Inclusion of oncology biosimilars in clinical pathways is one approach to reducing costs in this therapeutic area without compromising outcomes for cancer patients. There are currently eight Food and Drug Administration (FDA)-approved oncolytic biosimilars in the US market. Patients, providers, payers, policymakers, and manufacturers are all stakeholders that will be affected by these new biosimilars—and they all influence the placement of biosimilars in clinical pathways to ensure their appropriate use.
Several stakeholders within the health care system believe that drug costs are a major contributor to the rising total cost of care. However, this is not supported by the fact that only about 15% of health care spending is for prescription drugs.1 Further complicating the matter is the fact that prescription drugs cannot be viewed in a silo; rather, they require assessment based on their impact on clinical and financial outcomes. Those who are attacking prescription drug costs—especially those for oncology treatments—need to look beyond inappropriate utilization restrictions that can negatively impact clinical and financial outcomes.
There are ways to reduce prescription drug costs without restricting utilization.1 Oncology treatments have been an area of focus, as 80% of the most expensive therapies are biologics for cancer treatment.2 From the payer perspective, oncology is a significant cost driver that can be contained through different tools, such as clinical pathways and oncology value assessments.3 Inclusion of oncology biosimilars in clinical pathways is one approach to reducing costs in this therapeutic area without compromising outcomes for cancer patients. There are currently eight FDA-approved and marketed oncolytic biosimilars in the United States. Patients, providers, payers, policymakers, and manufacturers are all stakeholders that will be affected by these new biosimilars—and they all influence the placement of biosimilars in clinical pathways to ensure their appropriate use.
Biosimilars Market Implications for Stakeholders
The first oncolytic biosimilars have launched over the past year, and providers are starting to use them in the treatment of several types of cancer. The first three oncolytic reference products that have biosimilar competitors currently cost US commercial and government payers approximately $10 billion in peak annual sales.4 Oncolytic biosimilars are clinically equivalent products that are highly similar but not identical to an approved reference drug, with no variations in efficacy, safety, and purity. Table 1 provides key terms and context required to understand the oncolytic biosimilar market. This is important so that stakeholders are speaking the same language as they discuss this relatively new area of opportunity.
Patients
From a patient perspective, oncolytic biosimilars are not currently on patients’ radar, primarily because they have not been educated about biosimilars, and it is unclear who will inform them moving forward. A survey of 3198 patients revealed that almost 70% had never heard of biosimilars.5 This knowledge gap among patients may be an issue if long-term outcomes show clinically significant differences between oncolytic reference products and biosimilars, because patients may not even know that they received a biosimilar. Although prescribers and pharmacists are required by most current state laws to disclose to a patient if the biologic product they are being treated with has been switched to a biosimilar by the pharmacy, if the prescription initially calls for a biosimilar, they may not be required to disclose this information.6 It is important to note that all currently approved oncolytic biosimilars in the United States are infusions that are administered by providers rather than patient-administered injections available at pharmacies. It is unclear the extent to which patients are receiving education from providers about the complexities surrounding biosimilars vs generic small molecules.
This discussion may even be more challenging if an oncology patient develops a distrust of a provider who prescribes a lower-cost biosimilar oncolytic product rather than its reference product. Many patients do their own research on the oncolytic therapies they are prescribed before or soon after they start taking the medication. Most of the information patients receive are from patient groups and manufacturers’ product websites. They may discuss the prescribed biosimilar with their oncologist months after being started on it, and some patients may even ask to be switched to a reference product. In these discussions, it will be important to explain to patients that their out-of-pocket costs for biosimilars are expected to be lower compared with reference products because biosimilars have lower list prices.
Providers
The most important and influential stakeholders for oncolytic biosimilar acceptance and usage, oncologists and hematologists, have gaps in knowledge. Providers should be educated by their institutions and by manufacturers about biosimilar product issues such as immunogenicity, which may affect treatment outcomes, as well as the cost savings associated with these new products. Because biosimilars are generally manufactured using different cell lines than the reference product, there is concern that a biosimilar may produce antidrug antibodies, thereby impacting its efficacy or even rendering the reference product useless for a patient for subsequent therapies. Education around immunogenicity is needed to fully understand potential differences between reference products and biosimilars.
A survey of 376 oncologists found that 80% of them believed that it is important to be notified if a biosimilar is being substituted for the prescribed reference drug. Biosimilar substitution laws are determined by state, with many states requiring the physician to be notified if a substitution is made.7 According to this survey, US oncologists were also more likely than their Latin American or European peers to believe that patients could switch biologics from the reference product to a biosimilar mid-treatment and expect the same results. This is an important perception for clinical pathway developers, since making changes to a pathway may impact patients who have been on a reference product for months or even years.
One issue that will affect physician uptake of biosimilars is interchangeability, as it will have a major impact on pharmacists’ ability to replace a prescribed reference product with a biosimilar of a generic product. To receive interchangeability designation, the manufacturer must demonstrate not only that the biosimilar has efficacy and safety equivalent to the biologic, but also that switching between the original biologic and the biosimilar is essentially equal to remaining on the reference product. The manufacturer has some advantages in having a certain degree of exclusivity; a subsequent interchangeable product cannot be approved for 1 year after approval of the first interchangeable biosimilar. The FDA has developed a clear pathway to interchangeability and is expected to designate the first interchangeable products within the next few years.
Payers
Payers may feel the need to find ways to incentivize physicians to prescribe biosimilars instead of biologics, as well as to provide patient education on cost and quality, to drive uptake. One approach would be to reward prescribers who adopt biosimilars more quickly. Another way is to prefer oncolytic biosimilars over reference products in terms of coverage and clinical pathways to reduce out-of-pocket spending when a biosimilar is prescribed or even by reducing the provider’s administrative burden when a biosimilar is prescribed through no preauthorization. There are several risks to incentivizing a specific oncolytic biosimilar over a reference product, however, such as the potential for unexpected safety or efficacy issues or a lack of biosimilar supply due to manufacturing problems. Additionally, patient services provided by biosimilar manufacturers may not be on par with the reference manufacturer’s patient services, creating a gap that leaves patients with higher out-of-pocket costs when a biosimilar is prescribed.
A better way to improve oncologist and hematologist trust in oncolytic biosimilars is to level the playing field with formulary policies that offer prescribers a choice between a reference product and its biosimilar, while requiring additional price concessions from the reference product’s manufacturer to maintain parity coverage status.
Conclusion
Overall, oncolytic biosimilars have the potential to save the health care system billions of dollars each year as more biologics lose exclusivity. To ensure this cost savings, an educational campaign about these relatively new products must first be established to prepare for proper adoption by all relevant stakeholders, including employers. A foundation for this change can be clinical pathways that call out oncolytic biosimilars over their reference products as a means to promote this opportunity for cost savings.
References
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Accessed March 24, 2020. https://www.ncsl.org/documents/health/Biologics_BiosimilarsNCSLReport2015.pdf
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8. Biosimilar and interchangeable products. US Food and Drug Administration. Updated October 23, 2017. Accessed March 24, 2020. https://www.fda.gov/drugs/biosimilars/biosimilar-and-interchangeable-products
9. Immunogenicity of protein-based therapeutics. US Food and Drug Administration. Updated March 27, 2018. Accessed March 24, 2020. https://www.fda.gov/vaccines-blood-biologics/biologics-research-projects/immunogenicity-protein-based-therapeutics
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