Pharmacist Role in Promoting Proper Biosimilar Usage

A growing number of biosimilars are in development and more of the agents are expected to hit the market in the coming months. The biologics carry the promise of significant savings in the cost of treating a variety of diseases, but cost-savings alone aren’t enough to justify adding the medications to health-system formularies, according to Evelyn Hermes-Desantis, PharmD, BCPS, a clinical professor of pharmacy practice and administration at Rutgers University and director of drug information service at Robert Wood Johnson University Hospital in New Brunswick, N.J.

Dr. Hermes-Desantis recently discussed the many factors involved in managing biosimilars in the hospital setting and the role pharmacists play in promoting their appropriate use in the context of safe patient care.

What do pharmacists need to know about biosimilars as more of the agents gain approval and hit the market?

The major thing is that biosimilars can’t be replicated in the same way small molecule generics are, and therefore aren’t exact copies of their biologic reference products. Acetaminophen is acetaminophen is acetaminophen in all of its generic forms, but there are minor differences in the mixture of molecules found in various biosimilars. Clinical studies show that the agents have similar efficacy to their biologic originators, but biosimilars are approved for only very specific indications.

That’s why pharmacists need to be careful about how they’re utilizing clinical data when assessing individual biosimilars. They have to look beyond the headlines when new biosimilars hit the market and drill down to the details of how the drugs work and for which indications they’re approved. They have to be very careful to never assume that a biosimilar that’s approved for one indication is useful for all indications.

What must pharmacists consider when adding biosimilars to health-system formularies?

That depends on the level of formulary support in place at individual institutions, but in general, assessing biosimilars requires more due diligence than what’s needed when adding other types of medications. For example, here at Rutgers, all of the agents in our formulary receive a similar level of scrutiny. But when new generics are being added, we aren’t as concerned with assessing the clinical data as we are when biosimilars are up for consideration.

We essentially view multiple biosimilars for the same reference product as separate drugs, not identical reproductions, and never apply a blanket approval of agents that are said to treat the same indications. We have to be careful to review existing clinical trials for individual biosimilars to truly practice evidence-based medicine.

What else, beyond the clinical data, should pharmacists examine when assessing how biosimilars will work in practice?

From a management standpoint, the cost-saving potential of biosimilars is always going to be a benefit and health systems are always looking for ways to save money, so there will be constant pressure to add the agents to formularies.

Cost-savings aside, pharmacists need to assess if the drugs provide added efficacy without increasing risk to patients. Understanding the practical considerations of adding biosimilars—how the drugs are administered and how much they cost—is part of full evaluations typically conducted by formulary committees. Pharmacists have to look beyond the cost per vial and consider how the cost per therapy impacts overall patient care and hospital management.

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For example, a drug that takes 2 hours to infuse probably won’t make a big difference on the inpatient side, but it would make a significant impact in outpatient clinics, where chair turnover times are an important factor. Pharmacists can’t focus solely on the pharmacotherapy of biosimilars. They must also assess all aspects of pharmaceutical care when deciding to add biosimilars to hospital formularies.

It’s been reported that physicians aren’t as knowledgeable about biosimilars as they should be. Can pharmacists help to fill that knowledge gap?

I think they can. Prescribers often don’t want to try new and different medications because they’re comfortable with the agents they’re currently using and know that they work. Some physicians also believe there’s are no differences between biosimilars and generics, which isn’t true. Pharmacists are responsible for educating prescribers about the clinical efficacy of biosimilars and recognizing unique opportunities for using the new agents in clinical practice. They must be able to recommend biosimilars for proven indications or alert prescribers when no good literature exists to support their use.

Are you excited or wary about the continued development of biosimilars and the potential they bring to patient care?

Both! I’m excited to be able to offer patients cost-effective agents. That’s a wonderful way to advance patient care. I’m also excited by the opportunity to learn about the nuances involved in managing biosimilars. My area of expertise is evaluating clinical data and applying it to raise issues that clinicians and pharmacists might not consider.

Physicians often don’t know the cost of the drugs they prescribe and pharmacists aren’t always aware of the factors that impact how drugs are administered. It’s also exciting that the continued development of biosimilars will expand the role of the pharmacist as medication information specialists.

On the other hand, I’m wary that health systems will decide to add biosimilars based on potential cost savings alone when there’s no good evidence to support their use for particular indications. I’m also concerned that providers will assume they can be prescribed in the same manner as generics. Pharmacists need to take the lead in ensuring the agents are used appropriately and safely.

—Dan Cook

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