Author: Team

CONNECTING THE BEST MEDTECH IDEAS TO GLOBAL MARKETS

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[vc_row][vc_column][vc_column_text]Australia’s largest medical device accelerator program, MedTech’s Got Talent, will receive a $500,000 grant through the Incubator Support initiative to build start-ups in the fields of medical devices, laboratory equipment, diagnostics, bionics and eHealth.

MedTech’s Got Talent provides entrepreneurs with mentoring, resources, knowledge and access to business networks to help them develop their ideas, generate investment and get their products to market.

Minister for Jobs and Innovation, Michaelia Cash said the Incubator Support initiative was encouraging incubators and accelerators like MedTech’s Got Talent to improve the prospects of Australian start-ups.

“The Turnbull Government is committed to assisting STEM professionals with access to commercial opportunities and global markets in order to create jobs here at home,” Minister Cash said.

“The MedTech’s Got Talent program equips our scientists and researchers with the capability needed to transform ideas into viable businesses and access international markets faster than they otherwise would,” Minister Cash said.

Minister for Small and Family Business, the Workplace and Deregulation, Craig Laundy said the program provided many benefits for start-ups across the country.

“Programs like this level the playing field to allow start-ups to access the same resources as their multinational counterparts,” Minister Laundy said.

“The access to real talent, mentors, money, expertise and networks will put these start-ups in the best position for commercial success.”

The Federal Government is investing in science and innovation to ensure we grow new businesses and create jobs. The Incubator Support initiative is part of the continued implementation of the Government’s National Innovation and Science Agenda.

Further details of the grant recipients: www.business.gov.au/incubator-recipients

Further information on Incubator Support grants: www.business.gov.au/assistance/incubator-support[/vc_column_text][/vc_column][/vc_row]

SURVEY REVEALS PATIENTS FACING OUT-OF-POCKET BILL OF $10,000 OR MORE

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[vc_row][vc_column][vc_column_text]It seems like a week doesn’t go by when healthcare costs aren’t the front of the news.  Late last week the Consumer Health Forum of Australia released its national survey of out-of-pocket costs from some 1,200 patients. It highlights that specialist fees and critical services are becoming unaffordable to Australians raising further pressure on the private health insurance and the private health system more broadly.

 The survey report Out of Pocket Pain and a companion report Hear Our Pain containing scores of personal stories of people’s experience with treatment costs.

“The responses to the survey give a disturbing insight into the high costs of medical care and challenge the notion that everyone can access the care they need in Australia,” the CEO of the Consumers Health Forum Leanne Wells, said

“We have heard from pensioners and single mothers who have foregone recommended care because of cost, from many people exasperated to find that the insurance they have held for many years will not cover gaps of thousands of dollars, from patients who learn belatedly of unexpected extra costs for junior surgeons, anaesthetists and MRI scans, and from people who have had to call for special access to their superannuation funds to cover the bill.” Leanne Wells, said

Among key results of the survey are:

  • More than a quarter of respondents treated for breast cancer incurred out of pocket costs of more than $10,000;
  • More than a third of respondents with chronic conditions like multiple sclerosis reported out of pocket costs of more than $10,000;
  • One in six respondents said that out of pocket costs had a significant impact on their lives;
  • A frequently-expressed view that using private health insurance would expose people to more costs; and
  • A third of respondents said the out of pocket costs were not explained to them before treatment.

This comes as the second meeting of the Ministerial Advisory Committee on Out-of-Pocket Costs, chaired by Australia’s Chief Medical Officer, Professor Brendan Murphy recently took place.

The meeting was attended by the Minister for Health, the Hon Greg Hunt MP who reinforced that a healthy and stable private health insurance system is essential for the stability of Australia’s overall health care system.

Minister Hunt spoke about the Government’s commitment to work with the stakeholders to address community concerns around large unexpected out-of-pocket costs and the need for a transparent model to ensure consumers have the ability to make an informed decision on their medical treatment.

Breast Cancer Network Australia CEO Kirsten Pilatti said: “BCNA has been outraged by a number of our members reporting extreme variations in out of pocket costs. Only full disclosure will ensure consumers can make the right choice for themselves.”

The CEO of CHOICE, Alan Kirkland said: “It can be completely perplexing and sometimes impossible for patients in need of surgery to work out how much they will be out of pocket. What’s worse, this often occurs when you are at your most vulnerable and least able to bargain over costs.”

“It’s not surprising that so many patients have reported significant out-of-pocket medical costs, even when they have private health insurance, Australian Healthcare and Hospitals Association (AHHA) Chief Executive Alison Verhoeven said.

“As the private healthcare system, its out-of-pocket costs and increasing confusion continue to run away from us, we reiterate our own call for a Productivity Commission review of the health system, including an appropriate and affordable balance between private and public healthcare that is patient-centred rather than provider-centred.”

Rachel David from Private Healthcare Australia said: “While we can’t discount the very real concerns reported to the CHF, we need to be very careful about drawing conclusions about the extent of the problem from a survey that essentially solicits complaints.”

PulseLine will be interested to see if the Government’s forthcoming private health reforms deliver the much-needed transparency for consumers and puts downwards pressure on healthcare costs. Reform in healthcare is clearly a hot issue and will continue to be as we hurtle towards the next Federal election in the first half of 2019.[/vc_column_text][/vc_column][/vc_row]

PELVIC MESH SENATE INQUIRY REPORT RELEASED

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[vc_row][vc_column][vc_column_text]Since February 2017, the Senate Community Affairs References Committee has considered more than 550 submissions from patients, surgeons, medical device companies, regulators and other stakeholders. The Committee also held five public hearings across Australia, hearing testimony from a number of stakeholders, including from women who bravely shared their stories of experiencing complications from their treatments.

The Committee recognised both the complexity of the conditions – stress urinary incontinence and pelvic organ prolapse – and treatment options available to clinicians and acknowledging the many Australian women whom have benefited from procedures involving transvaginal mesh products.

The Medical Technology Association of Australia (MTAA) and some of its member companies also testified before the committee, acknowledging the pain and suffering experienced by the women who had testified before the Committee, but also reiterated its agreement with groups representing medical professionals, that the products remain important treatment options.

Urogynaecological Society of Australasia (UGSA) Chair, Dr Jenny King, said the Committee’s recommendation that all mesh devices should be used as a last resort would affects women’s options for care by limiting access to the safest and most effective surgical treatment for urinary incontinence, the mid-urethral slings.

“This decision is one of the most retrograde steps in the history of modern surgery. It simply disregards sound scientific data,” Dr King said.

Australian Medical Association President, Dr Michael Gannon, added that not all women had problems with the devices.

“It [the report] fails to recognise the massive number of women who have benefited from mid-urethral sling operations,” he said.

The MTAA’s CEO, Ian Burgess, said the industry body is committed to working with the Government as it considers its response to the Committee’s report.

“Registries can be invaluable but they are complex and expensive. We need to ensure that when we set up a registry we’re very clear around what data is being collected and the extent of that data,” Mr Burgess said.

“Further, in terms of the cost of registries, we need to ensure all those that benefit pay for it – including regulators, healthcare professionals, insurers, hospitals and policy makers.

“The Committee also recommends the Department of Health work with MTAA and the Medical Board to review systems in place to support consistent, high ethical standards. The report notes the evidence of MTAA and member companies that no financial or other incentives have been provided to medical practitioners to use or promote transvaginal mesh implants, and that members of MTAA are bound by a Code of Practice that sets high standards for ethical interactions with healthcare providers.

“Should the Government accept this recommendation, we look forward to working with the Department. A key reform would be the implementation of a harmonised industry code of practice which all device manufacturers and suppliers are required to adhere to by law or regulation. The MTAA Code of Practice would be an appropriate basis for such a harmonised code.”

PulseLine understands the Government will be looking to complete its response by the end of November.[/vc_column_text][/vc_column][/vc_row]

$5M HOSPITAL RE-DEVELOPMENT COMPLETE

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[vc_row][vc_column][vc_column_text]The ‘blue rooms’ as they are affectionately known (due to their blue glass walls and blue lighting) will help to reduce waiting times for patients as the rooms will facilitate procedures, which as recently as five years ago, may have required an operation.

RBWH’s Director of Gastroenterology and Hepatology Dr Mark Appleyard said the blue rooms were equipped with the latest technology.

“These rooms have the latest endoscopy medical equipment and operating room integration technologies including video streaming and external broadcasting. From a design perspective, the blue lighting and glass wall panels improve the contrast of the video monitors, so the tissues that we’re looking at become more crisp and easier to see.”

“Not only will these rooms allow us to see more patients, they also play a key role in the training and education of our staff by increasing collaboration amongst specialists and trainees and will also allow us to host live, online workshops,” said Dr Appleyard.

After the first ‘blue room’ went live in July 2017, the completion of the second room in late September 2017 has resulted in RBWH being able to perform an additional 2,500 endoscopy procedures per year, greatly improving patient services.

“The technology we have now will allow us to conduct procedures that traditionally four to five years ago patients may have needed operations for, so not only can we treat more patients, but we can look to avoid, where possible, the longer patient recovery times associated with surgery,” said Dr Appleyard.

The redevelopment at the Royal Brisbane and Women’s Hospital forms a pivotal part of the Queensland government’s $160m Endoscopy Action Plan aimed at delivering 50,000 additional procedures over the next four years to ensure Queensland public hospitals keep pace with the growing demand for the procedure.[/vc_column_text][/vc_column][/vc_row]

A CASE OF PATIENT POWER TO GENERATE REAL WORLD EVIDENCE

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[vc_row][vc_column][vc_column_text]VBHC in particular is a framework Australia and other countries around the world are increasingly focusing on in their quest to adopt a patient centred and more affordable approach to healthcare delivery.

Yet VBHC, which remunerates providers based on real world health outcomes and measures the cost-benefit of associated resource use and costs in achieving those outcomes, is challenging to implement, particularly in Australia which has a fragmented healthcare system with different provider and payer responsibilities.

As the upcoming VBHC summit fast approaches, which includes patient reported outcome measures and experiences as one of various session topics, it is timely for Clinical Research Corporation (CRC) to share a recent example highlighting the power of patient feedback in obtaining real world evidence.

Patient reported outcomes and experiences can be an effective and practical means of capturing necessary real-world evidence of the impact of an intervention not available elsewhere. The following case outlines how Australian patient feedback filled an absence of real world evidence required by decision makers in considering the potential reimbursement of a consumable medical device for a specific sub-population.

Problem

A client of CRC had been seeking reimbursement for several years for a consumable medical device under Australian state governments’ medical aids and equipment schemes. The device is for a well-defined post-surgical subgroup in the community and supported by a longstanding body of clinical evidence, as well as reports of improved quality of life (QoL).

A key benefit known anecdotally for years, yet not assessed in a dedicated study is the reduction of hospital days due to complications from the surgery. In addition, the QoL benefits of the device had never be shown among Australians, which was highly relevant to demonstrating need by patients in the local community setting. The absence of both Australian economic and QoL information was a major barrier to progressing reimbursement.

Exacerbating the situation was a silent patient population without a national advocacy voice nor representative bodies in most Australian states. The issue was also too small for national and state healthcare professional groups to address.

Solution

It was clear a compelling economic argument based on local evidence was needed to drive a funding decision in the various states.

A VBHC approach would have been ideal to generate real world ‘pay for performance’ data in showing the value of the medical device for this subpopulation. Yet VBHC was not logistically feasible, given the time, budget, resources and stakeholders required. Our client and the affected subpopulation needed a timely practical solution to gather real world evidence that could be shared with state health departments.

Going directly to the source, i.e. the patients themselves, was the only pragmatic solution. Thus, CRC proposed, prepared and implemented a patient survey conducted online and manually to collect the necessary economic and other data that was ‘fit for purpose’. The short simple survey captured patient experiences with and without use of the medical device to understand, in particular, their consumption of healthcare resources post-surgery and QoL.

The survey generated double the number of responders anticipated. Importantly, it clearly showed fewer hospital days due to post-surgery complications for individuals using the device compared with non-users, as well as better quality of life.

Outcome           

Interim survey results have been shared so far with two state health departments who are interested because for the first time they have a reference point from which to verify key data such as hospital days.

A further (unintentional) benefit of the survey is that it has invigorated a patient group previously silent who had given up hope of the possibility of the device ever being funded.

Survey results continue to be collected for which the plan is to share final results with state governments in progressing a funding decision.[/vc_column_text][/vc_column][/vc_row][vc_row][vc_column][vc_zigzag][/vc_column][/vc_row][vc_row][vc_column width=”1/4″][vc_single_image image=”1794″ img_size=”full”][/vc_column][vc_column width=”3/4″][vc_column_text]

ABOUT THE AUTHOR

Athena Kolivos is currently Head of Medical Affairs at CRC a member of the iQ Group Global. Athena is a pharmaceutical/device industry leader and practising pharmacist with extensive market access, reimbursement, government, PR and medical-marketing experience across a diverse range of therapies to enhance health and well-being.[/vc_column_text][/vc_column][/vc_row]

The Patient Will See You Now

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[vc_row][vc_column][vc_column_text]The details are contained in two recent publications on clinical trials activity. The June 2017 MTPConnect report titled ‘The Economic Profile and Competitive Advantage of the Sector’ is data rich and was developed with extensive input from the industry and Government. The document provides a status update and suggestions on how to further stimulate the sector. In January, Austrade issued a Clinical Trials Capability Report ‘A Dynamic Environment for Clinical Trials’, essentially a pitch to clients requiring clinical research of therapeutic products and medical devices. It highlights the range of expertise available in Australia, from cell culture and engineering to Independent Ethics Committees, by showcasing local companies and providing a directory of suppliers.

This becomes important when put in the context that approximately 75% of the direct expenditure on clinical trials in 2015 in Australia came from international inbound investment by commercial entities (pharmaceutical, biotechnology and medical device companies). Another statistic included in the Austrade report that requires consideration is that ‘medicines and vaccines are Australia’s largest manufactured export. China and the United States are the biggest markets, followed by New Zealand, South Korea and the United Kingdom.’

As Figure 1 demonstrates, multiple factors contribute to clinical trial placement. When considering the shift over time in the type of clinical trials being conducted in Australia, the influence of a number of these factors is obvious. Previously, Phase III studies were the largest component of activity, however Phase I trials numbers have increased steadily, growing 17.2 % from 2012–2015, compared with 1.8 % globally over the same period. This is a reflection of the strong competitive position of Australia in conducting complex studies as a result of our world-class healthcare system, high quality medical research infrastructure, skilled workforce of scientists and healthcare professionals, including internationally regarded clinicians.

At the same time, the later phase, higher patient number studies have been increasingly placed in more populous locations in the Asia Pacific, Eastern Europe or Latin America, as the larger patient pools shorten recruitment times, and ultimately, the time to market of new products. Additionally, Australia’s population size and distribution mean that more investigational sites must be established to reach target recruitments when studies are placed in Australia, resulting in a higher per patient cost than other countries. Significant efforts have been undertaken on a number of fronts over the past decade to increase recruitment efficiencies. These include the streamlining of ethic approval processes via mutual recognition and increased public awareness. In 2015, of the 1,305 industry-sponsored studies in Australia, Phase III accounted for 40%; Phase II, 22%; Phase I, 18%; Phase IV, 4% and Other, the remaining 16%.[/vc_column_text][/vc_column][/vc_row][vc_row][vc_column][vc_single_image image=”1759″ img_size=”full” add_caption=”yes” title=”Figure 1 Factors considered when selecting countries in which to conduct a clinical study”][vc_separator][/vc_column][/vc_row][vc_row][vc_column][vc_column_text]Investigational site governance continues to be an issue that negatively impacts Australian’s overall competitiveness. At present, sponsors must negotiate indemnity contracts individually with each study site, adding to the administrative burden and time required to initiate the study.

In terms of strengths, Australia’s stable business operating environment is currently ranked 14th out of 190 countries by the World Bank in terms of ease of doing business. The fast, streamlined regulatory pathway to conduct clinical trials via the TGA Clinical Trial Notification (CTN) system continues to be the envy of many countries. Harmonised ethics review processes and availability of Ethics Committees in both the private and public sectors, provide opportunities to speed up approvals. Australia’s strong intellectual property system which, in 2017 was ranked 10th globally, in terms of security (out of 127). Finally, research & development tax incentives for clinical trials mean that for the same early phase study, Australia is up to 28 % cheaper than the US before-tax incentives, and 60% after-tax.

The 2014-15 Federal Budget established a Medical Research Future Fund (MRFF) to be an ongoing source of funding to support medical research projects and infrastructure in Australia (the Government currently spends around AU$3 billion annually). By 2020-21, the MRFF is expected to have a balance of AU$20 billion, the net earnings from which will produce a permanent source of revenue. In 2016, a Biomedical Translation Fund (BTF) was created to complement the MRFF via commercialisation of health research.

Clearly, the strength of the sector today is in no small way due to the ongoing commitment and support of successive Australian Governments.  As Figure 2 illustrates this has, and will continue to, deliver enormous value to our nation and should be acknowledged.[/vc_column_text][/vc_column][/vc_row][vc_row][vc_column][vc_single_image image=”1760″ img_size=”full” add_caption=”yes” title=”Figure 2 The value of clinical trials in Australia”][/vc_column][/vc_row][vc_row][vc_column][vc_zigzag][/vc_column][/vc_row][vc_row][vc_column width=”1/4″][vc_single_image image=”1750″ img_size=”large”][/vc_column][vc_column width=”3/4″][vc_column_text]

ABOUT THE AUTHOR

Nick Campbell is the Chairman of Nexus Asia Pacific and has previously worked in the MedTech and pharmaceutical industries.[/vc_column_text][/vc_column][/vc_row]

Turning MedTech Ideas Into Action

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[vc_row][vc_column][vc_column_text]The Actuator is Australia’s premier medical technology commercialisation initiative: priming, augmenting and developing our state-based innovation ecosystems through a nationally-focused strategy. The Actuator employs a unique, powerful and differentiated approach that:

  1. is industry-led;
  2. activates players across the entire innovation spectrum;
  3. augments local ecosystems; and
  4. fosters an unwavering technology commercialisation focus.

Wherever an idea or venture is on the commercialisation pathway, the Actuator has a program designed to smooth its journey and accelerate its development, with a mission to catapult Australia into its rightful place at the head of the global innovation race. They are also home to Australia’s largest and longest-standing early-stage MedTech startup entrepreneurship program – MedTech’s Got Talent

The Actuator has announced the opening of round 2 of its Actuator Accelerator – the nation’s first industry-led, VC-backed 15-month Medtech acceleration program which simultaneously accelerates technology development, builds team capability and provides a pathway to $2.7 million in equity funding. Applications close on 27th April for a July 2018 intake.

For more details and or to apply, visit: http://medtechactuator.com/programs

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