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Large adjuvant trastuzumab trials
Source publication
Trastuzumab has significantly improved survival outcomes for women with Human Epidermal growth factor Receptor 2 (HER2)-positive early breast cancer. Trastuzumab was established as a cost-effective adjuvant treatment in 2006. We present an updated cost-effectiveness analysis from the UK perspective, which explores assumptions about the duration of...
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Similar publications
Adjuvant trastuzumab therapy improves survival of human epidermal growth factor receptor 2 (HER2)-positive women with early breast cancer (EBC). A careful monitoring of cardiac function is needed due to potential trastuzumab cardiotoxicity (Tcardiotox). To date, the incidence, timing, and phenotype of patients with Tcardiotox in clinical practice a...
Citations
... We identified 22 EEs comparing adjuvant trastuzumab therapy with chemotherapy alone for HER2-positive EBC, published from year 2006 to 2018 ( Table 1). As shown in Table 2, studies were mostly from high-income countries (HICs) [28][29][30][31][32][33][34][35][36][37][38][39][40][41][42][43], while some [44][45][46][47][48][49] were from upper-middleincome countries (UMICs). About half [15,[28][29][30][31][32][33][34][35][36][37]44] were conducted and published as early as 2006 to 2009, which was within the early years of trastuzumab's market entry for HER2-positive early stage indication in 2006. ...
... About half [15,[28][29][30][31][32][33][34][35][36][37]44] were conducted and published as early as 2006 to 2009, which was within the early years of trastuzumab's market entry for HER2-positive early stage indication in 2006. More than half [28][29][30][31][32][33][34][35][36][37][38][39][40]44] have been published even before 2013 when the WHO reviewed its inclusion in the WHO Essential Medicines List [50]. In terms of methodology, majority of the studies [30][31][32][36][37][38][39][40][41][42][43][44][45][46][47][48][49] adopted cost-utility analysis, while some [28,29,[33][34][35] used cost-effectiveness analysis. ...
... More than half [28][29][30][31][32][33][34][35][36][37][38][39][40]44] have been published even before 2013 when the WHO reviewed its inclusion in the WHO Essential Medicines List [50]. In terms of methodology, majority of the studies [30][31][32][36][37][38][39][40][41][42][43][44][45][46][47][48][49] adopted cost-utility analysis, while some [28,29,[33][34][35] used cost-effectiveness analysis. All except two studies [5,10] used decision analytic Markov modeling technique. ...
Introduction:
As the availability of new economic evaluations (EE) on adjuvant trastuzumab therapy for early-stage breast cancer (EBC) with HER2-positive since last search and other EEs missed warrant a more extensive review, this study aimed to systematically review EEs of adjuvant trastuzumab compared with chemotherapy alone for HER2-positive EBC.
Area covered:
The search was performed in February 2019 using MEDLINE and Scopus. Reviewers independently selected studies based on eligibility criteria, extracted data, assessed quality of reporting, and appraised quality of data sources.
Expert opinion:
22 studies were included which were from high-income (HICs) and upper-middle income countries (UMICs). Incremental cost-effectiveness ratios (ICERs) from HICs were within their cost-effectiveness thresholds and ranged from 6,018 to 78,929 USD per quality-adjusted life year (QALY) gained. ICERs from UMICs mostly exceeded their thresholds ranging from 3,526 to 174,901 USD per QALY gained. Evidence shows cost-effectiveness of trastuzumab for HER2-positive EBC in HICs. There were no methodological variations. The extent and adequacy of reporting were high. The quality of data sources was moderate to high. The quality of future EEs can be improved by enhancing the reporting quality, by using context-based data and real-world efficacy data, which would impact cost-effectiveness.
... Of 4088 patients, 2045 were randomly assigned to 12 months' trastuzumab and 2043 were randomly assigned to 6 months' trastuzumab. 91.5%) in the 12-month arm and 89.5% (95% confidence interval 88.1% to 90.8%) in the 6-month arm. The hazard ratio for 6 months compared with 12 months was 1.10 (90% confidence interval 0.96 to 1.26; non-inferiority p = 0.01), demonstrating non-inferiority of 6 months' trastuzumab. ...
... The structure of the model was developed in discussion with clinical experts and health economists, and it was adapted from the structure of a previously published model. 91 Cost and QALY data were elicited directly from patients and from CRFs for the subsequent 18 months, and these data were used to inform the first six cycles of the model (summarised in the within-trial analysis). During this period, the costs associated with symptomatic or asymptomatic reversible cardiac toxicity were captured. ...
... First-year costs and annual costs associated with developing a new primary or contralateral breast cancer were taken from a previous economic evaluation. 91 The cost of a new primary or contralateral breast cancer was estimated by calculating the expected cost for a 5-year period (based on a higher first-year cost and lower subsequent year costs) and converting this to a 3-monthly cost. ...
Background:
The addition of adjuvant trastuzumab to chemotherapy has significantly improved outcomes for people with human epidermal growth factor receptor 2 (HER2)-positive, early, potentially curable breast cancer. Twelve months' trastuzumab, tested in registration trials, was adopted as standard adjuvant treatment in 2006. Subsequently, similar outcomes were demonstrated using 9 weeks of trastuzumab. Shorter durations were therefore tested for non-inferiority.
Objectives:
To establish whether or not 6 months' adjuvant trastuzumab is non-inferior to 12 months' in the treatment of HER2-positive early breast cancer using a primary end point of 4-year disease-free survival.
Design:
This was a Phase III randomised controlled non-inferiority trial.
Setting:
The setting was 152 NHS hospitals.
Participants:
A total of 4088 patients with HER2-positive early breast cancer who it was planned would receive both chemotherapy and trastuzumab took part.
Intervention:
Randomisation (1 : 1) to 6 months' or 12 months' trastuzumab treatment.
Main outcomes:
The primary end point was disease-free survival. The secondary end points were overall survival, cost-effectiveness and cardiac function during treatment with trastuzumab. Assuming a 4-year disease-free survival rate of 80% with 12 months' trastuzumab, 4000 patients were required to demonstrate non-inferiority of 6 months' trastuzumab (5% one-sided significance, 85% power), defining the non-inferiority limit as no worse than 3% below the standard arm. Costs and quality-adjusted life-years were estimated using a within-trial analysis and a lifetime decision-analytic model.
Results:
Between 4 October 2007 and 31 July 2015, 2045 patients were randomised to 12 months' trastuzumab and 2043 were randomised to 6 months' trastuzumab. Sixty-nine per cent of patients had ER-positive disease; 90% received anthracyclines (49% with taxanes; 41% without taxanes); 10% received taxanes without anthracyclines; 54% received trastuzumab sequentially after chemotherapy; and 85% received adjuvant chemotherapy (58% were node negative). At 6.1 years' median follow-up, with 389 (10%) deaths and 566 (14%) disease-free survival events, the 4-year disease-free survival rates for the 4088 patients were 89.5% (95% confidence interval 88.1% to 90.8%) in the 6-month group and 90.3% (95% confidence interval 88.9% to 91.5%) in the 12-month group (hazard ratio 1.10, 90% confidence interval 0.96 to 1.26; non-inferiority p = 0.01), demonstrating non-inferiority of 6 months' trastuzumab. Congruent results were found for overall survival (non-inferiority p = 0.0003) and landmark analyses 6 months from starting trastuzumab [non-inferiority p = 0.03 (disease-free-survival) and p = 0.006 (overall survival)]. Six months' trastuzumab resulted in fewer patients reporting adverse events of severe grade [365/1929 (19%) vs. 460/1935 (24%) for 12-month patients; p = 0.0003] or stopping early because of cardiotoxicity [61/1977 (3%) vs. 146/1941 (8%) for 12-month patients; p < 0.0001]. Health economic analysis showed that 6 months' trastuzumab resulted in significantly lower lifetime costs than and similar lifetime quality-adjusted life-years to 12 months' trastuzumab, and thus there is a high probability that 6 months' trastuzumab is cost-effective compared with 12 months' trastuzumab. Patient-reported experiences in the trial highlighted fatigue and aches and pains most frequently.
Limitations:
The type of chemotherapy and timing of trastuzumab changed during the recruitment phase of the study as standard practice altered.
Conclusions:
PERSEPHONE demonstrated that, in the treatment of HER2-positive early breast cancer, 6 months' adjuvant trastuzumab is non-inferior to 12 months'. Six months' treatment resulted in significantly less cardiac toxicity and fewer severe adverse events.
Future work:
Ongoing translational work investigates patient and tumour genetic determinants of toxicity, and trastuzumab efficacy. An individual patient data meta-analysis with PHARE and other trastuzumab duration trials is planned.
Trial registration:
Current Controlled Trials ISRCTN52968807, EudraCT 2006-007018-39 and ClinicalTrials.gov NCT00712140.
Funding:
This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 40. See the NIHR Journals Library website for further project information.
... Hence, the administration of adjuvant trastuzumab for one year in early HER2-positive breast cancer is considered a milestone in breast cancer therapy. To our knowledge, from 2007 to 2019, twenty cost-effectiveness surveys of one-year adjuvant trastuzumab in cases of early HER2-positive breast cancer were published worldwide [9][10][11][12][13][14][15][16][17][18][19][20][21][22][23][24][25][26][27][28]. Only three studies were published from 2007 to 2019 using real-world data: in Canada (2012), The Netherlands (2017), and Taiwan (2019) [19,21,26]. ...
... In contrast, other studies have reported that the use of trastuzumab was not cost-effective [9,10,13,15,16]. Furthermore, yet other studies have concluded that the cost-effectiveness of adjuvant trastuzumab remains unclear [18,20,28]. Most of the previous studies were performed from a healthcare provider perspective. ...
... Most of the previous studies were performed from a healthcare provider perspective. The majority of them used Markov models and lifetime horizons [9,10,12,[14][15][16][17][18][19][20][21][22][23][24]26,28]. Two systematic reviews revealed that most researchers used QALYs as the health outcome measurements to evaluate trastuzumab's cost-effectiveness [29,30]. ...
Introduction:
This study is one of the first real-world cost-effectiveness analyses of one-year adjuvant trastuzumab used in HER2-positive early female breast cancer in comparison to chemotherapy alone. It is just the second one in Europe, the first one in Cyprus, and the fourth one worldwide ever carried out using real-world data.
Methods:
Using a Markov model (four health states), a cost-effectiveness analysis was carried out both over 20 years and for a lifetime horizon. The sampling method used in this study was the randomized sampling of 900 women.
Results:
The findings for the 20-year horizon showed that all trastuzumab arms were more cost-effective, with a willingness-to-pay threshold of only €60,000 per quality-adjusted life year (QALY) [incremental cost-effectiveness ratios (ICER): €40,436.10/QALY]. For the lifetime horizon, with thresholds of €20,000, €40,000, and €60,000/QALY, all trastuzumab arms were found to be more cost-effective (ICER: €17,753.85/QALY). Moreover, for the 20-year and the lifetime horizons, with thresholds of €20,000/QALY, €40,000/QALY, and €60,000/QALY, the most cost-effective of the three subgroups (anthracyclines and then trastuzumab, no anthracyclines and then trastuzumab, and anthracyclines, taxanes, and trastuzumab) was that of anthracyclines and then trastuzumab (ICER: €18,301.55/QALY and €8954.97/QALY, respectively).
Conclusions:
The study revealed that adjuvant trastuzumab for one year in female HER2-positive early breast cancer can be considered cost-effective.
... 9,10 Many cost-effectiveness analyses of trastuzumab have been reported, with variable results. [11][12][13][14][15][16][17][18][19] The variability in findings can be attributed to differences in perspective, modeling method, context, health care delivery structure, price, and other input parameters. ...
... Nearly 18 cost-effectiveness studies have been undertaken to evaluate trastuzumab. [11][12][13][14][16][17][18][19]21,25,26,[36][37][38][39][40][41][42] Eight studies modeled consequences using effectiveness estimates reported in the HERA trial, whereas 6 used the joint analysis of NSABP B-31 (ClinicalTrials.gov identifier: NCT00004067) and NCCTG N9831 (ClinicalTrials.gov ...
... to 2.87 in various studies, whereas QALYs gained have varied from 0.49 to 2.83.[11][12][13][14][16][17][18][19]21,25,26,[36][37][38][39][40][41][42]59 We found the incremental health benefit after treatment with trastuzumab to be 1.48 LYs and 1.29 QALYs, both of which are well within the range of values in published evidence.The incremental cost per QALY gained in terms of purchasing power parity ranges from 4,819 international dollars (Int$) to Int$110,283, with a median value of Int$40,998. ...
PURPOSE
We undertook this study to evaluate the incremental cost per quality-adjusted life-year (QALY) gained with use of adjuvant trastuzumab as compared with chemotherapy alone among patients with nonmetastatic breast cancer in India.
METHODS
We used a Markov model to estimate the incremental cost of using trastuzumab (for 1 year, 6 months, or 9 weeks) as compared with chemotherapy alone using a societal perspective, excluding indirect productivity losses. Although the outcomes (QALYs) in the standard chemotherapy arm were estimated after calibrating the model as per survival data from 2 Indian cancer registries, effectiveness estimates from the HERA trial and a joint analysis of the NSABP B-31 and NCCTG N9831 trials were used to estimate the consequences of 1-year trastuzumab use. The cost of treatment was estimated using national standard treatment guidelines and real-world use estimates for different treatment modalities as per data from Indian cancer registries. Probabilistic sensitivity analysis was undertaken to evaluate parameter uncertainty.
RESULTS
For 1 year of trastuzumab use, the incremental benefit per patient, incremental cost per QALY gained, and probability of being cost effective using HERA trial estimates were 1.29 QALYs, 178,877 Indian national rupees (INRs; US$2,558), and 4%, respectively, whereas the corresponding figures using joint analysis estimates were 1.69 QALYs, INR 134,413 (US$1,922), and 57.3%, respectively.
CONCLUSION
Use of trastuzumab for 1 year is not cost effective in India at the current price. However, trastuzumab use for 9 weeks is cost effective and should be included in clinical guidelines and reimbursement policies. A price reduction of 15% to 35% increases the probability of 1-year trastuzumab use being cost effective, to 90%.
... Assessing cost-effectiveness is critical in establishing equitable trade-off decisions between the sustainable access to such effective health technology that can improve survival and the limited health budget, especially for resource-constrained countries such as the Philippines. While many published economic evaluation (EE) studies have been previously conducted to assess its cost-effectiveness, all were conducted in settings that are not comparable to a lower-middle income country (LMIC) like the Philippines, as they were all from upper-middle and high-income countries [20][21][22][23][24][25][26][27][28][29][30][31][32][33][34][35]. Therefore, we conducted this economic evaluation to assess the cost-effectiveness and budget impact of adjuvant trastuzumab therapy compared to chemotherapy regimen alone for patients with HER2positive EBC in the Philippines, to guide coverage decisions. ...
Background:
Breast cancer is the leading malignancy among Filipino women, with about 23.50% of cases characterized by human epidermal growth factor receptor-2 (HER2) overexpression. Trastuzumab, in addition to standard chemotherapy, is currently recommended as primary treatment for HER2-positive early-stage breast cancer (EBC) in the adjuvant settings, and has been listed in the Philippine National Formulary (PNF) since 2008, but with no current evidence yet on its value for money, to date. Hence, despite several policy enablers, its accessibility remains to be limited in the Philippines. We performed an economic evaluation to assess the cost-effectiveness and budget impact of adjuvant trastuzumab therapy for HER2-positive EBC in the Philippines, using healthcare system and societal perspectives, in aid of guiding coverage decisions.
Methods:
A Markov model-based cost-utility and budget impact analyses were conducted to estimate the total costs incurred and outcomes gained in using 1 year of adjuvant trastuzumab added to standard chemotherapy versus standard chemotherapy alone, over a lifetime horizon. We discounted both costs and outcomes at 3.5% per annum. Parameters were estimated using country survival data, systematic review and meta-analysis of the relative treatment effect, local and international cost data, and published utility data. Univariate and probabilistic sensitivity analyses were used to account for parameter uncertainty.
Results:
Trastuzumab therapy was dominated with an incremental cost-effectiveness ratio (ICER) at PHP 453,505 per QALY gained from a healthcare system perspective or PHP 458,686 per QALY gained from a societal perspective, with 10% cost-effectiveness probability at the country cost-effectiveness threshold of PHP 120,000 per QALY gained. National implementation will cost an additional amount of PHP 13,909 million in year one alone, plus about PHP 2000 to 3000 million annually for the succeeding fiscal years.
Conclusion:
At its current cost, 1 year of adjuvant trastuzumab therapy compared to standard chemotherapy alone for HER2-positive EBC does not represent value for money in the Philippines. Its current cost will have to significantly lower down by one-half to achieve cost-effectiveness.
... The denominator for percentage was the number of patients who had breast surgery during the neoadjuvant period in the ITT population IMC internal mammary chain, ITT intent-to-treat, PPS per-protocol set, RT radiotherapy, SCV supraclavicular a All other region combinations not shown in the preceding list b Two patients in the CT-P6 treatment group who initiated hormonal treatment were excluded from the PPS as these were considered to be major protocol deviations [2,3]. While this approach can be cost-effective, analyses are particularly sensitive to the estimated duration of treatment benefit [14], and evidence suggests that trastuzumab is not cost-effective in low-income countries [15]. Trastuzumab biosimilars can deliver efficacy and safety equivalent to the reference product at a significantly reduced cost, improving cost-effectiveness and access to this beneficial treatment [4]. ...
Purpose
Neoadjuvant CT-P6, a trastuzumab biosimilar, demonstrated equivalent efficacy to reference trastuzumab in a phase 3 trial of HER2-positive early-stage breast cancer (EBC) (NCT02162667). We report post hoc analyses evaluating pathological complete response (pCR) and breast pCR alongside additional efficacy and safety measures.
Methods
Following neoadjuvant treatment and surgery, patients received adjuvant CT-P6 or trastuzumab (6 mg/kg) every 3 weeks for ≤ 1 year.
Results
In total, 271 and 278 patients received CT-P6 and trastuzumab, respectively. pCR and breast pCR rates were comparable between treatment groups regardless of age, region, or clinical stage. Overall, 47.6% (CT-P6) and 52.2% (trastuzumab) of patients experienced study drug-related treatment-emergent adverse events (TEAEs), including 17 patients reporting heart failure (CT-P6: 10; trastuzumab: 7). Two CT-P6 and three trastuzumab patients discontinued adjuvant treatment due to TEAEs.
Conclusion
Adjuvant CT-P6 demonstrated comparable efficacy and safety to trastuzumab at 1 year in patients with HER2-positive EBC, supporting CT-P6 and trastuzumab comparability.
... A number of studies have recently evaluated the cost-effectiveness of adding trastuzumab to SAC [10][11][12][13][14]. However, these studies only included patients aged 50 or older, did not distinguish disease-specific fatality by tumour size, and did not include data on the effect size of trastuzumab from all clinical trials. ...
Background:
Trastuzumab has a large financial impact on the average cost of breast cancer treatment. This study reassessed the cost-effectiveness of listing the drug on the subsidised Australian Pharmaceutical Benefits Scheme.
Methods:
Using a continuous-time, discrete-event microsimulation model, we examined the effect of 1-year trastuzumab on the total number of disability-adjusted life-years (DALYs) averted among Australian women with human epidermal growth factor receptor-2 (HER2) positive early breast cancer. Target population was women aged 30–100 years and newly diagnosed with the disease in 2003. The model adjusted for tumour size and followed the women up until death or age 100 years. Uncertainty was examined in univariate and probabilistic multivariate sensitivity analyses.
Results:
The incremental cost-effectiveness ratio (ICER) was A$132,537 (95% confidence interval 91,172–200,485) per DALY averted. Results were sensitive to restriction of trastuzumab to high-risk (large tumour) and/or high-benefit (young) patients. Suitable combinations of tumour size and age restrictions would improve the cost-effectiveness of trastuzumab. Specifically, restricting trastuzumab to women aged 40 years or younger with tumour sizes 40+ mm reduced the ICER to A$35,290 per DALY averted.
Conclusion:
Trastuzumab for HER2-positive early breast cancer had a high ICER. It is unclear why the Pharmaceutical Benefits Scheme listing does not use restrictions to improve the cost-effectiveness of the drug.
... In this paper, the cost-effectiveness of trastuzumab for treating breast cancer was examined. [19,[43][44][45]. Prior analyses in the UK, Australia, United States and Italy yielded similar results to those in our analysis. ...
... Although the ICER results are quite similar to other studies, their meaning is different when examined in Africa. While trastuzumab can be considered as costeffective in HICs [5,21,[42][43][44]48], this is not the case in LMICs. ICER results in HICs were close or below the suggested threshold by WHO, one GDP per capita, as can be seen in Table 6, while the calculated ICERs in Africa were significantly higher than one GDP per capita for each examined country. ...
Background:
Breast cancer is the second most common cancer worldwide, the most common among women, and the most frequent cause of death among women in less developed regions. Trastuzumab is a humanized monoclonal antibody that downregulates the extracellular domain of the HER2 protein. Using trastuzumab to treat women with localized HER2-positive breast cancer has been shown to improve survival. The objective of this study is to explore the cost-effectiveness of adjuvant trastuzumab, from a societal perspective, in 11 African countries. In addition, we aimed to establish value-based prices for trastuzumab based on the gross domestic product per capita in each country.
Methods:
We developed a Markov model in order to assess the costs and benefits associated with trastuzumab treatment over a lifetime horizon. A probabilistic sensitivity analysis was performed in order to estimate the impact of uncertainty of parameter-values on the results. Efficacy inputs were derived using clinical trial data from non-African countries.
Results:
In the base case analysis, trastuzumab yielded a gain ranging from 0.92 LYs in Nigeria to 1.07 LYs in South Africa, and 0.9 QALYs in Nigeria to 1.02 QALYs in South Africa. The incremental cost ranged from 19,561 USD in Nigeria to 19,997 USD in Congo, and an incremental cost-effectiveness ratio ranging from 19,534 USD/QALY in South Africa to 21,697 USD/QALY in Nigeria. Using willingness to pay estimates based on World Health Organization recommendations, trastuzumab appear to not be cost-effective in all countries analyzed. Cost-effectiveness estimates were most sensitive to the discount rate, trastuzumab cost, and the hazard ratio.
Conclusions:
Trastuzumab does not appear to be cost effective in the African countries analyzed. In order for trastuzumab to be cost-effective, the costs of treatment would require significant discounts.
... Hall et al. assessed [23] trastuzumab from the perspective of UK National Health System (NHS), primarily through using data from the HERA trial. They concluded that the ICER of trastuzumab is GBP £25,803 per QALY, indicating a cost-effective option in the UK setting. ...
Introduction: Breast cancer, the second most common cancer in women, exerts a multidimensional grave effect on affected women. Among the several sub-types of breast cancer, the overexpression of the human epidermal growth factor receptor-2 gene is associated with poorer survival and higher relapse rates. Trastuzumab, a monoclonal antibody, has proved its safety and efficacy in this specific subtype, nevertheless its high cost urges for caution among payers.
Areas covered: The scope of this study is to systematically search and critically assess the economic evaluation studies of trastuzumab in patients with early stage Her2+ breast cancer.
Expert Commentary: In the majority of the studies trastuzumab was found to be cost-effective. Its cost-effectiveness profile is contingent to treatment duration, benefit effect and age of the patient.
... Economic evaluations of trastuzumab-based adjuvant systemic therapy performed in high-income countries show that trastuzumab is a highly cost-effective intervention for most patients. [50][51][52] However, trastuzumab-based adjuvant systemic therapy is not considered cost-effective in several Latin American countries 53 and, like many therapeutic options, uncertainties remain regarding its cost-effectiveness in the metastatic setting. 54 This might be of particular relevance to patients who receive multiple lines of HER2 blockade for treatment of metastatic disease, because the most clinically effective sequence might not be considered costeffective and, therefore, might not be reimbursed. ...
Trastuzumab improves survival outcomes for patients with HER2-positive (HER2+) breast cancer, yet not all such women receive this important therapy. Trastuzumab was approved by the US Food and Drug Administration in 1998 and the European Medicines Agency in 2000 as treatment for HER2+ metastatic breast cancer (MBC). Observational studies between 2000 and 2015 in patients with HER2+ MBC suggest that nearly 12% in the United States, 27% to 54% in Europe, and 27.1% to 49.2% in China did not receive trastuzumab or any other HER2-targeted agent as first- and/or later-line for treatment of metastatic disease. In 2006, both agencies approved trastuzumab as adjuvant therapy for patients with HER2+ early breast cancer (EBC). Observational studies on real-world treatment patterns for HER2+ EBC between 2005 and 2015 suggest that 19.1% to 59.5% of patients across regions of North America, Europe, Australia, New Zealand, and China did not receive (neo)adjuvant trastuzumab. Data suggest that some patient subgroups, including older patients, those with HER2+/hormone receptor-positive disease, and women with small and/or node-negative HER2+ tumors, were less likely to receive anti-HER2 therapy. Barriers to accessing trastuzumab are multifactorial and include issues related to drug funding and high treatment costs for patients that have been reported worldwide. Herein, we review available literature on the use of, and barriers to, treatment with trastuzumab in patients with HER2+ breast cancer. We also discuss how the availability of safe and effective biosimilars might increase access to trastuzumab and allow greater use of anti-HER2 therapy, potentially improving patient outcomes.
