Unbranded Biologics: An Overview - Episode 3

Clinical Impacts of Biologics on Patient Quality of Care

Dr Charles discusses the clinical impacts that nonmedical switching of biologic treatments can have on quality of patient care.

David Charles, MD: When I’m treating patients, they’re occasionally subjected to something called nonmedical switching. What does that mean? When a patient has been started on a therapy and we fortunately find something that works for them and is covered by their plan, they’re happy and their clinician is happy. But sometimes as their care goes on, they’re subjected to nonmedical switching. That means their insurance benefit or pharmacy benefit alerts the patient and the clinician that the therapy they’re on might be available or is no longer available, so the patient has to switch to a different medication. In the case of biologics, maybe it’s a biosimilar.

There was a recent study that showed that patients who were switched from the originator biologic for infliximab to a biosimilar turned out to be 3½ times more likely to switch to another originator biologic than to stay on the newly prescribed biosimilar. There are lots of studies about switching, but here’s my perspective as a clinician on the topic. When a patient or clinician is alerted that the pharmacy benefit has changed and they’re going to have to switch to a different medication, whether it’s a biosimilar or potentially an unbranded biologic, the patient feels like something is being done to them. They didn’t choose this. Their physician didn’t choose this. Their health plan or their pharmacy benefit manager chose this.

When the patient feels as if a third party—that creepy third person in the room—is making a decision about their health care, here’s what happens: stress and anxiety. It can be terribly upsetting to a patient who may have tried 2 or 3 or more things to find something that works, only for them to be told later—once they’ve gone through that journey—that they’re going to be changed again for someone else’s benefit, not for their benefit. That can be enormously stressful to patients.

At the overarching level, when you think about treating patients with biologics, we first have to take a step back. Biologic medications are revolutionizing health care. The options that we have available are amazing compared with 10 years ago, and they’re unbelievable compared with 20 years ago. At the 60,000-foot level, biologics, biosimilars, and unbranded biologics in total are an amazing advance. Having these available, in a selfish way, makes it more fun to be a physician because we have many more options.

On the other hand, how can we make sure that we’re delivering high-quality care and improving the patient’s quality of life? First and foremost, they have to be available to patients. If we have all these amazing treatments but patients have difficulty accessing them, or some patients can access them and others can’t, then that drives serious problems into our health care systems. We have to be able to deliver an improved quality of care to everyone. People who have these conditions need access to these medications. In the end, if clinicians have more options—originator biologics, biosimilars, interchangeable biosimilars, and unbranded biologics all together creating more options—hopefully that means more patients will have access to these therapies, because the overall cost of providing these therapies will hopefully fall over time.

As we go forward, educating patients and clinicians about biologics, biosimilars, interchangeable biosimilars, and unbranded biologics is critical. After 2010, when the Affordable Care Act included a pathway for biosimilars to come along, surveys showed that clinicians didn’t understand what a biosimilar was. They said, “Why isn’t it a generic?” and so forth. If clinicians didn’t understand it, how could we expect patients to understand it? Going forward, the need for education of patients and clinicians is essential. We have to do a better job of that. With improved education, the stress and anxiety that patients feel could be lessened, and the opportunity for clinicians to take advantage of the full array of available options will be increased. It’s an essential component.

Transcript edited for clarity.