Pricing of Monoclonal Antibodies: The Need for Greater Transparency to Promote Global Access 

Aditi Mahajan, Jacqueline Dever
Former Research Assistants, Center for Global Health Policy & Politics

Introduction

Monoclonal antibodies (mAbs), first generated in 1975, have been widely regarded as a leading way to treat cancers and autoimmune conditions, pushing medicine into a new realm of targeted treatment.¹ MAbs are therapeutic agents that are designed and developed in laboratories to target antigens with high specificity and affinity, mimicking the biological immune system. Unlike vaccines, these “designer” antibodies provide rapid protection immediately after their administration. MAbs are also unique in that they do not require a robust immune system to function effectively, and can be given to those who are immunocompromised, a group often unable to receive certain vaccines.² MAbs have been propelled to the forefront of medical innovation due to their high specificity targeting specific antigens, minimal side effects, and positive outcomes in various cancer treatments over the last four decades. However, despite this growing area of biomedical research, mAbs that target infectious diseases and are designed for use in low- and middle-income countries (LMICs) are lacking, contributing to inequities in global access.³ MAb access remains highly concentrated in high income countries (HICs) with 77% of global sales in 2024 occurring in the U.S., Canada, and Europe and only 1% of sales occurring in Africa – although the continent is home to about 20% of the world’s population.⁴ As more mAbs are introduced, it is critical to act now to expand affordable, timely, and sustainable global access to mAbs. This viewpoint aims to highlight how high mAb prices and a lack of information on the pricing landscape hinders widespread access of these life-saving interventions, especially in LMICs, as well as provide concrete actions that civil society and communities can take to promote greater mAbs pricing transparency. This information is also critical to equip governments with the ability to negotiate prices, resulting in greater accessibility of mAbs globally. 

High mAbs Prices Impede Global Access

High prices of mAbs are one of the biggest barriers to global access. In the United States, the average price of mAbs in 2021 ranged between $15,000 and $200,000 per year, and the yearly price of cancer mAbs in 2018 averaged $96,731.^5,6 Access to trastuzumab, a monoclonal antibody widely used in high-income countries for the treatment of HER2-positive cancers, has been limited in many LMICs due to prices that are unaffordable for both health systems and patients alike.^7,8 Palivizumab, a monoclonal antibody targeting respiratory syncytial virus (RSV), was approved by the U.S. Food and Drug Administration (FDA) in 1998; however, 27 years later, it is still not widely accessible in LMICs, largely due to high costs.⁹ Palivizumab requires multiple injections, straining health system resources; however, in 2023, a single-injection mAb for RSV, Beyfortus (nirsevimab), was approved by the U.S. FDA. Despite the potential of this scientific advancement to protect infants and children from RSV with a single dose, there has not been widespread rollout in LMICs.¹⁰ Limited supply coupled with soaring demand for nirsevimab has contributed to its high market price, nearing $495 per dose in some markets.¹¹

The steep price of mAbs are, in part, a result of raw material costs, the complexity of their development and production, and the need for relatively high doses.^6,12,13 Reducing mAbs prices would be monumental in increasing their accessibility across the world along with expanding their impact to those affected by both communicable and non-communicable diseases. Strategies to reduce costs of mAbs include lowering the required number of doses, adjusting and optimizing the process of mAb manufacturing and production, increasing public and private partnerships, and emphasizing the importance of local and regional buy-in and coordination with manufacturing.^2,4,14,15 In addition to considerations of development and manufacturing costs for mAbs, driving down prices through competition with biosimilars presents another opportunity to make mAbs more affordable.¹⁶ In some cases, biosimilars have been developed for mAbs, but are not yet broadly available in LMIC markets.¹⁷

Global mAbs Pricing Information is Scarce

While the high prices of mAbs has been acknowledged as a significant barrier to their global access, few published studies have systematically documented the prices of mAbs for different indications. In the existing literature on mAbs prices, evidence suggests that the pricing landscape varies widely on the international stage.⁵ In their 2020 call to action entitled “Expanding Access to Monoclonal Antibody-based Products,” one of the most comprehensive reports to date on the global landscape of mAbs pricing, IAVI provides monthly cost information on mAbs for non-communicable diseases (including trastuzumab, pembrolizumab, and adalimumab) along with mAbs for infectious diseases (bezlotoxumab and palivizumab).⁵ While useful, these prices are reported for only a small subset of countries: the United States, China, United Kingdom, South Africa and India (with the exception of Malaysia and Costa Rica for palivizumab). The report cites limited access to pricing data in low-income countries.⁵ Recently, IAVI published an updated 2024 report which primarily focuses on the demonstrated need for mAbs in Africa, where the fewest mAbs were delivered in 2020 and access to biologic therapies remains severely limited.⁴ Furthermore, the pricing data on mAbs that is available tends to be varied in its reporting, decreasing its utility in understanding the pricing landscape. For example, reports on pricing of Herceptin (trastuzumab) from different countries lack a standardized method of reporting, making it difficult to compare prices across countries.^18–24

A Global Trend Towards Drug Price Opacity

Coupled with a lack of comprehensive information on global mAbs prices, pharmaceutical companies continue to demonstrate a lack of transparency in drug pricing.²⁵ There exists an intrinsic motivation for pharmaceutical companies to keep their prices confidential, as countries cannot then cross-reference prices to advocate for reduced rates.²⁶ With this approach, the pharmaceutical industry is safeguarded from any consequential forms of accountability for their drug pricing.²⁷ While national governments have expressed an interest in greater drug price transparency, few countries have implemented bolstering policies or practices, in part because there remains ambiguity across countries on what information should be made more transparent and how markets would be impacted by increased transparency.^25,27,28 One of the most profound effects of global drug price opacity is the reduced ability for manufacturers and governments to be held accountable for transaction drug prices–the actual price paid for a drug in a specific transaction between a manufacturer, wholesaler, pharmacy, or consumer.^25,27 As information fosters accountability, robust drug pricing data would strengthen the efforts of civil society and communities to advocate for lower global mAbs prices. Furthermore, a comprehensive platform with global drug pricing data would enable governments with the tools to better negotiate lower, more affordable costs. Additionally, without comprehensive and reliable information on mAbs costs, buyers and other stakeholders are barred from making informed, cost-effective decisions.²⁷ 

In 2019, WHO Member States adopted Resolution WHA 72.8 titled ‘Improving the transparency of markets for medicines, vaccines, and other health products’ which aimed to increase price transparency of medicines, vaccines and other health products.²⁹ This Resolution recognized the need for the availability of comparable price information in facilitating widespread and equitable access to life-saving health products and called upon Member States to take appropriate measures to publicly share information on health products including net prices, units sold, marketing costs and other relevant information. In practice, facilitating greater price transparency of health products should involve, but not be limited to, systematically collecting, analyzing and creating standards for information on prices, including R&D costs and promoting widespread cross-border information sharing. Despite this recognition from WHO Member States that price transparency is critical for equitable global access to medicines, there remains much to be done. 

A Call to Action: Increasing Global Access to mAbs through Pricing Transparency

In order to lower mAbs costs and facilitate their global access, advancing advocacy efforts to support drug price transparency is critical. Both civil society and community members play a key role in this movement towards greater price transparency and lowering the cost of mAbs, especially in LMICs. We outline four priority actions for advocates to spur immediate action to facilitate increased mAbs price transparency globally:

1. Develop and implement a learning agenda around mAbs and the need for pricing transparency: In order for civil society members to advocate for mAbs price transparency and hold governments accountable for implementing transparency measures, efforts are needed to equip advocates with tools and information about the importance of mAbs for both non-communicable and infectious diseases, the current lack of mAbs pricing information, and how increasing price transparency is critical to expand access to mAbs. Mobilizing around shared objectives will strengthen the voice of community and civil society members, maximizing their impact on mAbs pricing transparency and next steps. 
2. Advocate for governments to adopt fair measures and policies to improve pricing transparency of mAbs and health products in general: Civil society members should continue to urge regional bodies and national governments to take appropriate measures to publicly disseminate information on the prices of mAbs such as through aggregated data on costs, reports on sales revenues, units sold, and government subsidies. For example, some states within the U.S. have passed state level legislation for drug pricing transparency requiring manufacturers and wholesalers to provide detailed information on drug costs.³⁰ Civil society members should encourage their governments to continue to support existing efforts on pricing transparency of both mAbs and other health products by requesting consistent updates like yearly reports to track progress, ensure collaboration, and work towards a goal for more equitable drug treatment. 
3. Work alongside global stakeholders, such as the World Health Organization, to build and maintain a global database of global mAbs prices, enabling information sharing between stakeholders. Following the adoption of the WHA 72.8, the WHO established the WHO Essential Medicines and Health Products Price and Availability Monitoring Mobile Application (WHO EMP MedMon), a multi-language tool that enables users to monitor medication prices and availability.³¹ The WHO EMP MedMon is intended to primarily track medicines included in the WHO Model List of Essential Medicines (EML). Currently, there are 12 mAbs included in the EML [Table 1] – a stark contrast to the over 100 approved antibody therapies existing in the U.S. market alone.^32,33 In order to build upon the goals of WHA 72.8, monitoring efforts should be expanded to include mAbs beyond the EML; wherein consolidated price comparisons, affordability measures, and knowledge of regional and facility availability could ultimately improve global access to mAbs. The strategic inclusion of mAbs in an established monitoring system like WHO EMP MedMon would further operationalize WHA 72.8, working toward its goal of increasing transparency of medicines, vaccines and other health products.²⁹ 
4. Create governance mechanisms for accountability and to ensure progress towards achieving mAbs pricing transparency. The adoption of WHA 72.8 calls for the continuation of the Fair Pricing Forum, a biennial conference which convenes relevant stakeholders, including civil society members, to discuss health products’ affordability and transparency. The most recent forum took place in February 2024. Such fora, covenings and conferences are critical governance mechanisms to gauge progress towards pricing transparency; civil society and community advocates should continue to engage in these accountability mechanisms to highlight the importance of pricing transparency for mAbs. Additionally, tracking country-level progress on commitments made by Member States to pricing transparency is also essential. For example, the accountability scorecards established by AIDS Accountability International to track countries progress and adherence to global commitments could be used as a framework for civil society to closely monitor country-level progress towards mAbs price transparency.³⁴ Any accountability mechanism must ensure that the responsibility of mAbs pricing transparency incorporates all stakeholders, including both manufacturers and national governments. Ultimately, through the coexistence of established monitoring and accountability mechanisms, there can be greater movement toward the global access and affordability of mAbs. 

Conclusion 

Monoclonal antibodies stand at the forefront of future medical treatment and biomedical research. Despite their scientific value, the potential for impact of mAbs is stifled by their high costs. The lack of affordability of mAbs is especially prevalent in LMICs, where there exists a demonstrated need for mAbs treatment, yet mAbs are inaccessible for both patients and in the broader health systems. While there is a general recognition that the high pricing of mAbs presents a barrier to their global access, the actual pricing data itself is not easily accessible nor publicly available. In order for governments and manufacturers to be held accountable for mAbs prices, there needs to be greater pricing transparency. Civil society and community members can play a pivotal role in driving this change. Through calling for greater pricing transparency of mAbs, advocates can ensure the enhanced accountability of their prices and aid in the progress toward mAbs global affordability and accessibility. 

Table 1: Monoclonal Antibodies Included in the WHO Model Lists of Essential Medicines³²

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