Pharmacists will have the opportunity to use their knowledge of biosimilars to reinforce their benefits, safety, and efficacy.
Rheumatoid arthritis (RA), an autoimmune inflammatory disease that attacks the synovial tissues in the joints, is the most common form of autoimmune arthritis, affecting 1.3 million people in the United States.1 Rheumatologists often employ disease-modifying anti-rheumatic drugs (DMARDs) to slow disease progression, but many patients have an incomplete response. For those people, biologic DMARDs are usually prescribed, but these drugs are too costly for many, putting optimal disease management out of reach for this population.2
To meet the need for more affordable biologics, biosimilar DMARDs were developed, reducing costs to allow more patients to access these critical therapies.3 So far, 4 biosimilars for the RA reference product Remicade have received FDA approval, but only 3 are currently available on the US market: Inflectra, Renflexis, and Avolsa.4
Although these medications have no clinically meaningful differences with their reference biologics5 and offer significant cost advantages, adoption of these products by rheumatologists has been slow. Educating providers and patients about the biosimilar approval process could decrease patient resistance and increase the likelihood of rheumatologists embracing biosimilars.
Several more RA biosimilars will be released soon, and stakeholders remain cautiously optimistic. The impact of these biosimilars could be massive, both in terms of cost savings and health outcomes, so it is worthwhile to examine how pharmacists can help overcome obstacles blocking the uptake of these life-changing therapies.
Anytime biosimilars are discussed, the conversation quickly turns to cost savings compared to the reference product. The goal of biosimilars is to drive down costs to payers, whether the payer is Medicare, a private health insurance plan, or the patient.
Savings depend on how willing manufacturers are to lower their costs to gain market share. If most manufacturers keep their costs high, then savings will not be as substantial as they could be.
To support cost savings, the FDA made the biosimilar approval process less expensive than biologics through an abbreviated pathway. Manufacturers must demonstrate bio-similarity between the biosimilar and its reference product.
Biosimilars are still rigorously evaluated to ensure they are as safe and effective as the reference product, and that they are highly similar to the original biologic with no clinically meaningful differences from the existing FDA-approved reference product.6 Manufacturers must also meet the same quality standards as the reference product.7
This means rheumatologists and patients can expect the same clinical safety and efficacy from the biosimilar as would be obtained from the original biologic.8 Consequently, patients get the full clinical benefit of the more expensive brand product, which is an additional advantage over and above cost savings.
Both rheumatologists and patients have been slow to accept biosimilars due to the lack of awareness around the biosimilar streamlined approval process. Providers may not know that biosimilars have no clinically meaningful differences from the original product, which may lead to concerns that biosimilars might not be as effective or safe as brand products.
Patients also have concerns, especially if they switch to a biosimilar from a drug they have taken for a long time. Often when this happens, the nocebo effect comes into play. This is when adverse effects (AEs) or symptoms are experienced with a drug just because the patient believes they may occur.9
These symptoms may not actually materialize because the treatment is not working, but the patient believes that is what is happening. In other specialties like oncology, this situation is not as big an issue because the provider can use scans and lab tests to verify what is actually happening, but rheumatologists usually rely on qualitative factors, such as asking the patient about pain level or range of motion.
This is discouraging to rheumatologists, as these patients strongly believe they have experienced treatment failure with the biosimilar. Some patients may also refuse to even try a biosimilar because they do not understand the drug is highly similar to the more expensive brand product with no clinically meaningful differences in the safety and efficacy.
The public has a high level of trust in pharmacists, as demonstrated by more than 30 years of polling from Gallup, which for decades has placed pharmacists among the most trusted professions.10 Consequently, pharmacists can play a key role with helping rheumatologists and patients understand and accept the new RA biosimilars entering the market.
Pharmacists will have the opportunity to use their knowledge of biosimilars to reinforce their benefits, safety, and efficacy. Rather than just telling patients they will be getting a product similar to what they had in the past, the pharmacist can explain in detail they will be receiving a product just as clinically safe and effective as the one they have been taking, and it will actually cost less than the brand product. Additionally, they will be able to answer any questions that may arise.
The pharmacist’s skill set is tailor-made for the roll out of products such as biosimilars, and there is little doubt they can do a fantastic job of getting providers and patients on board with these complex products. Pharmacists have been tackling problems like this for years and have a proven track record of affecting change.
For example, when generics were launched in the late 1990s, there was a high level of patient distrust around their use. Pharmacists were able to educate patients to the point where today when patients fill a prescription, many request a generic. If history is any indication, pharmacists will be able to achieve comparable results with biosimilars.
Integrating pharmacists into the RA practice could provide many benefits to patients, providers, and the entire organization, and practices across many specialties are embracing this care model. Pharmacists bring value to the practice in many ways, such as consulting on treatment plans, educating patients about their disease and medications, monitoring and controlling AEs, and empowering patients to be more proactive about their own health.11
Not only can pharmacists contribute to these important areas of clinical care, but they can also speak to the economic picture as well. Having the added view of the economics around reimbursement and how rebates impact the bottom line is extremely beneficial. Their presence in the practice may also drive biosimilar use, helping practices succeed in new value-based reimbursement models.
Biosimilars give pharmacists yet another opportunity to be relevant by using their training and patient relationships to help patients and providers understand this new treatment. Because pharmacists are held in such high regard, people have confidence in their advice.
Hearing their trusted pharmacist explain that a biosimilar has the same efficacy and safety as the original product will build belief in this new drug group. Pharmacists can once again be in the spotlight, just as they were with generics, helping patients and providers understand they are not sacrificing anything with biosimilars, but are simply gaining cost savings.
About the Author
Bob Zutaut, RPh, clinical specialist, McKesson Provider Solutions.
1. Editorial Staff. How common is rheumatoid arthritis? MedicalNews Today. Accessed online April 4, 2023. https://www.medicalnewstoday.com/articles/rheumatoid-arthritis-prevalence
2. Conran C, Moreland L. A review of biosimilars for rheumatoid arthritis. Current Opinion in Pharmacology. Volume 64, June 2022, 102234.
Accessed online April 4, 2023. https://www.sciencedirect.com/science/article/abs/pii/S1471489222000613
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5. U.S. Food & Drug Administration. Biosimilars: Overview for Health Care Professionals. December 13, 2022. Accessed online July 1, 2023. https://www.fda.gov/drugs/biosimilars/overview-health-care-professionals#What%20is%20a%20biosimilar%20product
6. U.S. Food & Drug Administration. Biosimilars: Review and Approval. Accessed online April 5, 2023.
7. U.S. Food & Drug Administration. Biosimilar and Interchangeable Biologics: More Treatment Choices. October 12, 2021. Accessed online April 5, 2023.
9. National Cancer Institute. NCI Dictionary of Cancer Terms: nocebo effect. Accessed online April 5, 2023. https://www.cancer.gov/publications/dictionaries/cancer-terms/def/nocebo-effect
10. Editorial Staff. Why trust in pharmacists remains high. CVS Health. June 03, 2022. Accessed online April 10, 2023. https://www.cvshealth.com/news/pharmacy/why-trust-in-pharmacists-remains-high.html#:~:text=Americans%20have%20a%20special%20confidence,health%20care%20needs%20monthly2.
11. Ponushis A. Embedding Pharmacists with Physicians. American Association of Colleges of Pharmacy. October 1, 2018. Accessed online April 10, 2023. https://www.aacp.org/article/embedding-pharmacists-physicians