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. 2026 Apr 21;19:e70538. doi: 10.1111/cts.70538

Cancer Biomarker Test Utilization and Reimbursement in Australia: A National Analysis of Medicare Data

Leping Kong 1,2, Christine Y Lu 1,2,3,✉
PMCID: PMC13100301  PMID: 42015422

ABSTRACT

Biomarker testing plays a critical role in precision oncology by guiding targeted therapy selection. In Australia, public reimbursement for somatic tumor biomarker tests has expanded over the past decade, yet national data on utilization patterns, equity of access, and public expenditure remain limited. We identified all cancer biomarker tests listed in the March 2025 Medicare Benefits Schedule (MBS), defined as tumor‐based assays and selected germline tests used to guide systemic cancer therapy. National claims and expenditure (2010–2024) were extracted from publicly available Medicare Item Statistics. Trends were analyzed by test type, sex, age group, and jurisdiction, and standardized to the 2020 cancer incidence as a proxy for population‐level testing coverage. We identified 21 reimbursed cancer biomarker test items, of which 19 had claims during the study period. Between 2010 and 2024, annual claims increased nearly fivefold, from 5130 to 25,374, representing 6% of all MBS‐funded genetic test volume and 10% of total expenditure. Median reimbursement per test rose from AU$339 in 2014 to AU$667 in 2024, reflecting increased use of multigene panel tests. Uptake tripled among adults aged 75–84 years, while remaining below 3% among individuals under 35 years. Women accounted for 67% of claims in 2024, down from 88% in 2014. Geographic disparities were marked, with test uptake highest in New South Wales (23.8% of incident cancers) and lowest in the Northern Territory (8.7%). Although national funding for cancer biomarker testing has increased, utilization in Australia remains uneven across demographic and geographic lines. These findings highlight the need to ensure equitable access to genomic diagnostics as part of routine cancer care.

Keywords: cancer biomarker testing, equity in access, medicare benefits schedule, precision oncology

Study Highlights

What Is the Current Knowledge on the Topic

Public reimbursement for genomic and biomarker testing is expanding worldwide. In Australia, cancer biomarker tests are publicly funded under the Medicare Benefits Schedule (MBS); however, long‐term national evidence on utilization, expenditure, and equity of access within a publicly funded health system remains limited.

What Question Did This Study Address

This study quantified 15 years of publicly funded cancer biomarker testing in Australia, assessing trends in utilization and government expenditure, and examining demographic and geographic variation in uptake across states and territories.

What Does This Study Add to Our Knowledge

Between 2012 and 2024, claims for cancer biomarker tests increased approximately fivefold, yet these tests accounted for only 6% of all Medicare‐funded genetic testing. Public expenditure rose in parallel with the introduction of multigene panels and homologous recombination deficiency assays. Uptake was highest among older adults, women, and residents of New South Wales, Tasmania, and the Australian Capital Territory, while remaining consistently lower among younger men and residents of the Northern Territory.

How Might This Change Clinical Pharmacology or Translational Science

By providing a national, population‐level view of cancer biomarker testing linked to publicly funded therapies, these findings highlight where laboratory capacity, clinical integration, and implementation strategies may need to be strengthened to support equitable and sustainable delivery of biomarker‐guided cancer treatment across diverse populations and regions.

1. Introduction

Genomic testing has become a cornerstone of modern oncology, informing cancer risk assessment, diagnosis, prognosis, and treatment selection. Genomic testing can be broadly categorized into germline testing, which identifies inherited variants from blood or saliva to assess hereditary cancer risk and guide familial screening, and somatic testing, which detects tumor‐specific alterations in DNA, RNA, or protein expression to guide systemic therapy. While both approaches are integral to cancer management, they differ in clinical purpose, testing methods, and implementation pathways.

This study focuses on cancer biomarker testing used to guide systemic therapy, including somatic tumor assays, molecular diagnostics, and selected germline tests. Landmark examples include imatinib for BCR‐ABL1–positive chronic myeloid leukemia and EGFR tyrosine kinase inhibitors for EGFR‐mutated non‐small‐cell lung cancer (NSCLC) [1, 2, 3]. Advances in sequencing technologies have enabled more comprehensive tumor profiling from limited tissue samples, supporting precision oncology across multiple tumor types [4]. These assays detect actionable alterations, gene fusions, or protein expression biomarkers that predict response or resistance to targeted therapies and immunotherapies, while also improving diagnostic precision and enabling selection of biomarker‐matched therapies [4].

The clinical utility of cancer biomarker tests depends on rigorous validation of analytic performance, clinical validity, impact on treatment decisions, and cost‐effectiveness [5]. In Australia, public funding for these tests is managed through the national Medicare Benefits Schedule (MBS), with reimbursement decisions guided by the Medical Services Advisory Committee (MSAC) [6, 7]. MSAC evaluates biomarker tests alongside their corresponding therapies under a Codependent Technologies framework, requiring evidence that the biomarker identifies patients likely to benefit and that testing improves health outcomes at an acceptable cost‐effectiveness threshold [7, 8, 9].

Despite structured evaluation and funding frameworks, real‐world uptake of publicly funded genetic tests remains variable, reflecting limited clinician awareness, workforce shortages, and workflow integration challenges [10, 11]. Underutilization is observed in non‐oncology tests, such as thiopurine methyltransferase (TPMT) genotyping or exome sequencing for syndromic intellectual disability [10, 12]. While some regional or test‐specific analyses exist in Australia [13], comprehensive national data on cancer biomarker test utilization are limited. This gap highlights the need for robust real‐world evidence and aligns with MSAC's growing focus on downstream outcomes and equitable access in biomarker test assessments [14, 15]. Internationally, cancer biomarker testing rates vary widely, even for guideline‐recommended tests [16, 17, 18, 19, 20]. For example, EGFR and ALK testing rates in NSCLC range from 38% to over 90% across countries, including Brazil, China, Germany, Australia, and Taiwan [20, 21]. Differences in reimbursement policies, laboratory capacity, and clinical practice are associated with these disparities and are consistent with inequities in access to precision oncology [22].

Building on these gaps, our study provides the first nationwide, longitudinal analysis of Medicare‐funded cancer biomarker testing in Australia. We quantified utilization and government expenditure across all reimbursed cancer biomarker tests, stratified by demographics, jurisdiction, and cancer type. Herein, “cancer biomarker tests” refer to tumor‐based assays and selected germline tests used to guide systemic therapy, including somatic genomic tests (single‐gene assays and multigene sequencing panels) and molecular diagnostics (HER2 ISH). For comparison, “all genetic tests” encompasses the full suite of MBS Group P7 items, covering germline and somatic tests across oncology and non‐oncology indications. While germline testing remains vital in cancer care, only selected germline tests linked to therapy access are included in this analysis. By mapping national trends over 15 years, this study provides new insights into the implementation, reach, and equity of precision oncology in Australia, supporting the translational integration of biomarker testing into routine oncology practice.

2. Methods

2.1. Data Sources

We conducted a retrospective analysis of publicly available MBS claims data from the Medicare Item Statistics Reports, curated by Services Australia, covering January 2010 to December 2024. Cancer‐specific biomarker testing claims and expenditure data were available from January 2012 onward, reflecting the introduction of these items to the MBS. These data capture all reimbursed pathology services under Australia's national universal health insurance scheme and are considered complete for the publicly funded healthcare sector. We extracted all item numbers listed under Group P7—Genetics in Category 6—Pathology Services, as defined in the March 2025 MBS Book (version 1) [23]. To contextualize cancer biomarker test utilization relative to cancer burden, we obtained national cancer incidence estimates stratified by age, sex, and jurisdiction (state/territory) from the Australian Institute of Health and Welfare, using the most recent complete data (2020) [24].

2.2. Test Classification and Definitions

We defined cancer biomarker tests as tumor‐based assays and selected germline tests used to guide systemic therapy selection [23]. These comprised three categories: (1) tumor molecular diagnostics, specifically in situ hybridization (ISH) assays detecting gene amplification in tumor tissue (e.g., HER2 ISH testing, MBS item 73332), (2) somatic tumor genomic tests, which identify actionable DNA alterations using either single‐gene assays (e.g., EGFR, BRAF, KRAS) or multigene next‐generation sequencing (NGS) panels, and (3) selected germline tests used for therapy eligibility in defined clinical contexts (e.g., BRCA1/2 germline testing to determine eligibility for PARP inhibitor therapy in prostate cancer).

Tests were classified as cancer biomarker assays if their MBS item descriptor explicitly specified use for determining eligibility for a therapy reimbursed under the Pharmaceutical Benefits Scheme (PBS), consistent with the MSAC's codependent technology framework. Single‐gene tests were included only when linked to therapy selection, while multigene NGS panels were included if their listed clinical indications supported tumor profiling to inform treatment decisions. In total, 21 cancer biomarker test items were identified under the MBS. These included 14 single‐gene tests, four multigene panel tests (items 73433, 73437, 73438, 73439), and one molecular diagnostic (HER2 ISH, item 73332). Two additional items (73430 and 73431) met the classification criteria but recorded no claims during the study period. A full list of included cancer biomarker test items, classification rationale, and associated therapeutic indications is provided in Table S1.

Non‐therapy‐linked germline tests, non‐tumor tests, and genetic screening not directly linked to systemic therapy access were excluded from the cancer biomarker test category, even if listed under Group P7, including biomarkers without explicit PBS‐linked item definitions (e.g., PD‐L1 immunohistochemistry). For comparative analyses, “all genetic tests” were defined as the full set of MBS Group P7 items, encompassing both germline and somatic tests across oncology and non‐oncology indications.

2.3. Outcome Measures

For each MBS item, we extracted annual service claim counts and associated government benefit payments. Data were disaggregated by item code, sex, age group (0–4, 5–14, 15–24, 25–34, 35–44, 45–54, 55–64, 65–74, 75–84, and ≥ 85 years, as defined by Services Australia), and state or territory based on patient location [25]. Primary outcome measures included (i) annual claim volumes and expenditure for cancer biomarker tests, (ii) the proportion of cancer biomarker claims relative to all genetic testing activity, and (iii) estimated coverage of biomarker testing relative to incident cancer cases, stratified by sex, age, and jurisdiction. Expenditures are reported in nominal Australian dollars, consistent with unindexed MBS reimbursement rates [25]. Inflation adjustment was not applied, as MBS rebates are fixed in nominal terms over time.

2.4. Statistical Analysis

All analyses were descriptive. We calculated annual trends in test utilization and expenditure using tabulated MBS data. To estimate biomarker test uptake relative to cancer burden, we calculated the proportion of newly diagnosed cancer cases receiving at least one Medicare‐funded cancer biomarker test, stratified by demographic and geographic variables. Because the dataset represents whole‐population administrative claims, no sampling, randomization, or inferential statistical testing was conducted. All data cleaning and aggregation were performed in Microsoft Excel (RRID: SCR_016137), with data visualization completed using Python (RRID: SCR_008394). Privately funded, research‐based, or other non‐MBS‐reimbursed biomarker tests were not captured in this analysis.

3. Results

3.1. Cancer Biomarker Claims and Expenditures as a Proportion of All Genetic Testing

As of March 1, 2025, the Australian MBS included 160 distinct genetic testing items. Between 2010 and 2024, a total of 4,543,303 Medicare claims for genetic tests were processed. Cancer biomarker testing was first introduced in 2012, and by 2024, 21 biomarker test items were listed, 19 of which recorded claims. These 19 items contributed 253,854 claims over the study period, representing 5.6% of all genetic testing activity (items 73,430 and 73,431, ISH assays for NTRK fusions, recorded no claims during the study period; Table S2).

Although cancer biomarker tests represented 12% of listed genetic testing items, they consistently accounted for less than 10% of total annual genetic test claims. National genetic testing utilization increased from 202,089 claims in 2012 to 579,543 in 2024. Over the same period, cancer biomarker testing grew from 5648 to 25,374 claims, corresponding to an average annual growth rate of 13.4%, outpacing the 9.2% annual growth rate for all genetic tests (Figure 1A). Government expenditure followed similar trends. Total Medicare spending on genetic testing rose from AU$32.5 million in 2012 to AU$151.8 million in 2024. Expenditure on cancer biomarker testing increased from AU$1.2 million in 2012 (3.7% of total genetic test expenditure) to AU$15.0 million in 2024 (9.9%) (Figure 1B).

FIGURE 1.

FIGURE 1

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Trends in Medicare claims and expenditure for cancer biomarker tests, 2012–2024. (A) Proportion of cancer biomarker claims relative to all genetic tests. (B) Proportion of government spending on cancer biomarker tests. Cancer biomarker tests consistently account for a minority of total genetic test activity despite growth in volume and cost.

3.2. Utilization and Reimbursement of Individual Cancer Biomarker Tests

The most frequently used cancer biomarker test was the HER2 ISH assay for breast cancer (item 73332), used to determine eligibility for trastuzumab. Annual claims for this test increased from 5004 in 2012 to 9437 in 2024, with a cumulative total of 136,640 claims over the study period. Reimbursement levels for biomarker tests increased substantially over the study period (Figure 2). In 2014, the four listed biomarker items (for EGFR, KRAS, BRAF, and HER2) had reimbursement rates ranging from AU$230.95 to AU$397.35 (median: AU$339.00; mean: AU$326.57). By 2024, 63% of reimbursed biomarker test items had standard reimbursement rates of at least AU$400. The interquartile range for reimbursement increased from AU$106.80 in 2014 to AU$602.65 in 2024, reflecting greater heterogeneity in test complexity and methodology. The most expensive test in 2024 was a homologous recombination deficiency (HRD) assay (item 73307), used to determine eligibility for PARP inhibitors, reimbursed at AU$3000. In contrast, the lowest rebate remained unchanged at AU$230.95 for BRAF V600 single‐gene testing, used to guide access to dabrafenib, vemurafenib, or encorafenib. By 2024, the median reimbursement for cancer biomarker tests had risen to AU$667 and the mean to AU$783.95.

FIGURE 2.

FIGURE 2

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Distribution of Medicare reimbursement rates for cancer biomarker tests, 2014–2024. Median rebates increased over time, with wider variability reflecting the adoption of complex assays, including multigene NGS panels and HRD tests.

3.3. Demographic Variation in Cancer Biomarker Testing

To assess relative uptake, annual cancer biomarker test claims were calculated as a proportion of newly diagnosed cancer cases, due to the absence of national cancer prevalence data. In 2014, approximately 14% of female and 1.6% of male cancer cases were associated with at least one biomarker test claim (Figure 3A). By 2024, uptake increased to 17.6% among females and 6.9% among males (Figure 3B).

FIGURE 3.

FIGURE 3

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Cancer biomarker testing by age and sex, 2014 (A) and 2024 (B). Proportion of estimated new cancer cases receiving biomarker tests. Uptake is higher among older adults and females; testing in young adults remains low. Values for ages 0–4 years are rounded to zero on this scale.

Age‐related patterns evolved over time. In 2014, females aged 45–54 years had the highest testing rate (30%), while all male age groups remained below 3% (Figure 3A). By 2024, the highest uptake was observed among individuals aged 75–84 years, reaching 30% in females and 16% in males (Figure 3B). Testing rates approximately doubled among individuals aged over 55 years, but remained consistently low among those under 35 years.

In absolute terms, women accounted for 88% of cancer biomarker claims in 2014 (13,603 vs. 1851 for men) (Figure 1A). By 2024, male utilization had increased fourfold to 8306 claims, reducing the female share to 67% (17,068 claims; Figure 1B). This shift is consistent with expanded testing in lung and prostate cancers, which are more prevalent among men.

Cancer biomarker testing was concentrated in older adults. In 2014, nearly 50% of all cancer biomarker test claims occurred among individuals aged ≥ 55 years, led by those aged 65–74 years (4269 claims) and 55–64 years (3831 claims) (Figure 1A). By 2024, the largest growth occurred among those aged 75–84 years (from 2332 to 6838 claims), followed by 65–74 years (increased to 6837) and 55–64 years (to 4966) (Figure 1B). Testing among younger adults (< 35 years) remained low and stable over time (Figure 1B).

3.4. Geographic Variation in Cancer Biomarker Testing

While national cancer biomarker testing uptake rose to 17% of cancer cases in 2024, marked jurisdictional variation was observed (Figure 4). Testing uptake ranged from 23.8% in New South Wales to 8.7% in the Northern Territory. Uptake was also high in the Australian Capital Territory (22.8%) and Tasmania (22.3%), intermediate in Victoria (15.9%), Queensland (14.0%), South Australia (13.5%), and lower in Western Australia (12.3%) (Figure S2).

FIGURE 4.

FIGURE 4

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Geographic variation in cancer biomarker testing, 2024. Proportion of incident cancer cases receiving biomarker tests by state/territory. Uptake is highest in New South Wales, Tasmania, and the ACT, and lowest in the Northern Territory.

In 2014, more than 80% of cancer biomarker test claims across all jurisdictions were for single‐gene tests and HER2 ISH. By 2024, multigene panel tests (items 73433, 73437, 73438, 73439) accounted for 27% of cancer biomarker test claims nationally. Uptake of multigene panels was highest in Tasmania (29.0%) and New South Wales (26.7%), followed by South Australia (22.9%), Western Australia (19.1%), Victoria (16.5%), Northern Territory (16.0%), and Queensland (12%).

3.5. Variation by Cancer Type and Indication

Patterns by cancer indication were inferred from MBS item descriptors and associated PBS‐linked therapies. Cancer biomarker testing patterns shifted substantially by cancer type over time (Figure 5). In 2014, breast cancer accounted for 85% of all cancer biomarker test claims, driven predominantly by HER2 ISH linked to trastuzumab. Lung cancer (including immunotherapies and osimertinib) and melanoma (including dabrafenib, vemurafenib, or encorafenib) each accounted for approximately 7% of claims. By 2024, testing was more evenly distributed across indications. Breast cancer therapies accounted for 35% of claims, followed by lung cancer (30%), melanoma (12%), colorectal cancer (11%; e.g., cetuximab, panitumumab, or encorafenib), prostate cancer (7%; PARP inhibitors, BRCA/HRD), and ovarian‐type cancers (4%; PARP inhibitor, BRCA/HRD). Smaller proportions were observed for gastric cancer (1%; trastuzumab) and pan‐tumor NTRK fusion testing (< 1%; TRK inhibitor). The introduction of multigene panels and BRCA/HRD testing facilitated access to therapies in prostate and ovarian cancers. In contrast, uptake of biomarker tests for rare or complex indications, such as NTRK fusion detection for TRK inhibitors, remained low across all jurisdictions.

FIGURE 5.

FIGURE 5

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Distribution of cancer biomarker test claims by cancer type, 2014 vs. 2024. Shift from breast cancer dominance toward broader use in lung, melanoma, colorectal, and prostate cancers. Data highlight the diversification of testing across cancer types and regions over time. Item 73295 was classified as applicable to both epithelial ovarian, fallopian tube, or primary peritoneal cancer and breast cancer.

Jurisdictional patterns also varied by indication (Figure 5). Tasmania recorded the highest proportion of lung cancer‐related testing (41%), whereas Queensland remained more heavily weighted toward breast cancer‐related testing (44%). Western Australia and the Northern Territory showed lower uptake across newer cancer biomarker indications and multigene panels.

4. Discussion

This study provides the first national, longitudinal analysis of publicly funded cancer biomarker testing in Australia, offering insight into utilization and expenditure trends over 15 years. Despite a nearly five‐fold increase in claims between 2012 and 2024, cancer biomarker tests accounted for only 6% of all Medicare‐funded genetic test claims and 10% of associated government spending by 2024. This modest share likely reflects both their more recent introduction and narrower clinical indications compared with the broader range of genetic tests used across oncology (including hereditary cancer testing) and non‐oncology settings. Most cancer biomarker test items were introduced after 2014, with multigene panels reimbursed from 2022 to 2023. These tests are codependent on targeted therapies funded under the PBS and are used in defined patient subgroups [10, 26]. Monitoring both test volumes and expenditure provides insight into how public investment in precision oncology is being operationalized within the publicly funded health system.

Over the past decade, per‐test reimbursement and total public expenditure on cancer biomarker testing have increased. Higher rebates likely reflect both increased assay complexity and administrative pricing decisions associated with new MBS listings, including the transition from single‐gene tests (e.g., HER2, EGFR) to multigene NGS panels and HRD assays. These technologies require laboratory infrastructure, bioinformatics capability, and specialist workforce capacity, all of which have implications for long‐term system planning. Aggregate expenditure has also risen due to expanded clinical indications and increasing test volumes. Examining reimbursement levels alongside utilization trends provides important context for MSAC evaluations of new test listings, particularly in relation to clinical utility, cost‐effectiveness, and projected budget impact. Continued surveillance of pricing and uptake may help determine whether expansion of precision oncology services is occurring uniformly across health system settings or remains concentrated within well‐resourced centers.

Observed demographic patterns largely reflect the clinical distribution of cancers for which biomarker‐guided therapy is routinely used [4, 11]. In the early years, HER2 testing in breast cancer drove higher uptake among women. As biomarker testing expanded to additional indications, including lung and prostate cancers (e.g., EGFR, ALK, BRCA), utilization increased among men and older adults. Between 2014 and 2024, testing rates increased markedly among individuals aged 75–84 years, reaching 30% in females and 16% in males. This trend may reflect increasing clinician confidence in applying precision oncology approaches in older populations, supported by emerging evidence of therapeutic benefit in these age groups [27]. The very low number of claims observed in children aged 0–4 years likely reflects the limited scope of pediatric‐specific MBS items. Only four cancer biomarker test items (73430–73433) are specified for patients under 18 years of age and are restricted to FISH‐based NTRK testing with PBS‐linked treatment intent. In pediatric oncology, tumor testing is frequently performed using non‐FISH modalities or funded through non‐MBS pathways, including hospital‐based or jurisdictional programs. Uptake among younger adults also remained low, consistent with lower cancer incidence in these age groups. Additional factors such as variation in referral pathways or access to testing may also contribute [28, 29].

Substantial geographic variation in cancer biomarker testing persists. In this study, geographic variation is interpreted as a proxy for inequity, although differences in cancer type distribution and clinical eligibility may also contribute. In 2024, patients in New South Wales, Tasmania, and the Australian Capital Territory were nearly three times more likely to receive a reimbursed cancer biomarker test than those in the Northern Territory. This pattern corresponds with the geographic distribution of accredited NGS laboratories, five of the eight accredited facilities being located in Sydney, Brisbane, or Melbourne [30]. This is consistent with physical laboratory infrastructure remaining a key determinant of access despite national reimbursement. Patients in jurisdictions without local testing facilities may experience delays or logistical challenges, including specimen transport and coordination across services. Prior studies have documented similar barriers for rural and Indigenous populations, including long travel distances, limited access to culturally safe care, and difficulties navigating complex health systems [31, 32, 33]. For example, Luke et al. reported lower uptake of genomic services among Indigenous Australians in the Northern Territory due to these factors [34]. These findings suggest that equitable access depends not only on MBS item listing and reimbursement but also on service availability, cultural safety, and integration of genomic testing into routine care.

Australia's experience mirrors broader international trends. An international review identified consistently lower biomarker testing rates in rural areas [35]. In the U.S., Chehade et al. reported that only 29% of men with metastatic prostate cancer underwent biomarker testing, with disparities associated with insurance coverage and neighborhood‐level socioeconomic factors [36]. Similarly, Khan et al. observed very low uptake of NGS (1.8%), particularly outside metropolitan centers [37]. A pan‐European audit found that single‐gene tests continue to predominate, with multigene panels concentrated in large reference centers [38]. Australia's inter‐jurisdictional variation appears consistent with these shared challenges in scaling precision oncology equitably across diverse health systems.

Policy initiatives are beginning to address these issues. Australia's National Genomics in Health Strategy emphasizes universal access to genomic testing and counseling; however, workforce capacity, service integration, and outreach to underserved groups remain ongoing challenges [39]. Evidence on effective strategies to extend precision oncology to Aboriginal and Torres Strait Islander peoples and those living outside major cities remains limited [33]. Implementation research from germline testing contexts, such as BRCA testing for breast and ovarian cancer, suggests that clinician education, clearly defined referral pathways, and real‐time tracking systems can improve uptake and reduce disparities [40]. Similar approaches may be applicable to somatic biomarker testing when embedded within broader cancer care pathways.

Cancer biomarker testing enables more precise tumor classification and supports selection of targeted therapies, making access to testing a central component of precision oncology in routine care. Although this study does not evaluate patient‐level diagnostic accuracy or treatment outcomes, it characterizes the national reach and geographic distribution of publicly funded testing. Observed patterns highlight where variation in implementation may affect timely access to biomarker‐guided therapies. By linking Medicare claims with national cancer incidence data, this analysis provides a population‐level perspective on biomarker test uptake and coverage. Together, these findings can inform efforts to align laboratory capacity, funding mechanisms, and clinical integration with national goals for equitable precision oncology [41].

This study has several limitations. First, MBS claims data capture service utilization but lacks individual‐level clinical detail, including cancer stage, biomarker status, treatment received, or outcomes, precluding assessment of test appropriateness or clinical impact. Second, utilization was measured by claims volume rather than unique patients, potentially overestimating uptake due to repeat testing. Third, 2020 cancer incidence data were used as a proxy denominator for both 2014 and 2024 because national prevalence data were unavailable, which may misrepresent eligible populations for tests indicated in advanced disease or specific histological subtypes. Fourth, our analysis includes only MBS‐funded tests, excluding those reimbursed through state‐based programs, private insurance, or clinical trials, likely underestimating total testing, particularly in tertiary settings. Fifth, all expenditure data are reported in nominal Australian dollars and were not adjusted for inflation; part of the observed increase in rebates may therefore reflect inflationary effects. Sixth, our classification relied on explicit linkage to PBS‐funded therapies within the MBS item descriptors. Consequently, some clinically relevant biomarker tests may not have been included if this linkage was not specified. For example, MBS item 72,814 (PD‐L1 immunohistochemistry), which can be used to guide immune checkpoint inhibitor therapy, was not included in the analysis, potentially leading to underestimation of biomarker testing utilization. Finally, we were unable to assess disparities by socioeconomic status, Aboriginal and Torres Strait Islander identity, or culturally and linguistically diverse backgrounds, all of which influence access to genomic services. Despite these limitations, MBS claims represent the most comprehensive national data source currently available for monitoring cancer biomarker testing in Australia. Future linkage with cancer registries, pharmaceutical dispensing records, and clinical outcomes datasets will be important to evaluate clinical impact and equity more fully.

5. Conclusion

In summary, cancer biomarker testing within Australia's publicly funded system has expanded rapidly over the past decade but remains unevenly distributed across demographic and geographic groups. While increasing reimbursement and technological complexity reflects maturation of precision oncology, variation in uptake suggests that implementation remains shaped by structural and service‐level factors. Ongoing national surveillance and cross‐sector data linkage will be essential to ensure that expansion of biomarker‐guided care translates into equitable clinical benefit across the population.

Author Contributions

L.K. and C.Y.L. wrote the manuscript; C.Y.L. designed the research; L.K. performed the research and analyzed the data.

Funding

The authors have nothing to report.

Ethics Statement

This study used only publicly available, de‐identified Medicare Item Statistics data and did not require ethics approval.

Conflicts of Interest

The authors declare no conflicts of interest.

Supporting information

Figure S1A: Total cancer biomarker test claims in 2014, by age and sex.

Figure S1B: Total cancer biomarker test claims in 2024, by age and sex.

Figure S2: Total cancer biomarker test claims by state and territory in 2024.

CTS-19-e70538-s001.docx (267.1KB, docx)

Data S1: cts70538‐sup‐0002‐DataS1.xlsx.

CTS-19-e70538-s002.xlsx (49.7KB, xlsx)

Acknowledgments

We would like to acknowledge Bella Ianni (University of Sydney) for her valuable contributions in collecting and curating detailed item definitions and classifications from the MBS Book. Open access publishing facilitated by The University of Sydney, as part of the Wiley ‐ The University of Sydney agreement via the Council of Australasian University Librarians

Data Availability Statement

All data used in this study are publicly available. Medicare item‐level claims data can be accessed via the Services Australia Medicare Statistics Portal [25]. Processed datasets and item‐level classifications are provided within the article and (Figure S1)A and (Data S1).

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Associated Data

This section collects any data citations, data availability statements, or supplementary materials included in this article.

Supplementary Materials

Figure S1A: Total cancer biomarker test claims in 2014, by age and sex.

Figure S1B: Total cancer biomarker test claims in 2024, by age and sex.

Figure S2: Total cancer biomarker test claims by state and territory in 2024.

CTS-19-e70538-s001.docx (267.1KB, docx)

Data S1: cts70538‐sup‐0002‐DataS1.xlsx.

CTS-19-e70538-s002.xlsx (49.7KB, xlsx)

Data Availability Statement

All data used in this study are publicly available. Medicare item‐level claims data can be accessed via the Services Australia Medicare Statistics Portal [25]. Processed datasets and item‐level classifications are provided within the article and (Figure S1)A and (Data S1).

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