Transitioning to a Biosimilar Program

Two experts examine how the biosimilar programs at their organization were created and the initial goals they had in mind.

Ryan Haumschild, PharmD, MS, MBA: Gaining buy-in for biosimilars involves multiple stakeholders. We appreciate the relationship we have with our physician partners and advanced practice practitioners who had to be involved. Our physician medical leadership had to be involved because we value their input, and we like to make decisions through a shared decision-making process. We wanted to bring in their take. What are their observations around biosimilars? Have they been familiar with them through research? Do they understand the concepts? Do they understand the science and the manufacturing process and feel comfortable with the FDA-approval process? Some may be comfortable. Some may be familiar with the idea. Maybe they’re even familiar with some of the data available from Europe. Others might be a little more hesitant. That’s OK if they’re hesitant because that’s an opportunity for us both to look into the data more and answer some of the questions that come up.

As we take on biosimilars, we get stakeholders involved but there’s also a strategy. That strategy involves [asking], what type of patients do you initially start utilizing biosimilars in? Do you utilize it in those patients who are going to start on medication for the first time, or do you consider switching patients midcycle for those who have been stable on the reference product? Many organizations, depending on how aggressive they are or familiar with biosimilars, have taken a different route. We like to start with new-start patients. That’s where the providers felt comfortable. We felt comfortable that we could go ahead and get precertifications for the product and oversee those patients and monitor them. That was helpful because it allowed us to grow comfortable with the data and transition as more biosimilars came to market. We eventually felt comfortable switching patients, not only patients on new starts but switching patients who are stable on the reference product to the biosimilar. That’s a natural transition that works well through that shared decision-making model.

Kathy Oubre, MS: The first thing we did as an organization was to explain the why to everyone. As with many new programs or changes that we make within our organization, we’ve found that the most seamless transitions occur when everyone is involved. We started with the physicians and our nurse practitioners to ensure that they were comfortable with the science, the clinical trials, and the FDA-approval process. Next, we met with the nurses and because nurses spend the most time with our oncology patients in that infusion room. They often form very strong relationships, and the nurses take those relationships very personally.

We spend a lot of time with them talking about the biosimilar education and the science behind it, and we also included that potential cost savings that it would provide for their patients. Often we hear about the financial struggles of our patients, and we hear about it from the nurses. We felt it was important to include that financial piece in our discussion with them. Last, we met with the financial team and the authorization teams so they understand why we would be asking them to redo patients’ treatment plans a week after the original treatment plan had been completed but now a new biosimilar came to market. We used all these meetings as an opportunity to stress the importance of accuracy of authorizing and administering the correct and approved biosimilar or innovator product to the correct patient to help minimize error and risk to practice.

When we were doing those original sets of meetings with the providers, that decision was made then to move everyone as a whole, so everyone that was on current treatment were included in that decision making process. We made those decisions with all our new treatments moving forward.

Ryan Haumschild, PharmD, MS, MBA: The initial goals of implementing biosimilars are that we want to maintain patient safety, provide a clinical efficacious treatment, and provide the best care. That’s our true north for us when we’re making these decisions. When we look at these initial goals, we also wanted to comply with the payer mandates. We wanted to feel comfortable with the clinical data and in using these medications. We’re using biosimilars only because payers are making us. We know payers were forcing a lot of people across the country. We wanted to feel comfortable because we thought it was the right thing to do for patients who could potentially reduce their co-pays and reduce total cost of care, which is important in our health care system as drug prices continue to rise. We wanted to get more data around biosimilars so that we feel comfortable with the outcomes they gave us. As more biosimilars come to market for additional reference products, we had some real-world evidence.

Some of the successes we’ve seen are that we felt comfortable with the data, and we saw good outcomes with our patients. Patients felt comfortable moving to a biosimilar, and they started to understand the topic. One of the challenges was matching up our reimbursement with biosimilars. That’s something that’s always going to be a bit of a challenge. When you’re trying to maximize your margin and make sure you’re doing a good job and staying operationally excellent, sometimes biosimilars can help, but sometimes they can’t. We’re trying to track some of those financial outcomes with something that was a little more challenging at the beginning, especially because it could be payer specific in terms of what was being approved. Another challenge, as we transition with biosimilars, was that specific physicians had concerns around immunogenicity or individual patients didn’t want to be switched off the reference product. We dealt with those in 1-off situations. If the patient felt strongly enough, we try to appeal for the reference product because ultimately we want to do best by the patient and what makes them feel most comfortable.

Over time we’ve been able to get more familiar and feel more confident in utilizing biosimilars across the board, but those were some of the initial challenges we ran into as we wrapped up our program.

Kathy Oubre, MS: As an organization, our goal for biosimilars was to do our part in bringing down drug cost as a nation and an organization and support the biosimilar market because we, as an organization, feel that biosimilars are going to play a very pivotal role in helping drive down health care costs. Most important, our primary goal was to increase access to care for many of our patients by offering a high-quality, less costly alternative to the originator product, which is quality without compromise. The challenges around implementing and maintaining those are keeping track of all the biosimilars on market, how the payer formularies change, and ensuring that our authorization team, financial team, and nursing team are giving approved products to the correct patients. Holistically, this has been a huge win for our organization and our patients. In our first month, we saw a 23% decrease in out-of-pocket costs for our patients, which is a lower cost to a health care system.

This transcript has been edited for clarity.

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