Author: Team

BACK TO BASICS – HTA EXPLAINED

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[vc_row][vc_column][vc_column_text]HTA has been growing in popularity among reimbursement agencies worldwide in the last 20 years. Its application to medical devices has been slower for a range of reasons. Its popularity has a number of drivers including the desire to find an objective basis for funding decisions for health technology.

A cost-effectiveness or a cost-utility evaluation seeks to measure the additional clinical benefit and cost of using a new medical product compared to what is now used for the same condition. In cost-utility analysis, patient quality of life and length of life is combined into a single ‘utility’ measure. This is the analysis most commonly used by the Department of Health and its major committees.

To operate effectively, HTA generally requires two major components: firstly, clinical evidence that can be used to compare products; and secondly: an economic analysis of benefits and costs. It therefore requires research – usually by the sponsor – to gather and present data as well as a systematic process of evaluation.

When assessing whether HTA is being done properly, questions can be asked such as:

  • Is the process fair and transparent?
  • Is the depth and complexity of the process suitable for the expected clinical risk and cost?
  • Are the correct outcomes being evaluated?
  • Is there a reasonable way of dealing with uncertainty given data is never perfect?

Australia was one of the first countries to use HTA to assess reimbursement for pharmaceuticals through the Pharmaceutical Benefits Advisory Committee (PBAC). Typical submissions grew from a few dozen pages in the early 1990s to thousands of pages currently.

This was followed by assessment of other medical procedures and technologies through the Medical Services Advisory Committee (MSAC) starting in the late 1990s.

The Prostheses List Advisory Committee (PLAC) and its subcommittees also assess relative cost and effectiveness for prostheses to go on the Prostheses List where a higher benefit is requested. When a medical device is on the Prostheses List, private health insurers are required to pay for it if they have relevant hospital cover for the procedure.

The Australian Government has a policy of making assessment for reimbursement of medical technology and procedures more uniform. To this end it amalgamated the Department of Health sections responsible for supporting assessment process for the Pharmaceutical Benefits Scheme (PBS), Medicare Services Schedule (MBS) and the Prostheses List into one Branch – the Office of Health Technology Assessment.

The MedTech industry, through the Medical Technology Association of Australia (MTAA) is supportive of the appropriate use of HTA for Prostheses List applications but it needs to be undertaken with care. Medical devices are different from pharmaceuticals in that:

  • They are dependent on operator skill
  • Blinded trials are often not practicable
  • Short life cycles/incremental improvements narrow the evidence window
  • Low volume reduces the quantity of evidence
  • The effect on the patient is usually physical not chemical
  • They may require much more company support to use

PulseLine understand that MTAA is now in a process of Prostheses Reform discussion with the Australian Government and other stakeholders. The correct use of HTA for prostheses is a key part of that discussion. The industry has recommended that a ‘prostheses-specific pathway’ be developed that bolsters the capacity of PLAC to evaluate relative effectiveness and cost of new prostheses without requiring a full MSAC deliberation that is resource-intensive and lengthy.

HTA for medical devices is here to stay. Time will tell if the processes put in place by for the Prostheses List enable patient access to good technology or hinder it.[/vc_column_text][/vc_column][/vc_row]

Australia secures a further 50 million doses of COVID-19 vaccine

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[vc_row][vc_column][vc_column_text]Two more COVID-19 vaccines have been secured for the Australian population under new agreements, bringing the Australian Government’s COVID-19 vaccine investment to more than $3.2 billion.

Under the agreements, Novavax will supply 40 million vaccine doses and Pfizer/BioNTech will provide 10 million vaccine doses, should the vaccines be proven safe and effective.

Prime Minister Scott Morrison said the Government’s COVID-19 Vaccine and Treatment Strategy had now secured access to four COVID-19 vaccines and over 134 million doses.

“By securing multiple COVID-19 vaccines we are giving Australians the best shot at early access to a vaccine, should trials prove successful,” the Prime Minister said.

“We aren’t putting all our eggs in one basket and we will continue to pursue further vaccines should our medical experts recommend them.

“There are no guarantees that these vaccines will prove successful, however our Strategy puts Australia at the front of the queue, if our medical experts give the vaccines the green light.”

The Novavax and Pfizer/BioNTech vaccines are expected to be available in Australia from early to mid 2021 – subject to approval by the Therapeutic Goods Administration (TGA) for use in Australia.

The Pfizer/BioNTech is a messenger ribonucleic acid (mRNA) type vaccine and the Novavax vaccine is a protein vaccine containing an adjuvant (Matrix-M) which enhances the immune response.

Health Minister Greg Hunt said Australia’s COVID-19 vaccine portfolio now had two protein vaccines and one mRNA and one viral vector type vaccine, strengthening Australia’s position to access safe and effective vaccines as soon as available.

“The goal and the expectation is that Australians who sought vaccination will be vaccinated within 2021,” Minister Hunt said.

“There are no surprises, health and aged care workers and the elderly and vulnerable will be the first to gain access to a vaccine that’s deemed safe and effective.”

These new agreements build on the Australian Government’s existing commitments to purchase the University of Oxford/AstraZeneca vaccine and a local candidate from the University of Queensland together with Australian manufacturer CSL Limited (Seqirus).

Subject to the vaccine being registered by the TGA as safe and effective, preliminary advice from the Australian Technical Advisory Group on Immunisation is that the priority groups for the COVID-19 vaccine are those people who are at increased risk of exposure, such as health and aged care workers, the elderly and those working in services critical to societal functioning.

The Australian Government is currently consulting with the states and territories, key medical experts and industry peak bodies on the framework for the initial roll-out of the COVID-19 vaccination program in early 2021.

Key vaccination sites will initially include GPs, GP respiratory clinics, state and territory vaccination sites and workplaces such as aged care facilities.

Australia has a world class vaccination program with world leading vaccination rates. The COVID-19 vaccine will not be mandatory and individuals will maintain the option to choose not to vaccinate. The vaccine will be available for free to those who choose to be vaccinated.

This commitment forms a crucial part of the Australian Government’s response to COVID-19 and the strategy to protect the health and wellbeing of Australians and the national economy.

Internationally, Australia has also joined the COVAX facility, which will provide access to a large portfolio of COVID-19 candidates and manufactures around the world for up to 50 per cent of the Australian population.

The Australian Government has also committed to support access to safe and effective COVID-19 vaccines for the Pacific and Southeast Asia, as part of a shared recovery for the region from the pandemic, as well as $80 million to the international COVAX Facility for the benefit of high-risk populations in developing countries.

The Government’s agreements allow Australia to donate to partners in the Pacific and Southeast Asia, should these vaccines prove safe and effective, and units are available above domestic needs.

The Government is contributing significantly to vaccine research and development both in Australia and around the world, investing $363 million in vaccines, therapeutics and COVID medicines – including $257 million in vaccines.

The roll-out of a potential COVID-19 vaccine is a significant logistical challenge, suppliers that have a proven track record in vaccine logistics and distribution or booking systems, tracking and reporting of vaccines are being invited to participate in a limited tender process.

As part of Australia’s COVID-19 vaccines strategy and broader vaccines strategy, the Australian Government is considering an amendment to the Australian Immunisation Register Act 2015 to mandate reporting of all vaccinations to the Register.[/vc_column_text][/vc_column][/vc_row]

AAMRI WELCOMES MEDICAL RESEARCH FUTURE FUND COMPETITIVE FUNDING OUTCOMES

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[vc_row][vc_column][vc_column_text]The MRFF investment includes grants for:

  • Biologics for the prophylaxis and treatment of COVID-19
  • Ovarian cancer: investing variations in care and survival, aetiology and risk factors to improve outcomes in Australia via national data linkage
  • A randomised control trial of positive end-expiratory pressure levels during resuscitation of preterm infants at birth.

More than 90% of the grants and three quarters of the funding awarded to date have been through competitive funding rounds.

“This shows the MRFF is investing in the highest quality research and I applaud the Government for building competitive and robust funding structures,” said AAMRI President, Professor Jonathan Carapetis AM.

“It is great to see this new investment in medical research, the scale of which is unprecedented and will in turn deliver huge economic and health benefits for the nation.

“The value and trust that the Government has placed on research will enable some of our best and brightest minds to make life-changing medical discoveries which will help protect and save lives.

“I’m also very pleased to see the rapid investment in COVID-19 and bushfire health research. This fits with the vision of the MRFF, to include an ability to respond quickly to emerging health threats,” Professor Carapetis.

The MRFF is a once-in-a-generation funding opportunity that will make Australia a world-leader in medical research. It will invest an additional $650 million per year in medical research, which is on top of the near $900 million invested through the NHMRC.[/vc_column_text][/vc_column][/vc_row]

TTRA for Diabetes and Cardiovascular Disease Announces Research Plans and Partners

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[vc_row][vc_column][vc_column_text]The $47 million TTRA initiative, supported by the Medical Research Future Fund (MRFF), is providing a new integrated research program to improve the prevention, management and treatment of diabetes and cardiovascular disease (D&CVD) in Australia. Research efforts will focus on the most pressing areas of unmet clinical and research needs in D&CVD, which are leading causes of death and disability in Australia.

The TTRA program is designed to support and incentivise translation as a natural course of activity for those applying and receiving funding.

MTPConnect is pleased to announce partnerships with ANDHealth, Medical Device Partnering Program (MDPP) and UniQuest to provide advice and mentoring for funding recipients.

MTPConnect Managing Director & CEO, Dr Dan Grant, has welcomed the TTRA partners, citing their credentials as preeminent organisations specialising in translation and commercialisation of digital health, medical technology, medical devices, biotechnology and pharmaceuticals.

“We are delighted to announce our partnerships with ANDHealth, MDPP and UniQuest for the TTRA as we embark on a mission to improve the prevention, diagnosis, treatment and management of diabetes and cardiovascular disease in Australia,” Dr Grant said.

“Our experience leading a number of Medical Research Future Fund programs has proven the value of building in a component for guidance and support for research applicants,” he said.

UniQuest is Australia’s leading technology transfer company, whose innovation portfolio includes Australia’s first blockbuster vaccine Gardasil®. UniQuest’s Executive Director of Commercialisation, Dr Mark Ashton says bringing commercialisation experience to early stage research will transform ideas to impact.

”We are looking forward to drawing on the industry expertise of our team at the Queensland Emory Drug Discovery Initiative (QEDDI) and our 35 years’ experience in commercialisation to support applicants in the translation of their research, with the view to improving the outlook for patients with diabetes and cardiovascular disease around the world,” Dr Ashton said.

MDPP Executive Director, Professor Karen Reynolds leads the ideas incubator to support the development of novel medical devices and assistive technologies.

“MDPP is honoured to once again partner with MTPConnect and support the development of novel preventive, diagnostic and therapeutic approaches and products to improve outcomes for diabetes and cardiovascular disease. With the rapid changes within the community, health and business environments, the TTRA will provide a strategic and coordinated effort to translate cutting-edge research to knowledge for two disease states that affect millions of Australians each year,” Professor Karen Reynolds said.[/vc_column_text][/vc_column][/vc_row]

MEDTECH20, A VIRTUAL SUCCESS

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The annual conference brings together industry leaders, innovators, academics, policy-makers, researchers and clinicians to share their insights, experiences and achievements in new and cutting-edge MedTech that’s helping to improve the lives of everyday Australians.

This year’s conference was help virtually, due to the ongoing COVID-19 pandemic, and included 17 different sessions and multiple streaming options focused on particular topics that attendees were able to choose from.

MTAA’s CEO, Ian Burgess, said that MedTech conference was continuing to lead by example during the pandemic, by showing just how the MedTech industry had adapted to the challenges posed by the virus, not just with a reformatted virtual conference, but also with a once in a 100-year industry effort, with government, to coordinate Australia’s response to the global pandemic.

“MTAA took this opportunity to transform how our conference was conducted, tailoring every session to make it easily accessible to participants, including live recording for attendees to stream back later,” Mr Burgess said.

In an address to conference-goers, Minister for Health, Greg Hunt, who opened the conference acknowledged the “profound role of the medical device and technology sector in helping Australia through COVID in a way very few other countries have been able to achieve.”

Also speaking at the conference was Minister for Industry, Science and Technology, Karen Andrews, who said “the MTAA led the effort to ensure we had the essential medical equipment to meet a worst case scenario” during the pandemic.

This year’s conference featured a whose-who of industry leaders and experts, including:

  • Dr Sarah Aitken, Vascular & Endovascular Surgeon, Concord Repatriation General Hospital and Clinical Academic, University of Sydney
  • Mr Andrew Frye, Senior Vice President & President, APAC, Baxter Healthcare, Chairman of APACMed
  • Prof. John Skerritt, Deputy Secretary, Health Products Regulation Group, Therapeutic Goods Administration

If you missed the conference, don’t worry, MTAA says on-demand streaming of sessions is available anytime, anywhere, click here.[/vc_column_text][/vc_column][/vc_row]

Big jump in My Health Record from 2019 to 2020

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Whether it was due to natural disaster or the COVID-19 lockdowns and closed state borders, many patients couldn’t see their healthcare provider face-to-face.

This is when My Health Record really shines and healthcare providers can access their patients’ important medical information such as test results, medications and hospital discharge summaries anywhere, anytime.

Independent Clinical Advisor to the Australian Digital Health Agency, Dr Steve Hambleton, said more and more healthcare workers were realising the practical benefits of digital health.

“I want hospitals and specialists to have rapid access to relevant information about my patients when they are caring for them, and as a GP, when a patient comes back to see me having been discharged from hospital or with a report from a specialist, I value what those hospitals and specialists share and upload to My Health Record for the ongoing care I provide,” he said.

From July 2019 to June 2020:

  • the number of documents uploaded by GPs and viewed by others has risen to 187,000, a 165 per cent increase.
  • GPs viewed 416,000 documents uploaded by others, an increase of more than 250 per cent
  • the number of documents uploaded by public hospitals and viewed by other healthcare providers has risen to 322,000, an increase of nearly 300 per
  • Public hospitals viewed 271,000 documents uploaded by others, an increase of more than 300 per

[/vc_column_text][vc_single_image image=”4808″ img_size=”full” alignment=”center”][vc_column_text]Agency CEO Amanda Cattermole said “Over the last 12 months it’s been great to see the increases in clinically helpful data in the system and the sharing and viewing by health professionals.

“My Health Record provides the repository for consumers’ health data and a great way for them to safely and securely engage with their healthcare providers.

“I encourage people to log into their My Health Record and ensure their information including allergies, medicines, immunisations, and any pathology reports has been uploaded.

“This will give you peace of mind, knowing that in an emergency situation, information like your medications and allergies are rapidly available to medical staff.

“It can make a significant difference to health outcomes and assist medical staff in diagnosis and treatment.”

Key statistics July 2019 to June 2020:

  • Total number of My Health Records in Australia increased by 230,000, from 22.55 million to 22.78
  • Total number of records with data in them increased from 10.08 million to 19.41 million, a nearly 93 per cent increase.
  • Number of health documents in the My Health Record system has risen from 1.3 billion to 2.09 billion over the financial year. Clinical documents, uploaded by hospitals, pathologists or radiologists, have risen from 23 million to 75
  • Medicine documents, uploaded by pharmacies and GPs, have risen from 56 million to 143
  • Immunisation documents in the system have gone from 4.8 million to 15
  • Organ donor registrations have gone from one million to 1.5
  • Pharmacies registered with My Health Record have risen from 88 per cent to 99 per cent. GPs registered have risen from 86 per cent to 93 per cent. Public hospitals have risen from 75 per cent to 95
  • Pathology reports in My Health Record have gone from 13 million to 53
  • Diagnostic imaging reports have risen from 2.6 million to 8.2
  • Dispense records have risen from 27 million to 82 million.

Former Intensive Care Registrar at Armidale Health Service in Western Australia, Rowan Ellis, attests to the benefits of My Health Record: “We had a patient who presented as critically unwell and intensive care staff were asked to review the patient,” he said.

“It became apparent that they had been treated recently at a different hospital and we didn’t have access to their records, so we hopped onto My Health Record and found all the necessary discharge summary information details of their specialist who we then contacted directly to discuss their care. We then arranged transfer out to the hospital where they were already receiving ongoing treatment.”[/vc_column_text][/vc_column][/vc_row]

ACN endorses Nursing and Midwifery Digital Health Capability Framework

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“There is no denying the delivery of health care is changing, in large part due to technological advances,” Australian College of Nursing CEO, Adjunct Professor Kylie Ward FACN said.

“Digital health has the potential to bring about vast improvements in how healthcare is delivered, where people can access quality care, and health outcomes. This potential can only be realised if we have a workforce that is ready to adopt digital health tools and services and maximise the benefits.

“The goal of the Capability Framework is to ensure the nursing workforce can confidently utilise digital health technologies.”

ACN was represented on the Framework’s Advisory Committee by Adjunct Associate Professor Naomi Dobroff FACN, Chair of the ACN Nurse Informatics Community of Interest and Aaron Jones, Chair of the ACN Chief Nursing Information Officer Community of Interest.

“This work gives everyone involved in healthcare a guide as to the skills and knowledge nurses and midwives need to deliver health in a digital world,” Adjunct Professor Dobroff explained.

“I am particularly pleased a Framework specific to nurses and midwives has been developed not only because our profession makes up over 50 per cent of Australia’s health workforce, but because it recognises the leadership role nurses and midwives have.

“Nurses and midwives play a critical role in ensuring that clinical information and communication systems are designed and used to deliver high quality, coordinated care to Australians across all aspects of the patient journey.

“The Framework outlines the capabilities each of us as individual professionals, our workplaces and our educational organisations, such as ACN, who are required to extend our digital health development to develop all nurses.”

Reflecting the nursing profession’s enthusiasm for adoption of technology and innovation, the Australian College of Nursing has added a specific digital health unit to some of its Nursing Graduate Certificate courses. Learning outcomes include being able to appraise how clinical communication occurs in a digitalised health care system.

“In terms of technology take-up, nurses are vital, but more importantly we need nurses to take a leadership role, which is a domain in the Framework, in order to make sure digital health successfully enhances patient care,” Adjunct Professor Ward said.

“Technology cannot replicate the complex and holistic care provided by nurses, but it can help expand the profession’s scope of practice and delivery of best practice care to all Australians.

“Nurses provide care all day, every day, across every care setting and are best placed to assist in reimagining the delivery of healthcare aided by technology.

“Therefore, we commend the Framework and look forward to playing a role in making sure it inspires broader digital expertise within the nursing profession by providing free online educational resources at the foundational level of learning to all nurses and midwives on the ACN website next year.”[/vc_column_text][/vc_column][/vc_row]

TELEHEALTH MUST BE THE START OF THE HEALTH ‘REVOLUTION’

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“The Health Minister, Greg Hunt, has described the expansion of telehealth as a ‘revolution in the delivery of primary care’ which we strongly support,” the CEO of the Consumers Health Forum, Leanne Wells, said.

“The COVID-19 pandemic has shown the strength, and the opportunities for more public investments to improve Australia’s health system.

“It has shown the link between the health of the community and of the economy is inextricable.

“Telehealth has been stimulated by the pandemic to trigger easier and safe access to doctors and we look forward to further developments after the six month extension to March 2021 expires.

The telehealth disruption shows that transformative change is possible in healthcare and we hold great ambition for the scope of services that will be possible under the 10 Year Primary Health Care Plan currently in development.

“But the pandemic has also shown up the dramatic failings of the aged care system that has brought too many avoidable deaths and too much suffering.

“The lesson for Australia should be that we need to invest much more in a publicly-funded and effectively regulated system.

“The Government says it is making a record investment in health over four years of $467 billion, up by $32 billion on last year’s figures.

“It is to spend $2.4 billion on telehealth a development that just nine months ago would have seemed unbelievable.”[/vc_column_text][/vc_column][/vc_row]

COVID-19 A DOUBLE BLOW FOR CHRONIC DISEASE PATIENTS

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There has never been a more dangerous time than the COVID-19 pandemic for people with non- communicable diseases (NCDs) such as diabetes, cancer, respiratory problems or cardiovascular conditions, new UNSW Sydney research has found.

Among the adverse impacts of the pandemic for people with NCDs, the study found they are more vulnerable to catching and dying from COVID-19, while their exposure to NCD risk factors – such as substance abuse, social isolation and unhealthy diets – has increased during the pandemic.

The researchers also found COVID-19 disrupted essential public health services which people with NCDs rely on to manage their conditions.

The study, published in Frontiers in Public Health recently, reviewed the literature on the synergistic impact of COVID-19 on people with NCDs in low and middle-income countries such as Brazil, India, Bangladesh, Nepal, Pakistan and Nigeria.

The paper, which analysed almost 50 studies, was a collaboration between UNSW and public health researchers in Nepal, Bangladesh and India.

Lead author Uday Yadav, PhD candidate under Scientia Professor Mark Harris of UNSW Medicine, said the interaction between NCDs and COVID-19 was important to study because global data showed COVID-19-related deaths were disproportionally high among people with NCDs – as the UNSW researchers confirmed.

“This illustrates the negative effect of the COVID-19 ‘syndemic’ – also known as a ‘synergistic epidemic’ – a term coined by medical anthropologist Merrill Singer in the 1990s to describe the relationship between HIV/AIDS, substance abuse and violence,” Mr Yadav said.

“We applied this term to describe the interrelationship between COVID-19 and the various biological and socio-ecological factors behind NCDs.

“So, people are familiar with COVID-19 as a pandemic, but we analysed it through a syndemic lens in order to determine the impact of both COVID-19 and future pandemics on people with NCDs.”

Mr Yadav said the COVID-19 syndemic would persist, just as NCDs affected people in the long-term.

“NCDs are the result of a combination of genetic, physiological, environmental and behavioural factors and there is no quick fix, such as a vaccine or cure,” he said.

“So, it’s no surprise we found that NCD patients’ exposure to NCD risk factors has increased amid the pandemic, and they are more vulnerable to catching COVID-19 because of the syndemic interaction between biological and socio-ecological factors.

“The evidence we analysed also showed there was poor self-management of NCDs at a community level and COVID-19 has disrupted essential public health services which people with NCDs rely on.”[/vc_column_text][/vc_column][/vc_row]