Rheumatologist Marcus Snow, MD, is comfortable with prescribing biosimilars as a first-line, first-time biologic, and discussing them with patients.
"If a biosimilar is on the market, it has gone through rigorous study proving its effectiveness and equivalence to a bio-originator," said Snow, a rheumatologist with the University of Nebraska Medical Center and chair of the American College of Rheumatology's Committee on Rheumatologic Care.
The formulary makes a big difference in the conversation about options, he said. "The formularies dictate what we can prescribe. It may not be appropriate, but it is reality. The cost of biologics for a patient without insurance coverage makes it impossible to afford."
He will often tell patients that he'll fight any changes or formulary restrictions he does not agree with. "However, when I see patients in follow-up, even if there is no known change on the horizon, I may bring up biosimilars when we have a moment to chat about them to familiarize them with what may happen in the future."
The need for patient education on biosimilars presents a barrier to realizing their potential to save money and expand choice, noted Cardinal Health in its 2023 biosimilars report. Of 103 rheumatologists who responded to a Cardinal Health survey, 85% agreed that patient education was important. But those conversations can take an uncomfortable turn if the patient pushes back against taking a biosimilar owing to cost or safety concerns.
It's not uncommon for a patient to express some anxiety about biosimilars, especially if they're doing well on a current treatment plan. Most patients do not want any changes that may lead to worsening disease control, Snow said.
Patients and physicians alike often don't understand the mechanics of biosimilars. "There's a lot of misinformation about this," said Sameer Awsare, MD, an associate executive director for The Permanente Medical Group in Northern California. Patients should know that a biosimilar will be as clinically efficacious as the medicine they've been on, with the same safety profiles, said Awsare, who works with Kaiser Permanente's pharmacy partners on biosimilars.
Insurance Often Drives the Conversation
The global anti-inflammatory biologics market is anticipated to reach $150 billion by 2027, according to a recent CVS report. As of March 2023, the US Food and Drug Administration (FDA) had approved 40 biosimilars to 11 different reference products. There are 28 on the US market and 100 more in development. Projected to save more than $180 billion over the next 5 years, they are anticipated to expand choice and drive competition.
Rheumatologists, dermatologists, and gastroenterologists are frequent prescribers, although their choices for immune-mediated inflammatory diseases are limited to tumor necrosis factor inhibitors (infliximab [Remicade] originator and adalimumab [Humira] originator) and anti-CD20 agents, such as rituximab (Rituxan) originator.
Benefit design or formulary usually dictates what medicine a patient receives. "Because of significantly higher out-of-pocket cost or formulary positioning, patients may end up with a generic or a biosimilar instead of a brand-name medicine or branded biologic," said Robert Popovian, PharmD, MS, chief science policy officer of the Global Healthy Living Foundation.
Insurers rarely offer both Remicade and biosimilar infliximab, allowing the doctor to choose, said Miguel Regueiro, MD, chair of Cleveland Clinic's Digestive Disease & Surgery Institute, who prescribes infliximab biosimilars. Most often, the payer will choose the lower-cost biosimilar. "I am fine with the biosimilar, either as a new start or a switch from the reference product," Regueiro said.
However, the patient might feel differently. They can form an attachment to the reference medication if it has prevented severe illness. "They do not want to change, as they feel they are going on a 'new' medication that will not work as well," Regueiro said.
This is where the education comes in: to reassure patients that a biosimilar will work just as well as the reference product. "For patients who have done well for years on a biologic, more time needs to be spent reassuring them and answering questions," compared with a patient just starting on a biosimilar, he advised.
But not all physicians are quick to prescribe biosimilars.
Especially with psoriasis, which has so many strong options for reference drugs, a switch may be hard to justify, said dermatologist Stephanie K. Fabbro, MD, assistant professor at Northeast Ohio Medical University in Rootstown. "If I have a preference, I would rather switch a patient to a drug from a different class without a biosimilar option to reduce the possibility of pushback."
Fabbro, part of the core faculty in the Riverside Methodist Hospital Dermatology Residency Program in Columbus, will share data from clinical trials and postmarket surveillance with patients to support her decision.
Conversations About Cost
Patients may also push back if they don't save money when switching to a biosimilar. "This dilemma raises the question of who is profiting when a biosimilar is dispensed," Popovian said. Insurers and pharmacy benefit managers (PBMs) that take additional concessions from biopharmaceutical manufacturers in the form of rebates and fees will often pocket this money as profit instead of passing savings back to the patient to help reduce their out-of-pocket requirement, he added.
If an originator biologic and a biosimilar are available, "as a pharmacist, I will choose the medicine that will incur the lowest out-of-pocket cost for the patient," Popovian said.
Discussing cost — and who dictates which biosimilar is on the formulary — is an important conversation to have with patients, said Vivek Kaul, MD, Segal-Watson Professor of Medicine at the University of Rochester Medical Center in Rochester, New York.
Providing equivalent clinical efficacy while saving costs is the economic reality of biosimilars, Kaul said. Third-party payers regularly evaluate how to provide the same quality of care while saving money. Physicians and patients alike "must be mindful that as time goes on, if the science on biosimilars stays robust, if the adoption is more widespread and the cost-saving proposition turns out to be true, more formularies will be attracted to replacing the reference product with the biosimilar counterpart," he said.
Providers and patients can weigh the options if a formulary suddenly switches to a biosimilar, Kaul continued. "You can accept the novel product on the formulary or may have to face out-of-pocket expenses as a patient." If providers and patients have concerns about the biosimilar, they can always appeal if there's solid scientific evidence that supports reverting back to the reference product, Kaul said.
"If you think the biosimilar is equally efficacious, comes at a lower cost, and is right for the patient, then the providers should tell the patient that," he added.
Some studies have questioned whether the biosimilars will save money compared with the reference drug, Fabbro noted. Medicare, for example, may pay only for a certain percentage of an approved biosimilar, saddling the patient with a monthly copay costing thousands of dollars. "It is unclear whether biosimilar manufacturers will have the same level of patient support programs as the reference drug companies," she said.
For that reason, physicians should also inform patients about the robust patient assistance and copay assistance programs many reference drug manufacturers offer, she said.
Biosimilars 101: Familiarizing Patients
Safety and ease of use are other common concerns about biosimilars. Patients may ask if the application is different, or why it's advantageous to switch to a biosimilar, Awsare said.
Sometimes the syringe or injector for a biosimilar might look different from that of the originator drug, he said.
Anecdotally, Fabbro has heard stories of patients having injection reactions that they did not experience with the reference drug or having a disease flare-up after starting a biosimilar.
As is the case with reference products, in their conversations with patients, clinicians should address the adverse event profile of biosimilars, offering data points from published studies and clinical guidelines that support the use of these products. "There should be an emphasis on patient education around efficacy and any side effects, and how the profile of the reference product compares with a proposed biosimilar," Kaul suggested.
When Snow discusses biosimilars and generics, "I make sure to share this in an understandable way based on the patient's scientific background, or lack thereof," he said. If there is enough time, he also discusses how European-sourced and US-sourced biologics are slightly different.
Pharmacists should tell patients to expect the same clinical outcomes from a biosimilar, Popovian said. However, if they have any reduction in efficacy or potential safety concerns, they should communicate with their physician or pharmacist immediately.
In Regueiro's practice, a pharmacist specializing in inflammatory bowel disease often has a one-on-one meeting with patients to educate and answer questions. "Additionally, we provide them the Crohn's and Colitis Foundation web link on biosimilars," said Regueiro.
A Village Approach to Education
When biosimilars first came out, there were no formal education materials, Awsare said. Kaiser Permanente decided to create its own educational materials, not just for patients but also to help educate its primary care doctors; the rheumatologists, dermatologists, and gastroenterologists using the biosimilars; the nurses infusing patients; and the pharmacists preparing the biosimilars.
The health system also has a different approach to choosing medication. Instead of having an insurance company or PBM decide what's in the formulary, clinicians work with the pharmacists at Kaiser to look at clinical evidence and decide which biosimilar to use. Most of its plans also provide lower copays to patients when they use the biosimilar.
This was the approach for Humira biosimilars, Awsare said. Eight will be on the market this year. "Our rheumatologists, dermatologists, and gastroenterologists looked at the data from Europe, looked at some real-world evidence, and then said, 'We think this one's going to be the best one for our patients.'"
Having clinicians choose the biosimilar instead of a health plan makes it a lot easier to have conversations with patients, he said. "Once we've moved that market share to that particular biosimilar, we give our physicians the time to have those discussions."
Clinical pharmacists also provide educational support, offering guidance on issues such as side effects, as patients transition to the biosimilar. "We like to use the word 'transition' because it's essentially the same biologic. So, you're not actually switching," Awsare said.
No Consensus on Interchangeability
Whether the conversation on interchangeability will affect patient conversations with physicians depends on who you ask.
If a biosimilar has an interchangeability designation, it means that the pharmacist can substitute it without the intervention of the clinician who prescribed the reference product. It does not relate to the quality, safety, or effectiveness of biosimilars or interchangeable biosimilar products, Popovian said.
The United States is the only country that has this designation. Even though it's not identical to the originator drug, a biosimilar has the same clinical efficacy and safety profile. "So clinically, interchangeability is meaningless," Awsare said.
In its report on biosimilars in the autoimmune category, CVS acknowledged that interchangeability was important but would not be a significant factor in driving adoption of biosimilars. However, in a Cardinal Health survey of 72 gastroenterologists, 38% cited the interchangeability of biosimilars as a top concern for adalimumab biosimilars, along with transitioning patients from Humira to a biosimilar (44%).
"Patient education regarding biosimilar safety, efficacy, and interchangeability appears paramount to the acceptance of these products, particularly for patients who are switched from a reference product," Kaul noted in the Cardinal Health report.
Wherever supported by data, Kaul recommends incorporating biosimilar use and interchangeability into best practice guidelines going forward. "That will go a long way in disseminating the latest information on this topic and position this paradigm for increased adoption among providers," he said.
Some physicians like Snow aren't that concerned with interchangeability. This hasn't affected conversations with patients, he said. Multiple studies demonstrating the lack of antibody formation with multiple switches from different biosimilar drugs has eased his concern about multiple switches causing problems.
"Initially, there was a gap in demonstrating the long-term effect of multiple switches on antibody production and drug effectiveness. That gap has started to close as more data from Europe's experience with biosimilars becomes available," Snow said.
Resources for Physicians, Patients
The federal government has taken steps to advance biosimilars education and adoption. In 2021, President Biden signed the Advancing Education on Biosimilars Act into law, which directs the FDA to develop or improve continuing education programs that address prescribing of biosimilars and biological products.
The FDA provides educational materials on its website, including a comprehensive curriculum toolkit. The Accreditation Council for Medical Affairs has also created an online 40-hour curriculum for health care professionals called the Board-Certified Biologics and Biosimilars Specialist Program.
Fabbro recommends that patients use the FDA page Biosimilar Basics for Patients to educate themselves on biosimilars. The Global Healthy Living Foundation's podcast, Breaking Down Biosimilars, is another free resource for patients.
"While much has changed, the continued need for multi-stakeholder education, awareness and dedicated research remains even more important as we expand into newer therapeutic areas and classes," wrote the authors of the Cardinal Health report.
Help your patients understand biologics and biosimilars by using AGA resources for providers and patients available at gastro.org/biosimilars.
Regueiro is on advisory boards and consults for AbbVie, Janssen, UCB, Takeda, Pfizer, Bristol-Myers Squibb, Organon, Amgen, Genentech, Gilead, Salix, Prometheus, Lilly, Celgene, TARGET PharmaSolutions, Trellis, and Boehringer Ingelheim. Fabbro is a principal investigator for Castle Biosciences, on the speakers bureau for Valchlor, and on the advisory boards of Janssen and Bristol-Myers Squibb. Popovian, Snow, Awsare, and Kaul had no disclosures.
Jennifer Lubell is a freelance medical writer in the Washington, DC, area.
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Image 1: University of Nebraska Medical Center
Image 2: Kaiser Permanente
Image 3: Robert Popovian, PharmD, MS
Image 4: Miguel Regueiro, MD
Image 5: Jessica Miller Photography
Image 6: University of Rochester Medical Center
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Cite this: Biosimilars and Patients: Discussions Should Address Safety, Cost, and Anxiety About Change - Medscape - Mar 30, 2023.