A survey of US physicians who prescribe biologics to their patients revealed that 92% were confident in the safety and efficacy of biosimilars, 89% would prescribe a biosimilar to a new patient, and 80% were comfortable initiating the switching of patients who are stable on their current biologic medication to a biosimilar. However, the majority of respondents indicated that they were not comfortable with third-party substitution for nonmedical reasons, and felt that they, along with their patients, should have control over treatment choice. Results of this survey were discussed by Ralph McKibbin, MD, FACP, FACG, AGAF, Chairman of the Alliance for Safe Biologic Medicines, in a poster presentation during the Drug Information Association 2022 Global Annual Meeting.
The web-based survey, which was initiated in 2021, included 401 US physicians from 12 specialties in which biologics are routinely prescribed (eg, dermatology, gastroenterology, nephrology, neurology, oncology, rheumatology). The results provided a snapshot of the attitudes of these providers regarding the following topics:
- Confidence in the safety and efficacy of biosimilars
- Willingness to prescribe biosimilars to a new (bio-naïve) patient
- Comfort level with physician-instituted nonmedical switching
- Comfort level with third-party–initiated nonmedical switching
- Importance of treatment decision authority
- Importance of payer reimbursement of multiple products in a given drug class
- Importance of reimbursement coverage decisions, including factors other than price
- Perspectives on various biosimilar substitution and access scenarios
- Implications of FDA biologic naming conventions
- Implications of an FDA designation of “interchangeable.”
The survey is part of a series of physician surveys covering 13 countries and dating back to 2011. These surveys may be accessed at www.safebiologics.org/surveys.
Background
Biologics are very complex and effective drugs used in the treatment of numerous conditions, including cancer, rheumatoid arthritis, psoriasis, ulcerative colitis, and Crohn’s disease. However, the high cost of these therapies can create access issues for patients. Biosimilars are highly similar, but not identical, to the originator biologics on which they are based, and can offer more cost-effective treatment options. For this reason, payers are incentivized to change coverage policies to switch patients to these lower cost products. Although biosimilars are considered safe and effective, treatment strategies must often be developed over a period of time, requiring patients to try multiple drugs before finding the best one to stabilize their condition. Therefore, physicians and patients have expressed concerns regarding the unnecessary switching between products for nonmedical reasons such as cost or coverage policies, especially when a current treatment is working.
To address these concerns, the FDA created a designation of “interchangeability” to a biosimilar that has demonstrated that a patient can repeatedly be switched between it and its reference product and expect the same safety and efficacy outcomes as a patient who was not switched. Because a biosimilar cannot carry the same proprietary brand name as its reference product, the FDA also published guidance stating that biosimilars must include an FDA-designated suffix, consisting of 4 lowercase letters that are devoid of meaning. This was done to avoid the inadvertent substitution of products, improve pharmacovigilance for biosimilars (eg, accurate tracking of adverse events), and promote better manufacturer accountability.
Survey Results
Despite expressing a high level of confidence when it comes to switching to or prescribing a biosimilar, 58% of survey respondents said they were uncomfortable with third-party substitution for nonmedical reasons related to cost or coverage. In addition, 69% of respondents said it was “very important or critical” that patients and physicians collaborate on the decision to choose the most suitable biosimilar and 67% said that it was “very important or critical” that they were able to prevent a substitution they considered inappropriate.
Results of the survey also showed that the majority (71%) of physicians felt that payers should reimburse several biologics in a specific class, including the reference drug with its biosimilars, and 74% felt that private and public payers should base their decisions regarding biosimilars coverage on factors other than cost.
When asked about preferred biosimilar access, 81% said that their patients could be best served under the type of scenario used throughout most of Western Europe, in which biosimilars and reference products are both reimbursed and biosimilars may be encouraged for new patients, but automatic or pharmacy-level substitution is not allowed. Only 8% supported an access scenario used in several Canadian provinces, in which only a preferred, government-selected product is reimbursed and to which both new and stable patients must be switched. Eleven percent said that they are unsure.
Regarding the biosimilar naming system implemented by the FDA, 73% of respondents believed that this policy, which requires that biosimilars be differentiated from their reference product and other biosimilars, does not suggest or imply inferiority. However, 13% believed that it does, and 15% expressed uncertainty.
The “interchangeable” designation made 59% of survey respondents feel more comfortable with a pharmacy-initiated substitution of the interchangeable product for the reference product. Dr McKibbin and colleagues asserted that this designation may be helpful in addressing any lingering concerns that providers may have regarding these therapies.