BACK TO BASICS – HTA EXPLAINED

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.

Minister for Health Greg Hunt Delivers Federal Funding for New Cancer Centre

Ask the Minister:

Greg Hunt Federal Minister for Health

“This agreement gives The Bays the ability to continue their development of world-class treatment and research facilities, for the benefit of the local community.”

“Funding encompassing radiation oncology, clinical trials laboratory, consulting suites, and meeting education and support areas for patients affected by cancer, will help The Bays continue to save lives and protect lives.”

Ask the expert:

Dr Muhammad Alamgeer Consulting Medical Oncologist for The Bays Healthcare Group

“The real revolution of cancer care since the discovery of chemotherapy has been the practice of personalised care, which means matching the latest treatments to individual patient characteristics.  At the new comprehensive cancer centre at The Bays, we will deliver high-quality personalised care.”

Research Reveals Alarming New Measles Trend

How it works:

Australia has done such a good job at eliminating measles, people who have had only one vaccine aren’t getting a natural immunity boost as the disease isn’t circulating in the community.

While these cases were hospitalised, the symptoms weren’t considered ‘classic measles’ – patients weren’t reporting fever, cough and runny nose, but they did have a rash.

Ask the expert:

Dr Katherine Gibney, an epidemiologist Victorian Department of Health and Human Services

“Normally, if people have documented receiving two doses of the measles vaccine we would be confident they won’t contract measles, but that’s getting greyer – this research has demonstrated some vaccinated people are getting measles.”

“Anyone who is unsure if they have had two doses of measles vaccine should see their doctor about getting an additional dose. In particular, adults born after 1965 might not have received two doses of measles vaccine during their routine childhood immunisation.”

Dr Lisa Walker from the Royal Melbourne Hospital Awarded Top Prize

How it works:

During their last year of specialist Emergency Medicine training, doctors must complete a final oral and written exam. Every exam, the highest scoring candidate from among hundreds across Australia and New Zealand, is awarded The Buchanan Prize.

Ask the expert:

Dr Alex Paspaliaris, who won the prize in 2001

“The Australasian Emergency Medicine training program is one of the hardest and most highly recognised in the world.”

Study Finds Majority of Australians Don’t Understand Private Health and Tax

Facts and figures:

64% of Australians don’t understand what the Medicare Levy Surcharge (MLS) is.

39% are confused the MLS with the Medicare Levy paid by all taxpayers.

36% of Australians correctly understand that the MLS is an additional tax paid by higher income earners who don’t have private hospital cover.

Ask the expert:

Laura Crowden, spokesperson for iSelect:

“If you earn more than $90,000 a year and don’t have private hospital cover by June 30, then you will have to pay a minimum $900 in extra tax next financial year due to the MLS.”

“Exactly how much extra tax you’ll pay depends on how much you earn and for most higher income earners, taking out a basic hospital policy will generally cost less than paying the extra tax via the MLS.”

The details:

The YouGov Galaxy Research study was commissioned by the private health insurer iSelect.

Aboriginal HPV Vaccination Rates On The Rise

Facts and figures:

The study published in the Medical Journal of Australia has found Aboriginal students in NSW are achieving their first dose of the HPV vaccine at equal or higher rates than non-Aboriginal students.

Coverage is higher among Aboriginal females than non-Aboriginal females in NSW, with a rate of 95.9% and 89.9%, respectively. The rate for males is 85.6% and 86.0%.

HPV vaccination is a safe and effective method to prevent infection and disease due to the targeted HPV types that cause cervical cancer (almost all cases) and cancers of the anus (90%), vagina (65%), oropharyngeal area (60%), vulva (50%) and penis (35%).

Ask the expert:

Dr Vicky Sheppeard NSW Health’s Director of Communicable Diseases

“The HPV vaccination is particularly important for Aboriginal women to prevent cervical cancer as, compared to other Australian women, they have twice the incidence and four times a greater mortality rate from cervical cancer.”

The details:

Protecting children from potentially deadly diseases is a key priority for the NSW Government, which has invested approximately $130 million in the 2018-19 Immunisation Program budget, including Commonwealth and state vaccines.
To find out more go to www.health.nsw.gov.au/aboriginal/Pages/default.aspx​​

Back to basics – the Prostheses List and Private Health Insurance

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

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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Ground Breaking Project Aims For World First Bionic Vision

Why it matters:

The primary goal of the project is to restore vision. However, it has become clear that there are many other applications for this technology.

The project aims to explore these potential new applications:

  • Moderation of epilepsy and depression
  • Brain-controlled prosthetics
  • Restoration of vital senses beyond vision

How it works:

A brain-computer interface (BCI) is a direct communication pathway between an enhanced or wired brain and an external device.

BCI’s are directed at researching, mapping, assisting, augmenting, or repairing human cognitive or sensory-motor functions.

Ask the expert:

Professor Arthur Lowery, Director of the Monash Vision Group

“My team and I have developed wireless-connected electronic implants that sit on the surfaces of the brain, creating long-term brain-machine interfaces.”

The details:

Federal Minister for Health, Greg Hunt, has pledged almost $1 million to the University led project under the new Frontier Health and Medical Research Program.

The research program will invest $240 million over four years to support innovative ideas and discoveries with great potential for transformative impact on health care.

To find out more or how to apply for the program go to www.business.gov.au/assistance/frontier-health-and-medical-research