Shaina Shah, PharmD Candidate

Prescription drug expenditures accounted for $577 billion in 2021.

 A significant portion of the spending is attributable to biologic agents, which are different from traditional small-molecule pharmacological agents.

With the burgeoning costs associated with biologics, payers have responded with utilization management strategies. Although these have added value, there is an opportunity for further cost savings resulting from increased biosimilar availability and adoption.

According to estimates from IQVIA, savings from biosimilar utilization between 2020-2024 are projected to be around $104 billion.

 With multiple biosimilars of adalimumab(Humira) in the horizon, there are significant savings that could be realized; however, there are several challenges that need to be addressed to optimize the outcomes and cost-saving opportunities with increased adoption of biosimilars. This article highlights the challenges and potential solutions with biosimilar adoption from the perspectives of a patient and provider.

Unlike small molecule pharmacological agents, biosimilars are unlikely to be interchangeable at this point. This poses multiple logistical challenges for the prescribing provider.

First, the providers may not be aware of which biosimilar products are available in the market. Second, they may not be aware of which biosimilar product may be covered by the patients’ insurance carrier.

The lack of awareness of product availability and payer preferences for specific biosimilar products can be a disruptive process for the prescribing providers (and patients), especially when preferred drug lists are subject to change at the payers’ discretion.

 These challenges can be addressed by education and creating awareness of the products available on the market.

Additionally, provider education from payers is critical to reduce provider/member disruption. Tools such as electronic prior authorizations and automated decision support systems within electronic health record systems can minimize disruption. Next, many of the biologics are billed at an average selling price (ASP) plus a percentage.

Biosimilars are likely to be priced at a lower ASP, and billing for a biosimilar may result in a lower revenue for the billing provider compared to billing for the brand reference product with a comparatively higher ASP. The misalignment in financial incentives between the payers and billing providers can be addressed with alternative payment models/adjusted fee schedules that reward providers for utilizing biosimilars for their patients.

From a patient perspective, the lack of awareness of biosimilars is the biggest barrier to adoption. In a survey of 362 American Autoimmune Related Diseases Association (AARDA) members, researchers found that 80% of respondents did not know what biosimilars were, and 52% did not understand the differences between biosimilar and traditional small-molecule pharmacological agents.

Similar results were also seen in a survey conducted by PwC, which found that only 17% of respondents chose the correct definition of biosimilars from several choices.

 Strategies to increase awareness of biosimilars are critical to biosimilar adoption from the patients.

It is important for patients to understand how biosimilars differ from traditional generic drugs. Additionally, increasing understanding on what biologics are and their significance in managing conditions is critical.

Lastly, it is important that the patients understand the cost implications of biosimilar adoption. With many biologics being adjudicated in a co-insurance benefit design (especially for Medicare Part B), adoption of biosimilars can have significant cost implications for patients. Creating awareness on the potential cost savings can motivate patients to not only learn more about biosimilars, but also adopt them in their treatment plans.

Although there are significant cost savings associated with biosimilars, there are multiple gaps in evidence related to biosimilar adoption related to real-world outcomes on switching among biosimilars (immunogenicity, safety, efficacy). Addressing these gaps in evidence is critical to patient-provider confidence in biosimilar adoption.

With the increasing availability of multiple biosimilars, it is likely that there may be instances of non-medical switching. The data on adherence, discontinuation rates, and patient-reported outcomes are slowly emerging.

Insights on that patient experience with biosimilars are critical to providing patient-centered care. Patient-reported outcome measures and its association with underlying disease severity may provide additional insights on potential success rates while on biosimilars.

Additionally, it is important to recognize that although biosimilars are likely to be a lower net cost option, increased competition is likely going to drive down prices for the biologic reference product. Hence, for those patients/providers who are hesitant to use biosimilars, the reference product should still be considered until the factors related to biosimilar hesitancy are addressed with clinical evidence.

In conclusion, growing biosimilar availability, especially for blockbuster biologics such as adalimumab, presents a cost savings opportunity for the payers. However, several challenges that include provider and patient understanding of biosimilars, concerns over immunogenicity, interchangeability and underlying regulatory process, and misaligned financial incentives need to be addressed. Strategies such as education campaigns, robust real-world evidence, and adjusted fee-schedules can aid in biosimilar adoption.

Tichy EM, Hoffman JM, Suda KJ, et al. National trends in prescription drug expenditures and projections for 2022 [published online ahead of print, 2022 Apr 6]. 

IQVIA Institute for Human Data Science. Biosimilars in the United States 2020-2024.

Sarnola K, Merikoski M, Jyrkkä J, Hämeen-Anttila K. Physicians' perceptions of the uptake of biosimilars: a systematic review. 

. 2020;10(5):e034183. Published 2020 May 5. doi:10.1136/bmjopen-2019-034183

Edgar BS, Cheifetz AS, Helfgott SM, et al. Overcoming barriers to biosimilar adoption: real-world perspectives from a national payer and provider initiative. 

. 2021;27(8):1129-1135. doi:10.18553/jmcp.2021.27.8.1129

American Autoimmune Related Diseases Association. Accessed from 

https://autoimmune.org/wp-content/uploads/2017/04/BiosimilarsWhitePaperPressRelease.pdf

PwC. Top Health Industry Issues of 2016. Accessed from 

https://www.pwc.com/us/en/health-industries/top-health-industry-issues/assets/2016-us-hri-top-issues.pdf

Articles

From a patient perspective, the lack of awareness of biosimilars is the biggest barrier to adoption.