It is estimated that 350 million people worldwide use biologics on a regular basis to treat their medical conditions.1 These therapies are incredibly innovative and have expanded the arsenal of effective treatment options for cancer, rheumatoid arthritis, and other serious illnesses. However, the high costs of these therapies, although understandable, can create access issues for patients. That is why biosimilars are so important.
Biosimilars are, by definition, highly similar versions of their reference drugs. They have been proven to have comparable safety and efficacy as reference products but, by nature of being competitors and second to market, are priced lower than existing commercialized products. Often, these drugs will also address a market need not yet satisfied by reference products. For example, a biosimilar may offer more patient support services or different dosing and packaging options. Because the patents for several biologic drugs widely used in oncology are expiring, physicians now have the opportunity to offer their patients expanded treatment options.
Recent projections propose that the United States can reduce direct spending on biologics by $54 billion from 2017 to 2026 by adopting biosimilars.2 To date, 15 of the 26 FDA-approved biosimilars are for the treatment of cancer. Approximately half of these oncology drugs are already on the market. However, biosimilars will only be successful in lowering overall healthcare costs if physicians are willing to prescribe and support them. This starts with a better understanding of biosimilars overall and strategies for implementing them into a practice’s workflow.
First, we must understand a biosimilar’s regulatory pathway to FDA approval. Unlike generic and brand-name medicines, it is not possible for biosimilars to be exact replicas of their reference drugs because both the biosimilars and originators are derived from living cells. However, this does not mean that biosimilars are less safe or effective. In fact, this is exactly what a manufacturer must demonstrate to the FDA before a biosimilar is approved. Manufacturers must verify that their biosimilars offer the same safety, purity, and potency as their reference products; they can only have minor differences in clinically inactive components. Understanding the standards by which these new therapies are measured will help physicians be more confident when prescribing them to their patients. It will also prepare physicians to be better resources for patients who may have questions if their treatment plans are shifted to include biosimilars.
A poll conducted during ION Solutions’ Large Practice Program National Meeting found that almost 40% of respondents were unaware of the key factors that comprise the FDA approval process for biosimilars. I encourage all physicians to seek out information from their group purchasing organizations, industry associations (eg, Community Oncology Alliance), manufacturers, and government agencies until they are satisfied with the validity of these medications and what they can offer to patients.These same organizations can also provide ongoing, real-time updates on biosimilar approvals, launches, and regulatory changes that may affect biosimilar prescribing (eg, interchangeability news) and patient best practices.
Once physicians are comfortable prescribing biosimilars, they need to understand how these therapies fit into a practice’s workflow and the other benefits they provide—specifically navigating payer coverage and reimbursement. First, practices will need to establish a streamlined process to identify payer eligibility and coverage as well as contracting fees. Oncologists who successfully integrate biosimilars into their practices can reap significant reimbursement benefits under the Oncology Care Model (OCM), an episode-based payment model that encourages practices to improve patient care and lower costs through financial incentives. The OCM rewards practices that can demonstrate that they are providing the same or better care as their peers for a lower cost. Biosimilars are a natural fit for this dynamic: they allow oncologists to give their patients access to critical, potentially life-saving, biologic-based therapies but at more reasonable prices.
To receive this reimbursement benefit, however, practices must capture, report, and submit data that effectively demonstrate that they are fulfilling the model’s value-based objectives to the Center for Medicare & Medicaid Innovation. This process can be difficult and time-consuming, and it can take valuable time away from patients. However, oncologists can streamline OCM reporting by contracting a quality reporting engagement team that can work closely with practices to help them understand evolving quality measurements and avoid costly missteps while maximizing reimbursement. This includes helping oncologists identify value-based care gaps and pinpointing solutions. The quality reporting engagement group can also connect oncologists with practice performance insights, analytics tools, and other technologies that will help them improve their prescribing and success rate under the OCM.
Regardless of whether an oncologist chooses to participate in an OCM, the right technology-based tools are critical for supporting biosimilars—or any new class of drugs—in the practice setting. Cancer care providers can leverage the latest platforms to expedite everything from tracking industry trends and reporting data to navigating coverage support, starting with benefits verification.
Employing next-generation electronic benefit verification technology allows oncologists to spend less time navigating patients’ benefits, coverage eligibility, and out-of-pocket costs, which is particularly helpful for products as new as biosimilars. An electronic benefit verification solution ultimately reduces the time to benefit verification from days to hours, without consuming the valuable time of physicians. During the training process, these artificial intelligence–powered solutions use massive amounts of historical data to produce a coverage response while also examining elements such as out-of-pocket costs and a patient’s eligibility for payer assistance programs. In the rare instances that human intervention is required to clarify coverage, the solution will leverage its machine learning capabilities to analyze these new entries in real time and recognize them as new rules. This machine learning–based process ensures that accuracy and quality are never compromised, reduces the need for re-work, and translates to faster access to treatment for patients. This allows oncologists to focus on what they do best: providing personalized care to patients.
As we head into 2020 and beyond, oncologists who have experienced success with biosimilars have an obligation to showcase their positive results to other physicians and key healthcare stakeholders. These providers can use OCM data for case-based learning that demonstrates how biosimilars can deliver cost-savings and positive patient outcomes. Showing these results to physicians, payers, and other stakeholders will help bring more key players on board and get them involved in introducing these therapies to more patients as well as pushing for coverage and regulations that can pave the way for the future of biosimilars in oncology practices. Together, these efforts can lead to more affordable biologic-based therapies, improved patient access, and the ultimate goal of better patient health.
- Gifoni MAC, Fernandes GS, Chammas R. Biosimilar drugs: what would be a reasonable extrapolation? J Glob Oncol. 2018;4:1-5.
- Mulcahy AW, Hlavka JP, Case SR. Biosimilar cost savings in the United States: initial experience and future potential. Rand Health Q. 2018;7:3.