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John Goldman MD

by John Goldman, MD

State legislatures across the country are considering bills to ensure that physicians know when a pharmacist swaps a prescribed biologic medicine for a new “biosimilar.” Both types of medication have value for different patients, but they are extremely complex and sensitive drugs. Physicians need accurate information to direct patient care and to monitor these medications’ effect on patients.

Biologic medicines have had amazing and nearly immediate effects, particularly for my rheumatoid arthritis patients, who struggled with daily life under their condition’s painful symptoms. Prior to biologics, some of my patients’ only viable treatment was gold shots. Patients took these shots weekly, a significant inconvenience. Some saw no improvement. Others responded well, but only after three to five months of treatments.

Biologics offer these patients a chance to regain normalcy. Patients tell me that they have returned to their regular work schedules and day-to-day activities. In this sense, biologic medications are saving costs by preventing surgeries and hospitalizations.

Biosimilar Substitution Infographic

But, yes, these drugs are expensive. If biosimilars can achieve equal results at lower costs, they represent a real victory.

Still, we cannot opt for lower-cost options without factoring in the variations in molecular make-up between biologic medications and their substitutes. Biologics stem from living cell lines, which are inherently responsive to deviations in environment or production. Biosimilars, created from different cell lines, take on slightly altered designs.

For many patients, the response to biosimilars will be just that – similar to their response to the original biologic. These patients may succeed with biosimilars and save themselves and their insurance companies money by making the switch.

Not all patients will, however. Some may experience reduced responsiveness or new side effects, which can be dangerous. Physicians will need to respond to these incidents on an individualized basis.

To respond successfully, I must know which medicine the patient is taking.

Yet some pundits claim that communicating biosimilar swaps to physicians is too complicated, too burdensome. The facts suggest otherwise. In truth, few retail pharmacies dispense biosimilars or other “specialty drugs.” Thus, few will be affected.

Those that are affected probably communicate swaps on some medications, such as anti-epileptics, already. The concept will be a familiar one. In fact, one could argue that the process resembles what physicians encounter when prescribing medications that require prior authorizations – just another communication required in today’s health care environment.

Plus, the notification “process” is hardly even that; due to electronic communications, conveying information about a biosimilar swap can be nearly instantaneous.

Communication can be simple. More to the point, it’s essential. Otherwise, physicians may have patients complaining of unexpected side effects and advise them based on faulty information. And we can all agree that uninformed guidance has no place in responsible health care.

I welcome pharmaceutical innovation and lower-cost alternatives for my patients. Most all physicians do. But to keep patients safe, we must ensure that physicians know which medication their patients take.

John Goldman, MD, is a practicing rheumatologist in Georgia and a member of the Alliance for Patient Access’ National Physicians Biologics Working Group

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