Cost Effectiveness of Trastuzumab in Metastatic Breast Cancer in South Africa: A Systemic Review

Cost Effectiveness of Trastuzumab in Metastatic Breast Cancer in South Africa: A Systemic Review

Dr. Lesiba Khalo^*1, Dr. Florian Ebner²,  Prof. PD Rwelamila³

1. Military Hospital, Oncology Division, Pretoria, South Africa.

2. University of Ulm, Ulm, Germany, ADK Kliniken, O&G Department, Ehingen, Germany.

3. UNISA School of Business Leadership, South Africa, Priofessor of Project Management and Research.

*Correspondence to: Dr. Lesiba Khalo, Military Hospital, Oncology Division, Pretoria, South Africa.

Copyright.

© 2026 Dr. Lesiba Khalo, This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Received: 10 April 2026

Published: 01 May 2026

DOI:https://doi.org/10.5281/zenodo.19937994

Summary

The global landscape of oncology is currently defined by a tension between groundbreaking innovation and the economic sustainability of healthcare systems. While targeted therapies like trastuzumab have revolutionized the treatment of metastatic breast cancer (MBC) offering significant gains in survival their high costs present a formidable barrier in resource-constrained environments.

This systemic review evaluates the cost-effectiveness of trastuzumab as a first-line therapy for MBC, with a specific focus on its viability within the South African (SA) public healthcare sector.

Key Findings & Global Perspectives

By analysing health economic evaluations from diverse international contexts, this paper highlights a critical disparity in affordability:

• Western Economic Success: Various studies in the USA, France, the UK, and Sweden demonstrated that trastuzumab is cost-effective within their respective healthcare frameworks. For example, French studies reported an Incremental Cost- Effectiveness Ratio (ICER) as low as €15,370 per Quality Adjusted Life Year (QALY).
• The BRICS & Emerging Markets: Countries like Brazil and India have successfully integrated trastuzumab by utilizing generics and price-reduction strategies, making the drug economically reasonable within their Willingness to Pay (WTP) thresholds.
• The Mexican Model: Mexico achieved cost-effectiveness in its public sector through rigorous pharmaceutical price negotiations and a strict threshold of one times the GDP per capita.

The South African Dilemma.

South Africa operates a dual healthcare system where access to life-saving biologics is highly inequitable:

• Current Status: Trastuzumab is primarily funded in the private sector but remains largely unavailable or to a limited extent through buyouts in selected patients in the government-funded public sector due to perceived lack of cost- effectiveness and affordability.

• The Affordability Gap: The estimated treatment exceeds the calculated South African WTP threshold of R228,000–R342,000 (based on WHO recommendations of 2-3 times GDP per capita).
• Economic Impact: Currently, the cost of trastuzumab falls outside the acceptable SA public sector range by approximately 32%.

Strategic Recommendations

To bridge the gap between clinical benefit and economic feasibility, the paper proposes the following:

1. Accelerated Negotiations: Facilitate transparent price-reduction dialogues between the South African government and pharmaceutical manufacturers.
2. Generic & Biosimilar Integration: Prioritize and accelerate the introduction of biosimilars, noting that generic versions have already reduced costs by up to 74%.
3. National Health Policy Reform: Encourage clinicians and policy makers to conduct local economic evaluations to determine precise direct and indirect oncological costs in the public sector.

Conclusion: While trastuzumab is a gold standard for HER2+ MBC globally, its adoption in the South African public sector requires a strategic shift toward generic and biosimilar procurement and competitive pricing to align with the country's economic reality.

List of Abbreviations

ASCO: American Society of Clinical Oncology. BRICS: Brazil, Russia, India, China and South Africa. CBA: Cost benefits analysis.

CEA: Cost effectiveness analysis. CUA: Cost utility analysis.

ESMO: European Society of Medical Oncology. FDA: Food and Drug Administration.

FISH: Fluorescence in Situ Hybridization. GDP: Gross domestic product.

HER2: human endothelial receptor 2. ICER: Incremental cost effectiveness ratio. IHC: Immunohistochemistry.

MBC: Metastatic breast cancer.

MCBS: Magnitude of Clinical Benefit Scale. MESH: Medical subject heading.

NICE: National Institute for Health and Care Excellence. OS: Overall survival.

PFS: Progression free survival. QALY: Quality adjusted life years. SA: South Africa.

SAMHS: South African Military Health Services. SEER: Surveillance, Epidemiology, and End Results. UK: United Kingdom.

USA: United States of America. USD: United States dollars.

WHO: World Health Organization. WTP: Willingness to pay.

ZAR: South African rand.

Introduction

Background

In the last decade the term ‘cancer survivor’ has become quite popular as more and more patients are living their lives longer and longer with an oncological diagnosis. A prime example for these medical advances is breast cancer patients. Currently large population based databases show a 5-year survival of about 93% over all stages (SEER). Even though this is very promising, Narod, et al. (2015) reported that the survival still depends very much on the stage it is diagnosed (Figure 1.1). Moreover, Blank, et al. (2010) estimated that 25- 40% of breast cancer patients present or will develop metastasis in the history of their disease.

• To prolong life.
• To reduce and to control burden of disease.
• To minimize cancer related symptoms and complications.
• To maintain the quality of life.

DeVita, Lawrence and Rosenburg (2015) defined metastatic breast cancer as stage IV disease that has spread beyond the breast, chest wall and the regional lymphatic drainage. Although there have been some literature case reports that breast can spread to any organ in the body, there are common sites of dissemination. Soni, et al. (2015) reported common distant sites namely: bone, liver, lungs, brain and pleura. The hierarchy is well demonstrated in Figure1.2 in the descending order.

However, Kimbung, et al. (2015) further discussed that, even though they agree with Soni et al. (2015) on common sites of metastasis, the pattern of spread is influenced by breast cancer subtypes. For example, Kimbung, et al. (2015) argued that oestrogen receptor positive tumours turn to spread commonly to the bone and oestrogen negative tumours have a visceral spread pattern. The pattern of spread, Kimbung, et al. (2015) showed in Figure 1.3 that the frequency of site metastasis is based on molecular subtype. Bone is predominantly (about 50%) the common site of spread in all molecular subtypes. In addition, a Chinese study by Xiong, et al. (2018) reported bone metastasis to be between 60 -75% with Zhang, et al. (2010) also indicated bone metastasis in breast cancer is approximately 70%.