Although the role of biosimilars in the treatment of patients with cancer has been under review by payers and providers for several years, there remains conflicting application regarding policy and strategy. There is a growing need for discussions on biosimilars in the context of the current landscape, utilization and evidence, impact on costs of care, quality and payment reform, and potential policy and strategy solutions. To address these issues, the National Association of Managed Care Physicians (NAMCP) Medical Directors Institute developed the NAMCP Medical Directors Spotlight Guide: Biosimilars in Oncology 2021,1 which was published in March 2021 as a special issue of the Journal of Managed Care Medicine. The goal of this guide was to present an overview of the growing trends regarding biosimilars in oncology, as well as the challenges and issues for physicians and oncology management challenges from the health plan perspective.
This article provides a brief overview of some of the ongoing issues related to the use of biosimilars covered in the guide, which can be downloaded at http://jmcmpub.org/wp-content/uploads/2021/04/March2021.pdf.
Biosimilars and Biologics
Biologic products are derived from living organisms. Because they have large and complex structures, there are slight differences during the manufacturing process, which are both normal and expected and classified with “acceptable within-product variations.” Biologics are used in the primary treatment of cancer (eg, bevacizumab [Avastin], rituximab [Rituxan], trastuzumab [Herceptin]) as well as in supportive care (eg, epoetin alfa, filgrastim, and pegfilgrastim), and are considered one of the fastest growing drug classes in oncology.
Basic molecule patent expirations for many of these agents have opened the door to the development of biosimilars to biologic reference products. The FDA defines a biosimilar as “a type of biological product that is licensed (approved) by the FDA because it is highly similar to an already FDA-approved biological product (the reference product) and has been shown to have no clinical differences in safety purity or potency from the reference product.”2 Biosimilars are manufactured with the same natural resources as their reference product, with specific criteria to meet necessary “highly similar” and no “clinically meaningful differences” requirements.2 The manufacturing of biosimilars is tightly regulated by the FDA.
Addressing Challenges in the Integration of Biosimilars
The recent expansion of both federal and private value-based programs, as well as the operational and financial pressures thrust upon the medical community by the COVID-19 pandemic, have led to a heightened focus on biosimilars as cost-effective alternatives to biologic treatments, especially in oncology. Increased utilization of biosimilars through formularies, policy, and clinical treatment protocols, as well as a better understanding of their role in value-based care, will depend on engagement from providers and payers, and their ability to overcome existing challenges.
Currently, no biosimilar has been approved by the FDA as “interchangeable” with its reference product. Physicians may choose to treat with either a biosimilar or a reference product and may substitute a biosimilar in place of a reference product. However, pharmacists may not substitute biosimilars for reference products without a direct prescription from the treating physician. This has direct implications regarding payer or specialty pharmacy involvement in any biosimilar policy or management behavior and is an important point for treating physicians to understand in oncology management.
Variations in PBM and Private Payer Approaches
Pharmacy benefit managers (PBMs) and private payers vary in their approach to biosimilars. Although some PBMs and payers have chosen to be inclusive of biosimilars without aggressive management, others have taken reference products off formulary and replaced them with certain biosimilars, and some have made the decision to restrict coverage of reference products or to create preferred coverage for one or more biosimilars.
Challenges for Providers
The challenges facing providers are numerous and multifactorial. The following are a few of the issues that need consideration and further discussion:
- There may be hesitancy among patients (and some providers) to switch from a biologic product to a biosimilar.
- Provider payment rates seeking to influence use of biosimilars or reference products could lead to unintended financial penalties for treating providers, in addition to influencing medical decision-making.
- Continued clinical evaluation among the provider community related to “switching” between reference and biosimilar products during active patient treatment will be needed to address provider concerns and lead to clarity of provider policy.
- States are looking at legislative positions that could preserve or affect prescriber management.
- Physicians, patients, payers, and employers may disagree on the varying fiscal, operational, and quality-of-life impacts of a choice between 2 infused products (reference or biosimilar), a choice between an infusion or an injection on patient and chair time, or the stocking of multiple products to meet varying product preferences of the physician and possibly multiple payer formularies.
Factors Affecting Biosimilar Policy and Adoption
Given the varying degrees of understanding and awareness of biosimilars as a new market category, we have seen a slower than anticipated uptake of biosimilars. Some of the factors that have contributed to this delay include: operational challenges in internal formularies and billing and health records formatting; financial challenges from reimbursement policy; contracting issues with manufacturers of both biosimilar and reference products; the burden of documentation and patient tracking incurred by use of any new product; and the need for education of patients on biosimilars versus reference products.
In addition, multiple products may be difficult for providers to manage. If 1 reference product now requires 2, 3, or more biosimilars to meet payer formulary demands, the inventory and space limitations on medical practices may be overwhelming.
Accessibility of product from trusted drug wholesalers may also present a challenge. Most physicians will seek solutions that support continued internal drug inventory, rather than accept drugs shipped to them for use (commonly called “white bagging”) for a variety of operational and administrative reasons. Value-based payment relationships that increase the accountability of total costs of care by treating physicians do appear to increase the uptake of biosimilars, as long as physicians have the flexibility to make their own choices for which biosimilar to use and when.
Biosimilars present opportunities as well as challenges for the healthcare delivery system. Some payers and providers are eager to incorporate these agents into treatment plans, whereas others find themselves hesitant to navigate the various economic, clinical, and operational implications. Moving forward, it is essential for stakeholders to openly address the changes that biosimilars will bring and initiate the necessary discussions to support the integration of these agents into cancer care. Resources such as the NAMCP Medical Directors Spotlight Guide: Biosimilars in Oncology 2021 can be extremely valuable for facilitating these discussions.
- Holcombe D. NAMCP medical directors spotlight guide: biosimilars in oncology 2021. March 2021. http://jmcmpub.org/wp-content/uploads/2021/04/March2021.pdf. Accessed June 3, 2021.
- Christl L, Lim S. Biosimilar and interchangeable products in the United States: scientific concepts, clinical use, and practical considerations. December 18, 2018. www.fda.gov/media/122832/download. Accessed June 3, 2021.