Summary of PICO/PPICO criteria to ... - Department of Health



RATIFIED PICOApplication 1632:PSMA PET/CT imaging for informing treatment of patients with Prostate CancerSummary of PICO/PPICO criteria to define the question(s) to be addressed in an Assessment Report to the Medical Services Advisory Committee (MSAC)ComponentDescriptionPatientsTwo populations are included in this application:Population 1Prostate specific membrane antigen (PSMA) positron emission tomography (PET)/computed tomography (CT) imaging performed for the initial (N- and M-) staging of intermediate- to high-risk prostate adenocarcinoma, for previously untreated patients considered suitable for locoregional therapy with curative intent.Population 2PSMA PET/CT imaging performed for restaging of recurrent prostate adenocarcinoma, for patients considered suitable for locoregional therapy to delay systemic therapy.Intermediate-risk localised prostate cancer is defined by:PSA of 10-20ng/ml, orGleason score of 7 or ISUP grade group 2 or 3, orStage T2b or T2c (depending on guideline) .High-risk localised (or locally advanced) prostate cancer is defined by:PSA of >20ng/ml, orGleason score >7 or ISUP grade group 4 or 5, orStage T2c (depending on guideline), or ≥T3.Recurrent prostate cancer is defined by PSA levels after locoregional therapy. Population 2 includes patients with PSA persistence/recurrence, which is defined by:PSA increase of 2ng/ml above the nadir after external beam radiotherapy (EBRT), orfailure of PSA to fall to undetectable levels or rising serum PSA after radical prostatectomy.Prior tests(for investigative medical services only)For initial staging, patients will likely have undergone a digital rectal exam (DRE) and/or prostate specific antigen (PSA) testing, prostate biopsy, and multiparametric magnetic resonance imaging (MRI) prior to referral for PSMA PET/CT (or comparator) imaging. For restaging in patients with BCR after locoregional ablative therapies, patients will have undergone routine PSA testing (i.e. serial PSA tests) prior to referral for PSMA PET/CT (or comparator) imaging.InterventionPSMA PET/ CT imaging.PSMA PET/CT is to be treated as a single intervention, irrespective of which radiopharmaceutical tracer is used. Choice of tracer is not expected to impact the safety or effectiveness outcomes of PSMA PET/CT. Nonetheless, data permitting, secondary analysis comparing outcomes between various tracers should be considered to confirm this paratorsCT, and/orwhole-body bone scan (WBBS) with single photon emission computed tomography (SPECT)/CT.OutcomesSafety outcomesRadiation exposure (patients, nuclear medicine technologists, nurses)Adverse reaction to the contrast agents, including renal toxicityEffectiveness outcomesDiagnostic accuracySensitivity and specificity Positive predictive value (PPV), negative predictive value (NPV)Area under the curve (AUC) of the receiver operating characteristic (ROC) curveNumber of equivocal findingsChange in managementNeed for subsequent diagnostic tests, including biopsy i.e. investigations avoidedChange in planned management (intent), including change in planned treatment modality, extension of radiation fieldChange in management i.e. overall change, types of changes, futile locoregional curative intent treatments avoided, therapies instigatedOncologic and patient outcomesMorbidityMortality, including cancer specific mortalitySurvival, including overall survival, progression-free survival, metastases-free survival, androgen deprivation therapy (ADT)-free survivalQuality of life Healthcare system outcomesCost of PSMA PET/CT (or comparator) imaging used for initial staging, or for restaging in patients with PSA persistence/recurrenceCost of additional imaging tests or biopsies requiredCost of treatments received and/or costs offset due to avoidance of futile locoregional ablative procedureTotal cost to Medicare Benefits Schedule (MBS), Pharmaceutical Benefits Scheme (PBS) and other government health budgetsEconomic outcomesCost effectiveness or cost utilityPICO or PPICO rationale for therapeutic and investigative medical services onlyPopulationThis application covers two patient populations that benefit from PSMA PET/CT imaging:PSMA PET/CT performed for the initial (N- and M-) staging of intermediate- to high-risk prostate adenocarcinoma, for previously untreated patients considered suitable for locoregional therapy with curative intent.PSMA PET/CT performed for restaging of recurrent prostate adenocarcinoma, for patients considered suitable for locoregional therapy to delay systemic therapy.PASC considered for Population 1, that ‘initial (N- and M-) staging’ was the correct term for the use of the intervention rather than ‘primary (T-) staging’, which is done with digital rectal examination and multiparametric-magnetic resonance imaging (mpMRI).PASC advised that, for Population 2, the words “with curative intent” should be replaced with “to delay systemic therapy”. PASC noted that the treatment goal for recurrent disease is not curative, but that the intent of treatment should be specified to prevent leakage to therapy monitoring.ContextThe MBS Review Taskforce recommended that the Medical Services Advisory Committee (MSAC) consider the inclusion of gallium-68 (68Ga)-PSMA PET/CT on the MBS, referring to the modality’s superiority over conventional imaging for staging and restaging of prostate cancer and its ability to change management intent for newly diagnosed and recurrent prostate cancer patients ADDIN EN.CITE <EndNote><Cite><Author>Medicare Benefits Schedule Review Taskforce</Author><Year>2018</Year><RecNum>1</RecNum><DisplayText>(Medicare Benefits Schedule Review Taskforce, 2018)</DisplayText><record><rec-number>1</rec-number><foreign-keys><key app="EN" db-id="rtafpsxaepf2d8epwsz5rdx8pr9fwvwwtzd0" timestamp="1591774835">1</key></foreign-keys><ref-type name="Report">27</ref-type><contributors><authors><author>Medicare Benefits Schedule Review Taskforce,</author></authors></contributors><titles><title>Report from the Diagnostic Imaging Committee - Nuclear Medicine</title></titles><dates><year>2018</year></dates><urls></urls></record></Cite></EndNote>(Medicare Benefits Schedule Review Taskforce, 2018).PSMA PET/CT was developed to improve detection of metastatic disease in prostate cancer, particularly in the setting of disease recurrence PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5QZXJlcmE8L0F1dGhvcj48WWVhcj4yMDIwPC9ZZWFyPjxS

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ADDIN EN.CITE.DATA (Perera et al., 2020). Research shows that PSMA PET/CT improves detection of metastases in patients with biochemical recurrence [BCR] (particularly at low PSA levels) PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5QZXJlcmE8L0F1dGhvcj48WWVhcj4yMDIwPC9ZZWFyPjxS

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ADDIN EN.CITE.DATA (Hofman et al., 2020).A multicentre Australian prospective study has shown that use of 68Ga-PSMA PET/CT for initial staging or restaging on BCR has a considerable impact on management intent, changing the planned management for approximately half of patients overall PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Sb2FjaDwvQXV0aG9yPjxZZWFyPjIwMTg8L1llYXI+PFJl

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ADDIN EN.CITE.DATA (Roach et al., 2018).Full health technology assessment (HTA) evaluations for Populations 1 and 2 (as defined above) are recommended.PASC advised that the assessment group should first consider the safety, effectiveness and cost-effectiveness of Population 1. Population 2 should be considered as an incremental add-on to Population 1 (i.e. stepped evaluation).BackgroundThe prostate is a small, walnut-size gland of the male reproductive system, which produces the fluid that combines with sperm to form semen ADDIN EN.CITE <EndNote><Cite><Author>Prostate Cancer Foundation of Australia</Author><Year>2020</Year><RecNum>2</RecNum><DisplayText>(Cancer Council, 2020; Prostate Cancer Foundation of Australia, 2020b)</DisplayText><record><rec-number>2</rec-number><foreign-keys><key app="EN" db-id="rtafpsxaepf2d8epwsz5rdx8pr9fwvwwtzd0" timestamp="1592186289">2</key></foreign-keys><ref-type name="Web Page">12</ref-type><contributors><authors><author>Prostate Cancer Foundation of Australia,</author></authors></contributors><titles><title>What you need to know about prostate cancer</title></titles><volume>2020</volume><number>3 July</number><dates><year>2020</year></dates><urls><related-urls><url> Council</Author><Year>2020</Year><RecNum>3</RecNum><record><rec-number>3</rec-number><foreign-keys><key app="EN" db-id="rtafpsxaepf2d8epwsz5rdx8pr9fwvwwtzd0" timestamp="1592186409">3</key></foreign-keys><ref-type name="Report">27</ref-type><contributors><authors><author>Cancer Council,</author></authors></contributors><titles><title>Understanding Prostate Cancer. A guide for people with cancer, their families and friends</title></titles><dates><year>2020</year></dates><urls><related-urls><url>;(Cancer Council, 2020; Prostate Cancer Foundation of Australia, 2020b). It is normal for the prostate to enlarge with age, which can cause problems for older males, particularly difficulty urinating. These problems are not always symptoms or signs of cancer. Prostate cancer is caused by the development and uncontrolled multiplication of abnormal cells in the prostate gland ADDIN EN.CITE <EndNote><Cite><Author>Prostate Cancer Foundation of Australia</Author><Year>2020</Year><RecNum>2</RecNum><DisplayText>(Cancer Council, 2020; Prostate Cancer Foundation of Australia, 2020b)</DisplayText><record><rec-number>2</rec-number><foreign-keys><key app="EN" db-id="rtafpsxaepf2d8epwsz5rdx8pr9fwvwwtzd0" timestamp="1592186289">2</key></foreign-keys><ref-type name="Web Page">12</ref-type><contributors><authors><author>Prostate Cancer Foundation of Australia,</author></authors></contributors><titles><title>What you need to know about prostate cancer</title></titles><volume>2020</volume><number>3 July</number><dates><year>2020</year></dates><urls><related-urls><url> Council</Author><Year>2020</Year><RecNum>3</RecNum><record><rec-number>3</rec-number><foreign-keys><key app="EN" db-id="rtafpsxaepf2d8epwsz5rdx8pr9fwvwwtzd0" timestamp="1592186409">3</key></foreign-keys><ref-type name="Report">27</ref-type><contributors><authors><author>Cancer Council,</author></authors></contributors><titles><title>Understanding Prostate Cancer. A guide for people with cancer, their families and friends</title></titles><dates><year>2020</year></dates><urls><related-urls><url>;(Cancer Council, 2020; Prostate Cancer Foundation of Australia, 2020b). It is often slow growing and remains within the prostate (localised or early stage disease). Some prostate cancers grow quickly, spreading to nearby body parts such as the bladder or rectum, nearby lymph nodes, or distant sites such as the bones, liver or lungs ADDIN EN.CITE <EndNote><Cite><Author>Prostate Cancer Foundation of Australia</Author><Year>2020</Year><RecNum>37</RecNum><DisplayText>(National Comprehensive Cancer Network, 2019; Prostate Cancer Foundation of Australia, 2020a)</DisplayText><record><rec-number>37</rec-number><foreign-keys><key app="EN" db-id="rtafpsxaepf2d8epwsz5rdx8pr9fwvwwtzd0" timestamp="1592534132">37</key></foreign-keys><ref-type name="Web Page">12</ref-type><contributors><authors><author>Prostate Cancer Foundation of Australia,</author></authors></contributors><titles><title>Grading and staging of prostate cancer</title></titles><volume>2020</volume><number>19 June</number><dates><year>2020</year></dates><urls><related-urls><url> June</custom2></record></Cite><Cite><Author>National Comprehensive Cancer Network</Author><Year>2019</Year><RecNum>38</RecNum><record><rec-number>38</rec-number><foreign-keys><key app="EN" db-id="rtafpsxaepf2d8epwsz5rdx8pr9fwvwwtzd0" timestamp="1592534235">38</key></foreign-keys><ref-type name="Report">27</ref-type><contributors><authors><author>National Comprehensive Cancer Network,</author></authors></contributors><titles><title>NCCN Guidelines for Patients: Prostate Cancer, 2019</title></titles><dates><year>2019</year></dates><urls></urls></record></Cite></EndNote>(National Comprehensive Cancer Network, 2019; Prostate Cancer Foundation of Australia, 2020a). In the early stages, prostate cancer rarely causes symptoms. Patients with advanced disease may experience symptoms such as unexplained weight loss; frequent or urgent need to urinate; difficulty or discomfort while urinating; blood in the urine or semen; or pain in the lower back, upper thighs or hips ADDIN EN.CITE <EndNote><Cite><Author>Prostate Cancer Foundation of Australia</Author><Year>2020</Year><RecNum>2</RecNum><DisplayText>(Cancer Council, 2020; Prostate Cancer Foundation of Australia, 2020b)</DisplayText><record><rec-number>2</rec-number><foreign-keys><key app="EN" db-id="rtafpsxaepf2d8epwsz5rdx8pr9fwvwwtzd0" timestamp="1592186289">2</key></foreign-keys><ref-type name="Web Page">12</ref-type><contributors><authors><author>Prostate Cancer Foundation of Australia,</author></authors></contributors><titles><title>What you need to know about prostate cancer</title></titles><volume>2020</volume><number>3 July</number><dates><year>2020</year></dates><urls><related-urls><url> Council</Author><Year>2020</Year><RecNum>3</RecNum><record><rec-number>3</rec-number><foreign-keys><key app="EN" db-id="rtafpsxaepf2d8epwsz5rdx8pr9fwvwwtzd0" timestamp="1592186409">3</key></foreign-keys><ref-type name="Report">27</ref-type><contributors><authors><author>Cancer Council,</author></authors></contributors><titles><title>Understanding Prostate Cancer. A guide for people with cancer, their families and friends</title></titles><dates><year>2020</year></dates><urls><related-urls><url>;(Cancer Council, 2020; Prostate Cancer Foundation of Australia, 2020b).Stage and grade terminologyStage Stage refers to how far the prostate cancer has spread. The most common staging system for prostate cancer is the tumour, node, metastasis (TNM) system, which describes the size of the primary tumour (T) and whether the cancer has spread to nearby lymph nodes (N) or to bones and other organs (M) ADDIN EN.CITE <EndNote><Cite><Author>Cancer Council</Author><Year>2020</Year><RecNum>3</RecNum><DisplayText>(Cancer Council, 2020)</DisplayText><record><rec-number>3</rec-number><foreign-keys><key app="EN" db-id="rtafpsxaepf2d8epwsz5rdx8pr9fwvwwtzd0" timestamp="1592186409">3</key></foreign-keys><ref-type name="Report">27</ref-type><contributors><authors><author>Cancer Council,</author></authors></contributors><titles><title>Understanding Prostate Cancer. A guide for people with cancer, their families and friends</title></titles><dates><year>2020</year></dates><urls><related-urls><url>;(Cancer Council, 2020).A simple overview of the TNM staging system is provided in REF _Ref43472852 \h Table 1 ADDIN EN.CITE <EndNote><Cite><Author>National Comprehensive Cancer Network</Author><Year>2019</Year><RecNum>38</RecNum><DisplayText>(National Comprehensive Cancer Network, 2019)</DisplayText><record><rec-number>38</rec-number><foreign-keys><key app="EN" db-id="rtafpsxaepf2d8epwsz5rdx8pr9fwvwwtzd0" timestamp="1592534235">38</key></foreign-keys><ref-type name="Report">27</ref-type><contributors><authors><author>National Comprehensive Cancer Network,</author></authors></contributors><titles><title>NCCN Guidelines for Patients: Prostate Cancer, 2019</title></titles><dates><year>2019</year></dates><urls></urls></record></Cite></EndNote>(National Comprehensive Cancer Network, 2019). Details of further sub-divisions (e.g. T2a) are not shown.Table SEQ Table \* ARABIC 1Tumour, node, metastases staging system (simplified) for prostate cancer StagePrimary tumour (T)Regional lymph nodes (N)Distant metastases (M)LocalisedT1Tumour cannot be felt during DRE and is not found on imaging tests, but cancer is presentN0No cancer in nearby lymph nodesM0Cancer has not spread to other parts of bodyT2Tumour is felt during DRE and is found only in prostateN0M0T3Tumour has broken through outside layer of prostate and may have grown into seminal vesicle(s)N0M0T4Tumour has spread to nearby structures such as bladder, rectum, pelvic muscles and/or pelvic wallN0M0RegionalAny TN1Cancer present (metastasis) in nearby lymph nodesM0MetastaticAny TAny NM1Cancer has spread to other parts of body (metastasized)Abbreviations: DRE = digital rectal examSource: NCCN Guidelines for Patients: Prostate Cancer, 2019 TNM scores may be combined to describe an overall cancer stage (I to IV). These are outlined in REF _Ref43472959 \h \* MERGEFORMAT Table 2 ADDIN EN.CITE <EndNote><Cite><Author>Cancer Council</Author><Year>2020</Year><RecNum>3</RecNum><DisplayText>(Cancer Council, 2020)</DisplayText><record><rec-number>3</rec-number><foreign-keys><key app="EN" db-id="rtafpsxaepf2d8epwsz5rdx8pr9fwvwwtzd0" timestamp="1592186409">3</key></foreign-keys><ref-type name="Report">27</ref-type><contributors><authors><author>Cancer Council,</author></authors></contributors><titles><title>Understanding Prostate Cancer. A guide for people with cancer, their families and friends</title></titles><dates><year>2020</year></dates><urls><related-urls><url>;(Cancer Council, 2020). Higher numbers indicate larger size or spread.Table SEQ Table \* ARABIC 2Overall prostate cancer stages, I to IVStage I and IILocalised Cancer is contained inside prostate.Stage IIILocally advancedCancer is larger and has spread outside prostate to nearby tissues or organs such as bladder, rectum or pelvic wall.Stage IVAdvanced Cancer has spread to distant parts of the body such as lymph glands or bone. Source: Cancer Council (2020)GradeGrade describes the appearance of prostate cancer cells under a microscope. Either the Gleason scoring system or the International Society of Uropathology (ISUP) grade group system is used to grade tissue taken during biopsy. Higher scores indicate a more aggressive appearance.The Gleason scoring system was superseded by the ISUP grade group system in 2014 PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5DYW5jZXIgQ291bmNpbDwvQXV0aG9yPjxZZWFyPjIwMjA8

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ADDIN EN.CITE.DATA (Cancer Council, 2020; Srigley et al., 2019). Grade groups are derived from Gleason scores, however they are more equipped to reflect modern diagnostic and therapeutic practices PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5TcmlnbGV5PC9BdXRob3I+PFllYXI+MjAxOTwvWWVhcj48

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ADDIN EN.CITE.DATA (Mohler et al., 2019; Srigley et al., 2019). A simplified overview of the link between the two systems is provided in REF _Ref43473382 \h Table 3 ADDIN EN.CITE <EndNote><Cite><Author>Cancer Council</Author><Year>2020</Year><RecNum>3</RecNum><DisplayText>(Cancer Council, 2020)</DisplayText><record><rec-number>3</rec-number><foreign-keys><key app="EN" db-id="rtafpsxaepf2d8epwsz5rdx8pr9fwvwwtzd0" timestamp="1592186409">3</key></foreign-keys><ref-type name="Report">27</ref-type><contributors><authors><author>Cancer Council,</author></authors></contributors><titles><title>Understanding Prostate Cancer. A guide for people with cancer, their families and friends</title></titles><dates><year>2020</year></dates><urls><related-urls><url>;(Cancer Council, 2020).Table SEQ Table \* ARABIC 3Link between Gleason scores and ISUP grade groupsISUP Grade GroupGleason Score1≤62–374–5≥8Abbreviations: ISUP = International Society of UropathologySource: Cancer Council (2020)Disease burdenProstate cancer is the most frequently diagnosed cancer among Australian males. The Australian Institute of Health and Welfare (AIHW) estimated that 19,508 men would be diagnosed with the disease in 2019 ADDIN EN.CITE <EndNote><Cite><Author>Australian Institute of Health and Welfare</Author><Year>2019</Year><RecNum>4</RecNum><DisplayText>(Australian Institute of Health and Welfare, 2019)</DisplayText><record><rec-number>4</rec-number><foreign-keys><key app="EN" db-id="rtafpsxaepf2d8epwsz5rdx8pr9fwvwwtzd0" timestamp="1592186511">4</key></foreign-keys><ref-type name="Report">27</ref-type><contributors><authors><author>Australian Institute of Health and Welfare,</author></authors></contributors><titles><title>Cancer in Australia 2019</title><secondary-title>Cancer Series no.119. Cat. no. 123</secondary-title></titles><dates><year>2019</year></dates><pub-location>Canberra</pub-location><publisher>AIHW</publisher><urls></urls></record></Cite></EndNote>(Australian Institute of Health and Welfare, 2019). The age-standardised incidence rate was estimated at 130.2 per 100,000 men (62.6 per 100,000 people).Prostate cancer is the second most common cause of death in Australian men, behind lung cancer. The AIHW reported that prostate cancer would be responsible for an estimated 3,306 deaths in 2019, or 23.0 deaths per 100,000 men (10.0 per 100,000 people) ADDIN EN.CITE <EndNote><Cite><Author>Australian Institute of Health and Welfare</Author><Year>2019</Year><RecNum>4</RecNum><DisplayText>(Australian Institute of Health and Welfare, 2019)</DisplayText><record><rec-number>4</rec-number><foreign-keys><key app="EN" db-id="rtafpsxaepf2d8epwsz5rdx8pr9fwvwwtzd0" timestamp="1592186511">4</key></foreign-keys><ref-type name="Report">27</ref-type><contributors><authors><author>Australian Institute of Health and Welfare,</author></authors></contributors><titles><title>Cancer in Australia 2019</title><secondary-title>Cancer Series no.119. Cat. no. 123</secondary-title></titles><dates><year>2019</year></dates><pub-location>Canberra</pub-location><publisher>AIHW</publisher><urls></urls></record></Cite></EndNote>(Australian Institute of Health and Welfare, 2019).The overall five-year relative survival rate (i.e. the probability of being alive 5 years after diagnosis compared to the general population) for men with prostate cancer was 95.2% between 2011 and 2015 ADDIN EN.CITE <EndNote><Cite><Author>Australian Institute of Health and Welfare</Author><Year>2019</Year><RecNum>4</RecNum><DisplayText>(Australian Institute of Health and Welfare, 2019)</DisplayText><record><rec-number>4</rec-number><foreign-keys><key app="EN" db-id="rtafpsxaepf2d8epwsz5rdx8pr9fwvwwtzd0" timestamp="1592186511">4</key></foreign-keys><ref-type name="Report">27</ref-type><contributors><authors><author>Australian Institute of Health and Welfare,</author></authors></contributors><titles><title>Cancer in Australia 2019</title><secondary-title>Cancer Series no.119. Cat. no. 123</secondary-title></titles><dates><year>2019</year></dates><pub-location>Canberra</pub-location><publisher>AIHW</publisher><urls></urls></record></Cite></EndNote>(Australian Institute of Health and Welfare, 2019). For patients with stage I–III disease, the five-year relative survival rate was close to 100%, whilst for patients with stage IV disease it was significantly lower, at 36%.The five-year relative survival for prostate cancer has significantly improved over the last 25 years. According to data collected by Cancer Australia in collaboration with the AIHW, most prostate cancer cases are now diagnosed as stage I or II (82.0% in 2011) ADDIN EN.CITE <EndNote><Cite><Author>Australian Institute of Health and Welfare</Author><Year>2019</Year><RecNum>4</RecNum><DisplayText>(Australian Institute of Health and Welfare, 2019)</DisplayText><record><rec-number>4</rec-number><foreign-keys><key app="EN" db-id="rtafpsxaepf2d8epwsz5rdx8pr9fwvwwtzd0" timestamp="1592186511">4</key></foreign-keys><ref-type name="Report">27</ref-type><contributors><authors><author>Australian Institute of Health and Welfare,</author></authors></contributors><titles><title>Cancer in Australia 2019</title><secondary-title>Cancer Series no.119. Cat. no. 123</secondary-title></titles><dates><year>2019</year></dates><pub-location>Canberra</pub-location><publisher>AIHW</publisher><urls></urls></record></Cite></EndNote>(Australian Institute of Health and Welfare, 2019). It is possible the advent of PSA testing is linked to the early diagnosis of most cases ADDIN EN.CITE <EndNote><Cite><Author>Australian Institute of Health and Welfare</Author><Year>2019</Year><RecNum>4</RecNum><DisplayText>(Australian Institute of Health and Welfare, 2019)</DisplayText><record><rec-number>4</rec-number><foreign-keys><key app="EN" db-id="rtafpsxaepf2d8epwsz5rdx8pr9fwvwwtzd0" timestamp="1592186511">4</key></foreign-keys><ref-type name="Report">27</ref-type><contributors><authors><author>Australian Institute of Health and Welfare,</author></authors></contributors><titles><title>Cancer in Australia 2019</title><secondary-title>Cancer Series no.119. Cat. no. 123</secondary-title></titles><dates><year>2019</year></dates><pub-location>Canberra</pub-location><publisher>AIHW</publisher><urls></urls></record></Cite></EndNote>(Australian Institute of Health and Welfare, 2019).Population 1Population 1 comprises patients with biopsy-proven prostate adenocarcinoma with intermediate- or high-risk features, for whom locoregional therapy with curative intent is considered suitable. PSMA PET/CT imaging in this population is used for initial staging.Patients with intermediate-risk features include those with at least one of the following risk factors, in the absence of any high-risk features:PSA of 10-20ng/ml, orGleason score of 7 or ISUP grade group 2 or 3, orStage T2b or T2c (depending on guideline).Patients with high-risk features include those with at least one of the following risk factors: PSA of >20ng/ml, orGleason score >7 or ISUP grade group 4 or 5, orStage T2c (depending on guideline), or ≥T3.Initial risk stratificationRisk stratification of patients with localised or locally advanced disease assists in treatment decision-making and moreover, predicts the patient’s risk of BCR after definitive treatment ADDIN EN.CITE <EndNote><Cite><Author>Mohler</Author><Year>2019</Year><RecNum>36</RecNum><DisplayText>(Mohler et al., 2019)</DisplayText><record><rec-number>36</rec-number><foreign-keys><key app="EN" db-id="rtafpsxaepf2d8epwsz5rdx8pr9fwvwwtzd0" timestamp="1592373464">36</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>James L. Mohler</author><author>Emmanuel S. Antonarakis</author><author>Andrew J. Armstrong</author><author>Anthony V. D’Amico</author><author>Brian J. Davis</author><author>Tanya Dorff</author><author>James A. Eastham</author><author>Charles A. Enke</author><author>Thomas A. Farrington</author><author>Celestia S. Higano</author><author>Eric Mark Horwitz</author><author>Michael Hurwitz</author><author>Joseph E. Ippolito</author><author>Christopher J. Kane</author><author>Michael R. Kuettel</author><author>Joshua M. Lang</author><author>Jesse McKenney</author><author>George Netto</author><author>David F. Penson</author><author>Elizabeth R. Plimack</author><author>Julio M. Pow-Sang</author><author>Thomas J. Pugh</author><author>Sylvia Richey</author><author>Mack Roach</author><author>Stan Rosenfeld</author><author>Edward Schaeffer</author><author>Ahmad Shabsigh</author><author>Eric J. Small</author><author>Daniel E. Spratt</author><author>Sandy Srinivas</author><author>Jonathan Tward</author><author>Dorothy A. Shead</author><author>Deborah A. Freedman-Cass</author></authors></contributors><titles><title>Prostate Cancer, Version 2.2019, NCCN Clinical Practice Guidelines in Oncology</title></titles><pages>479</pages><volume>17</volume><number>5</number><dates><year>2019</year></dates><isbn>1540-1405</isbn><urls><related-urls><url>;(Mohler et al., 2019). At a minimum, a patient’s PSA level, and stage and grade of cancer are taken into consideration.The intermediate- and high-risk features of clinically localised (or locally advanced) disease specified in European Association of Urology (EAU) and National Comprehensive Cancer Network (NCCN) guidelines are summarised in REF _Ref43473640 \h Table 4 PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Nb3R0ZXQ8L0F1dGhvcj48WWVhcj4yMDIwPC9ZZWFyPjxS

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ADDIN EN.CITE.DATA (Mohler et al., 2019; Mottet et al., 2020). Both NCCN and EAU guidelines are accepted in clinical practice (personal communication, expert radiation oncologist, 25 June 2020).Table SEQ Table \* ARABIC 4EAU and NCCN guideline definitions of intermediate risk and high riskEAU guidelinesNCCN guidelinesIntermediate riskPSA 10-20 ng/ml, orGleason score of 7 or ISUP grade group 2 or 3, orStage T2bPSA 10-20 ng/ml, orISUP grade group 2 or 3, orStage T2b–T2cFavourable intermediate: 1 IRF, and grade group 1 or 2, and <50% biopsy cores positiveUnfavourable intermediate: 2 or 3 IRFs, and/or grade group 3, and/or ≥50% biopsy cores positiveHigh riskPSA >20ng/mL, orGleason score >7 or ISUP grade group 4 or 5, orStage T2cOr, for locally advanced disease:Any PSAAny Gleason score or ISUP grade group, andStage T3–T4, or N+ PSA >20ng/ml, orISUP grade group 4 or 5, orStage T3aVery-high-risk features:Primary Gleason pattern 5, or>4 cores of ISUP grade group 4 or 5, orStage T3b–T4Abbreviations: EAU = European Association of Urology, ISUP = International Society of Uropathology, IRF = intermediate risk factor, NCCN = National Comprehensive Cancer Network, N+ = cancer present in regional lymph nodes, PSA = prostate specific antigenSource: EAU guidelines ADDIN EN.CITE <EndNote><Cite><Author>Mottet</Author><Year>2020</Year><RecNum>10</RecNum><DisplayText>(Mottet et al., 2020)</DisplayText><record><rec-number>10</rec-number><foreign-keys><key app="EN" db-id="rtafpsxaepf2d8epwsz5rdx8pr9fwvwwtzd0" timestamp="1592204157">10</key></foreign-keys><ref-type name="Web Page">12</ref-type><contributors><authors><author>Mottet, N.</author><author>van den Bergh, R. C. N.</author><author>Briers, E.</author><author>Cornford, P.</author><author>De Santis, M.</author><author>Fanti, S.</author><author>Gillessen, S.</author><author>Grummet, J.</author><author>Henry, A. M.</author><author>Lam, T. B.</author><author>Mason, M. D.</author><author>van der Poel, H. G.</author><author>van der Kwast, T. H.</author><author>Rouvière, O.</author><author>Schoots, I.</author><author>Tilki, D.</author><author>Wiegel, T.</author></authors></contributors><titles><title>EAU - ESTRO - ESUR - SIOG Guidelines on Prostate Cancer 2020</title></titles><volume>2020</volume><number>15 June</number><dates><year>2020</year></dates><isbn>978-94-92671-07-3</isbn><urls><related-urls><url>;(Mottet et al., 2020) and NCCN guidelines ADDIN EN.CITE <EndNote><Cite><Author>Mohler</Author><Year>2019</Year><RecNum>36</RecNum><DisplayText>(Mohler et al., 2019)</DisplayText><record><rec-number>36</rec-number><foreign-keys><key app="EN" db-id="rtafpsxaepf2d8epwsz5rdx8pr9fwvwwtzd0" timestamp="1592373464">36</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>James L. Mohler</author><author>Emmanuel S. Antonarakis</author><author>Andrew J. Armstrong</author><author>Anthony V. D’Amico</author><author>Brian J. Davis</author><author>Tanya Dorff</author><author>James A. Eastham</author><author>Charles A. Enke</author><author>Thomas A. Farrington</author><author>Celestia S. Higano</author><author>Eric Mark Horwitz</author><author>Michael Hurwitz</author><author>Joseph E. Ippolito</author><author>Christopher J. Kane</author><author>Michael R. Kuettel</author><author>Joshua M. Lang</author><author>Jesse McKenney</author><author>George Netto</author><author>David F. Penson</author><author>Elizabeth R. Plimack</author><author>Julio M. Pow-Sang</author><author>Thomas J. Pugh</author><author>Sylvia Richey</author><author>Mack Roach</author><author>Stan Rosenfeld</author><author>Edward Schaeffer</author><author>Ahmad Shabsigh</author><author>Eric J. Small</author><author>Daniel E. Spratt</author><author>Sandy Srinivas</author><author>Jonathan Tward</author><author>Dorothy A. Shead</author><author>Deborah A. Freedman-Cass</author></authors></contributors><titles><title>Prostate Cancer, Version 2.2019, NCCN Clinical Practice Guidelines in Oncology</title></titles><pages>479</pages><volume>17</volume><number>5</number><dates><year>2019</year></dates><isbn>1540-1405</isbn><urls><related-urls><url>;(Mohler et al., 2019) The guidelines are in alignment with respect to PSA levels (10-20ng/ml for intermediate risk, >20ng/ml for high risk) and ISUP grade group (grade 2 or 3 for intermediate risk, grade 4 or 5 for high risk). Clinical stage T2c is defined as an intermediate-risk feature in NCCN guidelines, but a high-risk feature in EAU guidelines.Intermediate- and high-risk features defined in the inclusion criteria of two recent Australian clinical studies on PSMA PET/CT PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Sb2FjaDwvQXV0aG9yPjxZZWFyPjIwMTg8L1llYXI+PFJl

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ADDIN EN.CITE.DATA (Bryant et al., 2020) are listed in REF _Ref43473732 \h Table 5.Table SEQ Table \* ARABIC 5Representative clinical study definitions of intermediate- and high-risk featuresRoach et al. (2018)Hofman et al. (2020)Bryant et al. 2020IntermediatePSA 10-20 ng/mlGleason score of 7, andClinical or MRI evidence of stage T2 diseaseNot included in study populationPSA >10 and ≤20ng/mlGleason score 7 (grade group 2 or 3), orT2b diseaseHighPSA >20ng/ml, orGleason score ≥8, andClinical or MRI evidence of disease stage T3 or greater PSA concentration ≥20ng/ml (measured within last 12 weeks)ISUP grade group 3 or 5, orClinical stage T3 or greaterPSA >20ng/mlGleason score ≥8 (grade group ≥4)T2c diseaseAbbreviations: ISUP = International Society of Uropathology, MRI = magnetic resonance imaging, PSA = prostate specific antigenSource: PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Ib2ZtYW48L0F1dGhvcj48WWVhcj4yMDIwPC9ZZWFyPjxS

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ADDIN EN.CITE.DATA (Bryant et al., 2020; Hofman et al., 2020; Roach et al., 2018)There is slight variation between the inclusion criteria used by Hofman et al. (2020) and guideline definitions regarding ISUP grade groupings, with Hofman et al. (2020) defining ISUP grade group 3 as a high-risk feature.Clinical stage T2c is defined by Hofman et al. (2020) and Roach et al. (2018) as an intermediate-risk feature for patients with a histologic diagnosis of prostate cancer undergoing initial staging, in line with NCCN guidelines. Bryant et al. (2020) define clinical stage T2c as a high-risk feature in post hoc risk stratification of patients diagnosed with clinically localised disease randomised to active monitoring, surgery or radiotherapy, conforming to EAU risk groups. Higher clinical stages consistent with locally advanced disease (T3 and T4) were not included PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5CcnlhbnQ8L0F1dGhvcj48WWVhcj4yMDIwPC9ZZWFyPjxS

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ADDIN EN.CITE.DATA (Bryant et al., 2020; Hamdy et al., 2016).Estimated patient numbers for Population 1The Applicant estimated that of the approximate 20,000 new cases of prostate cancer diagnosed per annum, around half (10,000 cases) would show intermediate- to high-risk features and thus be considered for PSMA PET/CT imaging.Post hoc risk stratification undertaken by Bryant et al. (2020) on a cohort of patients with an initial diagnosis of clinically localised disease (T1c or T2a–c) found 34% of patients to have intermediate- or high-risk features PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5CcnlhbnQ8L0F1dGhvcj48WWVhcj4yMDIwPC9ZZWFyPjxS

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ADDIN EN.CITE.DATA (Bryant et al., 2020). This estimate does not take into those with locally advanced disease (T3 or T4).AIHW data suggests that of all localised or locally advanced prostate cancers diagnosed in 2011, approximately 12.0% were diagnosed with locally advanced (stage III) disease (see REF _Ref44066555 \h Table 6). According to clinical guidelines, patients with locally advanced disease are high risk (see REF _Ref43473640 \h Table 4).Table SEQ Table \* ARABIC 6Number of patients diagnosed with stage I, II or III disease in Australia, 2011Clinical stage at diagnosisStage IStage IIStage IIITotalCross reference and/or sourceExtent of diseaseLocalisedLocalisedLocally advanced REF _Ref43472959 \h \* MERGEFORMAT Table 2, ADDIN EN.CITE <EndNote><Cite><Author>Cancer Council</Author><Year>2020</Year><RecNum>3</RecNum><DisplayText>(Cancer Council, 2020)</DisplayText><record><rec-number>3</rec-number><foreign-keys><key app="EN" db-id="rtafpsxaepf2d8epwsz5rdx8pr9fwvwwtzd0" timestamp="1592186409">3</key></foreign-keys><ref-type name="Report">27</ref-type><contributors><authors><author>Cancer Council,</author></authors></contributors><titles><title>Understanding Prostate Cancer. A guide for people with cancer, their families and friends</title></titles><dates><year>2020</year></dates><urls><related-urls><url>;(Cancer Council, 2020)Number of cases7,1869,2452,24618,677 ADDIN EN.CITE <EndNote><Cite><Author>Australian Institute of Health and Welfare</Author><Year>2019</Year><RecNum>4</RecNum><DisplayText>(Australian Institute of Health and Welfare, 2019)</DisplayText><record><rec-number>4</rec-number><foreign-keys><key app="EN" db-id="rtafpsxaepf2d8epwsz5rdx8pr9fwvwwtzd0" timestamp="1592186511">4</key></foreign-keys><ref-type name="Report">27</ref-type><contributors><authors><author>Australian Institute of Health and Welfare,</author></authors></contributors><titles><title>Cancer in Australia 2019</title><secondary-title>Cancer Series no.119. Cat. no. 123</secondary-title></titles><dates><year>2019</year></dates><pub-location>Canberra</pub-location><publisher>AIHW</publisher><urls></urls></record></Cite></EndNote>(Australian Institute of Health and Welfare, 2019)Proportion ?38.5%49.5%12.0%100%CalculatedNotes: ? = excluding stage IV and disease of unknown stageWith a combined estimate of 46%, these figures support the Applicant’s estimate that approximately half of the patients diagnosed with prostate cancer have intermediate- or high-risk features at diagnosis.Population 2Population 2 includes patients with recurrent prostate adenocarcinoma, for whom locoregional therapy to delay systemic therapy is considered suitable. For these patients, PSMA PET/CT is used for restaging; primarily, for ruling out metastatic disease to help guide treatment decisions. Moreover, for patients for whom radiotherapy is the best option, PSMA PET/CT may help guide the radiation field and dose.Specifically, Population 2 includes patients with PSA persistence/recurrence after prior locoregional therapy. This includes patients with:a PSA increase of 2ng/ml above the nadir after external beam radiotherapy (EBRT), orfailure of PSA to fall to undetectable levels or rising serum PSA after radical prostatectomy.PSA persistenceA detectable or persistent PSA level after radical prostatectomy is considered PSA persistence PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5WYW4gZGVuIEJyb2VjazwvQXV0aG9yPjxZZWFyPjIwMjA8

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AG==

ADDIN EN.CITE.DATA (Van den Broeck et al., 2020). The presence of persistent local disease, pre-existing metastases or residual benign prostate tissue may be responsible ADDIN EN.CITE <EndNote><Cite><Author>Mottet</Author><Year>2020</Year><RecNum>10</RecNum><DisplayText>(Mottet et al., 2020)</DisplayText><record><rec-number>10</rec-number><foreign-keys><key app="EN" db-id="rtafpsxaepf2d8epwsz5rdx8pr9fwvwwtzd0" timestamp="1592204157">10</key></foreign-keys><ref-type name="Web Page">12</ref-type><contributors><authors><author>Mottet, N.</author><author>van den Bergh, R. C. N.</author><author>Briers, E.</author><author>Cornford, P.</author><author>De Santis, M.</author><author>Fanti, S.</author><author>Gillessen, S.</author><author>Grummet, J.</author><author>Henry, A. M.</author><author>Lam, T. B.</author><author>Mason, M. D.</author><author>van der Poel, H. G.</author><author>van der Kwast, T. H.</author><author>Rouvière, O.</author><author>Schoots, I.</author><author>Tilki, D.</author><author>Wiegel, T.</author></authors></contributors><titles><title>EAU - ESTRO - ESUR - SIOG Guidelines on Prostate Cancer 2020</title></titles><volume>2020</volume><number>15 June</number><dates><year>2020</year></dates><isbn>978-94-92671-07-3</isbn><urls><related-urls><url>;(Mottet et al., 2020).Biochemical recurrenceBCR occurs when there is a significant rise in PSA levels following definitive treatment. Relapse following curative intent treatment is thought to be due, in part, to poor sensitivity and specificity of conventional imaging in detecting non-localised disease PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Ib2ZtYW48L0F1dGhvcj48WWVhcj4yMDIwPC9ZZWFyPjxS

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AG==

ADDIN EN.CITE.DATA (Van den Broeck et al., 2020).The Radiation Therapy Oncology Group/American Society for Therapeutic Radiology and Oncology Phoenix Consensus Conference proposed a PSA increase of 2ng/ml or more above the PSA nadir—regardless of the nadir value—as a standard definition for BCR after EBRT PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Sb2FjaDwvQXV0aG9yPjxZZWFyPjIwMDY8L1llYXI+PFJl

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ADDIN EN.CITE.DATA (Roach et al., 2006; Van den Broeck et al., 2020). Expert clinical advice confirmed that this ‘Phoenix definition’ is accepted clinically, although this is not definitive (personal communication, expert radiation oncologist, 25 June 2020).American Society for Radiation Oncology/American Urological Association guidelines recommend clinicians define BCR after prostatectomy as a rise in PSA levels of ≥0.2ng/ml with a secondary confirmatory level ≥0.2ng/ml ADDIN EN.CITE <EndNote><Cite><Author>Thompson</Author><Year>2019</Year><RecNum>23</RecNum><DisplayText>(Thompson et al., 2019)</DisplayText><record><rec-number>23</rec-number><foreign-keys><key app="EN" db-id="rtafpsxaepf2d8epwsz5rdx8pr9fwvwwtzd0" timestamp="1592354647">23</key><key app="ENWeb" db-id="">0</key></foreign-keys><ref-type name="Report">27</ref-type><contributors><authors><author>Thompson, I. M.</author><author>Valicenti, R.</author><author>Albertsen, P. C.</author><author>Davis, B.</author><author>Goldenburg, L.</author><author>Hahn, C. A.</author><author>Klein, E. A.</author><author>Michalski, J.</author><author>Roach, M.</author><author>Sartor, O</author><author>Wolf., J. S. </author><author>Faraday, M</author></authors></contributors><titles><title>Adjuvant and Salvage Radiotherapy after Prostatectomy: ASTRO/AUA Guideline</title></titles><dates><year>2019</year></dates><publisher>American Urology Association</publisher><urls><related-urls><url>;(Thompson et al., 2019). The guidelines note that most published studies use a PSA threshold of 0.2ng/ml to define recurrence after surgery. However, a lower threshold (PSA level ≥0.05ng/ml) has been used in some studies PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5IdWl0czwvQXV0aG9yPjxZZWFyPjIwMjA8L1llYXI+PFJl

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ADDIN EN.CITE.DATA (Huits et al., 2020; van Leeuwen et al., 2016). Expert clinical advice confirmed that, generally, a PSA level of 0.2ng/ml and rising is accepted clinically to signify BCR after radical prostatectomy, although again, is not definitive (personal communication, expert radiation oncologist, 25 June 2020).According to EAU guidelines, the following can be considered evidence of BCR ADDIN EN.CITE <EndNote><Cite><Author>Mottet</Author><Year>2020</Year><RecNum>10</RecNum><DisplayText>(Mottet et al., 2020)</DisplayText><record><rec-number>10</rec-number><foreign-keys><key app="EN" db-id="rtafpsxaepf2d8epwsz5rdx8pr9fwvwwtzd0" timestamp="1592204157">10</key></foreign-keys><ref-type name="Web Page">12</ref-type><contributors><authors><author>Mottet, N.</author><author>van den Bergh, R. C. N.</author><author>Briers, E.</author><author>Cornford, P.</author><author>De Santis, M.</author><author>Fanti, S.</author><author>Gillessen, S.</author><author>Grummet, J.</author><author>Henry, A. M.</author><author>Lam, T. B.</author><author>Mason, M. D.</author><author>van der Poel, H. G.</author><author>van der Kwast, T. H.</author><author>Rouvière, O.</author><author>Schoots, I.</author><author>Tilki, D.</author><author>Wiegel, T.</author></authors></contributors><titles><title>EAU - ESTRO - ESUR - SIOG Guidelines on Prostate Cancer 2020</title></titles><volume>2020</volume><number>15 June</number><dates><year>2020</year></dates><isbn>978-94-92671-07-3</isbn><urls><related-urls><url>;(Mottet et al., 2020):increase in PSA of >2ng/ml above the nadir (lowest PSA value) after radiotherapyrising serum PSA level after radical prostatectomy.Estimated patient numbers for Population 2BCR is a common occurrence, it being reported that 27-53% of patients who undergo curative intent ablative procedures will experience BCR PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5WYW4gZGVuIEJyb2VjazwvQXV0aG9yPjxZZWFyPjIwMjA8

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ADDIN EN.CITE.DATA (Van den Broeck et al., 2020). A detectable or persistent PSA after radical prostatectomy may occur in 5-20% of patients ADDIN EN.CITE <EndNote><Cite><Author>Mottet</Author><Year>2020</Year><RecNum>10</RecNum><DisplayText>(Mottet et al., 2020)</DisplayText><record><rec-number>10</rec-number><foreign-keys><key app="EN" db-id="rtafpsxaepf2d8epwsz5rdx8pr9fwvwwtzd0" timestamp="1592204157">10</key></foreign-keys><ref-type name="Web Page">12</ref-type><contributors><authors><author>Mottet, N.</author><author>van den Bergh, R. C. N.</author><author>Briers, E.</author><author>Cornford, P.</author><author>De Santis, M.</author><author>Fanti, S.</author><author>Gillessen, S.</author><author>Grummet, J.</author><author>Henry, A. M.</author><author>Lam, T. B.</author><author>Mason, M. D.</author><author>van der Poel, H. G.</author><author>van der Kwast, T. H.</author><author>Rouvière, O.</author><author>Schoots, I.</author><author>Tilki, D.</author><author>Wiegel, T.</author></authors></contributors><titles><title>EAU - ESTRO - ESUR - SIOG Guidelines on Prostate Cancer 2020</title></titles><volume>2020</volume><number>15 June</number><dates><year>2020</year></dates><isbn>978-94-92671-07-3</isbn><urls><related-urls><url>;(Mottet et al., 2020).The Applicant advised that of all patients who undergo curative intent ablative procedures, around half (5,000 men) experience BCR. Thus, the Applicant’s estimate of 50% BCR frequency falls within the range of reported figures.The Applicant further advised that of those with BCR, approximately 80% (4,000 patients) would benefit from PSMA PET/CT imaging.Not all patients with BCR develop disease progression and metastatic disease. A patient’s risk of progression may influence whether early salvage treatment is initiated, or if treatment can be deferred PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5WYW4gZGVuIEJyb2VjazwvQXV0aG9yPjxZZWFyPjIwMjA8

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ADDIN EN.CITE.DATA (Van den Broeck et al., 2020). For patients with BCR and low-risk features who may not benefit from intervention, the guidelines recommend offering PSA monitoring.RationaleFor patients with low-risk features and a life expectancy of 10 years or greater, active surveillance as an alternative to immediate radical treatment is recommended PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Nb3R0ZXQ8L0F1dGhvcj48WWVhcj4yMDIwPC9ZZWFyPjxS

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ADDIN EN.CITE.DATA (Carroll and Mohler, 2018; Mottet et al., 2020; National Institute of Health and Care Excellence, 2019).PSMA PET/CT is a helpful test in early high-risk prostate cancer because most of these cancers have high (>95%) PSMA expression ADDIN EN.CITE <EndNote><Cite><Author>Hofman</Author><Year>2019</Year><RecNum>19</RecNum><DisplayText>(Hofman, 2019)</DisplayText><record><rec-number>19</rec-number><foreign-keys><key app="EN" db-id="rtafpsxaepf2d8epwsz5rdx8pr9fwvwwtzd0" timestamp="1592284112">19</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Hofman, M.</author></authors></contributors><auth-address>Peter MacCallum Cancer Centre, The University of Melbourne, Melbourne, Australia.</auth-address><titles><title>PSMA PET/CT for staging and treatment of prostate cancer</title><secondary-title>Clin Adv Hematol Oncol</secondary-title></titles><periodical><full-title>Clin Adv Hematol Oncol</full-title></periodical><pages>370-373</pages><volume>17</volume><number>7</number><edition>2019/08/27</edition><keywords><keyword>Antigens, Neoplasm/*metabolism</keyword><keyword>Antigens, Surface/*metabolism</keyword><keyword>Glutamate Carboxypeptidase II/*metabolism</keyword><keyword>Humans</keyword><keyword>Male</keyword><keyword>Neoplasm Proteins/*metabolism</keyword><keyword>Neoplasm Staging</keyword><keyword>*Positron Emission Tomography Computed Tomography</keyword><keyword>*Prostatic Neoplasms/diagnostic imaging/metabolism</keyword></keywords><dates><year>2019</year><pub-dates><date>Jul</date></pub-dates></dates><isbn>1543-0790 (Print)&#xD;1543-0790 (Linking)</isbn><accession-num>31449501</accession-num><urls><related-urls><url>;(Hofman, 2019). Early-stage prostate adenocarcinoma with neuroendocrine differentiation, and small- or large-cell neuroendocrine tumours of the prostate have low PSMA expression, therefore PSMA PET/CT is inadequate as a lone staging modality in these circumstances PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5BbGlwb3VyPC9BdXRob3I+PFllYXI+MjAxOTwvWWVhcj48

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ADDIN EN.CITE.DATA (Alipour et al., 2019).Thus, this application is restricted to adenocarcinoma type prostate cancers (personal email communication, Applicant, 10 July 2020).Monitoring systemic treatment in metastatic diseasePSMA PET/CT imaging for the monitoring of systemic therapy in metastatic disease is not included in the current submission (personal email communication, Applicant, 26 June 2020) given the present lack of evidence. However, the Applicant has advised that there is clinical utility for PSMA PET/CT in guiding therapy for patients with metastatic prostate cancer. Given a growing evidence base, the Applicant believes that this population should receive future consideration from MSAC.Expert clinical advice confirmed that, at present, PSMA PET/CT has very little clinical role in therapeutic monitoring except perhaps when prostate cancer patients are transitioning or progressing to a castrate resistant state as new treatment regimens are decided upon (personal communication, expert radiation oncologist, 25 June 2020). In hormone-sensitive patients where ADT is still working, PSMA PET/CT imaging is thought to be of no or minimal clinical value (personal teleconference communication, Applicant, 25 June 2020).PSMA-directed radionuclide therapyPSMA-directed radionuclide therapy is a potential second-line systemic treatment for metastatic prostate cancer with high PSMA expression.Radionuclide treatment with 177 Lutetium [???Lu]-PSMA-617 has been shown to have high response rates and low toxic effects, while reducing pain in patients with metastatic castrate-resistant prostate cancer (CRPC) who have progressed after conventional treatments PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Ib2ZtYW48L0F1dGhvcj48WWVhcj4yMDE4PC9ZZWFyPjxS

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ADDIN EN.CITE.DATA (Hofman et al., 2018). Two randomised clinical trials of [???Lu]-PSMA-617 radionuclide therapy in progressive CPRC are currently underway.The Applicant advises that patients having PSMA-targeting radionuclide therapy, or those being assessed for its suitability, require PSMA PET/CT imaging because comparator imaging modalities are not helpful.The Applicant notes that evidence supporting PSMA-targeting radionuclide therapy is currently available only in the setting of very-late-stage CRPC. This indication for PSMA PET/CT is beyond the scope of the current application. The applicant advised that a separate submission will be completed when further evidence on PSMA-based radionuclide therapy becomes available. PSMA PET/CT used in combination with radionuclide PSMA therapy is to be assessed as a co-dependent therapy in a subsequent submission (personal email communication, Applicant, 25 June 2020).PASC noted that the applicant had decided to remove two populations from its initial application: PSMA PET/CT imaging for the monitoring of patients treated with systemic therapy in metastatic disease (i.e. therapy monitoring); and for patients with metastatic prostate cancer being considered for targeted radionuclide treatment with Lutetium-177 [???Lu]-PSMA-617 (i.e. therapy guidance).Prior tests Population 1Prior to being referred for PSMA PET/CT (or comparator) imaging, patients will likely have undergone a DRE and/or PSA testing, multiparametric MRI and prostate biopsy to diagnose prostate cancer.DRE and/or PSA testing are used initially, to find prostate cancer early ADDIN EN.CITE <EndNote><Cite><Author>Prostate Cancer Foundation of Australia</Author><Year>2016</Year><RecNum>43</RecNum><DisplayText>(Prostate Cancer Foundation of Australia and Cancer Council Australia, 2016)</DisplayText><record><rec-number>43</rec-number><foreign-keys><key app="EN" db-id="rtafpsxaepf2d8epwsz5rdx8pr9fwvwwtzd0" timestamp="1592892882">43</key></foreign-keys><ref-type name="Report">27</ref-type><contributors><authors><author>Prostate Cancer Foundation of Australia,</author><author>Cancer Council Australia,</author></authors></contributors><titles><title>PSA testing and early management of test-detected prostate cancer: Clinical practice guidelines</title></titles><dates><year>2016</year></dates><pub-location>Sydney</pub-location><urls></urls></record></Cite></EndNote>(Prostate Cancer Foundation of Australia and Cancer Council Australia, 2016).If cancer is suspected based on DRE and/or PSA results, for a diagnosis to be made a prostate biopsy is required to provide histopathological evidence of adenocarcinoma ADDIN EN.CITE <EndNote><Cite><Author>Mottet</Author><Year>2020</Year><RecNum>10</RecNum><DisplayText>(Mottet et al., 2020)</DisplayText><record><rec-number>10</rec-number><foreign-keys><key app="EN" db-id="rtafpsxaepf2d8epwsz5rdx8pr9fwvwwtzd0" timestamp="1592204157">10</key></foreign-keys><ref-type name="Web Page">12</ref-type><contributors><authors><author>Mottet, N.</author><author>van den Bergh, R. C. N.</author><author>Briers, E.</author><author>Cornford, P.</author><author>De Santis, M.</author><author>Fanti, S.</author><author>Gillessen, S.</author><author>Grummet, J.</author><author>Henry, A. M.</author><author>Lam, T. B.</author><author>Mason, M. D.</author><author>van der Poel, H. G.</author><author>van der Kwast, T. H.</author><author>Rouvière, O.</author><author>Schoots, I.</author><author>Tilki, D.</author><author>Wiegel, T.</author></authors></contributors><titles><title>EAU - ESTRO - ESUR - SIOG Guidelines on Prostate Cancer 2020</title></titles><volume>2020</volume><number>15 June</number><dates><year>2020</year></dates><isbn>978-94-92671-07-3</isbn><urls><related-urls><url>;(Mottet et al., 2020). Current standard of care is an ultrasound-guided biopsy by either the transrectal or transperineal approach.Clinical practice guidelines increasingly recommend the use of multiparametric MRI prior to biopsy for initial prostate cancer diagnosis. For example, NCCN 2015 guidelines recommended multiparametric MRI in select cases after a previous negative biopsy, whilst 2018 guideline updates recommend consideration of multiparametric MRI or biomarker testing before biopsy PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5DYXJyb2xsPC9BdXRob3I+PFllYXI+MjAxNTwvWWVhcj48

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ADDIN EN.CITE.DATA (Carroll and Mohler, 2018; Carroll et al., 2015). Both EAU guidelines and National Institute of Health and Care Excellence (NICE) guidelines recommend multiparametric MRI prior to biopsy ADDIN EN.CITE <EndNote><Cite><Author>Mottet</Author><Year>2020</Year><RecNum>10</RecNum><DisplayText>(Mottet et al., 2020; National Institute of Health and Care Excellence, 2019)</DisplayText><record><rec-number>10</rec-number><foreign-keys><key app="EN" db-id="rtafpsxaepf2d8epwsz5rdx8pr9fwvwwtzd0" timestamp="1592204157">10</key></foreign-keys><ref-type name="Web Page">12</ref-type><contributors><authors><author>Mottet, N.</author><author>van den Bergh, R. C. N.</author><author>Briers, E.</author><author>Cornford, P.</author><author>De Santis, M.</author><author>Fanti, S.</author><author>Gillessen, S.</author><author>Grummet, J.</author><author>Henry, A. M.</author><author>Lam, T. B.</author><author>Mason, M. D.</author><author>van der Poel, H. G.</author><author>van der Kwast, T. H.</author><author>Rouvière, O.</author><author>Schoots, I.</author><author>Tilki, D.</author><author>Wiegel, T.</author></authors></contributors><titles><title>EAU - ESTRO - ESUR - SIOG Guidelines on Prostate Cancer 2020</title></titles><volume>2020</volume><number>15 June</number><dates><year>2020</year></dates><isbn>978-94-92671-07-3</isbn><urls><related-urls><url> Institute of Health and Care Excellence</Author><Year>2019</Year><RecNum>41</RecNum><record><rec-number>41</rec-number><foreign-keys><key app="EN" db-id="rtafpsxaepf2d8epwsz5rdx8pr9fwvwwtzd0" timestamp="1592823309">41</key></foreign-keys><ref-type name="Web Page">12</ref-type><contributors><authors><author>National Institute of Health and Care Excellence,</author></authors></contributors><titles><title>Prostate cancer: diagnosis and management. NICE guideline [NG131]</title></titles><volume>2020</volume><number>22 June</number><dates><year>2019</year></dates><urls><related-urls><url>;(Mottet et al., 2020; National Institute of Health and Care Excellence, 2019).In Australia, multiparametric MRI is listed on the MBS for the diagnosis of prostate cancer (item 63541) and the surveillance of prostate cancer in patients not currently undergoing treatment (item 63543) ADDIN EN.CITE <EndNote><Cite><Author>Australian Government Department of Health</Author><Year>2020</Year><RecNum>64</RecNum><DisplayText>(Australian Government Department of Health, 2020a)</DisplayText><record><rec-number>64</rec-number><foreign-keys><key app="EN" db-id="rtafpsxaepf2d8epwsz5rdx8pr9fwvwwtzd0" timestamp="1593493768">64</key></foreign-keys><ref-type name="Web Page">12</ref-type><contributors><authors><author>Australian Government Department of Health,</author></authors></contributors><titles><title>MBS Online</title></titles><volume>2020</volume><number>30 June</number><dates><year>2020</year></dates><urls><related-urls><url>;(Australian Government Department of Health, 2020a).Population 2For restaging after locoregional ablative therapies, patients will have undergone routine PSA monitoring prior to being referred for PSMA PET/CT (or comparator) imaging.NICE recommends PSA levels be checked no earlier than six weeks after radical treatment, at least every six months for the first two years, and then at least once per year after that ADDIN EN.CITE <EndNote><Cite><Author>National Institute of Health and Care Excellence</Author><Year>2019</Year><RecNum>41</RecNum><DisplayText>(National Institute of Health and Care Excellence, 2019)</DisplayText><record><rec-number>41</rec-number><foreign-keys><key app="EN" db-id="rtafpsxaepf2d8epwsz5rdx8pr9fwvwwtzd0" timestamp="1592823309">41</key></foreign-keys><ref-type name="Web Page">12</ref-type><contributors><authors><author>National Institute of Health and Care Excellence,</author></authors></contributors><titles><title>Prostate cancer: diagnosis and management. NICE guideline [NG131]</title></titles><volume>2020</volume><number>22 June</number><dates><year>2019</year></dates><urls><related-urls><url>;(National Institute of Health and Care Excellence, 2019). EAU guidelines recommend that after local treatment, asymptomatic patients be routinely followed up for disease-specific history and serum PSA levels at 3, 6 and 12 months; then every 6 months up to 3 years; then annually ADDIN EN.CITE <EndNote><Cite><Author>Mottet</Author><Year>2020</Year><RecNum>10</RecNum><DisplayText>(Mottet et al., 2020)</DisplayText><record><rec-number>10</rec-number><foreign-keys><key app="EN" db-id="rtafpsxaepf2d8epwsz5rdx8pr9fwvwwtzd0" timestamp="1592204157">10</key></foreign-keys><ref-type name="Web Page">12</ref-type><contributors><authors><author>Mottet, N.</author><author>van den Bergh, R. C. N.</author><author>Briers, E.</author><author>Cornford, P.</author><author>De Santis, M.</author><author>Fanti, S.</author><author>Gillessen, S.</author><author>Grummet, J.</author><author>Henry, A. M.</author><author>Lam, T. B.</author><author>Mason, M. D.</author><author>van der Poel, H. G.</author><author>van der Kwast, T. H.</author><author>Rouvière, O.</author><author>Schoots, I.</author><author>Tilki, D.</author><author>Wiegel, T.</author></authors></contributors><titles><title>EAU - ESTRO - ESUR - SIOG Guidelines on Prostate Cancer 2020</title></titles><volume>2020</volume><number>15 June</number><dates><year>2020</year></dates><isbn>978-94-92671-07-3</isbn><urls><related-urls><url>;(Mottet et al., 2020).InterventionThe intervention is PSMA PET/CT.Background on PET/CTPET imaging measures the biodistribution of an intravenously injected biological tracer labelled with a positron-emitting radionuclide ADDIN EN.CITE <EndNote><Cite><Author>Scott</Author><Year>2001</Year><RecNum>49</RecNum><DisplayText>(Scott, 2001)</DisplayText><record><rec-number>49</rec-number><foreign-keys><key app="EN" db-id="rtafpsxaepf2d8epwsz5rdx8pr9fwvwwtzd0" timestamp="1593047466">49</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Scott, A. M.</author></authors></contributors><auth-address>Centre for Positron Emission Tomography, Ludwig Institute for Cancer Research, Melbourne, Victoria, Australia.</auth-address><titles><title>Current status of positron emission tomography in oncology</title><secondary-title>Intern Med J</secondary-title><alt-title>Internal medicine journal</alt-title></titles><periodical><full-title>Intern Med J</full-title><abbr-1>Internal medicine journal</abbr-1></periodical><alt-periodical><full-title>Intern Med J</full-title><abbr-1>Internal medicine journal</abbr-1></alt-periodical><pages>27-36</pages><volume>31</volume><number>1</number><edition>2001/08/02</edition><keywords><keyword>Australia</keyword><keyword>Evaluation Studies as Topic</keyword><keyword>Fluorodeoxyglucose F18</keyword><keyword>Humans</keyword><keyword>Neoplasms/*diagnosis/diagnostic imaging</keyword><keyword>Tomography, Emission-Computed/*standards</keyword></keywords><dates><year>2001</year><pub-dates><date>Jan-Feb</date></pub-dates></dates><isbn>1444-0903 (Print)&#xD;1444-0903</isbn><accession-num>11478353</accession-num><urls></urls><electronic-resource-num>10.1046/j.1445-5994.2001.00015.x</electronic-resource-num><remote-database-provider>NLM</remote-database-provider><language>eng</language></record></Cite></EndNote>(Scott, 2001). In this way, PET imaging can detect and quantify a biological process occurring within the body.PET imaging is now almost always combined with CT, with scans collected using a single, hybrid PET/CT scanner. If used alone, PET imaging provides limited anatomical information and attenuation correction is a time-consuming process PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5MYXU8L0F1dGhvcj48WWVhcj4yMDA1PC9ZZWFyPjxSZWNO

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ADDIN EN.CITE.DATA (Lau et al., 2005).Various radiolabelled compounds targeting different physiological or biochemical processes can be used for PET/CT imaging.PSMA PET/CTPSMA is a glycoprotein found on the surface of prostate cells. It is highly overexpressed in prostate cancer cells (particularly in metastatic and castrate-resistant disease) and is thus a good target for staging and treatment ADDIN EN.CITE <EndNote><Cite><Author>Hofman</Author><Year>2019</Year><RecNum>19</RecNum><DisplayText>(Hofman, 2019)</DisplayText><record><rec-number>19</rec-number><foreign-keys><key app="EN" db-id="rtafpsxaepf2d8epwsz5rdx8pr9fwvwwtzd0" timestamp="1592284112">19</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Hofman, M.</author></authors></contributors><auth-address>Peter MacCallum Cancer Centre, The University of Melbourne, Melbourne, Australia.</auth-address><titles><title>PSMA PET/CT for staging and treatment of prostate cancer</title><secondary-title>Clin Adv Hematol Oncol</secondary-title></titles><periodical><full-title>Clin Adv Hematol Oncol</full-title></periodical><pages>370-373</pages><volume>17</volume><number>7</number><edition>2019/08/27</edition><keywords><keyword>Antigens, Neoplasm/*metabolism</keyword><keyword>Antigens, Surface/*metabolism</keyword><keyword>Glutamate Carboxypeptidase II/*metabolism</keyword><keyword>Humans</keyword><keyword>Male</keyword><keyword>Neoplasm Proteins/*metabolism</keyword><keyword>Neoplasm Staging</keyword><keyword>*Positron Emission Tomography Computed Tomography</keyword><keyword>*Prostatic Neoplasms/diagnostic imaging/metabolism</keyword></keywords><dates><year>2019</year><pub-dates><date>Jul</date></pub-dates></dates><isbn>1543-0790 (Print)&#xD;1543-0790 (Linking)</isbn><accession-num>31449501</accession-num><urls><related-urls><url>;(Hofman, 2019). Its exact function in prostate cancer is unclear.During a PSMA PET/CT scan, small radiolabelled molecules that bind to PSMA receptors are intravenously injected into the patient and given time to disperse throughout the body. PET/CT imaging detects these molecules, with a concentration at any location suggesting prostate cancer cells may be present.The Applicant specified that after intravenous administration of the tracer, 45 to 120 minutes may pass prior to PET/CT imaging. Imaging time is approximately 30 minutes, after which the image is interpreted by a qualified specialist and a report provided to the referring specialist.Health professionals involved in the delivery of PSMA PET/CT include nuclear medicine technologists, medical physicists, radiochemists, radiopharmacists, nuclear medicine physicians and radiologists. The proposed medical service cannot be delegated or referred to another professional for delivery.The Applicant advises that no additional healthcare resources or medical services need to be delivered at the same time as PSMA PET/CT.Access to PSMA PET/CT imaging is limited by the number of PET/CT equipped sites. As of 31 March 2019, 77 sites were listed on the Australian Department of Health’s website ADDIN EN.CITE <EndNote><Cite><Author>Australian Government Department of Health</Author><Year>2020</Year><RecNum>20</RecNum><DisplayText>(Australian Government Department of Health, 2020b)</DisplayText><record><rec-number>20</rec-number><foreign-keys><key app="EN" db-id="rtafpsxaepf2d8epwsz5rdx8pr9fwvwwtzd0" timestamp="1592287614">20</key></foreign-keys><ref-type name="Web Page">12</ref-type><contributors><authors><author>Australian Government Department of Health,</author></authors></contributors><titles><title>PET unit locations by Australian state and territory</title></titles><volume>2020</volume><number>16 June</number><dates><year>2020</year><pub-dates><date>7 January 2020</date></pub-dates></dates><urls><related-urls><url>;(Australian Government Department of Health, 2020b). According to the Applicant, approximately 91 scanners are currently available, with 9 more under consideration. Notably, most PET scanners are in major cities, therefore uptake of PSMA PET/CT among patients in rural or remote areas may be restricted.The radioactive tracerThe most widely used radiopharmaceutical tracer is 68Ga-PSMA-11, which combines a small molecule that binds to PSMA receptors (PSMA-11) with a radioactive carrier (68Ga). Two other radiopharmaceutical tracers gaining in popularity are the Fluorine-18 (18F)-labelled tracers 18F-DCFPyL and 18F-PSMA1007 ADDIN EN.CITE <EndNote><Cite><Author>Hofman</Author><Year>2019</Year><RecNum>19</RecNum><DisplayText>(Hofman, 2019)</DisplayText><record><rec-number>19</rec-number><foreign-keys><key app="EN" db-id="rtafpsxaepf2d8epwsz5rdx8pr9fwvwwtzd0" timestamp="1592284112">19</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Hofman, M.</author></authors></contributors><auth-address>Peter MacCallum Cancer Centre, The University of Melbourne, Melbourne, Australia.</auth-address><titles><title>PSMA PET/CT for staging and treatment of prostate cancer</title><secondary-title>Clin Adv Hematol Oncol</secondary-title></titles><periodical><full-title>Clin Adv Hematol Oncol</full-title></periodical><pages>370-373</pages><volume>17</volume><number>7</number><edition>2019/08/27</edition><keywords><keyword>Antigens, Neoplasm/*metabolism</keyword><keyword>Antigens, Surface/*metabolism</keyword><keyword>Glutamate Carboxypeptidase II/*metabolism</keyword><keyword>Humans</keyword><keyword>Male</keyword><keyword>Neoplasm Proteins/*metabolism</keyword><keyword>Neoplasm Staging</keyword><keyword>*Positron Emission Tomography Computed Tomography</keyword><keyword>*Prostatic Neoplasms/diagnostic imaging/metabolism</keyword></keywords><dates><year>2019</year><pub-dates><date>Jul</date></pub-dates></dates><isbn>1543-0790 (Print)&#xD;1543-0790 (Linking)</isbn><accession-num>31449501</accession-num><urls><related-urls><url>;(Hofman, 2019). 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ADDIN EN.CITE.DATA (Alipour et al., 2019).PASC noted that the most widely used radiopharmaceutical tracer in clinical practice in Australia and internationally is 68Ga-PSMA-11. The Fluorine-18 (18F)-labelled tracer: 18F-DCFPyL is currently used in clinical trials in Australia (ACTRN12620000261910; ACTRN12618001530213).The applicant noted that 18F-DCFPyL is not only used in the clinical trial setting, and approximately 8000 patient doses had been dispensed under the SAS provisions to support clinical management decisions. The applicant further noted that clinical expert Professor Declan Murphy, confirmed that in practice at Peter MacCallum Cancer Centre, 68Ga-PSMA-11 and 18F-DCFPyL were considered to be clinically equivalent and were used interchangeably depending upon daily availability.Supply of radioactive tracers is regulated by the Therapeutic Goods Act 1989, administered by the Therapeutic Goods Administration. Radiopharmaceuticals prepared extemporaneously are specifically exempt from the requirement for an Australian Register of Therapeutic Goods (ARTG) listing.The Applicant advised that these radioactive tracers are supplied either by in-house production of 68Ga-based pharmaceuticals or by commercial provision of longer lasting fluorine-based tracers, and supply is expected to be able to keep pace with increasing demand. Expert clinical advice confirmed that there is now a well-established distribution network across major centres, noting the greatest logistical issues are around the supply of 68Ga tracers, which must be made in-house due to their shorter half-life (personal communication, expert radiation oncologist, 25 June 2020).Frequency of useThe Applicant provided the following advice for the two populations included in this application:Approximately half of all patients will be cured by primary therapy. For these patients only a single PSMA PET/CT scan for initial staging is required.For patients who experience BCR, a second PSMA PET/CT scan would be required to inform treatment decisions when planning active therapy. This may occur months to many years after initial curative intent therapies.Current use in Australian clinical practiceThe MBS Review Taskforce recommended that MSAC consider listing 68Ga-PSMA PET/CT for patients with prostate cancer ADDIN EN.CITE <EndNote><Cite><Author>Medicare Benefits Schedule Review Taskforce</Author><Year>2018</Year><RecNum>1</RecNum><DisplayText>(Medicare Benefits Schedule Review Taskforce, 2018)</DisplayText><record><rec-number>1</rec-number><foreign-keys><key app="EN" db-id="rtafpsxaepf2d8epwsz5rdx8pr9fwvwwtzd0" timestamp="1591774835">1</key></foreign-keys><ref-type name="Report">27</ref-type><contributors><authors><author>Medicare Benefits Schedule Review Taskforce,</author></authors></contributors><titles><title>Report from the Diagnostic Imaging Committee - Nuclear Medicine</title></titles><dates><year>2018</year></dates><urls></urls></record></Cite></EndNote>(Medicare Benefits Schedule Review Taskforce, 2018). The Taskforce noted that 68Ga-PSMA PET/CT is now being offered in private practice settings around Australia despite a lack of MBS funding.The Applicant advises that Australian clinicians have accepted the superiority of PSMA PET/CT over MBS-funded conventional imaging modalities for defining the location and extent of active prostate cancer, and that PSMA PET/CT is now routinely used in patients who can arrange funding for the scan. The MBS Review Taskforce noted that the lack of federal funding—despite adoption of the modality in routine practice—has resulted in an equity gap ADDIN EN.CITE <EndNote><Cite><Author>Medicare Benefits Schedule Review Taskforce</Author><Year>2018</Year><RecNum>1</RecNum><DisplayText>(Medicare Benefits Schedule Review Taskforce, 2018)</DisplayText><record><rec-number>1</rec-number><foreign-keys><key app="EN" db-id="rtafpsxaepf2d8epwsz5rdx8pr9fwvwwtzd0" timestamp="1591774835">1</key></foreign-keys><ref-type name="Report">27</ref-type><contributors><authors><author>Medicare Benefits Schedule Review Taskforce,</author></authors></contributors><titles><title>Report from the Diagnostic Imaging Committee - Nuclear Medicine</title></titles><dates><year>2018</year></dates><urls></urls></record></Cite></EndNote>(Medicare Benefits Schedule Review Taskforce, 2018).There are no current listings of PSMA PET/CT on the MBS, however, PET imaging combined with a different tracer (fluorodeoxyglucose, a radio-analogue of glucose), is listed for a restricted number of indications, not including prostate cancer (Items 61523–61646). A single MBS item for 68Ga DOTA-peptide PET is also listed (Item 61647) ADDIN EN.CITE <EndNote><Cite><Author>Australian Government Department of Health</Author><Year>2020</Year><RecNum>64</RecNum><DisplayText>(Australian Government Department of Health, 2020a)</DisplayText><record><rec-number>64</rec-number><foreign-keys><key app="EN" db-id="rtafpsxaepf2d8epwsz5rdx8pr9fwvwwtzd0" timestamp="1593493768">64</key></foreign-keys><ref-type name="Web Page">12</ref-type><contributors><authors><author>Australian Government Department of Health,</author></authors></contributors><titles><title>MBS Online</title></titles><volume>2020</volume><number>30 June</number><dates><year>2020</year></dates><urls><related-urls><url>;(Australian Government Department of Health, 2020a).RationaleAs discussed above, one of several radiopharmaceutical tracers may be used during a PSMA PET/CT scan. It has been advised that PSMA PET/CT can be treated as one intervention, irrespective of which tracer is used to target the PSMA receptor. Secondary analysis comparing across tracer options available in Australia should be considered, data permitting.PASC noted the applicant’s preference to not specify the radioactive tracer for the intervention, which would allow any available tracer to be used, including new tracers that may become available in the future. However, PASC advised that the application would need to demonstrate equivalence among tracers before a generic item descriptor could be considered appropriate, or else the evidence-supported tracer(s) would need to be specified.According to expert clinical advice, there is no standard or preferred tracer in Australia. Choice is largely dictated by availability and logistics, namely, whether the tracer is made in-house or sourced through an external distribution network (personal communication, expert radiation oncologist, 25 June 2020).The Applicant notes that where multiple similar radiotracers are available, MBS item descriptors for nuclear medicine do not specify which individual radiotracer should be used (personal email communication, 25 June 2020). However, this is not true for PET items, which specify the radiopharmaceutical (FDG, Ga-68 DOTA-peptide).The PSMA ligand can be also be imaged with PET/MRI combinations, noting there is a prospective single centre, single arm Australian study comparing PSMA PET/MRI with conventional imaging in the clinical setting of BCR following definitive therapy (ACTRN12616000186459).ComparatorThe comparators for this application are conventional imaging modalities with:CT, and/orWBBS with SPECT/CT.PASC agreed with the proposed comparators, noting that these are listed in European and US guidelines.BackgroundA CT scan of the abdomen and/or pelvis is one of the tests that may be used to look for cancer that has metastasized, particularly in the lymph nodes and the area around the prostate ADDIN EN.CITE <EndNote><Cite><Author>National Comprehensive Cancer Network</Author><Year>2019</Year><RecNum>38</RecNum><DisplayText>(National Comprehensive Cancer Network, 2019)</DisplayText><record><rec-number>38</rec-number><foreign-keys><key app="EN" db-id="rtafpsxaepf2d8epwsz5rdx8pr9fwvwwtzd0" timestamp="1592534235">38</key></foreign-keys><ref-type name="Report">27</ref-type><contributors><authors><author>National Comprehensive Cancer Network,</author></authors></contributors><titles><title>NCCN Guidelines for Patients: Prostate Cancer, 2019</title></titles><dates><year>2019</year></dates><urls></urls></record></Cite></EndNote>(National Comprehensive Cancer Network, 2019).A bone scan is a nuclear medicine imaging technology used to look for cancer that has metastasized to the bones. A bone scan may be used for patients with bone pain, for those at high risk of bone metastases, if there are changes in certain tests results, or to monitor treatment ADDIN EN.CITE <EndNote><Cite><Author>National Comprehensive Cancer Network</Author><Year>2019</Year><RecNum>38</RecNum><DisplayText>(National Comprehensive Cancer Network, 2019)</DisplayText><record><rec-number>38</rec-number><foreign-keys><key app="EN" db-id="rtafpsxaepf2d8epwsz5rdx8pr9fwvwwtzd0" timestamp="1592534235">38</key></foreign-keys><ref-type name="Report">27</ref-type><contributors><authors><author>National Comprehensive Cancer Network,</author></authors></contributors><titles><title>NCCN Guidelines for Patients: Prostate Cancer, 2019</title></titles><dates><year>2019</year></dates><urls></urls></record></Cite></EndNote>(National Comprehensive Cancer Network, 2019). During a bone scan, a bisphosphonate labelled with technetium 99m (radioactive tracer) is injected intravenously to identify sites of active bone formation (osteogenesis) ADDIN EN.CITE <EndNote><Cite><Author>National Comprehensive Cancer Network</Author><Year>2019</Year><RecNum>38</RecNum><DisplayText>(Lee et al., 2012; National Comprehensive Cancer Network, 2019)</DisplayText><record><rec-number>38</rec-number><foreign-keys><key app="EN" db-id="rtafpsxaepf2d8epwsz5rdx8pr9fwvwwtzd0" timestamp="1592534235">38</key></foreign-keys><ref-type name="Report">27</ref-type><contributors><authors><author>National Comprehensive Cancer Network,</author></authors></contributors><titles><title>NCCN Guidelines for Patients: Prostate Cancer, 2019</title></titles><dates><year>2019</year></dates><urls></urls></record></Cite><Cite><Author>Lee</Author><Year>2012</Year><RecNum>65</RecNum><record><rec-number>65</rec-number><foreign-keys><key app="EN" db-id="rtafpsxaepf2d8epwsz5rdx8pr9fwvwwtzd0" timestamp="1593576676">65</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Lee, J.</author><author>Hennessy, A.</author><author>Khafagi, F.</author></authors></contributors><titles><title>Bone scans</title><secondary-title>Australian Family Physician</secondary-title></titles><periodical><full-title>Australian Family Physician</full-title></periodical><pages>689-692</pages><volume>41</volume><keywords><keyword>diagnostic imaging, radionuclide imaging, bone, nuclear medicine</keyword></keywords><dates><year>2012</year><pub-dates><date>9/01</date></pub-dates></dates><publisher>The Royal Australian College of General Practitioners (RACGP)</publisher><urls><related-urls><url>;(Lee et al., 2012; National Comprehensive Cancer Network, 2019). 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ADDIN EN.CITE.DATA (Palmedo et al., 2014).The comparator diagnostic tests are currently MBS funded, with relevant item numbers listed below ( REF _Ref44082993 \h Table 7). The Applicant advises that for most patients with prostate cancer, no additional healthcare resources are required when providing these comparator tests.Table SEQ Table \* ARABIC 7Relevant MBS items for comparator CT and bone scan with SPECT/CT imaging modalitiesMBS item numberItem descriptor and fee56507Computed tomography—scan of upper abdomen and pelvis with intravenous contrast medium and with any scans of upper abdomen and pelvis before intravenous contrast injection, when performed, not for the purposes of virtual colonoscopy and not being a service to which item 56807 or 57007 applies (R) (Anaes.)Fee: $480.05 Benefit: 75% = $360.05 85% = $408.0556807 ?Computed tomography—scan of chest, abdomen and pelvis with or without scans of soft tissues of neck with intravenous contrast medium and with any scans of chest, abdomen and pelvis with or without scans of soft tissue of neck before intravenous contrast injection, when performed, not including a study performed to exclude coronary artery calcification or image the coronary arteries (R) (Anaes.)Fee: $560.00 Benefit: 75% = $420.00 85% = $476.00 61425Bone study—whole body and single photon emission tomography, with, when undertaken, blood flow, blood pool and delayed imaging on a separate occasion (R)Fee: $600.70 Benefit: 75% = $450.55 85% = $516.0061505CT scan performed at the same time and covering the same body area as single photon emission tomography or positron emission tomography for the purpose of anatomic localisation or attenuation correction if no separate diagnostic CT report is issued and only in association with items 61302 to 61647 (R)Fee: $100.00 Benefit: 75% = $75.00 85% = $85.00 Notes: ? = the Applicant advises that item 56807, which includes the chest, is used less frequently than item 56507 (upper abdomen & pelvis only).Source: Item numbers listed on p.29 of application form, excluding item 61719 which has been removed (personal email communication, Applicant, 10 July 2020); item descriptor and fee information sourced from the MBS ADDIN EN.CITE <EndNote><Cite><Author>Australian Government Department of Health</Author><Year>2020</Year><RecNum>64</RecNum><DisplayText>(Australian Government Department of Health, 2020a)</DisplayText><record><rec-number>64</rec-number><foreign-keys><key app="EN" db-id="rtafpsxaepf2d8epwsz5rdx8pr9fwvwwtzd0" timestamp="1593493768">64</key></foreign-keys><ref-type name="Web Page">12</ref-type><contributors><authors><author>Australian Government Department of Health,</author></authors></contributors><titles><title>MBS Online</title></titles><volume>2020</volume><number>30 June</number><dates><year>2020</year></dates><urls><related-urls><url>;(Australian Government Department of Health, 2020a)Population 1 The Applicant advises that prostate cancer patients with intermediate- to high-risk features would, in the absence of PSMA PET/CT, be referred for an abdominopelvic CT and a bone scan to determine nodal and metastatic spread. A regional MRI may be required to clarify findings of the CT/bone scan.NCCN guidelines recommend the following imaging modalities for initial staging workup of patients with intermediate- or high-risk features ADDIN EN.CITE <EndNote><Cite><Author>Mohler</Author><Year>2019</Year><RecNum>36</RecNum><DisplayText>(Mohler et al., 2019)</DisplayText><record><rec-number>36</rec-number><foreign-keys><key app="EN" db-id="rtafpsxaepf2d8epwsz5rdx8pr9fwvwwtzd0" timestamp="1592373464">36</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>James L. Mohler</author><author>Emmanuel S. Antonarakis</author><author>Andrew J. Armstrong</author><author>Anthony V. D’Amico</author><author>Brian J. Davis</author><author>Tanya Dorff</author><author>James A. Eastham</author><author>Charles A. Enke</author><author>Thomas A. Farrington</author><author>Celestia S. Higano</author><author>Eric Mark Horwitz</author><author>Michael Hurwitz</author><author>Joseph E. Ippolito</author><author>Christopher J. Kane</author><author>Michael R. Kuettel</author><author>Joshua M. Lang</author><author>Jesse McKenney</author><author>George Netto</author><author>David F. Penson</author><author>Elizabeth R. Plimack</author><author>Julio M. Pow-Sang</author><author>Thomas J. Pugh</author><author>Sylvia Richey</author><author>Mack Roach</author><author>Stan Rosenfeld</author><author>Edward Schaeffer</author><author>Ahmad Shabsigh</author><author>Eric J. Small</author><author>Daniel E. Spratt</author><author>Sandy Srinivas</author><author>Jonathan Tward</author><author>Dorothy A. Shead</author><author>Deborah A. Freedman-Cass</author></authors></contributors><titles><title>Prostate Cancer, Version 2.2019, NCCN Clinical Practice Guidelines in Oncology</title></titles><pages>479</pages><volume>17</volume><number>5</number><dates><year>2019</year></dates><isbn>1540-1405</isbn><urls><related-urls><url>;(Mohler et al., 2019):Pelvic ± abdominal imaging for patients with intermediate- or high-risk features and predicted >10% probability of pelvic lymph node involvement.Bone imaging for patients with unfavourable intermediate-risk features who have T2 stage cancer and PSA level >10ng/ml.Bone imaging for all patients with high-risk features.EAU guidelines recommend metastatic screening with at least cross-sectional abdominopelvic imaging plus a bone scan for patients with intermediate-risk features if their cancer is graded ISUP grade group 3 or above, and for all patients with high-risk features ADDIN EN.CITE <EndNote><Cite><Author>Mottet</Author><Year>2020</Year><RecNum>10</RecNum><DisplayText>(Mottet et al., 2020)</DisplayText><record><rec-number>10</rec-number><foreign-keys><key app="EN" db-id="rtafpsxaepf2d8epwsz5rdx8pr9fwvwwtzd0" timestamp="1592204157">10</key></foreign-keys><ref-type name="Web Page">12</ref-type><contributors><authors><author>Mottet, N.</author><author>van den Bergh, R. C. N.</author><author>Briers, E.</author><author>Cornford, P.</author><author>De Santis, M.</author><author>Fanti, S.</author><author>Gillessen, S.</author><author>Grummet, J.</author><author>Henry, A. M.</author><author>Lam, T. B.</author><author>Mason, M. D.</author><author>van der Poel, H. G.</author><author>van der Kwast, T. H.</author><author>Rouvière, O.</author><author>Schoots, I.</author><author>Tilki, D.</author><author>Wiegel, T.</author></authors></contributors><titles><title>EAU - ESTRO - ESUR - SIOG Guidelines on Prostate Cancer 2020</title></titles><volume>2020</volume><number>15 June</number><dates><year>2020</year></dates><isbn>978-94-92671-07-3</isbn><urls><related-urls><url>;(Mottet et al., 2020).The Applicant predicts a near perfect substitution of conventional imaging modalities (CT and bone scan) with PSMA PET/CT for detecting pelvic nodal and distant metastatic disease in initial staging when ablative locoregional therapies are planned.PASC noted that the applicant expects near-complete substitution of conventional imaging with PSMA PET/CT.Population 2The Applicant advises that some patients with recurrent prostate cancer may be offered salvage radiotherapy to the pelvic lymph node pathways and/or prostate bed with the field of treatment determined empirically.EAU guidelines specify that histological proof of local recurrence is not required prior to salvage radiotherapy, and that most patients undergo treatment without local imaging ADDIN EN.CITE <EndNote><Cite><Author>Mottet</Author><Year>2020</Year><RecNum>10</RecNum><DisplayText>(Mottet et al., 2020)</DisplayText><record><rec-number>10</rec-number><foreign-keys><key app="EN" db-id="rtafpsxaepf2d8epwsz5rdx8pr9fwvwwtzd0" timestamp="1592204157">10</key></foreign-keys><ref-type name="Web Page">12</ref-type><contributors><authors><author>Mottet, N.</author><author>van den Bergh, R. C. N.</author><author>Briers, E.</author><author>Cornford, P.</author><author>De Santis, M.</author><author>Fanti, S.</author><author>Gillessen, S.</author><author>Grummet, J.</author><author>Henry, A. M.</author><author>Lam, T. B.</author><author>Mason, M. D.</author><author>van der Poel, H. G.</author><author>van der Kwast, T. H.</author><author>Rouvière, O.</author><author>Schoots, I.</author><author>Tilki, D.</author><author>Wiegel, T.</author></authors></contributors><titles><title>EAU - ESTRO - ESUR - SIOG Guidelines on Prostate Cancer 2020</title></titles><volume>2020</volume><number>15 June</number><dates><year>2020</year></dates><isbn>978-94-92671-07-3</isbn><urls><related-urls><url>;(Mottet et al., 2020). Precise localisation of local recurrences is required for focal dose escalation however, this treatment remains investigational at present ADDIN EN.CITE <EndNote><Cite><Author>Mottet</Author><Year>2020</Year><RecNum>10</RecNum><DisplayText>(Mottet et al., 2020)</DisplayText><record><rec-number>10</rec-number><foreign-keys><key app="EN" db-id="rtafpsxaepf2d8epwsz5rdx8pr9fwvwwtzd0" timestamp="1592204157">10</key></foreign-keys><ref-type name="Web Page">12</ref-type><contributors><authors><author>Mottet, N.</author><author>van den Bergh, R. C. N.</author><author>Briers, E.</author><author>Cornford, P.</author><author>De Santis, M.</author><author>Fanti, S.</author><author>Gillessen, S.</author><author>Grummet, J.</author><author>Henry, A. M.</author><author>Lam, T. B.</author><author>Mason, M. D.</author><author>van der Poel, H. G.</author><author>van der Kwast, T. H.</author><author>Rouvière, O.</author><author>Schoots, I.</author><author>Tilki, D.</author><author>Wiegel, T.</author></authors></contributors><titles><title>EAU - ESTRO - ESUR - SIOG Guidelines on Prostate Cancer 2020</title></titles><volume>2020</volume><number>15 June</number><dates><year>2020</year></dates><isbn>978-94-92671-07-3</isbn><urls><related-urls><url>;(Mottet et al., 2020).Alternatively, and despite the low sensitivity of conventional imaging, the Applicant advises that patients with recurrent prostate cancer may be referred for a bone scan and/or CT prior to salvage therapy to look for previously undetected metastatic disease, or in the hope that identifying the sites of disease will enable localised increases in radiotherapy doses.NICE guidelines (NG131) recommend that patients with evidence of BCR after radical treatment, who are considering radical salvage therapy, be offered an isotope bone scan if their symptoms or PSA trends suggest metastasis ADDIN EN.CITE <EndNote><Cite><Author>National Institute of Health and Care Excellence</Author><Year>2019</Year><RecNum>41</RecNum><DisplayText>(National Institute of Health and Care Excellence, 2019)</DisplayText><record><rec-number>41</rec-number><foreign-keys><key app="EN" db-id="rtafpsxaepf2d8epwsz5rdx8pr9fwvwwtzd0" timestamp="1592823309">41</key></foreign-keys><ref-type name="Web Page">12</ref-type><contributors><authors><author>National Institute of Health and Care Excellence,</author></authors></contributors><titles><title>Prostate cancer: diagnosis and management. NICE guideline [NG131]</title></titles><volume>2020</volume><number>22 June</number><dates><year>2019</year></dates><urls><related-urls><url>;(National Institute of Health and Care Excellence, 2019).EAU guidelines recommend PSMA PET/CT rather than conventional imaging modalities in circumstances of BCR, noting that in asymptomatic patients, conventional imaging techniques such as abdominopelvic CT and bone scan imaging have a low diagnostic yield because BCR precedes clinical metastases by many years ADDIN EN.CITE <EndNote><Cite><Author>Mottet</Author><Year>2020</Year><RecNum>10</RecNum><DisplayText>(Mottet et al., 2020)</DisplayText><record><rec-number>10</rec-number><foreign-keys><key app="EN" db-id="rtafpsxaepf2d8epwsz5rdx8pr9fwvwwtzd0" timestamp="1592204157">10</key></foreign-keys><ref-type name="Web Page">12</ref-type><contributors><authors><author>Mottet, N.</author><author>van den Bergh, R. C. N.</author><author>Briers, E.</author><author>Cornford, P.</author><author>De Santis, M.</author><author>Fanti, S.</author><author>Gillessen, S.</author><author>Grummet, J.</author><author>Henry, A. M.</author><author>Lam, T. B.</author><author>Mason, M. D.</author><author>van der Poel, H. G.</author><author>van der Kwast, T. H.</author><author>Rouvière, O.</author><author>Schoots, I.</author><author>Tilki, D.</author><author>Wiegel, T.</author></authors></contributors><titles><title>EAU - ESTRO - ESUR - SIOG Guidelines on Prostate Cancer 2020</title></titles><volume>2020</volume><number>15 June</number><dates><year>2020</year></dates><isbn>978-94-92671-07-3</isbn><urls><related-urls><url>;(Mottet et al., 2020). EAU guidelines also recommend PSMA PET/CT for excluding metastases for patients with persistent PSA >0.2ng/ml, given standard imaging with bone scan and MRI has a low diagnostic yield at PSA levels below 2ng/ml ADDIN EN.CITE <EndNote><Cite><Author>Mottet</Author><Year>2020</Year><RecNum>10</RecNum><DisplayText>(Mottet et al., 2020)</DisplayText><record><rec-number>10</rec-number><foreign-keys><key app="EN" db-id="rtafpsxaepf2d8epwsz5rdx8pr9fwvwwtzd0" timestamp="1592204157">10</key></foreign-keys><ref-type name="Web Page">12</ref-type><contributors><authors><author>Mottet, N.</author><author>van den Bergh, R. C. N.</author><author>Briers, E.</author><author>Cornford, P.</author><author>De Santis, M.</author><author>Fanti, S.</author><author>Gillessen, S.</author><author>Grummet, J.</author><author>Henry, A. M.</author><author>Lam, T. B.</author><author>Mason, M. D.</author><author>van der Poel, H. G.</author><author>van der Kwast, T. H.</author><author>Rouvière, O.</author><author>Schoots, I.</author><author>Tilki, D.</author><author>Wiegel, T.</author></authors></contributors><titles><title>EAU - ESTRO - ESUR - SIOG Guidelines on Prostate Cancer 2020</title></titles><volume>2020</volume><number>15 June</number><dates><year>2020</year></dates><isbn>978-94-92671-07-3</isbn><urls><related-urls><url>;(Mottet et al., 2020).In a review of the management of BCR, Artibani et al. (2018) document that the standard workup for detecting metastases involves a bone scan and abdominopelvic CT but highlight the poor ability of these imaging modalities to detect metastases in asymptomatic patients ADDIN EN.CITE <EndNote><Cite><Author>Artibani</Author><Year>2018</Year><RecNum>69</RecNum><DisplayText>(Artibani et al., 2018)</DisplayText><record><rec-number>69</rec-number><foreign-keys><key app="EN" db-id="rtafpsxaepf2d8epwsz5rdx8pr9fwvwwtzd0" timestamp="1594006264">69</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Artibani, W.</author><author>Porcaro, A. B.</author><author>De Marco, V.</author><author>Cerruto, M. A.</author><author>Siracusano, S.</author></authors></contributors><titles><title>Management of Biochemical Recurrence after Primary Curative Treatment for Prostate Cancer: A Review</title><secondary-title>Urol Int</secondary-title></titles><periodical><full-title>Urol Int</full-title></periodical><pages>251-262</pages><volume>100</volume><number>3</number><edition>2017/11/22</edition><keywords><keyword>Androgen Antagonists/therapeutic use</keyword><keyword>Brachytherapy</keyword><keyword>Cryotherapy</keyword><keyword>Humans</keyword><keyword>Male</keyword><keyword>Medical Oncology</keyword><keyword>Neoplasm Metastasis</keyword><keyword>Neoplasm Recurrence, Local/*pathology/*therapy</keyword><keyword>Prostate-Specific Antigen/analysis</keyword><keyword>Prostatectomy</keyword><keyword>Prostatic Neoplasms/*pathology/*therapy</keyword><keyword>Quality of Life</keyword><keyword>Radiotherapy</keyword><keyword>Recurrence</keyword><keyword>Risk</keyword><keyword>Salvage Therapy</keyword><keyword>Treatment Outcome</keyword><keyword>Ultrasonic Therapy</keyword><keyword>Androgen deprivation therapy</keyword><keyword>Biochemical recurrence</keyword><keyword>Prostate cancer</keyword></keywords><dates><year>2018</year></dates><isbn>1423-0399 (Electronic)&#xD;0042-1138 (Linking)</isbn><accession-num>29161715</accession-num><urls><related-urls><url>;(Artibani et al., 2018).The Applicant predicts a near perfect substitution of conventional imaging modalities (CT and WBBS with SPECT/CT) with PSMA PET/CT for detecting pelvic nodal and distant metastatic disease in the setting of BCR when ablative locoregional therapies offer the best opportunity for improved oncological outcomes.PASC noted that the applicant expects near-complete substitution of conventional imaging with PSMA PET/CT.RationaleFor the purpose of ruling out pelvic nodal and distant metastatic disease, CT and bone scan are the relevant comparators.Other modalities may be used to confirm the presence of local recurrence. 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ADDIN EN.CITE.DATA (Artibani et al., 2018; Mottet et al., 2020). Multiparametric MRI can be used for biopsy-targeting and guiding local treatment ADDIN EN.CITE <EndNote><Cite><Author>Mottet</Author><Year>2020</Year><RecNum>10</RecNum><DisplayText>(Mottet et al., 2020)</DisplayText><record><rec-number>10</rec-number><foreign-keys><key app="EN" db-id="rtafpsxaepf2d8epwsz5rdx8pr9fwvwwtzd0" timestamp="1592204157">10</key></foreign-keys><ref-type name="Web Page">12</ref-type><contributors><authors><author>Mottet, N.</author><author>van den Bergh, R. C. N.</author><author>Briers, E.</author><author>Cornford, P.</author><author>De Santis, M.</author><author>Fanti, S.</author><author>Gillessen, S.</author><author>Grummet, J.</author><author>Henry, A. M.</author><author>Lam, T. B.</author><author>Mason, M. D.</author><author>van der Poel, H. G.</author><author>van der Kwast, T. H.</author><author>Rouvière, O.</author><author>Schoots, I.</author><author>Tilki, D.</author><author>Wiegel, T.</author></authors></contributors><titles><title>EAU - ESTRO - ESUR - SIOG Guidelines on Prostate Cancer 2020</title></titles><volume>2020</volume><number>15 June</number><dates><year>2020</year></dates><isbn>978-94-92671-07-3</isbn><urls><related-urls><url>;(Mottet et al., 2020) although in Australia, is not reimbursed for use in recurrent prostate cancer.OutcomesPASC considered that morbidity and mortality as a result of subsequent treatment was not an appropriate safety outcome for a diagnostic/staging intervention, and advised that this be removed. The Outcomes below were updated accordingly. Patient relevantThe clinical claim is that PSMA PET/CT is superior to CT and WBBS with SPECT/CT in terms of analytical validity, clinical validity and clinical utility, in patients with biopsy-proven prostate adenocarcinoma with intermediate- and high-risk features, and in patients with recurrent prostate adenocarcinoma.Safety outcomesRadiation exposure (patients, nuclear medicine technologists, nurses)Adverse reaction to the contrast agents, including renal toxicityPASC noted that there are no adverse reactions to the radiopharmaceutical tracers, but adverse reactions can occur from the administration of radiological contrast agents Effectiveness outcomesDiagnostic accuracySensitivity and specificity Positive predictive value (PPV), negative predictive value (NPV)Area under the curve (AUC) of the receiver operating characteristic (ROC) curveNumber of equivocal findingsChange in managementNeed for subsequent diagnostic tests, including biopsy i.e. investigations avoidedChange in planned management (intent), including change in planned treatment modality, extension of radiation fieldChange in management i.e. overall change, types of changes, futile locoregional curative intent treatments avoided, therapies instigatedOncologic and patient outcomesMorbidityMortality, including cancer specific mortalitySurvival, including overall survival, progression-free survival, metastases-free survival, ADT-free survivalQuality of lifeHealthcare system outcomesCost of PSMA PET/CT (or comparator) imaging used for initial staging or restaging in patients with PSA persistence/recurrenceCost of additional imaging tests or biopsies requiredCost of treatments received and/or costs offset due to avoidance of futile locoregional ablative procedureTotal cost to MBS, PBS and other government health budgets.Reference standardThe reference standard is an investigative medical test or series of tests used to determine the presence or absence of the target condition, assumed to be, theoretically, 100% sensitive and specific ADDIN EN.CITE <EndNote><Cite><Author>Medical Services Advisory Committee</Author><Year>2017</Year><RecNum>62</RecNum><DisplayText>(Medical Services Advisory Committee, 2017)</DisplayText><record><rec-number>62</rec-number><foreign-keys><key app="EN" db-id="rtafpsxaepf2d8epwsz5rdx8pr9fwvwwtzd0" timestamp="1593476452">62</key></foreign-keys><ref-type name="Report">27</ref-type><contributors><authors><author>Medical Services Advisory Committee,</author></authors></contributors><titles><title>Technical Guidelines for preparing assessment reports for the Medical Services Advisory Committee – Service Type: Investigative (Version 3.0)</title></titles><dates><year>2017</year></dates><urls><related-urls><url>$File/InvestigativeTechnicalGuidelines-December-2016-Version-3.0.pdf</url></related-urls></urls></record></Cite></EndNote>(Medical Services Advisory Committee, 2017).The reference standard for detecting prostate cancer is usually histopathologic assessment combined with other imaging, clinical and biochemical findings.A recently published systematic review and meta-analysis of 68Ga-PSMA PET/CT for initial staging or restaging in BCR reported that half of the included studies (18 of 37) included histopathological correlation of 68Ga-PSMA PET-positive lesions as a reference test PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5QZXJlcmE8L0F1dGhvcj48WWVhcj4yMDIwPC9ZZWFyPjxS

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ADDIN EN.CITE.DATA (Perera et al., 2020). However, many studies performed targeted biopsies of suspicious lesions only. Five studies performed 68Ga-PSMA PET prior to planned lymph node sampling PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5QZXJlcmE8L0F1dGhvcj48WWVhcj4yMDIwPC9ZZWFyPjxS

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ADDIN EN.CITE.DATA (Perera et al., 2020).In a key randomised controlled trial of PSMA PET/CT versus conventional imaging in initial staging of high-risk prostate cancer PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Ib2ZtYW48L0F1dGhvcj48WWVhcj4yMDIwPC9ZZWFyPjxS

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ADDIN EN.CITE.DATA (Hofman et al., 2020), the reference standard for presence of nodal or distant metastases used a predefined composite panel that included histopathologic, imaging, clinical and biochemical findings. Cases were considered positive if one hard criterion (histopathological confirmation of adenocarcinoma or change of bone lesion to sclerotic or blastic on follow-up imaging), or three of the nine soft criteria (not listed here) were met.PASC noted that histopathology is rarely used alone as a reference standard, and advised that a composite reference standard after 6 months’ follow-up is more frequently used in the diagnostic accuracy studies, combining histopathology, imaging, clinical and biochemical findings. Linked-evidence approachA linked-evidence approach is the synthesis of systematically acquired evidence on the accuracy of a medical test, its impact on clinical decision-making, and the effectiveness of consequent treatment options ADDIN EN.CITE <EndNote><Cite><Author>Merlin</Author><Year>2013</Year><RecNum>59</RecNum><DisplayText>(Merlin et al., 2013)</DisplayText><record><rec-number>59</rec-number><foreign-keys><key app="EN" db-id="rtafpsxaepf2d8epwsz5rdx8pr9fwvwwtzd0" timestamp="1593476197">59</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Merlin, T.</author><author>Lehman, S.</author><author>Hiller, J. E.</author><author>Ryan, P.</author></authors></contributors><auth-address>Adelaide Health Technology Assessment (AHTA), Discipline of Public Health, School of Population Health, University of Adelaide, Adelaide, South Australia, Australia.</auth-address><titles><title>The &quot;linked evidence approach&quot; to assess medical tests: a critical analysis</title><secondary-title>Int J Technol Assess Health Care</secondary-title></titles><periodical><full-title>Int J Technol Assess Health Care</full-title></periodical><pages>343-50</pages><volume>29</volume><number>3</number><edition>2013/06/19</edition><keywords><keyword>Advisory Committees</keyword><keyword>Australia</keyword><keyword>*Diagnostic Techniques and Procedures</keyword><keyword>Eligibility Determination/*methods</keyword><keyword>*Evidence-Based Medicine</keyword><keyword>Gatekeeping</keyword><keyword>*Health Services Accessibility</keyword><keyword>Humans</keyword><keyword>Reimbursement Mechanisms</keyword><keyword>Technology Assessment, Biomedical</keyword></keywords><dates><year>2013</year><pub-dates><date>Jul</date></pub-dates></dates><isbn>1471-6348 (Electronic)&#xD;0266-4623 (Linking)</isbn><accession-num>23769128</accession-num><urls><related-urls><url>;(Merlin et al., 2013). By linking evidence from different sources, a linked-evidence approach forms a chain of argument to estimate the impact of a diagnostic test ADDIN EN.CITE <EndNote><Cite><Author>Medical Services Advisory Committee</Author><Year>2017</Year><RecNum>62</RecNum><DisplayText>(Medical Services Advisory Committee, 2017)</DisplayText><record><rec-number>62</rec-number><foreign-keys><key app="EN" db-id="rtafpsxaepf2d8epwsz5rdx8pr9fwvwwtzd0" timestamp="1593476452">62</key></foreign-keys><ref-type name="Report">27</ref-type><contributors><authors><author>Medical Services Advisory Committee,</author></authors></contributors><titles><title>Technical Guidelines for preparing assessment reports for the Medical Services Advisory Committee – Service Type: Investigative (Version 3.0)</title></titles><dates><year>2017</year></dates><urls><related-urls><url>$File/InvestigativeTechnicalGuidelines-December-2016-Version-3.0.pdf</url></related-urls></urls></record></Cite></EndNote>(Medical Services Advisory Committee, 2017).MSAC guidelines specify that for a linked-evidence approach, the following pieces of information are generally required ADDIN EN.CITE <EndNote><Cite><Author>Medical Services Advisory Committee</Author><Year>2017</Year><RecNum>62</RecNum><DisplayText>(Medical Services Advisory Committee, 2017)</DisplayText><record><rec-number>62</rec-number><foreign-keys><key app="EN" db-id="rtafpsxaepf2d8epwsz5rdx8pr9fwvwwtzd0" timestamp="1593476452">62</key></foreign-keys><ref-type name="Report">27</ref-type><contributors><authors><author>Medical Services Advisory Committee,</author></authors></contributors><titles><title>Technical Guidelines for preparing assessment reports for the Medical Services Advisory Committee – Service Type: Investigative (Version 3.0)</title></titles><dates><year>2017</year></dates><urls><related-urls><url>$File/InvestigativeTechnicalGuidelines-December-2016-Version-3.0.pdf</url></related-urls></urls></record></Cite></EndNote>(Medical Services Advisory Committee, 2017):diagnostic performance and clinical validity (where relevant) of the investigative medical serviceclinical utility of the investigative medical service in terms of impact of positive vs. negative test results on patient management, contribution and clinical importance of false negatives vs. false positives, and direct impact of each therapeutic medical service option on health outcomesimpact of repeat testing (if relevant)relative safety of performing the investigative service, encompassing immediate safety issues of directly performing the test and ‘flow on’ safety issues arising as a result of conducting the investigative service. RationaleWhilst direct evidence suggests PSMA PET/CT has superior sensitivity and specificity over conventional imaging PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5QZXJlcmE8L0F1dGhvcj48WWVhcj4yMDIwPC9ZZWFyPjxS

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ADDIN EN.CITE.DATA (Hofman et al., 2020; Perera et al., 2020) and leads to changes in management in approximately half of patients PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Sb2FjaDwvQXV0aG9yPjxZZWFyPjIwMTg8L1llYXI+PFJl

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ADDIN EN.CITE.DATA (Han et al., 2018; Roach et al., 2018), determining the consequences of treatment instigated or avoided following PSMA PET/CT is challenging. A linked-evidence approach will likely be required to determine the patient relevant outcomes resulting from such changes in management.SafetyThe Applicant advises that adverse events relating to the administration of diagnostic PSMA-targeting PET radiotracers are extremely rare. Expert clinical advice confirmed the low risks associated with PSMA PET/CT (personal communication, expert radiation oncologist, 25 June 2020).Notably, the patient is exposed to a low radiation dose during delivery of the intervention. A recent Australian clinical study found radiation exposure to be 10.9?mSv (95% confidence interval [CI] 9.9, 12.0) higher during conventional imaging than during PSMA PET/CT PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Ib2ZtYW48L0F1dGhvcj48WWVhcj4yMDIwPC9ZZWFyPjxS

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ADDIN EN.CITE.DATA (Hofman et al., 2020). The radiation dose delivered with PSMA PET/CT was 8.4?mSv (95% CI 8.1, 8.7).Current and proposed clinical management algorithmsPASC accepted the current and proposed clinical management algorithms, noting that ‘initial (N- and M-) staging’ was the correct term for Population 1. However, PASC considered that “extrapelvic” should be clarified in the algorithms, since it is claimed that conventional imaging may underestimate the extent of pelvic lymph node involvement. PASC also queried for Population 2 whether it was limited to BCR or included ‘PSA persistence’. The clinical management algorithms below have been updated according to PASC’s advice. Current clinical management algorithm for identified populationClinical management algorithms depicting the management of patients in Populations 1 and 2 in the absence of PSMA PET/CT imaging are shown in REF _Ref45269465 \h Figure 1 and REF _Ref45269467 \h Figure 2, below. Proposed clinical management algorithm for identified populationClinical management algorithms depicting the management of patients in Populations 1 and 2 if PSMA PET/CT imaging was available are shown in REF _Ref45269649 \h Figure 3and REF _Ref45269650 \h Figure 4, below.Figure SEQ Figure \* ARABIC 1Current clinical management algorithm for the initial N- and M-staging of intermediate- and high-risk patients (Population 1)47560682173025*00*13578512170430*00*Abbreviations: ADT = androgen deprivation therapy; BCR = biochemical recurrence; CT = computed tomography; EBRT = external beam radiotherapy; PSA = prostate specific antigen; SBR = stereotactic body radiotherapy; SPECT = single photon emission tomography; WBBS = whole-body bone scan *Extrapelvic refers to distant metastasesSource: adopted from management pathways provided by the ApplicantFigure SEQ Figure \* ARABIC 2Current clinical management algorithm for the restaging of patients with biochemical recurrence or PSA persistence (Population 2)49624142212837*00*34111092136223*00*17095312144229*00*Abbreviations: ADT = androgen deprivation therapy; CT = computed tomography; EBRT = external beam radiotherapy; PSA = prostate specific antigen; SBR = stereotactic body radiotherapy; SPECT = single photon emission tomography; WBBS = whole-body bone scan*Extrapelvic refers to distant metastasesSource: adopted from management pathways provided by the ApplicantFigure SEQ Figure \* ARABIC 3Proposed clinical management algorithm for the initial N- and M-staging of intermediate- and high-risk patients (Population 1)47397502157151*00*14153322160132*00*Abbreviations: ADT = androgen deprivation therapy; BCR = biochemical recurrence; EBRT = external beam radiotherapy; PSA = prostate specific antigen; PSMA PET/CT = prostrate specific membrane antigen positron emission tomography/computed tomography; SBR = stereotactic body radiotherapy*Extrapelvic refers to distant metastasesSource: adopted from management pathways provided by the ApplicantFigure SEQ Figure \* ARABIC 4Proposed clinical management algorithm for the restaging of patients with biochemical recurrence or PSA persistence (Population 2)49623872212837*00*34278692141275*00*17333842144229*00*Abbreviations: ADT = androgen deprivation therapy; EBRT = external beam radiotherapy; PSA = prostate specific antigen; PSMA PET/CT = prostrate specific membrane antigen positron emission tomography/computed tomography; SBR = stereotactic body radiotherapy*Extrapelvic refers to distant metastasesSource: adopted from management pathways provided by the ApplicantProposed economic evaluationThe Applicant claims that PSMA PET/CT has superior diagnostic accuracy compared to conventional imaging (CT ± WBBS with SPECT/CT) for detecting pelvic nodal and distant metastases. The Applicant claims that PSMA PET/CT, by virtue of its superior diagnostic accuracy, improves a range of health care outcomes for individual patients.By detecting previously unknown sites of prostate cancer, PSMA PET/CT may reduce the number of patients subjected to futile locoregional interventions, facilitate the delivery of metastasis-directed therapy such as surgery or SBRT for patients with oligometastatic disease, and improve treatment delivery for patients receiving locoregional ablative procedures with curative intent.The most appropriate economic evaluation is a cost-effectiveness or cost-utility analysis to determine overall costs relative to the effectiveness of the intervention in improving the detection of pelvic nodal and distant metastasis, the choice and delivery of treatment, and subsequent oncologic and patient outcomes (relative to the comparator).PASC confirmed that a cost-effectiveness or cost-utility analysis was appropriate.Proposed item descriptor and feePASC advised that, for Population 2, the words “with curative intent” should be replaced with “to delay systemic therapy”. PASC noted that the treatment goal for recurrent disease is not curative, but that the intent of treatment should be specified to prevent leakage to therapy monitoring. The wording in the MBS item descriptor for population 2 was updated to reflect PASC’s advice.The MBS item descriptors and associated fees proposed by the Applicant are listed below. The application provided a breakdown of the proposed fee comprising of the radiotracer and transport ($500) and the PET/CT imaging and report ($900).Category 5 – DIAGNOSTIC IMAGING SERVICESProstate specific membrane antigen (PSMA) PET study, performed for the initial N- and M- staging of intermediate to high risk prostate adenocarcinoma, for a previously untreated patient who is otherwise considered suitable for locoregional therapy with curative intentFee: $1,400Category 5 – DIAGNOSTIC IMAGING SERVICESProstate specific membrane antigen (PSMA) PET study, performed for the restaging of recurrent prostate adenocarcinoma, for a patient who has undergone prior locoregional therapy and who is otherwise considered suitable for further locoregional therapy to delay systemic therapyFee: $1,400PASC noted that the proposed item descriptors do not align with other MBS items for PET. For example, the proposed descriptors specify “PET/CT”, while other descriptors specify “PET” only. PASC advised that alignment with other PET items should be considered in the application.PASC advised that the application would need to justify the proposed fee, which is higher than the fee for other PET items (including Item 61647 for Ga-68 DOTA-peptide PET).PASC noted that there is a separate fee of $100 for CT when performed at the same time as PET (MBS item 61505).The applicant noted PASC’s advice, however it noted all the current MBS descriptors follow from the 2000 PET review process before PET/CT was available. The applicant noted that the accuracy figures for PET alone have not been defined and claim that the false positive rate would be higher with PET alone. Further, the applicant considered the economics and patient inconvenience of longer scan times using PET alone indicate that the indication should reflect current practice and not historical largely irrelevant precedent. Therefore, the applicant concluded that in that case the current fee for CT in conjunction with PET should be rolled up into the proposed PET/CT fee. The applicant agreed that adequate justification for higher fee for PSMA PET/CT than existing PET +CT item numbers requires justification in the application.Consultation FeedbackTargeted consultation feedback Eight organisations responded to the request for targeted consultation feedback, universally in support of MBS funding for PSMA PET/CT imaging in prostate cancer.PopulationThe value of PSMA PET/CT in the settings of high-risk localised disease prior to definitive therapy, and in biochemical recurrence prior to salvage radiation therapy is apparent.Two organisations commented that PSMA PET/CT has a limited role in advanced disease, unless linked to PSMA-directed therapy, and that the argument supporting PSMA PET/CT in the therapeutic monitoring setting is speculative at present. Therapeutic monitoring has since been removed as a population from the current application.Two organisations recommended MBS items also be made available for PSMA PET/CT for the following indications:Investigation of raised PSA where MRI is contraindicated,Initial staging in low-grade disease, and Re-staging in patients with metastatic prostate cancer where such information would influence treatment options.InterventionMultiple organisations supported an MBS item descriptor that is open to any PSMA radiotracer (as proposed).One responder noted that 68Ga- and 18F-labelled radiotracers are not interchangeable. Another noted a distinction should be made between 68Ga- and 18F-labelled radiotracers, given the potential differences in performance, and associated paratorWhere discussed, responders agreed with the comparators identified in the application form.OtherWhere discussed, responders agreed with the proposed MBS fee. Two organisations acknowledged the proposed fee is higher than the existing fee for FDG PET; one justified this as appropriate given the higher radiopharmaceutical cost of PSMA (vs. FDG), the other felt the scheduled fee for FDG PET is inadequate.Many responders expressed a preference for a single MBS item (rather than multiple) to avoid unnecessary confusion.Two organisations discussed the possibility of restricting patients approved for PSMA PET/CT from accessing an MBS-funded CT and/or bone scan for the same indication, one responder emphasising the need to ensure patients’ radiation doses are kept as low as reasonably possible (radiation dose is cumulative over a lifetime). The same responder emphasised the importance of ensuring WBBS and CT with contrast are still available in circumstances were PSMA PET/CT is not (e.g. rural settings).PASC noted the extensive consultation feedback, which was supportive of the application. PASC noted two organisations raised the issue of ownership of intellectual property for the radiopharmaceuticals. PASC considered this may need to be considered in the application. The Assessment Report should note intellectual property details for each radiopharmaceutical, and any impact this may have on patient access or cost.The applicant clarified that one of the applicants, Cyclotek Australia Pty Ltd, had obtained an exclusive license to distribute 18F-DCFPyL in Australia from John Hopkins University (USA) who hold the IP for this molecular entity. They noted that the IP rights to 68Ga-PSMA-11 and several other PSMA radiotracers was unclear at the time of the PSAC meeting, however the issue will be addressed within the Assessment Report and any related access and cost issues will also be addressed.PASC noted two organisations discussed the possibility of restricting patients approved for PSMA PET/CT from accessing an MBS-funded CT and/or bone scan for the same indication. However, PASC advised that restricting access to subsequent MBS-funded CT and/or whole-body bone scan was not appropriate, as patients may receive these scans for various reasons that are unrelated to prostate cancer.Next stepsPASC advised that, upon ratification of the post-PASC PICO, the application can proceed to the Evaluation Sub-Committee (ESC) stage of the MSAC process.PASC noted the applicant has elected to progress its application as an ADAR (applicant-developed assessment report).References ADDIN EN.REFLIST Alipour, R., Azad, A. & Hofman, M. S. 2019. Guiding management of therapy in prostate cancer: time to switch from conventional imaging to PSMA PET? Ther Adv Med Oncol, 11, 1758835919876828.Artibani, W., Porcaro, A. B., De Marco, V., Cerruto, M. A. & Siracusano, S. 2018. Management of Biochemical Recurrence after Primary Curative Treatment for Prostate Cancer: A Review. Urol Int, 100, 251-262.Australian Government Department of Health. 2020a. MBS Online [Online]. 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G. 2016. 10-Year Outcomes after Monitoring, Surgery, or Radiotherapy for Localized Prostate Cancer. N Engl J Med, 375, 1415-1424.Han, S., Woo, S., Kim, Y. J. & Suh, C. H. 2018. Impact of (68)Ga-PSMA PET on the Management of Patients with Prostate Cancer: A Systematic Review and Meta-analysis. Eur Urol, 74, 179-190.Hofman, M. 2019. PSMA PET/CT for staging and treatment of prostate cancer. Clin Adv Hematol Oncol, 17, 370-373.Hofman, M. S., Lawrentschuk, N., Francis, R. J., Tang, C., Vela, I., Thomas, P., Rutherford, N., Martin, J. M., Frydenberg, M., Shakher, R., Wong, L. M., Taubman, K., Ting Lee, S., Hsiao, E., Roach, P., Nottage, M., Kirkwood, I., Hayne, D., Link, E., Marusic, P., Matera, A., Herschtal, A., Iravani, A., Hicks, R. J., Williams, S., Murphy, D. G. & pro, P. S. G. C. 2020. Prostate-specific membrane antigen PET-CT in patients with high-risk prostate cancer before curative-intent surgery or radiotherapy (proPSMA): a prospective, randomised, multicentre study. 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