed medicines will be available for $40.30 for general patients and $6.50 for concession patients – regardless of what the drug would normally cost.[/vc_column_text][/vc_column][/vc_row]

BIPARTISAN SUPPORT FOR RADIATION THERAPY FOR REGIONAL AUSTRALIA

[vc_row][vc_column][vc_column_text]Announced as part of the $2.3 billion Medicare Cancer Plan announced in the Budget-in-reply this week, an elected Labor government would provide $60 million towards 13 radiation therapy facilities in rural and regional areas.

This follows on from the Coalition’s commitment of $45.5 million for regional radiation therapy in Tuesday’s Budget.

In Australia, radiation therapy is underused in the fight against cancer. In Europe and North America, 1 in 2 cancer patients receives it as part of their treatment, here it is only 1 in 3.

The medical technology industry has long called for greater funding for radiotherapy in Australia, with a campaign launched recently by the Radiation Therapy Advisory Group, a group formed in 2017, comprising of expert individuals and organisations dedicated to raising the profile of radiation therapy.

The Radiation Therapy for Regional Australia campaign was launched in Newcastle earlier this year, and their success in bringing the plight of rural and regional cancer patients to the attention of government has helped to ensure that all Australians have access to the treatment they need.[/vc_column_text][/vc_column][/vc_row]

GOVERNMENT ACKNOWLEDGES STRENGTH OF AUSTRALIA’S DEVICE REGULATIONS

[vc_row][vc_column][vc_column_text]The medical devices industry welcomed this acknowledgement by the Federal Government that the regulatory requirements for medical devices in Australia are highly rigorous.

Patients benefit most when they have timely access to innovative new technologies and Government’s recognition of this as they work to strike right balance with effective and appropriate scrutiny of these technologies is crucial.

The medical devices industry supports measures proposed in the Action Plan to improve adverse event reporting by healthcare professionals and hospitals and welcomes moves to strengthen community awareness of how the safety and performance of medical devices is assessed.

Medical Technology Association of Australia’s CEO, Ian Burgess, said the MedTech industry welcomed the Government’s ongoing recognition of Australia’s regulatory requirements for medical devices as being amongst the most rigorous in the world.

“We are also pleased that Government has acknowledged that this rigor must be balanced with the need for patients to be able to access to new breakthrough technologies in a timely manner.

“Medical technology companies are legally required to report adverse events and often report beyond what is required by regulation, however, we welcome any moves to make this process more efficient.

“MTAA looks forward to continuing to participate in the ongoing review processes described in the Action Plan to ensure that Australians have access to the best and most innovative new technologies in order to live better and more fulfilling lives.”[/vc_column_text][/vc_column][/vc_row]

FIND OUT HOW MUCH $$$ YOUR LOCAL HOSPITAL GETS

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That sounds interesting! Tell me more.

The Federal Government is responsible for jointly funding Australia’s public hospitals, which are owned and operated by the State and Territory Governments. Health Funding Facts shows how much hospital, Medicare and medicines funding your local hospital network and electorate receive from the Australian Government – think of it as a one-stop-shop!

So how does the website work?

  • Hospital funding – enter your postcode or your local public hospital from the menu to reveal the Australian Government’s funding
  • Medicare funding – enter your postcode or Federal electorate to find out how much Medicare funding was received between 2012-13 and 2017-18
  • PBS funding – reveals how much was received in PBS benefits by people in your area between 2012-13 and 2017-18

Hit me with the facts!

Under the next National Health Reform Agreement, from 1 July 2020 to 30 June 2025, the Federal Government will contribute $130 billion in funding to Australia’s public hospitals

Nationwide, the Federal Government’s funding to all States and Territories for public hospital services is growing from $13.3 billion in 2012-13 to an estimated $28.7 billion in 2024-25

KEY INSIGHT: Currently in Australia, close to nine out of every ten GP services are bulk-billed, meaning that Aussie patients do not have any out-of-pocket costs when they visit their local GP.

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BATTLE LINES DRAWN

[vc_row][vc_column][vc_column_text]Both the Government and Opposition have laid out bold and competing visions for the nation’s future and, come May, it will be for the people to decide which one they choose.

What is clear is that both the Government’s budget and Labor’s response play to their natural political strengths and philosophical beliefs.

For the Government it is about economic management delivering strong budget surpluses to investment in areas like health but also offering tax cuts.

Their mantra is ‘only a strong economy under the Coalition can provide the money needed to both cut taxes and invest in services’.

For Labor, it was a big investment in health, underpinned by a $2.3 billion cancer plan to see out of pocket expenses for cancer patients abolished.

This will, essentially, be funded by Labor’s unwavering commitment to raise revenue through a series of major tax changes covering franking credits, negative gearing and capital gains tax.

Health –  Front and Centre Election Issue

Once again, health is looking to be the key battle ground for this Federal Election.

On Tuesday night, the Government did a good job to try and neutralise health as a defining issue for the election through their spending on health to try to avoid, at all costs, a repeat of the 2016 “MediScare” campaign run by Labor.

At every opportunity, the Government has trumpeted its commitment to health led by, for example, Minister Hunt consistently reminding the community how many new drugs the Government has listed on the PBS, in comparison to when Labor were last in Government.

The Government also sought to bury the hatchet with GPs on Tuesday night by reinstating indexation of Medicare items to nullify an expected attack from Labor.

With Labor’s cancer plan announcement, it once again sets up health as a major political battle ground for the election.

The choice for the community is now quite clear.

Under the Coalition you can have sound economic management, exemplified by tax cuts for all and some more spending on key services such as health that a well-run economy allows a Coalition Government to deliver.

Alternatively, under Labor, you can have similar tax cuts for low- and middle-income earners, major spending in health – as demonstrated by the cancer plan – and even larger surpluses that Labor has committed to delivering.

The fundamental difference is that the Coalition is promising to deliver their manifesto with no new taxes, in fact less taxes, whereas Labor is promising to deliver their manifesto through an increase in tax revenue, while distributing part of that to those they deem the neediest.

Will people vote with their hip-pocket in mind, or for more spending on services like health funded by increased taxation?

All will be clear when the nation votes on either May 18, or possibly May 11.

As for the Prime Minister visiting the Governor-General, that will either be this weekend or next weekend at the latest.[/vc_column_text][vc_zigzag][vc_row_inner][vc_column_inner width=”1/4″][vc_single_image image=”1915″ img_size=”full”][/vc_column_inner][vc_column_inner width=”3/4″][vc_column_text]

ABOUT THE AUTHOR

Jody Fassina is the Managing Director of Insight Strategy and has served as a strategic adviser to MedTech and pharmaceutical stakeholders.[/vc_column_text][/vc_column_inner][/vc_row_inner][/vc_column][/vc_row]

The human cost of Australia’s health handbrake

[vc_row][vc_column][vc_column_text]Essential Tremor affects 500,000 Australians over 45. Whilst only 2% develop severe debilitating tremors that fail to respond to drugs, half a million patients and families may live in fear of their condition deteriorating.

The ABC’s 7.30 Report covered the story of David Harvey, whose debilitating tremor was almost eliminated in just a few hours by what ABC described as ‘breakthrough’ incisionless Trans Cranial MRI guided Focused Ultrasound (tcMRgFUS) therapy at St Vincent’s Hospital Sydney. The piece attracted remarkably high viewership on air and online.

ABC presented tcMRgFUS as new – yet St Vincent’s is the 58th global site to adopt this now widely internationally used, therapy. tcMRgFUS has positive UK NICE guidance, reimbursement in US, Israel, Japan, Health Canada. Nearly 2,000 patients have been treated globally with zero deaths or intracerebral hemorrhages. Long term data is available. Compelling health economics and evidence has been published across multiple sources, 87 in 2018 alone, and includes the lead study on the front page of the New England Journal of Medicine.

The procedure is a ‘thalamotomy’ or the creation of a lesion in the thalamus. It has an MBS Item, over 1,500 publications and has been performed surgically since the 1950s. The tcMRgFUS innovation is an instrument that does not need to drill through the skull and push probes through the brain to perform a thalamotomy on the target, avoiding operative risks, increasing precision and neuromodulating to test effects before permanent changes are made. In the hands of a skilled operator, this combination dramatically changes the balance of efficacy and complications of performing a tcMRgFUS thalamotomy vs alternatives. In Australia, thalamotomy surgery is 3-5 times more expensive than performing the same procedure with tcMRgFUS.

Yet uniquely in the world, NSW public hospitals restrict tcMRgFUS thalamotomy use to clinical trials only – based on a HealthPACT analysis that curiously omitted the term ‘thalamotomy’ from the literature search. Unsurprisingly, this resulted in the erroneous finding of “no long term evidence for the long term effects of [thalamotomy] a lesion”. The report also did not reference a publicly available draft tcMRgFUS NICE guidance, tcMRgFUS Health Canada review, international Neurological Associations guidance documents, or long term tcMRgFUS data available. HealthPACT noted “no comparator costs available” but omitted reference to Australian MSAC data that gave both comparator costs for the standard of care ($120,000 per patient in 2008) and actually described “thalamotomy as the standard against which others should be judged”. These errors could have been avoided, perhaps by inviting comment on the final draft; or State Health authorities might consult their own clinicians they employ that are experts in a field, acknowledging HealthPACT’s reports are authored by generalists.

In turn, Private Health Insurers (PHIs) have refused to pay interested hospitals, despite the procedure having an MBS Item. Those PHIs who have provided reasons for rejection have included arguments such as the location of tcMRgFUS not taking place in the same room as open neurosurgery, even though the thalamotomy procedure is identical. Ironically, other PHIs use evidence of fewer complications and shorter length of stay to justify limiting funding. Whilst tcMRgFUS can avoid the need for $40,000 of implants, the tcMRgFUS procedure kit itself is not an implant so PHIs simply refuse to pay.

PHIs are acting rationally to maximise profits, with $534m for Medibank alone in 2018. So of course, PHI happily pocket the $120,000 of savings, including potentially $40,000 of prosthesis.

This means hundreds of patients, many of whom have spent a lifetime paying taxes and private health premiums, are paying 100% out of pocket for treatment that elsewhere is the standard of care. And while they await treatment, their severe tremor prevents them working, with many claiming government support for the care they require.

Can there be a clearer example that PHI, an industry motivated by profits, cannot decide on what it pays for? There is an urgent need for the government to follow through on their commitment to include devices that are non-implants on the Prostheses List. Or ordinary patients and their families, like David in this story, who have paid PHI all their lives, will keep needing to take out loans to prop up PHI profits.

Patients and wider society pay the price if profit-driven PHIs are in total control – the Federal Government must follow through on its promise to industry to reimburse non-implantable prostheses.[/vc_column_text][vc_zigzag][/vc_column][/vc_row][vc_row][vc_column width=”1/4″][vc_single_image image=”2962″ img_size=”full”][/vc_column][vc_column width=”3/4″][vc_column_text]

ABOUT THE AUTHOR

Christopher Selwa is Managing Director of MediGroup EBI. MediGroup EBI is an Australian, family-owned SME focusing on the introduction of groundbreaking medical technology into Australia and New Zealand.

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