Today, biologics make up more than half of the oncologic therapies in the pipeline. These pioneering therapies now allow more than 350 million patients with cancer globally to receive their treatment through a painless injection rather than an 8-hour chemotherapy session.1
But, bringing innovation to patients with groundbreaking therapies can be a time intensive, intricate, confusing, and expensive process. As patents of biologics begin to expire, the market for biosimilars is opening up. If widely used in oncologic practice, biosimilars have the potential to increase accessibility and positive outcomes for more patients. Further, with proper incorporation into practice, biosimilars can lower healthcare costs and diversify treatment options for cancer patients. In fact, savings projections suggest that the United States can reduce direct spending on biologics by $54 billion from 2017 to 2026 with the adoption of biosimilars.2 With this new opportunity comes the dire need for proper provider and patient education, payer coverage navigation support, and streamlined workflows to meet value-based objectives.
Bridging the Education Gap
Physicians, pharmacists, nurses, and other providers are all entrusted to bring the best treatment possible to their patients. While providers are confident in biologics, further education around the safety and efficacy of biosimilars will allow providers to confidently prescribe them to patients.
Bridging this gap presents a tremendous opportunity for oncologists to increase patient access to a powerful class of new therapies. First, understanding the US Food and Drug Administration (FDA) 351(k) approval pathway for biosimilars will create a clearer picture of the rigorous testing these products experience.
A recent poll conducted (Kashyap Patel, oral communication, April 2018) during ION Solution’s Large Practice Program National Meeting in Washington, D.C., found that almost 40% of the respondents were unaware of the key factors that make up the FDA approval process for biosimilars. Yet, physicians are eager to prescribe biosimilars.3 Joining oncology-focused network organizations, such as Community Oncology Alliance, is one way that providers can equip themselves with the educational resources and opportunities necessary to bridge crucial knowledge gaps.
In addition to education about the safety and efficacy of biosimilars, it is acutely important for oncologists to evaluate both the biosimilar and manufacturer before prescribing. As with any therapy, having a deep understanding of how the therapy works, its indications, and its potential side effects will allow an oncologist to best prescribe the treatment and educate their patients on how it will treat their disease.
Further, investigating how long the manufacturer of the biosimilar therapy has been in the marketplace can help ensure that the supply chain for the product is well established and stable. Providers should also consider whether the manufacturer’s distribution partner has a long-standing track record of excellence in product commercialization.
An experienced distribution partner will ensure the manufacturer has access to best-in-class commercialization and channel management strategies. Lastly, a “real-world evidence” designation should be considered when investigating an established manufacturer partner to ensure stakeholder confidence and sustainable market presence.