In an ageing society with increasing medical need, biological treatments have played a key role in reforming the management of cancer, autoimmune and certain preventable diseases. Yet, biological treatments impose a significant financial burden on the healthcare system and healthcare payers.
Biosimilars, which are molecularly similar to their reference biologicals, offer similar efficacy and safety profiles. These biosimilars are often offered at a lower cost than the reference drug, thereby reducing the per-patient treatment cost and potentially expanding treatment access among patients.
Truxima (rituximab) and Herzuma (trastuzumab) are biosimilars available in intravenous (IV) formulations, that gained European Medicines Agency (EMA) approval in 2017 and 2018, respectively. Rituximab and trastuzumab originators are also available in subcutaneous (SC) formulations. Biologicals with a SC mode of administration have been increasingly used in recent years due to the shorter administration times required, resulting in greater patient convenience. However, SC formulations do not keep patients away from IV treatments entirely, as some patient conditions necessitate treatment regimens that require combination therapy with other IV drugs. SC administration saves patient travel time, caregiver time and resources spent on administration such as physician and nursing time and consumables. However, often the drug acquisition price of a SC product is higher than for biosimilar or originator IV products. Therefore, an economic evaluation is necessary to consider the differences between IV and SC formulations and to evaluate whether the drug cost savings would offset the extra administration cost burden, and ultimately lead to net cost savings for healthcare providers.
To this effect, a study  was conducted to examine the budget impact from a payer’s perspective for the EU-5 countries (France, Germany, Italy, Spain, and the UK) to demonstrate the economic impact of using IV trastuzumab and rituximab biosimilars. An incidence-based budget impact model (BIM) was developed to estimate the costs from the payer’s perspective of a market with and without the availability of trastuzumab and rituximab biosimilars, and in the presence of IV and SC reference products, in the EU-5 countries. The model included the complete indication profile of the reference products over a 5-year period.
Overall, analysis using the base-case results indicated that adoption of trastuzumab and rituximab biosimilars would result in net cost savings across the EU-5 countries. At Year 5, the net budget saving ranged from €4.05 million to €303.86 million for rituximab and from €19 million to €172 million for trastuzumab.
The study authors suggest that adoption of IV trastuzumab and rituximab biosimilars can lead to cost savings from lower drug acquisition costs that outweigh any additional administration costs associated with the IV formulation, where applicable. Especially in countries with no additional administration costs due to equivalent tariffs between IV/SC products, the lower biosimilar drug costs contributed exclusively to the cost savings. Furthermore, minor variations in administration costs may not be a barrier to the uptake of IV biosimilars. Therefore, realizing the benefits from biosimilar usage will depend on the price of biosimilars and the capacity of hospitals to distribute a greater volume of IV infusions.
Conflict of interest
Author Steven Simoens reported conflict of interest, including involved in a stakeholder roundtable and speaker engagements, participated in advisory board meetings for Pfizer and Amgen and more. Authors Minyoung Jang and Taeksang Kwon are employees of Celltrion. For full details of the authors’ conflict of interest, see the research paper .
Abstracted by Minyoung Jang, Celltrion Healthcare, Incheon, South Korea.
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1. Jang M, Simoens S, Kwon T. Budget impact analysis of the introduction of rituximab and trastuzumab intravenous biosimilars to EU-5 Markets. BioDrugs. 2021;35(1):89-101.
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