Category: Community

[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]

[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]

[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 58^th 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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[vc_row][vc_column][vc_column_text]As health insurers resort to increasingly more desperate attacks on the medical device industry, let’s take a look at another ‘choice’, the choice that contributes so much to the value proposition of health insurance – choice of medical device.

As the April 1 changes to private health insurance draw closer, most policy-holders have received letters from their insurers explaining that things are about to change. Some letters even refer to cuts to the Prostheses List and the contribution this has made to the lowest premium increase for 18 years.

But how many people actually know what the Prostheses List is and what it adds to the value proposition of their health insurance?

The Prostheses List is what gives privately insured patients choice. Choice and access to a wide range of cutting-edge implantable medical devices, at no cost to them. The Prostheses List has also played a significant role in supporting private health insurance whilst at the same time suppressing benefit inflation.

Until consumers better understand the Prostheses List and what it is that their private health insurers are trying to take away from them, insurers will continue to play on the dearth of information available to their customers to make disingenuous claims about the device industry.

Such as their fixation on comparing apples with oranges as they attempt to resuscitate the tired old argument of international reference pricing.

There is no denying that our ageing population and the increasing prevalence of chronic disease is driving up the overall cost of healthcare in Australia, which means it is even more incumbent on our private health insurers to take an honest look at their costs, and, let’s be realistic, their not insignificant profits, without coming back to medical devices for another round.

The future of our private health system depends on it.[/vc_column_text][/vc_column][/vc_row]

[vc_row][vc_column][vc_column_text]It marked the 50^th Newspoll, in a row, the Government has lost with the two-party preferred result, placing Labor ahead of the Coalition, 54 to 46.

The poll had the Government with a primary vote of 36 versus 39 for the ALP.  In 2016 the Turnbull Government won a one seat majority with 43% of the primary vote.  This is the fundamental challenge for the Government – their primary vote is too low to win.

The last fortnight saw the Government campaigning hard on the economy and border security, with little apparent impact on their electoral standing.  It also makes the Ipsos poll from a month ago look like an aberration rather than a change in sentiment towards the Government.

Energy policy continues to divide the government, bedevilling many prime ministers and governments alike, starting with Kevin Rudd back in 2010.

Regardless of the party in government, energy policy – synonymous for climate change policy – continues to dog the government-of-the-day.

For Rudd and Gillard, it was putting a price on Carbon, for the Liberals it is renewables versus coal and committing to action like the Paris agreement.

This week saw former Deputy PM Barnaby Joyce actively calling for a Government funded coal fired power station in central Queensland.

While it might be popular in central Queensland, for southern Liberals in leafy progressive seats, where climate change is seen as a real issue requiring a real response, calls for Government funded coal power stations is not exactly a vote winner.

Joyce has also caused more leadership heartache by saying he is ready and willing to serve as Nationals leader should the position become vacant.

This set off another round of leadership speculation within the Government and in particular the National Party, just two months before the federal election and less than two weeks before the NSW state election.

For a Government that has had 3 Prime Ministers in 3 years, the last thing it needs is a constant reminder of leadership instability, but Joyce’s support for a coal fired power station made sure it was front page news, drowning out any other Government message.

Bill Shorten announced this week that a Labor Government could seek to legislate a living wage by changing the law to compel the Fair Work Commission to set a higher minimum wage.

While there are competing economic views on whether a higher minimum wage would price workers out of the market, the issue plays right into Labor’s fair go agenda.

The Government attacked the plan with the Prime Minister stating, “I don’t think Australians want to see their co-workers sacked for them to do better. But that is Bill Shorten’s plan for Australia. To set one Australian against another. He is engaged in this war of envy on Australians.”

With many Australians experiencing low to stagnating wage growth, Labor is all too happy to be seen championing higher minimum wages in the face of Government opposition.

Until next week[/vc_column_text][vc_zigzag][/vc_column][/vc_row][vc_row][vc_column width=”1/4″][vc_single_image image=”1915″ img_size=”full”][/vc_column][vc_column 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][/vc_row]