The creation of current cancer treatments has evolved through history as a response to the evolution of man, environment, and scientific advances. In the previous centuries, fatal infections diminished due to public health measures and the increase in effective antibiotics. With the decrease in deaths from infection and life expectancy increasing into the 80s based on the premise that the incidence of cancer rises with increasing age, cancer incidence increased. The historical factors with the environment show that when a possible oncologic causing factor is identified, its impact is allayed, and after a period related cancer cases decline. This has been shown with scrotal cancer, lung cancer, asbestos exposure, and now obesity. And cancer treatment in all forms has evolved where more is not necessarily the best option of care, but targeted therapy is a key to identify critical mutations to aim at for disease obliteration. All this evolution came at a cost to the public, with $245 billion expected to be spent on cancer care in the United States by 2030.1 But with the trend in oncology for value-based care, patient outcomes are being transformed by emphasizing personalized and efficient healthcare, including the development and use of new medicines at a lower cost.
Biosimilars are oncology drugs that are “similar” to already approved biological drugs used to treat cancer. They have the potential to provide lower-cost options for cancer treatment and thus enhance value-based care as the patent protection for some of the universally used biologics begin to expire. As biosimilars increase in the care arena of oncology treatment, it is critical that patients be informed of this classification of treatment in a way that allows them to participate in shared decision-making.
Basic concepts of why this drug is being prescribed to the individual, as well as primary concepts explaining the new product, are helpful to the patient. Analogies and visuals can help enhance teaching.
Biosimilars have been in the European market for 2 decades, so lessons on educating patients can be deduced from their experience when this new classification of treatment was introduced. A literature review of the European landscape stressed that patients need to be provided understandable and up-to-date information communicated in a positive manner.2 Basic concepts of why this drug is being prescribed to the individual, as well are primary concepts explaining the new product, are helpful to the patient. Analogies and visuals can help enhance teaching.
For example, many oncology patients are familiar with Neupogen to stimulate the growth of white blood cells. If a prescribing healthcare provider opts to use Nypozi, a man-made form of granulocyte colony-stimulating factor, Neupogen can be described as the reference biologic (originally approved product) and Nypozi is the biologic product created from living cells that has no clinically meaningful differences in terms of safety, purity, and potency. A key point is to openly share that to be considered equal, the biosimilar must go through robust testing for quality, efficacy, and safety, and only minor differences in clinically inactive components are allowed in biosimilar products.
The conversation around the biosimilar not being a generic should be addressed since some patients associate the “brand name” with higher quality and may perceive generics as inferior, even when they are not.3 Biosimilars are complex molecules made from living cells, and the similarity derives from the natural variability of the cells used to make them. Generic drugs are chemically synthesized from small molecules that are exact copies of brand-name drugs. Both have the same treatment risks and benefits as their reference drugs but are made differently. A clinical study is required to compare pharmacokinetics of a reference biologic and biosimilar, and a large randomized controlled trial to demonstrate clinical equivalence is performed. Generic drug applicants do not have to repeat animal and human studies that were required of the brand-name medicines to demonstrate safety and effectiveness.
The cost is a primary factor when addressing another education suggestion from the European literature review—provide information tailored to the individual patient’s needs.2 Biosimilar and generic drugs are made and regulated differently, but they can both help save money. The illusion of an expensive drug judged as significantly more effective is real for some patients and can influence decision-making.4 A phenomenon identified as the “nocebo” effect, where pessimistic expectations of treatment lead to potentially worse outcomes, needs to be considered by healthcare providers.5 Open and trusting communication by healthcare providers can alleviate patient concerns. Patient cost-savings comes from lower out-of-pocket costs due to the lower price of biosimilars. While biosimilars are cheaper, patient out-of-pocket costs can vary depending on insurance plan design and coverage policies. Lower prices can enable more patients to afford necessary biologic medications, which enhances access to necessary treatments. The price competition from biosimilars can lead to lower overall healthcare costs for insurers, which may translate to lower premiums for patients.
In the larger picture for value-based care, biosimilars have the potential to generate savings and efficiencies for healthcare systems. This in turn can extend access to biologic medicines or free up resources for other important aspects of healthcare, including the development and use of new medicines. In the Oncology Care Model population, the Centers for Medicare & Medicaid Services used data from 2 pegfilgrastim biosimilars and demonstrated that the utilization of biosimilars is associated with a $4.8-million cost-saving relative to the total expected reimbursement without biosimilars in the market.5 Texas Oncology highlighted the importance that education can be foundational in a cost reduction of $4 million in 1 month by utilizing a comprehensive team approach that involved creation of educational materials on biosimilar conversion for patients and clinical staff.6
An open discussion and positive attitude during patient education on biosimilars will enhance shared decision- making. Some patients will ask for more information, while other patients will have no further questions or concerns about biosimilars. If more information is requested, connecting with a pharmacist to discuss potential cost-savings and whether switching to a biosimilar is appropriate for their individual situation can be arranged. Written information should be shared, and audiovisual aids can be used to increase the understandability and confidence in the key biosimilar concepts.
Currently 64 biosimilars are approved by the FDA, and this list will grow in the coming years.7 The availability and use of biosimilars varies across different countries and is influenced by supportive regulatory frameworks, physician acceptance, and in turn patient understanding and assent for treatment. In the United States, the FDA has developed the Biosimilars Action Plan to encourage innovation and competition in the market for biological products and facilitate the development of biosimilars.8,9 In the oncology realm, ASCO emphasizes the importance of educating both patients and clinicians about biosimilars to address concerns and promote confidence in their use and supports transparent processes when adding biosimilars to formularies, including clear communication about the rationale for selecting specific biosimilars.10
Biosimilars are used to treat many illnesses besides cancer, including chronic skin diseases, arthritis, diabetes, kidney conditions, macular degeneration, and others. Clinical trials verify the safety, potency, and purity of the biosimilars, which are also evaluated for quality and stability. Patient participation in the use of new treatments is critical for the ongoing success of cancer care. Foundational to their participation is an open conversation on new therapy and its safety. Communication is one of the standards of Oncology Navigation Standards of Professional Practice that all navigators effectively advocate with and on behalf of patients.11 By introducing biosimilars and addressing misconceptions, patients have more care options available to them with the potential to reduce their personal healthcare cost, and they can actively participate in discussions with their healthcare providers regarding the best treatment options for their specific needs.
Download a table of Biosimilar Education Resources that you can share with your patients.
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