AANMS Position on Re-Indexation of Nuclear Medicine Items in the MBS – Summary
The AANMS is seeking an initial 10 per cent increase for all MBS items for nuclear medicine in the 2022-23 Budget, to bring reimbursement levels closer to appropriate levels. Given that inflation has risen over 58 percent since rebates were frozen in 1998, this initial payment is crucial to re-establish the viability of nuclear medicine in Australia.
In subsequent years, nuclear medicine MBS items should be reindexed in line with inflation, based on the Consumer Price Index (CPI).
AANMS Position Paper on Practice of Theranostics in Australia
Therapeutic options in malignant disease are expanding rapidly with the aim of improving patient outcomes. With the increasing cost of health care, there is a need to ensure the most cost-effective modalities are both available and appropriately implemented as part of the armamentarium of therapies available for patients. Molecular imaging and radionuclide therapy are relatively new options that offers many benefits, including cost and safety, in comparison to those currently available.
Theranostics is a term that has been coined to cover the use of a radiopharmaceutical for both diagnosis and, after demonstrating appropriate levels of concentration of the radiopharmaceutical in tumours, subsequent therapy. This often, though not universally, involves a different isotope bound to the same targeting ligand.
This position paper establishes a consensus on recommendations regarding the care of patients receiving theranostic therapy and to support the provision of safe, high quality, targeted care by qualified professionals in this area. These recommendations include, but not limited to: identifying the optimal workplace and facility requirements; specialist training requirements; patient workflow and MDT requirements.
While a range of theranostic therapies are currently available, there is sufficient commonality among these therapies to allow uniform guidelines to be developed whilst accepting that some specific flexibility will be necessary. Important aspects of theranostics considered in the development of these guidelines include:
- The rapidly evolving scientific and technological advances in the practice of theranostics often see a delay between availability and sufficient clinical evidence to indicate widespread use
- The design of disease, and patient specific, treatment options and delivery methodologies
- The complexity of managing patients with cancer when there is a wide range of differing treatment options each with their own inherent strengths and weaknesses. This has required a multidisciplinary approach for many therapies, particularly the newer ones, requiring input from medical experts in different sub-specialties to encompass all aspects of the patient’s current medical status in order to select the optimal treatment pathway.
- The need to understand and respect patients’ values, goals, needs and financial situation, and engage them in an informative process of treatment options and shared decision-making
- Requirements related to each patient’s disease, as well as the specific risks vs the benefits of the treatment, needs to be assessed by a multidisciplinary team. This assessment will be influenced by local capabilities that may change with time.
The AANMS is of the position that the development of skills and expertise in theranostics is necessary for its safe and effective use in a clinical setting and that these should also be AANMS Theranostics Position Statement (Version 1.0, February 2021) 5 maintained through life-long learning. A multidisciplinary approach to patient selection, management and administration of the therapy is a key component of theranostic treatments.
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Submission to the Australian Government consultation on critical technologies
Thank you for the opportunity to comment on the Australian Government consultation on critical technologies. This is a joint submission from the Australasian Association of Nuclear Medicine Specialists (AANMS) and the Australian and New Zealand Society of Nuclear Medicine (ANZSNM).
The AANMS and ANZSNM are the peak bodies representing the clinical practice of nuclear medicine in Australia and New Zealand. The organisations work to advance nuclear medicine in practice, research and education.
The AANMS and ANZSNM made a joint submission to the House of Representatives Standing Committee on Health, Aged Care and Sport Inquiry into the approval processes for new drugs and novel medical technologies in Australia (the Parliamentary inquiry) and gave evidence to a hearing of the inquiry on 11 March 2021. This inquiry addresses many of the same issues being examined in the critical technologies consultation.
The stated purpose of the critical technologies consultation is to identify key critical technology developments, assess risks to and opportunities in Australia’s national interest, and examine the approach of academia, industry and government to critical technologies. We would refer the Australian Government, through the Critical Technologies Policy Coordination Office, to the AANMS and ANZSNM submission to the Standing Committee inquiry. Below is a summary of the key points and recommendations in the submission and the full submission is attached separately for consideration.
Developing a new industry in novel radiopharmaceuticals and theranostics
Australia has an opportunity to develop a new industry of national significance and has the foundations for a very strong competitive advantage compared to other countries in the development of novel radiopharmaceuticals and theranostics. With relatively limited but targeted investment and with national coordination, Australia could become a world leader in the introduction of radiopharmaceuticals and theranostics. This could become a significant national industry generating economic returns, employment and expertise. It would also give Australian patients early access to the latest treatments in trials and novel therapies. Such an industry would involve radiopharmaceutical discovery, development, clinical trials and ultimately clinical drug manufacture or IP licensing.
AANMS and ANZSNM recommended in the submission to the Parliamentary inquiry that the Australian Government:
- Target the radiopharmaceutical industry for special assistance to develop a nationally significant industry.
- Ensure national unification of strategic intent and coordination of investment in the existing, largely government funded, assets such as CSIRO, ANSTO and NIF towards the development of a national scale radiopharmaceutical industry.
- Prioritise research funding from the Medical Research Future Fund (MRFF), NHMRC and other funding and research support agencies towards radiopharmaceutical drug discovery and clinical translation.
- Provide industry support and funding to ensure that intellectual property, drug discovery and manufacture are retained in Australia.
AANMS and ANZSNM also made recommendations to the Parliamentary inquiry regarding radiopharmaceuticals being considered as a separate class of “drug” for the purposes of assessment for registration on the Australian Register of Therapeutic Goods (ARTG). Further information on this is available in the full submission provided.
The case for an Australian medical cyclotron
ANZSNM have developed a report to build the case for an Australian medical cyclotron for domestic radionuclide supply. The report highlights the problems with Australia’s reliance on the importation of short-lived radionuclides and the impact this has on the practice of nuclear medicine. The lack of a sustainable supply of radiopharmaceuticals impacts patients, resulting in suboptimal patient management and increased health care costs. The report is attached separately to this submission for consideration.
A national facility to supply radionuclides would create a sustainable domestic supply and open up export markets and generate income for the Australian economy.
ANZSNM and AANMS have recommended that the Australian Government develop a business case and national strategy for the domestic supply cyclotron-produced gamma emitting radionuclides used in nuclear medicine.
Once again, we would like to thank the Australian Government for the opportunity to make a submission to the inquiry on critical technologies. The AANMS and ANZSNM would be happy to meet with the Critical Technologies Policy Coordination Office to discuss and expand on the issues and reports referred to in this submission.
Yours sincerely
Geoff Schembri
President AANMS
Daniel Badger
President ANZSNM
9 April 2021
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Communications sent to:
Professor Margaret Harding
Chair, National Imaging Facility Board
Dear Professor Harding
RE: Support for establishment of an Alpha Radioisotope and Radiopharmaceutical Facility at ANSTO I am writing in support of ANSTO’s submission to establish an alpha radio chemistry facility. The Australasian Association of Nuclear Medicine Specialists (AANMS) is the body representing nuclear medicine specialists throughout Australia and New Zealand. Our members provide almost the entirety of radionuclide therapy in this country and have been central to research within the field of theranostics.
Theranostics is a potential boom area within the therapy field and indeed has been garnering a lot of financial support overseas. Australia is almost uniquely positioned to create a globally beneficial industry which will benefit patients in the forms of better targeted therapy and benefit the country in terms of export dollars.
Australia has access to raw materials for alpha production as well as the expertise at ANSTO and CSIRO to develop the industry and required infrastructure. We have a solid research base with proven ability to work in this space. Research in this area has developed skilled radiochemistry and radiophysics resources in this country which would be available to support the development of this industry.
Alpha emitters will be critical in the development of theranostics providing dramatic cell killing which, if targeted well, avoids many of the side-effects of standard chemotherapy. Hence, we strongly support this application and believe that it should be given a high priority for the betterment of our population’s health and to strengthen our export industry.
Yours sincerely
Dr Geoff Schembri FRACP FAANMS
President
22 March 2021
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Executive Summary
Australia is currently facing a crisis of supply of technetium 99m. This is a crucial component in 70% of nuclear medicine studies in Australia and 98% of non PET studies. Nuclear Medicine is a branch of imaging utilising radioisotopes for imaging of functional processes in the body. For example, an X-ray shows the structure of a bone, a bone scan shows how, on a cellular level, the bone is reacting to disease allowing insights into the pathology and disease progress not readily available from pure anatomic modalities.
Technetium production has a number of steps. It is derived from molybdenum 99. The molybdenum is produced at the Lucas Heights OPAL reactor. After production, it goes to the ANSTO Nuclear medicine (ANM) facility to be processed. After processing it goes to the generator production unit to be packaged into a container that allows transport and access to the technetium for nuclear medicine facilities.
These three steps all have no redundancy and so are all potential single points of failure. Currently, the ANM facility has a production issue. The time frame for remediation of this remains unclear.
Nuclear medicine provides services largely to oncology patients but has a significant role in all areas of medicine including infection and transplant patients. While we can defer some studies or use alternatives in the short term, none of these are true viable long term options and re-establishment of supply is crucial. Over 500,000 studies are done each year or about 12000 per week nationwide. While isotope is limited, we will clearly prioritise emergency patients but the longer the shortage continues, the more scans become urgent as patient management and treatment cannot be indefinitely delayed.
The AANMS has considered that the following substitutions and priorities would be beneficial until ANSTO can return supply to normal.
13 September 2019
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AANMS Position Statement – Actinium (Ac-225) PSMA
Ac-225 PSMA is presently being used in Australia as a treatment for prostate cancer when other treatment options have been exhausted. Ac-225 is not registered by the Therapeutic Goods Administration (TGA) for use in Australia but can be administered under the Special Access Scheme (SAS) Category A for when a patient is seriously ill with a condition from which death is reasonably likely to occur within a matter of months, or from which premature death is reasonably likely to occur in the absence of early treatment.
There is presently insufficient clinical data on both safety and the optimal dose for administration of Ac-225 to patients to support general clinical use given the significant potential harm that this alpha emitting radionuclide could cause. Clinical trials are planned to commence mid to late 2019.
Developing A Sovereign Nuclear Medicine Industry
- Nuclear medicine is a rapidly growing area of medicine which can treat many serious health conditions, including cancer, dementia, stroke, heart and lung diseases.
- Australia has the potential to develop a world-leading nuclear medicine industry, providing both health and economic benefits to the Australian community.
- This potential is put at risk due to Australia’s aging and inadequate nuclear medicine infrastructure.
- Upgrading Australia’s nuclear medicine infrastructure would increase access to nuclear medicine services for Australians and provide export opportunities to meet growing demand worldwide for nuclear medicine.
- This would ensure Australia is well-positioned to take full advantage of the medical advances in this area, including anticipated growth in theranostics, a form of precision cancer treatment in which Australia is a world leader.
Standard Adult DXA Report – Australian Guidelines
- The AANMS, ANZBMS, ESA and RANZCR have endorsed the 2023 Minimum Requirements for a Standard Adult DXA report.
- The AANMS recommends these Guidelines to all members who undertake DXA reporting.