Dataset Information

Cost-utility analysis of genomic profiling in early breast cancer in Colombia.

ABSTRACT:

Background

In Colombia, the best strategy to establish indication for adjuvant chemotherapy in early breast cancer (EBC) remains unknown. This study aimed to identify the cost-utility of Oncotype DX™ (ODX) or Mammaprint™ (MMP) tests to establish the necessity of adjuvant chemotherapy.

Methods

This study used an adapted decision-analytic model to compare cost and outcomes of care between ODX or MMP tests and routine care without ODX or MMP tests (adjuvant chemotherapy for all patients) over a 5-year time horizon from the perspective of the Colombian National Health System (NHS; payer). Inputs were obtained from national unit cost tariffs, published literature, and clinical trial database. The study population comprised women with hormone-receptor-positive (HR +), HER2-negative, lymph-node-negative (LN0) EBC with high-risk clinical criteria for recurrence. The outcome measures were discounted incremental cost-utility ratio (ICUR; 2021 United States dollar per quality-adjusted life-year [QALY] gained) and net monetary benefit (NMB). Probabilistic (PSA) and deterministic sensitivity analysis (DSA) were performed.

Results

ODX increases QALYs by 0.05 and MMP by 0.03 with savings of $2374 and $554 compared with the standard strategy, respectively, and were cost-saving in cost-utility plane. NMB for ODX was $2203 and for MMP was $416. Both tests dominate the standard strategy. Sensitivity analysis revealed that with a threshold of 1 gross domestic product per capita, ODX will be cost-effective in 95.5% of the cases compared with 70.2% cases involving MMP.DSA showed that the variable with significant influence was the monthly cost of adjuvant chemotherapy. PSA revealed that ODX was a consistently superior strategy.

Conclusions

Genomic profiling using ODX or MMP tests to define the need of adjuvant chemotherapy treatment in patients with HR + and HER2 -EBC is a cost-effective strategy that allows Colombian NHS to maintain budget.

SUBMITTER: Rojas L

PROVIDER: S-EPMC10334609 | biostudies-literature | 2023 Jul

REPOSITORIES: biostudies-literature

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Publications

Cost-utility analysis of genomic profiling in early breast cancer in Colombia.

Rojas Leonardo L Rojas-Reyes María X MX Rosselli Diego D Ariza Juan Guillermo JG Ruiz-Patiño Alejandro A Cardona Andrés F AF

Cost effectiveness and resource allocation : C/E 20230710 1

<h4>Background</h4>In Colombia, the best strategy to establish indication for adjuvant chemotherapy in early breast cancer (EBC) remains unknown. This study aimed to identify the cost-utility of Oncotype DX™ (ODX) or Mammaprint™ (MMP) tests to establish the necessity of adjuvant chemotherapy.<h4>Methods</h4>This study used an adapted decision-analytic model to compare cost and outcomes of care between ODX or MMP tests and routine care without ODX or MMP tests (adjuvant chemotherapy for all patie ...[more]

PMID: 37430303

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Project description:IntroductionClinicopathologic and patient factors, such as tumor grade, size, age, and menopausal status, provide limited prognostic and predictive information in hormone receptor positive (HR +), human epidermal growth receptor 2 negative (HER2-), node-negative early-stage breast cancer, leading to potential over- or under-treatment. Multigene expression profile tests used in clinical practice in the USA, including the 21-gene assay, 70-gene assay, 12-gene assay, and 50-gene assay, offer prognostic information beyond traditional clinicopathologic features to improve treatment decisions. This study aimed to estimate the cost-effectiveness of these four multigene assays compared with clinicopathologic risk assessment alone.MethodsA decision tree categorized hypothetical patients with HR + /HER2- early-stage invasive breast cancer according to clinical and genomic risk, and integrated clinical expert insights for chemotherapy allocation with literature inputs. A Markov model simulated lifetime costs and outcomes of chemotherapy decisions over a patient's lifetime. The probability of distant breast cancer recurrence was derived from TAILORx (21-gene assay), MINDACT (70-gene assay), and TransATAC (12-gene assay, 50-gene assay) studies. Costs were calculated from a US societal perspective in 2021 US dollars, considering healthcare costs, lost productivity, and patient out-of-pocket expenses.ResultsThe 21-gene assay and 50-gene assay were less costly ( -$12,189 and -$2410, respectively) and more effective [0.23 and 0.07 quality-adjusted life years (QALYs), respectively] compared with clinicopathologic risk alone. Similarly, the 70-gene assay and 12-gene assay are also cost-effective alternatives [incremental cost-effectiveness ratio (ICER): 27,760 and 7942, respectively].ConclusionsAll four multigene assays were cost-effective from a societal perspective, offering low net lifetime costs or savings with improved outcomes compared with clinicopathologic risk assessment alone. These assays can help refine treatment decisions by providing prognostic risk estimates. In the case of the 21-gene assay, it can also predict chemotherapy benefit leading to the highest lifetime cost savings and greatest QALY gain.

Project description:BackgroundThe anti-human epidermal growth factor receptor 2 (HER2) monoclonal antibody trastuzumab improves outcomes in patients with node-positive HER2+ early breast cancer. Given trastuzumab's high cost, we aimed to estimate its cost-effectiveness by heterogeneity in age and estrogen receptor (ER) and progesterone receptor (PR) status, which has previously been unexplored, to assist prioritisation.Methods and findingsA cost-utility analysis was performed using a Markov macro-simulation model, with a lifetime horizon, comparing a 12-mo regimen of trastuzumab with chemotherapy alone using the latest (2014) effectiveness measures from landmark randomised trials. A New Zealand (NZ) health system perspective was adopted, employing high-quality national administrative data. Incremental quality-adjusted life-years for trastuzumab versus chemotherapy alone are two times higher (2.33 times for the age group 50-54 y; 95% CI 2.29-2.37) for the worst prognosis (ER-/PR-) subtype compared to the best prognosis (ER+/PR+) subtype, causing incremental cost-effectiveness ratios (ICERs) for the former to be less than half those of the latter for the age groups from 25-29 to 90-94 y (0.44 times for the age group 50-54 y; 95% CI 0.43-0.45). If we were to strictly apply an arbitrary cost-effectiveness threshold equal to the NZ gross domestic product per capita (2011 purchasing power parity [PPP]-adjusted: US$30,300; €23,700; £21,200), our study suggests that trastuzumab (2011 PPP-adjusted US$45,400/€35,900/£21,900 for 1 y at formulary prices) may not be cost-effective for ER+ (which are 61% of all) node-positive HER2+ early breast cancer patients but cost-effective for ER-/PR- subtypes (37% of all cases) to age 69 y. Market entry of trastuzumab biosimilars will likely reduce the ICER to below this threshold for premenopausal ER+/PR- cancer but not for ER+/PR+ cancer. Sensitivity analysis using the best-case effectiveness measure for ER+ cancer had the same result. A key limitation was a lack of treatment-effect data by hormone receptor subtype. Heterogeneity was restricted to age and hormone receptor status; tumour size/grade heterogeneity could be explored in future work.ConclusionsThis study highlights how cost-effectiveness can vary greatly by heterogeneity in age and hormone receptor subtype. Resource allocation and licensing of subsidised therapies such as trastuzumab should consider demographic and clinical heterogeneity; there is currently a profound disconnect between how funding decisions are made (largely agnostic to heterogeneity) and the principles of personalised medicine.

Dataset Information

Cost-utility analysis of genomic profiling in early breast cancer in Colombia.

Background

Methods

Results

Conclusions

Publications

Cost-utility analysis of genomic profiling in early breast cancer in Colombia.

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