Author: Team

MTANZ WARNS OF IMPACT OF MEDICAL DEVICE REGULATION CHANGES ON PATIENTS

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[vc_row][vc_column][vc_column_text]MTANZ CEO, Faye Sumner, said the “proposed Therapeutic Products Bill and the ongoing centralised procurement process by PHARMAC could have the joint effect of increasing the costs of medical devices and procedures while potentially reducing choice for the clinician and delaying access to life-saving, innovative medical technology.”

MTANZ has assured patients that medical devices used in New Zealand currently meet the highest quality standards both in New Zealand and internationally.

Currently, all devices entering New Zealand must be notified to the Government’s regulator, Medsafe. However, MTANZ argues that this will become a more complex registration process with associated costs, under the proposed NZ Therapeutic Products legislation replacing the Medicines Act 1981.

At the same time, PHARMAC is taking control of the procurement of medical devices supplied to the District Health Boards.

Ms Sumner says the New Zealand MedTech industry believes the proposed PHARMAC cost-based procurement system is not best suited to the procurement of medical devices.

“We propose a value-based procurement system that ensures clinicians have the autonomy and authority to acquire the right device for the right procedure. It is about treating a patient with the best possible device rather than the cheapest possible device.

“Our industry is very concerned at the multiplying effect of both significant changes being introduced in parallel and the potential disruption to the supply chain which could lead to the reduced availability of medical device products in the New Zealand market,” Ms Sumner said.

Ultimately the impact of both these changes will be felt by New Zealand patients.

These changes will no doubt be watched very closely by both the Australian MedTech companies and Private Health Insurers.

The Australian Private Health Insurance industry has been advocating for the introduction of a similar national procurement system here in Australia.[/vc_column_text][/vc_column][/vc_row]

Back To School – The Parliament Returns

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Tax

As expected, the week was dominated by the Government’s signature election policy, $158 billion in personal income tax cuts.

By the end of the week the Government had a major victory in securing the passage of its income tax cuts package in its entirety.

In doing so it had to secure deals with key crossbench Senators from Centre Alliance and Jacqui Lambie from Tasmania.

Centre Alliance secured from the Government a commitment to bring down gas prices, through yet to be announced policy changes to ensure downward pressure is brought to bear on retail gas prices.

For Jacqui Lambie, the Government have committed to provide as yet undefined aid to help with Tasmania’s homelessness crisis.  As she said earlier in the week she couldn’t support tax cuts for high income earners, while many in her home state “don’t even have a roof over their head”.

The week was also notable for what the Government outlined as its third term policy agenda through the Governor-General’s traditional opening speech to Parliament.

Is Industrial Relations back on the Agenda?

In the speech the Government flagged potential industrial relations reform.

The Government announced that, “…the Minister for Industrial Relations is reviewing the impediments to shared workplace gains for employers and employees.”

While lacking in detail it does flag a renewed interest in industrial relations reform that the Coalition Government previously had been loath to touch, for fear of a Work Choices style campaign that cost them Government in 2007.

For business they will take some heart that at last, the Coalition Government is willing to engage in a debate around IR reform, which for many is a ‘holy grail’ of economic reform.

Given Work Choices was over 12 year ago now, many in business have been waiting for the Government to show signs of interest in workplace reform.

A Touch of Bipartisanship

In the spirit of bipartisanship both the Prime Minister and Opposition Leader have agreed to work together on the issue of indigenous recognition in the constitution.

The Prime Minister has tasked his Minister for Indigenous Affairs, Ken Wyatt to work with Labor’s Shadow Minister Lynda Burney on a joint approach to this challenging issue.

What the final shape of such a joint approach will look is too soon to know, the issue of an indigenous voice to Parliament will no doubt feature prominently in discussions.

Summary

A big week for the Government and a big win for the Government with the passage of its $158 billion in personal income tax cuts.

The Parliament is now in recess until 22 July.

When the Parliament next resumes, no doubt the Government will be looking to resurrect its proposals to crackdown on lawlessness within unions and also implement its policy commitments from the April budget.[/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]

ZIMMER BIOMET AND APPLE COLLABORATION

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This collaboration has yielded Zimmer Biomet mymobility™, an app that uses Apple Watch to facilitate a new level of connection between patients and their surgical care teams, which can immediately impact the journey patients experience when they undergo these procedures.

In addition to the app, Zimmer Biomet commenced the mymobility Clinical Study in October last year, designed to study the app’s impact on patient outcomes and overall costs for joint replacement patients.

During this research study, patients are using Zimmer Biomet mymobility with Apple Watch as they progress through their hip or knee replacement journey. Researchers combine patient-reported feedback with continuous health and activity data from Apple Watch to provide new insights into the power of the Zimmer Biomet mymobility app to impact the standard of care for these common surgeries. The study launched in October 2018 for patients based in the US.

“We are incredibly excited to work with Apple to transform the knee and hip replacement experience for patients and surgeons,” said Bryan Hanson, President and CEO, Zimmer Biomet. “At Zimmer Biomet, we are committed to improving care decisions through digital health and we are thrilled to launch one of the largest evidence-gathering clinical studies in orthopaedic history.”

“We believe one of the best ways to empower consumers is by giving them the ability to use their health and activity information to improve their own care,” said Jeff Williams, Chief Operating Officer, Apple. “We are proud to enable knee and hip replacement patients to use their own data and share it with their doctors seamlessly, so that they can participate in their care and recovery in a way not previously possible through traditional in-person visits. This solution will connect consumers with their doctors continuously, before and after surgery.”

More than one million knee and hip replacements occur annually in the U.S. This number is expected to grow to 3.5 million by 2035, yet standardization of care and recovery for the procedures is still lacking and costs to the U.S. healthcare system continue to rise. Zimmer Biomet mymobility and Apple Watch will act as a virtual and continuous care team on a patient’s wrist. Patients will be provided with support and guidance as they prepare for and recover from these surgeries, while surgeons will be delivered continuous data to optimize care.

The new Zimmer Biomet mymobility app has several features that use both Apple Watch and iPhone through the joint replacement journey, including the ability for surgeons to send education and therapy reminders directly to the patient’s Apple Watch.

The app also allows surgeons to monitor patient activity levels throughout the days and weeks while they are preparing for and recovering from surgery.

BACK TO BASICS – HTA EXPLAINED

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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.

Back to basics – the Prostheses List and Private Health Insurance

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So, what is the Prostheses List?

Put simply, the Prostheses List is a list of medical devices for which insurers are required to pay a benefit when a member has the relevant coverage.

For example, if you had hospital orthopaedic cover and you needed a hip replacement, your health fund would be required to pay the minimum benefit for any artificial hip on the Prostheses List.

The Prostheses List is a crucial contributor to the value of private health insurance, enabling members to receive the best quality health care as determined by their doctor.

The Prostheses List ensures that surgeons can choose the best available prostheses for privately insured patients without the options being restricted by health funds.

There are approximately 11,000 items on the Prostheses List. The List is divided into Parts A, B and C.

Part A covers devices that are used as part of hospital or hospital substitute treatment where a Medicare benefit must be paid to the doctor for the procedure performed. The device must be surgically implanted in the body or enable another device to be implanted or allow an implant to continue to function after surgery.

Devices on Part A also must be approved for use by the Therapeutic Goods Administration and assessed for effectiveness and cost against other products by the Prostheses List Advisory Committee before they can be listed.

Part A is divided into 13 major categories according to the broad conditions they address, and is further divided into sub-categories, groups and sub-groups. Each prosthesis has its own billing code with a benefit that must be paid for the device.

Part B covers products that are derived from human tissue for treatment of a condition. Part C covers specific groups of medical devices which don’t meet the criteria of Part A but which the Minister for Health considers suitable for benefit payments by private health insurers.

Contrary to popular belief, external prostheses, such as artificial limbs, or prostheses used for cosmetic rather than reconstructive purposes, are not eligible for reimbursement according to Prostheses List criteria.

Despite the cost of private health insurance being a top level concern for many Australians, the existence of the Prostheses List and the major contribution that it makes to the value of private health insurance is largely unknown.

Insurers caught out fudging facts again

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Mr Koce used data for 2016-1­­7 from the Private Hospital Data Bureau and the National Hospital Cost Data Collection published by Independent Hospital Pricing Authority (IHPA) in an attempt to compare prices for prostheses in the public and private sector. The information on costs for both these data sets is based on analysis of Australian Refined – Diagnosis Related Groups (AR-DRGs). One dataset is for private hospitals and one is for public hospitals and each are compiled by different agencies.

The 2016-17 data does not fully reflect the cuts imposed on prostheses across four main categories in February 2017, and also precedes the cuts implemented as part of the MTAA-Government Agreement signed in October 2017.

The latter cuts are estimated to be worth $1.1 billion over the life of the Agreement and resulted in the lowest premium increase in 19 years in 2019. This is even before a further round of Prostheses List benefit reductions under the Agreement, which will take place in February 2020. MTAA estimates that the February 2017 and Agreement cuts have delivered $450 million in savings already in the 2017-18 premium years, higher than forecast under the Agreement.

It is, therefore, inappropriate and completely disingenuous for Mr Koce to quote three-year-old statistics to make his case.

Furthermore, DRGs are not an appropriate tool to compare prostheses costs. DRGs are used to determine hospital funding in Australia. A DRG will not explain which prostheses was the best for the patient, including whether a more expensive one makes more sense based on the many factors that could impact treatment under that DRG. They describe averages, not specifics, and will not take into account legitimate differences in volume mix between prostheses use between public and private patients.

The numbers floated by Mr Koce are similar to those used time and again by the PHI industry in their attempts to get the device industry to temporarily rescue it from difficulties. MTAA has demonstrated that they are not correct, and by the time the last cuts under the Agreement are implemented in February 2020, there will be very little continuing justification for the comparison.

Private health insurers should rather pay heed to APRA’s recent warnings that “often [their] strategies are vague, fail to address the material risk or rely heavily on actions by others”, that “waiting for a third party to ‘serve-up’ a solution is not a defensible strategy” and that “APRA would expect that better prepared insurers are taking actions to improve the value of services for members”.

Insurers must focus on providing value – access to a comprehensive range of life-saving and life-changing medical devices, with generally no out-of-pocket costs for those devices, is a key contributor to the value proposition of private health.

RECORD BREAKING $26.7 BILLION HEALTH BUDGET

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What to know:

The Government’s health investment includes a $2.7 billion dollar spend on top of $24 billion in recurrent spending over the coming year – taking the total 2019-20 health budget to $26.7 billion.

The recurrent funding investment will focus on families with additional funding to provide an extra 8,000 paediatric operations and 10,000 cataract surgeries, over four years.

What Minister Hazzard had to say:

“This record Budget will see the first stage of an unprecedented boost to the frontline workforce with an extra 8,300 staff over the next four years under a $2.8 billion commitment – 45 per cent to staff to go to the regions.

“This record Budget will ensure patients, their families and those in regional communities already doing it tough in drought-affected areas continue to get timely, world-class care, no matter where they live.”

The health highlights:

  • $2.8 billion to recruit a total of 8,300 frontline health staff over four years;
  • $10.1 billion over four years to invest in NSW’s health infrastructure to continue current works and commence upgrading and building a further 29 hospital and health facility projects, as well as ensure compliance with new leasing standards;
  • $70 million over four years to provide 35 new free mobile dental clinics allowing access to dental checks and basic dental care for up to 136,000 primary school children in Western Sydney, Mid North Coast and the Central Coast each year;
  • $42 million over four years to provide women with greater choice around IVF services and a partnership with the University of NSW for the first state-wide fertility preservation service for young cancer patients at The Royal Hospital for Women;
  • $76 million over four years to boost elective surgery, focusing on children and cataract patients, with delivery of an additional 8,000 paediatric operations and 10,000 cataract surgeries in addition to the investment in frontline staff;
  • $27.1 million to employ 221 paramedics and call centre staff (second tranche of record 750 workforce announced last year) to improve response times, reduce paramedic fatigue and support safety;
  • $23.5 million for mental health to expand the capacity of Lifeline and Kids Helpline over four years;
  • $45 million over four years in palliative care for 100 palliative care nurses, Aboriginal health workers, digital health solutions and the refurbishment of existing facilities. This is in addition to a $100 million package for palliative care that was announced as part of the 2017-18 Budget; and
  • In 2019-20, the Government will invest $2.9 billion in the Health capital program, which includes $148 million from the Ministry of Health’s recurrent expense budget and $78 million for lease acquisitions.

Health infrastructure investment:

One of the largest health projects in NSW is on track to deliver world-class care to local communities for decades to come. This includes a $2.7 billion spend on health infrastructure in 2019-20, up 27 per cent on last year.

The record $2.7 billion health infrastructure investment in 2019-20 will enable the following works:

  • Commencement of new works John Hunter Hospital ($780 million), the Children’s Hospital at Westmead ($619 million) and Tumut Hospital ($50 million);
  • Continuing works at Griffith Hospital, Goulburn Hospital, Hornsby Hospital and Mona Vale Hospital;
  • New hospital car parks at Liverpool, Shellharbour and Wagga Wagga; and
  • Planning for major projects including Sutherland Hospital, Sydney Children’s Hospitals Network at Randwick and the Comprehensive Children’s Cancer Centre, and Royal Prince Alfred Hospital.

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BioMedTech Horizons Program Now Open!

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[vc_row][vc_column][vc_column_text]MTPConnect has opened a call for Expressions of Interest to identify and select a number of biological and medical technology innovation initiatives that address one of the following four priority therapeutic areas:

  1. Cardiovascular;
  2. Orthopaedics;
  3. Emergency medicine/trauma; or
  4. Ophthalmology.

Up to $1 million of funding is offered for individual projects over a two-year period.[/vc_column_text][vc_separator][vc_row_inner][vc_column_inner width=”1/3″][/vc_column_inner][vc_column_inner width=”1/3″][vc_btn title=”Click Here To Apply” link=”url:https%3A%2F%2Fmtpconnect.smartygrants.com.au%2FBMTH20||target:%20_blank|”][/vc_column_inner][vc_column_inner width=”1/3″][/vc_column_inner][/vc_row_inner][vc_separator][vc_row_inner][vc_column_inner width=”1/3″][/vc_column_inner][vc_column_inner width=”1/3″][vc_btn title=”View the program guidelines” link=”url:https%3A%2F%2Fwww.mtpconnect.org.au%2Fimages%2FBMTH%25202.0%2520Guidelines.pdf||target:%20_blank|”][/vc_column_inner][vc_column_inner width=”1/3″][/vc_column_inner][/vc_row_inner][vc_column_text]The BioMedTech Horizons Program was one of the commitments delivered as part of the Medical Technology Association of Australia’s (MTAA) 2017 Agreement with the Commonwealth to promote the sustainability of privately insured health care through rebalancing the costs of medical devices to privately insured patients.

This funding is being delivered via the Medical Research Future Fund (MRFF), and administered by MTPConnect, the Medical Technology and Pharmaceutical Industry Growth Centre.

Investments from the program will be focused on funding proof-of-concept to commercial development of biomedical and medical technologies (biomedtech).[/vc_column_text][vc_separator][/vc_column][/vc_row][vc_row][vc_column][/vc_column][/vc_row]