Biosimilar Nonmedical Switching Must Never Undermine Patient Safety

Gregory Schimizzi, MD, is a co-convener of the Biologics Prescribers Collaborative (BPC) and the cofounder of Carolina Arthritis Associates, PA, in Wilmington, NC.  He has been a licensed and board-certified rheumatologist in private practice for 30 years. He co-founded, and previously served as president, of the Coalition for State Rheumatology Organizations (CSRO). He has also previously served as president, and a member of the executive board, at the North Carolina Rheumatology Association. Dr Schimizzi completed his undergraduate and medical school studies at Wayne State University in Detroit and completed his fellowship training at the University of California at Irvine.
June 29, 2018
The primary goal of medical treatment for any chronic inflammatory illness is to implement the most effective therapy with the widest margin of patient safety and tolerability. Successful treatment may require a patient to visit their physician multiple times over months or even years in order to establish control of a chronic illness like rheumatoid arthritis or inflammatory bowel disease. If effective treatment is interrupted for any reason, the patient may be at risk for disease progression and a decline in function. Once effective treatment is established, it should not be undermined by administrative interference through nonmedical switching.  

Nonmedical switching is a coverage tactic used by insurers to limit prescribing to formulary ‘preferred’ medications. These formulary-driven medication changes—including in the case of a reference biologic medicine and biosimilar—may force patients to be “switched” off a medicine, on which their disease symptoms are well controlled, to a completely different medication within the health plan’s formulary. Pharmacy benefit managers (PBMs), who develop drug formularies for insurers, accomplish this by placing medicines in tiers, with preferred drugs in lower-numbered tiers and nonpreferred drugs in higher-numbered tiers. However, this process lacks transparency and is likely based more upon profitability achieved through contractual arrangements with pharmaceutical companies than on evidence-based safety and efficacy studies or concern for patient out-of-pocket cost savings.

Nonmedical switching due to formulary changes by insurers and PBMs places patients at risk for treatment failures, worsening disease activity, declining physical function, permanent tissue damage, and an increase in complications and medication toxicities. This practice is in essence made mandatory by placing excessive financial burden on patients who wish to stay on their current, nonpreferred, medicine. This is poor medical practice and undermines both the specific treatment decisions made by patients and their physicians and the patient-physician relationship, as well as ignores patient safety concerns.

In order for a biosimilar to achieve an interchangeable product designation by FDA, the manufacturer must demonstrate through additional data that it produces the same clinical result as the reference product in any given patient. There is concern that without an interchangeable designation or medical input from a physician, nonmedical switching at the pharmacy level between biologic medicines could jeopardize patient health and safety. Scientific and clinical data, along with physician and patient decision-making, must be the basis of all medication switching.

A formulary-driven nonmedical switching program for biologics and biosimilars should include mandatory provisions for extensive and vigorous pharmacovigilance processes. Insurers who implement such programs must take responsibility for the related costs of data collection and management, data analysis, and publication of the data in reputable medical journals. The FDA should mandate this type of study whenever insurers mandate switching patients to biologic agents that are not designated as interchangeable.

While managing costs is extremely important to physicians and their patients, achieving and maintaining disease control without increasing the risk of complications or toxicities must remain the primary goal in the treatment of chronic inflammatory diseases. Additionally, patients should not be placed in financial jeopardy for formulary changes when their disease is stable on current therapy.

In the interest of providing the physicians’ perspectives on patient care, the Biologics Prescribers Collaborative (BPC) convened a member roundtable to discuss the impact of nonmedical switching on patients who are prescribed biologic drugs. The roundtable discussion led to the development of a series of principles and guidelines that prioritize patient safety and the protection of the physician-patient relationship. It is BPC’s hope that both physicians and patients alike become educated on the potential and likely impacts of non-medical switching, and that patients remain empowered while navigating the healthcare system.

BPC welcomes your commentary on this important medical issue.  Please direct questions and comments to  



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