Alliance for Patient Access Releases Paper on Biosimilar Best Practices in Oncology

Oncologists from the Alliance for Patient Access wrote a paper from the physician’s perspective regarding the benefits of using oncology biosimilars, reasons behind physician hesitancy to switch patients away from reference products, and best practices to ensure physician and patient confidence in these products.

“Because cancer can be deadly, decisions about treatment must be made with the utmost precision. Whether in determining the initial course of treatment or navigating changes along the way, the best care stems from shared decision-making between a patient and a trusted clinician,” wrote coauthors Arturo Loaiza-Bonilla, MD, and Jeffrey B. VanDeusen, MD, PhD.

One of the benefits beyond cost-effectiveness that the authors mentioned about biosimilars was that the subtle, clinically meaningless differences between biosimilars and their reference products allow doctors to prescribe the same therapeutic pathway while potentially avoiding adverse side effects.

“These differences, while not clinically meaningful, can be an asset if a patient experiences an adverse reaction to the reference product,” wrote the authors.

This phenomenon is unique to biologic drugs because generic drugs are identical to brand drugs and if a patient experiences adverse events serious enough to discontinue treatment, they would need to switch drugs completely.

Additionally, biosimilars offer a way around potential drug shortages and supply chain disruptions, such as those observed during the COVID-19 pandemic, ensuring that patients could continue therapy.

The authors cited the natural skepticism the oncologists have regarding biosimilar products as a reason that physicians are hesitant to use biosimilars, saying that failed innovations in the past combined with the high stakes patients with cancer face make oncologists “intrinsically risk averse” when it comes to using new medicines.

Physicians also experience confusion surrounding the evidence supporting biosimilar approvals, which makes data difficult to keep up with and could lead to more hesitancy among doctors and patients. The authors suggested that data and other information needs to be collected and shared regularly and real-world data needs to be consistently relayed to physicians to reassure them of the efficacy and safety of biosimilars.

“The potential benefits of biosimilars are meaningless if the medications are not utilized,” the authors said.

Another polarizing issue for biosimilars is the concept of nonmedical switching, which involves health care policies requiring patients to be switched from 1 product to another without a medical reason. Health plans typically base their formulary preferences on which agents best meet their financial interests.

However, insurers overriding treatment decisions based on their preference lists can make patients feel uncertain, powerless, or resentful. Agents may be switched if an insurer changes their formulary lists or a patient changes their insurance provider, which could result in patients being forced to switch to a product that could produce adverse events and potentially pay more out-of-pocket costs.

“It should not be discounted, particularly in the case of a lengthy battle with cancer, that patients also may have an emotional attachment to medication that’s working for them and not want to change,” wrote the authors.

Nonmedical switching can also create a lot of administrative work for clinics, which may not have the manpower needed to handle it. Insurer-directed switches may require filling out new paperwork, sending letters, making phone calls, and obtaining new patient consent forms, which could undermine confidence in the switched medication and create a sense of increased risks among patients.

“Physicians and patients both benefit when policies support access to multiple treatment options and allow shared decision-making about which treatments work best for each individual patient,” the authors noted.

Reference

Loaiza-Bonilla A, VanDeusen JB. Biosimilars: Expanding options for cancer care. IfPA website. https://admin.allianceforpatientaccess.org/wp-content/uploads/2021/06/AfPA_Biosimilars_Oncology_Paper_June2021.pdf. Published June 24, 2021. Accessed July 26, 2021.