scholarly journals The addition of neoadjuvant pertuzumab for the treatment of HER2+ breast cancer: a cost estimate with real-world data

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Andreia Borges ◽  
Filipa Pereira ◽  
Patrícia Redondo ◽  
Luís Antunes ◽  
Cláudia Vieira ◽  
...  

Abstract Background Breast cancer (BC) is largely prevalent worldwide. HER2-positive BC account for roughly 20–25% of all BC cases and has an overall survival lower than other BC. Innovation on BC therapeutics is a constant, but novel therapies have higher costs. Therefore, cost-effectiveness research is essential to provide healthcare decision-makers with solid foundations for a resource allocation. This study aims to estimate the average direct medical costs/patient and cost-effectiveness of adding pertuzumab in neoadjuvant treatment (NeoT) for HER2-positive breast cancer (BC). Methods Two retrospective real-world consecutive cohorts of ≥18yo female patients diagnosed with HER2-positive BC treated with NeoT at the Breast Clinic of IPO-Porto were studied. The AC-DH regimen (2012–2015) comprised 8 cycles of neoadjuvant therapy (4 cycles of doxorubicin + cyclosphosphamide followed by 4 cycles ofdocetaxel + trastuzumab), while the AC-DHP regimen (2015–2017) included also pertuzumab as NeoT. NeoT was followed by surgery and adjuvant trastuzumab. Micro-costing technique and a bottom-up approach was used comprising all medical direct costs from the hospital perspective. Unit costs were obtained from government official prices or from IPO-Porto costing system. Costs were adjusted to 2017 and are expressed in euros. Multivariable logistic regression models were used for effectiveness assessment, while generalized linear models with gamma distribution were used for costs. ICER was calculated using the pathological complete response (pCR) as the preferential measure of effectiveness. Sensitivity analysis was also performed. Results AC-DHP (n = 40) and AC-DH (n = 54) cohorts had heterogenous patient profiles (median age 43y/53y; 67.5%/59.3% positive HR; 60.0%/27.8% operable; 25.0%/24.1% inflammatory, respectively). The AC-DHP average total cost/patient was 56,375€, with pertuzumab accounting for 13,978€ (24.79%) and increasing in 15,982€ the average cost/patient (p < 0.001). Clinical staging and hormone receptors (HR) were significantly associated with pCR. ICER was 1.370€ per percentage point of pCR. Conclusions ICER was more favourable in stage III HR negative BC patients compared to other patient profiles. Innovative treatments access is critical to deliver high-quality healthcare, but sustainability must be considered. These results suggest the importance of establishing a cost-effectiveness profile of Pertuzumab in NeoT for HER2-positive BC.

Author(s):  
Savvas S. Ioannou ◽  
Yiola Marcou ◽  
Eleni Kakouri ◽  
Michael A. Talias

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.


2020 ◽  
Vol 23 (6) ◽  
pp. 575-580
Author(s):  
Gihan Hamdy Elsisi ◽  
Yousery Nada ◽  
Noha Rashad ◽  
João Carapinha ◽  
Ahmad O. Noor ◽  
...  

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 9547-9547
Author(s):  
S. K. Pal ◽  
A. Naeim ◽  
F. L. Wong ◽  
C. T. Chung ◽  
S. Bhatia ◽  
...  

9547 Background: Though substantial evidence supports the use of adjuvant trastuzumab in patients with HER2-positive breast cancer, a lesser amount of data is available to guide use of this therapy in older adults. The objective of the current study is to understand how patient age and health status impact the oncologists' decision to recommend adjuvant therapy in older women with HER2-positive breast cancer. Methods: Medical oncologists (n=151) participated in an online survey comprised of case scenarios with patients of varying age (70, 75, 80, 85) and health status (good, average, poor) with a T2(4 cm) N2(4+ LN) ER(-), HER2(+) breast cancer. Oncologists could offer the hypothetical patient treatment with chemotherapy and trastuzumab, chemotherapy alone, trastuzumab alone, or no therapy. The influence of age and health status on treatment recommendations was assessed using a generalized linear mixed-effects model. Results: With increasing age and deterioration of health status, the recommendation for chemotherapy with trastuzumab decreased (P<0.0001 for both). In contrast, recommendation for trastuzumab alone or no therapy increased with advancing age (P<0.0001 for both) and deteriorating health status (P<0.0035 and P=0.059, respectively). Chemotherapy alone was not frequently recommended, irrespective of age or health status. Conclusions: Given the relative dearth of evidence-based data for adjuvant treatment of HER2-positive breast cancer in older adults of varying health, oncologists recommend a diverse array of therapeutic approaches for this subgroup. Increasing age and declining health status lead to more frequent recommendation of trastuzumab alone or no therapy, and less frequent recommendation of chemotherapy with trastuzumab. [Table: see text] [Table: see text]


2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 6625-6625
Author(s):  
Naomi RM Schwartz ◽  
Meghan Rose Flanagan ◽  
Joseph B Babigumira ◽  
Lotte Maria Gertruda Steuten ◽  
Joshua A. Roth

6625 Background: Neratinib after adjuvant trastuzumab significantly improves disease-free survival (DFS) in human epidermal growth factor receptor 2-postiive (HER2+) breast cancer, but the median absolute DFS gain is only 1.3 months. There has been much controversy in the clinical and lay media as to whether the substantial cost of neratinib is justified by its effects, including a prominent ASCO Post article from Dr. Vogl about a year ago. We performed a cost-utility analysis to formally assess the value of adding neratinib based on Phase III ExteNET trial results. Methods: We developed a Markov state-transition model to assess the value of neratinib in Stage I-III HER2+ breast cancer. Five-year recurrence rates were derived from ExteNet. Mortality and recurrence rates after 5 years were derived from the HERceptin Adjuvant (HERA) trial. Costs were derived from wholesale acquisition costs and peer-reviewed literature. Health state utilities were derived from ExteNET and prior publications. Outcomes included life years (LY), quality-adjusted life years (QALYs), direct medical expenditures, and cost per QALY gained. The analysis took a payer perspective over a lifetime horizon and results were discounted at 3% per year. One-way and probabilistic analyses were conducted to evaluate uncertainty. As neratinib conferred more clinical benefit in hormone receptor-positive (HR+) disease, we also assessed value in that specific subgroup. Results: Base case results are presented in Table. At typical U.S. willingness to pay thresholds of $100,000 and $150,000 per QALY gained, neratinib had 16.7% and 27.2%, probabilities of cost-effectiveness, respectively. In the HR+ subgroup, neratinib had a cost of $275,311 per QALY gained (19.9% & 31.2% probability of cost-effectiveness at $100,000 & $150,000 per QALY). Conclusions: In the first independent assessment of the value of neratinib after adjuvant trastuzumab, neratinib is not projected to be cost-effective, even among patients who derived the most clinical benefit. Future analyses should reassess the cost-effectiveness of neratinib treatment as trial data mature. Base case results. [Table: see text]


2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e13012-e13012
Author(s):  
Jifeng Feng ◽  
Lili Zhang ◽  
Xiaohong Wu ◽  
Jun Zhou ◽  
Mingzhen Zhu ◽  
...  

e13012 Background: Pyrotinib is a newly-developed irreversible pan-ErbB receptor tyrosine kinase inhibitor. The efficacy of pyrotinib in patients with different baseline characteristics in the actual clinical practice has been rarely reported. This study analyzed the efficacy and safety of pyrotinib in the real world. Methods: Patients with histologically confirmed advanced HER2 positive breast cancer were included in the analyses. All patients received pyrotinib-based therapy were given pyrotinib once a day in a 21-day cycle. The primary endpoint was progression-free survival (PFS). Secondary endpoints included adverse events (AE), objective response rate (ORR), disease control rate (DCR), and overall survival (OS). Results: A total of 132 patients (median age: 52 years [29-78]) were enrolled from February 2019 to March 2020. 94(71.21%) patients had visceral metastatic lesions and 20 (15.15%) had brain metastases. HR+, HR-, or unknown HR status for primary tumor accounted for 56.82%, 42.42%, 0.76%, respectively. 115(87.12%) patients were previously administered with trastuzumab. 96(72.73%) patients received pyrotinib-based therapy as a second or further line of treatment. 94(71.21%) patients initiated pyrotinib treatment at 400 mg. Treatment regimens were pyrotinib plus capecitabine (55.30%), pyrotinib combined with trastuzumab (18.18%), and pyrotinib monotherapy (8.33%), pyrotinib combined with endocrine therapy, radiotherapy or antiangiogenic drugs (3.79%). A total of 132 patients were included in PFS analysis. mPFS was 12.0 months (95%CI 8.1-18.8). mPFS for patients without primary trastuzumab-resistant breast cancer was 14.1 months (95%CI 8.7-23.3). Patients receiving pyrotinib-based therapy as their ≥3 lines treatment had lower mPFS than those receiving pyrotinib-based therapy as their < 3 lines treatment (8.8 vs. 15.1 months, P= 0.119). mPFS in patients receiving regimen with and without capecitabine were 15.1 months and 8.4 months, respectively ( P= 0.081). As of data cutoff, mOS has not yet been reached. Among the 65 patients available for efficacy evaluation, 1 (1.54%) patient achieved complete response (CR), 24 (36.92%) patients had partial response (PR), 30 (46.15%) patients achieved stable disease (SD), and 10 (15.38%) patients had progression disease (PD), resulting in an ORR of 38.46% and DCR of 84.62%. The most common AE was diarrhea (84.17%), but only 5 (4.17%) patients were reported grade ≥ 3 diarrhea which could be well controlled. Other AEs with an incidence higher than 20.00% were anemia (36.67%), leukopenia (25.83%), vomiting (25.00%), neutropenia (22.50%). No treatment-related death occurred. Conclusions: Pyrotinib demonstrated an encouraging efficacy and manageable safety in patients with advanced HER2+ breast cancer. More data would be analyzed and reported in the future. Clinical trial information: ChiCTR1900021819.


2021 ◽  
Author(s):  
Ornella Garrone ◽  
Tommaso Giarratano ◽  
Eva Blondeaux ◽  
Loretta D'Onofrio ◽  
Andrea Michelotti ◽  
...  

Abstract Background: Real world data have the potential to demonstrate the applicability of the results of randomized studies in the general population. SUPER trial was conducted in order to assess the activity, the efficacy and the safety of the combination of pertuzumab, trastuzumab and chemotherapy in clinical practice.Material and methods: Patients diagnosed with HER2 positive metastatic breast cancer (mBC) and treated with pertuzumab, trastuzumab and chemotherapy were accrued at 18 italian hospitals. Data were retrospectively collected in the time frame between pertuzumab availability in clinical practice and study approval in 2016, and prospectively collected thereafter. Results: Overall 342 HER2 positive mBC were accrued. 172 patients had relapsed disease and 56.4% of them received neo/adjuvant trastuzumab. 205 patients received docetaxel. Objective response rate was 76.3% (95%CI: 71.4–80.7). Median progression free survival (PFS) and overall survival (OS) were 24.3 months (95% CI: 20.0–28.9) and 70.2 months (95% CI: 61.4–79.0) respectively. Triple positive patients treated with endocrine therapy in addition to pertuzumab and trastuzumab maintenance had a significant longer PFS and OS than patients who did not. mPFS was 31.2 months and 13 months respectively (HR=0.47; 95% CI: 0.33–0.66; p<0.001) and mOS was 72.3 months and 56.8 months respectively (HR=0.58; 95% CI: 0.36–0.92; p=0.02). Pretreatment with trastuzumab did not hamper the outcome. In addition, maintaining the dual blockade inhibition at disease progression with the same CT partner or alternative endocrine agent leading to further benefit.Conclusions: SUPER suggests that results of first-line treatment with pertuzumab, trastuzumab and chemotherapy in unselected patients are consistent with findings from CLEOPATRA trial.Moreover, as expected from real world evidence, new insights have emerged.


2018 ◽  
Vol 4 (Supplement 2) ◽  
pp. 72s-72s
Author(s):  
F.K. Hanin ◽  
L. Sit Wai ◽  
J. Sabirin ◽  
W.P. Sharifa Ezat ◽  
D. Maznah

Background: In Malaysia, breast cancer is the most common cancer in females and also the first most common cancer among population regardless of gender. The percentage of breast cancer detected at stage I and II was 61%, another 27% with locally advanced cancer and 11% with late stage metastatic cancer. From the total, 28% are human epidermal growth factor receptor 2 (HER2) positive and access to targeted therapy (trastuzumab) was very limited; only 19% of eligible patients could be treated. Aim: To determine the incremental cost-effectiveness ratio (ICER) between chemotherapy plus trastuzumab and chemotherapy alone as adjuvant treatment of early breast cancer from Malaysian perspective. Methods: A Markov cohort simulation was developed using Microsoft Excel Workbook 2007 to estimate the cost-utility of adjuvant trastuzumab compared with chemotherapy alone for treatment of early breast cancer with HER2 positive status. Two adjuvant treatment strategies were evaluated: 1) chemotherapy plus trastuzumab and 2) chemotherapy alone as adjuvant treatment. This Markov model was projected to lifetime horizon. All costs and outcomes were discounted at 3% and the cost-effectiveness result was expressed in ICER. One-way sensitivity analysis was performed to address the uncertainty. Results: The base case analysis indicated that 1-year adjuvant trastuzumab treatment generates a deterministic ICER of RM 83,544.59 per QALY gained. Over the lifetime, there is a marginal cost increase of RM 85,659.10 and a marginal benefit of 1.025 QALYs per patient when trastuzumab is added to standard chemotherapy compared with no trastuzumab strategy. Based on one-way sensitivity analysis, these components have shown to be a sensitive parameter for ICER determination: discount rate, disease-free state utility, route of trastuzumab administration and cost of trastuzumab. Conclusion: Addition of 1-year treatment with trastuzumab on top of standard adjuvant chemotherapy is considered as a cost-effective strategy for early breast cancer with HER2 positive, yielding an ICER of RM 83,544.59 per QALY gained, which is within the suggested value of cost-effectiveness threshold by WHO (1-3 times GDP per capita). However, if suggested threshold for Malaysia is taken into consideration, this treatment may not be a cost-effective strategy.


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