Budget Impact Analysis of Biosimilar Trastuzumab for the Treatment of Breast Cancer in Croatia

Cesarec, August; Likić, Robert

doi:10.1007/s40258-016-0285-7

Cited by 33 publications

(35 citation statements)

References 29 publications

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“…A recent study in Europe found that, on average, biosimilars were 15% less expensive than their corresponding reference product [40]. A Croatian budget impact analysis (BIA) that modelled the impact of the introduction of biosimilar trastuzumab predicted savings of up to €0.69 million in the initial year of introduction into that country (assuming a 35% price discount), with up to 47 extra patients able to access trastuzumab [41]. Data from [42].…”

Section: Discussionmentioning

confidence: 99%

A randomised trial comparing the pharmacokinetics and safety of the biosimilar CT-P6 with reference trastuzumab

Esteva¹,

Stebbing

Wood-Horrall³

et al. 2018

Cancer Chemother Pharmacol

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Purpose Access to trastuzumab, a valuable anti-cancer treatment, can be limited by cost. The primary aim of this study was to evaluate and compare the PK profiles of CT-P6, a biosimilar of trastuzumab, and US-licensed reference trastuzumab (Herceptin ® ) in healthy subjects. Secondary study aims included comparison of the safety and immunogenicity of CT-P6 and reference trastuzumab in these subjects. Methods We performed a single-dose, randomised, double-blind, parallel group study (NCT02665637) comparing CT-P6 with reference trastuzumab (6 mg/kg, 90 min intravenous infusion) in 70 healthy adult males. Pharmacokinetics, safety and immunogenicity were evaluated up to 10 weeks post-dose. Primary endpoints were area under the serum concentration-time curve (AUC) from time 0 to infinity (AUC inf ); AUC from time 0 to last quantifiable concentration (AUC last ); and observed maximum serum concentration (C max ). The pre-determined equivalence criterion was a 90% confidence interval of 80-125% for ratios of geometric least squares (LS) means. Results Equivalence of CT-P6 and reference trastuzumab was demonstrated. Ratios (CT-P6/reference trastuzumab) of geometric LS means (90% confidence interval) were: AUC inf 99.05 (93.00, 105.51); AUC last 99.30 (92.85, 106.20); C max 96.58 (90.93, 102.59). Safety profiles were similar; treatment-emergent adverse events occurred in ten subjects (28.6%) in the CT-P6 group and 11 (31.4%) in the reference trastuzumab group. No serious adverse events or deaths occurred. No subjects tested positive for anti-drug antibodies. Conclusions These data add to the totality of evidence required to demonstrate biosimilarity. A phase III study of CT-P6-in which equivalent neoadjuvant efficacy to reference trastuzumab has been demonstrated-is ongoing.

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Section: Discussionmentioning

confidence: 99%

A randomised trial comparing the pharmacokinetics and safety of the biosimilar CT-P6 with reference trastuzumab

Esteva¹,

Stebbing

Wood-Horrall³

et al. 2018

Cancer Chemother Pharmacol

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“…107 In this analysis introduction of trastuzumab biosimilars in Croatia was estimated to generate potential savings varying from V0.26 million (15% price discount) to V0.69 million (35% price discount) that could be reinvested to treat an additional 14 (15% price discount) to 47 (35% price discount) patients. 107 The extent of cost savings achieved with biosimilars will depend on many factors; thus, drug price in and of itself is not sufficient to understand the potential savings. 106,108,109 An important consideration will be future trends in biologic drug utilization.…”

Section: Economic Effect Of Biosimilarsmentioning

confidence: 99%

The Global Need for a Trastuzumab Biosimilar for Patients With HER2-Positive Breast Cancer

Blackwell

Gligorov

Jacobs

et al. 2018

Clinical Breast Cancer

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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.

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“…An English summary of this BIA is available in a 2016 ISPOR presentation by Drummond and Martin [ 10 ]. Second, as with all reviews, studies published after the study cut-off date (30 June 2016) were not included, namely a BIA of trastuzumab in Croatia [ 55 ]. Third, this review did not include other types of economic analyses of biosimilars, such as cost-utility or cost-effectiveness analyses.…”

Section: Discussionmentioning

confidence: 99%

Assessing the Value of Biosimilars: A Review of the Role of Budget Impact Analysis

et al. 2017

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Biosimilar drugs are highly similar to an originator (reference) biologic, with no clinically meaningful differences in terms of safety or efficacy. As biosimilars offer the potential for lower acquisition costs versus the originator biologic, evaluating the economic implications of the introduction of biosimilars is of interest. Budget impact analysis (BIA) is a commonly used methodology. This review of published BIAs of biosimilar fusion proteins and/or monoclonal antibodies identified 12 unique publications (three full papers and nine congress posters). When evaluated alongside professional guidance on conducting BIA, the majority of BIAs identified were generally in line with international recommendations. However, a lack of peer-reviewed journal articles and considerable shortcomings in the publications were identified. Deficiencies included a limited range of cost parameters, a reliance on assumptions for parameters such as uptake and drug pricing, a lack of expert validation, and a limited range of sensitivity analyses that were based on arbitrary ranges. The rationale for the methods employed, limitations of the BIA approach, and instructions for local adaptation often were inadequately discussed. To understand fully the potential economic impact and value of biosimilars, the impact of biosimilar supply, manufacturer-provided supporting services, and price competition should be included in BIAs. Alternative approaches, such as cost minimization, which requires evidence demonstrating similarity to the originator biologic, and those that integrate a range of economic assessment methods, are needed to assess the value of biosimilars.

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Budget Impact Analysis of Biosimilar Trastuzumab for the Treatment of Breast Cancer in Croatia

Abstract: The introduction of biosimilar trastuzumab could lead to significant drug cost savings in Croatia.

Cited by 33 publications

References 29 publications

A randomised trial comparing the pharmacokinetics and safety of the biosimilar CT-P6 with reference trastuzumab

A randomised trial comparing the pharmacokinetics and safety of the biosimilar CT-P6 with reference trastuzumab

The Global Need for a Trastuzumab Biosimilar for Patients With HER2-Positive Breast Cancer

Assessing the Value of Biosimilars: A Review of the Role of Budget Impact Analysis

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