A journey through challenges to reach advanced breast cancer treatment.

Trastuzumab Under Scrutiny: Is the Subcutaneous Hype Justified?

Kai Mendoza in Health & Wellness November 2025 • 4 min read.

"A deep dive into the benefits, transferability, and economic implications of subcutaneous trastuzumab in Central and Eastern European countries."

Biological medicines are revolutionizing treatments across various fields, including oncology. However, the high costs associated with these innovative drugs often create significant barriers to access, especially in countries with economic constraints. As patents for originator biologics expire, new formulations emerge, promising improved efficacy and patient convenience. Understanding the true value and economic impact of these alternatives is crucial for ensuring equitable healthcare access.

Trastuzumab, a standard treatment for HER-2 positive breast cancer, exemplifies this challenge. While highly effective, its cost raises affordability concerns, particularly in Central and Eastern Europe (CEE). The introduction of a subcutaneous formulation (SCT) aims to offer comparable efficacy with shorter administration times and potential for self-administration, raising questions about its cost-effectiveness and real-world benefits in resource-limited settings.

This article delves into a systematic review of the benefits and disadvantages of subcutaneous versus intravenous trastuzumab, evaluating the transferability of claimed benefits to CEE countries. By examining clinical data, cost analyses, and real-world considerations, we aim to provide a comprehensive understanding of the economic and practical implications of adopting SCT in healthcare systems facing unique challenges.

Decoding the Subcutaneous Trastuzumab Debate

A journey through challenges to reach advanced breast cancer treatment.

A systematic literature search was conducted to compare subcutaneous (SCT) and intravenous (IVT) trastuzumab, focusing on efficacy, safety, patient-reported outcomes, and cost. Initial searches yielded 376 hits, with 42 articles meeting the inclusion criteria after thorough screening. The review prioritized studies comparing the two formulations directly, extracting data on key clinical and economic outcomes.

While several studies suggest comparable efficacy between SCT and IVT, a closer examination reveals nuanced differences. A significant observation was the relatively higher incidence of adverse events (AE) with SCT in some studies, with relative increases ranging from 3% to 53%. However, statistical significance was not consistently reported, making it difficult to draw definitive conclusions about the safety profiles of the two formulations.

Efficacy: Subcutaneous trastuzumab showed non-inferior efficacy compared to intravenous administration.
Safety: Some studies indicated a higher incidence of adverse events with subcutaneous trastuzumab.
Patient Preference: A few studies, using both validated and non-validated questionnaires, suggested a preference for subcutaneous administration due to convenience.
Cost: Several studies suggested reduced direct healthcare costs with subcutaneous trastuzumab due to reduced administration time.

The study also reviewed the cost implications of adopting SCT, noting that most analyses focused on direct healthcare costs, such as drug costs and healthcare professional time. However, factors like the cost of managing side effects and the potential impact of biosimilar competition were often overlooked. Additionally, the transferability of cost savings to CEE countries is questionable, given differences in healthcare practices and economic conditions.

The Path Forward: Balancing Innovation and Access

The review underscores the importance of carefully evaluating the real-world benefits and economic implications of new drug formulations, particularly in resource-limited settings. While subcutaneous trastuzumab offers potential advantages in terms of convenience and administration time, its widespread adoption should be guided by robust evidence of cost-effectiveness and improved patient outcomes. Facilitating the uptake of biosimilars and implementing strategic pricing policies remain critical for ensuring equitable access to life-saving treatments for all patients, regardless of their geographic location or economic status.

About this Article -

This article was crafted using a human-AI hybrid and collaborative approach. AI assisted our team with initial drafting, research insights, identifying key questions, and image generation. Our human editors guided topic selection, defined the angle, structured the content, ensured factual accuracy and relevance, refined the tone, and conducted thorough editing to deliver helpful, high-quality information.See our About page for more information.

This article is based on research published under:

DOI-LINK: 10.1080/14737167.2019.1554437, Alternate LINK

Title: Behind The Subcutaneous Trastuzumab Hype: Evaluation Of Benefits And Their Transferability To Central Eastern European Countries

Subject: Pharmacology (medical)

Journal: Expert Review of Pharmacoeconomics & Outcomes Research

Publisher: Informa UK Limited

Authors: András Inotai, Tamás Ágh, Alexei Willem Karpenko, Antal Zemplényi, Zoltán Kaló

Published: 2018-12-07

Everything You Need To Know

How does subcutaneous trastuzumab compare to intravenous trastuzumab in terms of efficacy and safety for treating HER-2 positive breast cancer?

Subcutaneous trastuzumab has shown non-inferior efficacy compared to intravenous trastuzumab in treating HER-2 positive breast cancer. Some studies suggest it may offer convenience through shorter administration times and potential self-administration. However, it's crucial to consider that certain studies have indicated a higher incidence of adverse events with subcutaneous trastuzumab, although these findings weren't always statistically significant.

What factors are often overlooked in cost analyses when evaluating the economic impact of subcutaneous trastuzumab?

The review found that many cost analyses focus on direct healthcare costs like drug expenses and professional time. However, they often overlook the costs associated with managing side effects and the potential impact of biosimilar competition. Also, the transferability of cost savings to Central and Eastern European countries is uncertain due to differences in healthcare practices and economic conditions.

What advantages does subcutaneous trastuzumab offer over intravenous trastuzumab, and what key questions arise from its introduction?

The introduction of subcutaneous trastuzumab aims to offer comparable efficacy to intravenous trastuzumab, but with shorter administration times and the possibility of self-administration. The key question is whether it offers a cost-effective alternative without compromising patient safety, especially in resource-limited healthcare systems. Its potential to reduce healthcare costs depends on various factors, including drug pricing, administration costs, and the management of potential side effects.

Why are biosimilars important in the context of trastuzumab treatment, particularly in Central and Eastern European countries?

Biosimilars are crucial for ensuring equitable access to life-saving treatments like trastuzumab, especially in countries with economic constraints. As patents for originator biologics expire, biosimilars can offer more affordable alternatives. Encouraging their uptake and implementing strategic pricing policies are essential for making trastuzumab accessible to all patients, regardless of their geographic location or economic status. The cost implications surrounding side effect management need to be factored in when considering implementing biosimilars.

What are the key considerations for healthcare systems in Central and Eastern European countries when deciding whether to adopt subcutaneous trastuzumab?

The review highlights that while subcutaneous trastuzumab may offer benefits like convenience and reduced administration time, healthcare systems in Central and Eastern European countries must carefully evaluate its cost-effectiveness and real-world benefits. Factors like healthcare infrastructure, pricing policies, and patient populations can significantly impact the transferability of claimed advantages. It is important to consider the practical implications and economic viability before widespread adoption of the subcutaneous formulation.