Part 2: Jim Koeller Discusses the Complexities of Multiple Biosimilars

The Center for Biosimilars® (CfB): Hello, I'm Matthew Gavidia. Today on MJH Life Sciences News Network, The Center for Biosimilars® is pleased to welcome Jim Koeller, who's currently professor of pharmacotherapy and member of the Center for Pharmacoeconomic Studies in the College of Pharmacy at the University of Texas at Austin, where he holds the Eli Lilly/CR Sublett Endowed Fellowship in Pharmacy.

Why is it difficult or impractical to keep multiple brands of intravenous products available in a clinic pharmacy versus an oral medicine?

Koeller: Well, as I said injectables in most institutions now have what we call electronic medical record. In the electronic medical record, we have electronic order sets for all the orders, the actual drug orders. So, every order of drug would have its own order set in the computer, and basically if the patient is ordered to get a drug, you will pull down that order and the drug would be listed. Now, understand, all biologics are their own agents, they all have their own codes, their own NDC [National Drug Code] codes, their own cost, their own reimburse rate, and their own ASP [average sale price].

So, every drug we put in an order for, needs to be coded specifically so that when our billing [department] bills for that product, they're billing for the correct drug with the correct units of drug so that we can get reimbursed for giving that drug. If we were to have multiple drugs of the same kind, we'd have to be able to have separate order sets for all those drugs, because each drug in the case of a biosimilar or biologic would have its own code.

But then if you're getting multiple order sets, we have to be able to identify which order set goes with which patient. Is it this payer? Is that payer? Is it this Medicare or is it that? Who's paying and then how do you do that? How do you do that in a pull down? How do you keep 3 different kinds of the same drug in my pharmacy? We have very limited fridge space.

We have a hard time just keeping enough of a single drug, much less 4 versions of that drug. What happens on a Friday or Saturday when you have part-time people covering staffing, and a person grabs the wrong drug and gives the wrong drug to a patient? That just causes a mess for somebody that will need to clean that up.

So, it's really logistics of trying to make sure patients get the right drug they're supposed to; to have multiple products available where you may have to pick and choose who gets which one and it's done at the time they come in to the clinic to get treated. All of that needs to be done in real time. That just creates a lot of special training hassle and it's fraught with making mistakes. A good example of that would be pegfilgrastim. I mean, right now, Amgen's originator, Neulasta, has what's called an On-Body Injected, an OBI [Neulasta Onpro]. They have a patch that you stick on to give the drug. All the biosimilars only have the subcutaneous injectable form.

So, in most clinics and most hospitals with cancer clinics, they will now have both versions of drugs in their stock. Some patients will still want to give that on-body injector to; but other patients, you'll want to give the biosimilar to. Well now, just because of how the drugs are made, I have to keep those 2 versions in our pharmacy. And that can create [issues] trying to figure out order sets, make sure the right patient gets the right drug, make sure nursing doesn't make a mistake, pharmacy doesn't make a mistake, who's going to write the order, who checks the order, who makes the drug.

So, again, the complexity of giving injectable drugs in an institution is far greater than being able to identify oral therapies and bottles that you can keep multiple versions of. That's a lot easier. That isn't a problem, but it's certainly easier to do than trying to manage multiple injectables.

CfB: What is the process for getting a treating institution to approve the use of a new biosimilar? Why does this add complexity to the process?

Koeller: Well, I've always said one of my rules is biosimilars are not generics. We've had generic drugs available for years, decades. In many cases, pharmacy just switches these out, almost at will, based off a contract and then all of the people know, we've got a new generic of this [drug]. It's done routinely and it's done quickly. For biosimilars, it's not that easy.

Biosimilars, again, just based off the nature, they're new drugs that are highly similar to the originator drug. People aren't used to recombinant DNA technology and they don't know the manufacturing. They do know [some things], but they don't know [everything]. There's still some question about how effective these drugs are. This is a therapeutic drug. [Doctors could say,] "I'm used to giving this drug but you're asking me to give something different."

There's a lot more complexity to the approval process to the data needed to approve a biosimilar. [It had to be] proven that it's has biosimilarity to the originator. This all falls on the P&T [Pharmacy and Therapeutics] committee. No drug comes into a center except through the doorway of a P&T committee.

So, P&T committees, in most cases, are probably doing more work to bring in a biosimilar. They do the scientific review, the financial review, contracting, figure out who gets and who doesn't get what, how many drugs do we have to have. All that work needs to be done by them. Now some centers are ahead of others. Some centers have basically reviewed now that biosimilars is a pharmacy issue. They don't need to go through all this hoopla again. They've kind of figured it out.

So, pharmacy can make the decision, but there's still a lot of education that takes place. If you've got a large institution with several thousand employees, you still have to educate the nurses, the staffing, the physicians on the drug, what's being done, where's it going to be used, where's it not going to be used. Someone has to do that and most of them, usually falls to pharmacy to do the training. So, at least now, because of the newness of these agents, it's certainly been more complicated than bringing other general generics into an institutional practice setting.

CfB: How might this problem unfold as more trastuzumab, pegfilgrastim, and adalimumab products are approved?

Koeller: Actually, it's interesting. If just 1 biosimilar gets approved, then you can compare that biosimilar to the originator. There aren't any other [biosimilars] around so you know what its cost is going to be. So, you can do the financials relatively and you can figure out the training and all of that. And now, all of a sudden, if you have 2 or 3 coming at once [it's more complicated].

For instance, there are 5 commercially available trastuzumab biosimilars on the market and then, we had 3 come in a relatively short period of time. So, anytime you have competing products that are equivalent, you have a scenario that will drive the cost down. Anytime you have more competition, the cost goes down, but it's going down in real time.

So, when the first biosimilar comes out, they want to set up a contract that last year for me to use their drug. But if I know there are 2 or 3 others coming very quickly behind them, I'm going to go, "No, no, no. Timeout. I don't want to contract now. I'm going to see what the others have to offer." So, I can play one against the other and I can try and get the best deal so I can create the best value for the drug I'm going to bring on board.

But that takes into account that the drugs are still going to be comparative, you still have to look at manufacturing, you still have to look at all the issues and why you pick a drug for a company. That again, in many cases now, with multiple providers, it'll put more pressure on them to take their time and maybe not contract initially. Maybe they'll wait until there's more competition and the others come so we can make a better decision between multiple products, and then try and get the best deal we can for their institution.

The other problem with that is [how time consuming all that is. With generics,] once you pick a product you can bounce back and forth between generics and it's usually not a big deal. It is a big deal with biosimilars. For us to put a biosimilar on board can take months of time, changing order sets, doing the training, getting the approval through P&T committees, deciding who's going to get what, who’s not going to get what, what are the payers paying. So, that can take months to get all that done.

Once we get that done, it can cost thousands of dollars for the institution to pay to bring a drug on board. Once we do that, [institutions] don't want to switch out the next month and do this all over again. They would like to keep that drug on board for as long as they can, as long as there's a good deal for it, and as long as they can make the case that it's still good for us to keep it.

So, people talk about just switching back and forth between these biosimilars. I don't see that happening. It's too complicated and difficult to go to bring 1 on board, much less bouncing back and forth. Plus, with biologics and immunogenicity, I'm not sure we want to go bouncing back and forth between drugs too much anyway. So, [institutions] like to pick 1 and be able to stick with that drug in that company for some period of time, if that makes sense.

CfB: What are the potential solutions for these problems? Notably, can you describe how a parity system would work and why this might improve the situation?

Koeller: Well, as I said, the insurance insurers can say, "Yes, we want you to use the biosimilar first." But if they decide they want institutions to pick the biosimilar they want and insurers will cover it, that make that, again, means decisions have to be made on which agent they want to use, which best fits their scenario in their setting. And the institutions should be the ones to pick which agents they use, again, in this injectable scenario.

So, hopefully, if the insurers can allow parity, it'll make life for us a lot easier. And also, it will create less numbers of agents providers have to have. If every major insurer picks its own product and an institution has 3 or 4 major payers, it may be where they are being asked to have 3 or 4 of the same of a drug available. That's not manageable. Having 2 or 3 is hard to do. I would challenge that most institutions probably don't want to have to get into that scenario at all.

So, again, hopefully, if the insurers do want to have institutions use a biosimilar up front instead of the originator, they allow institutions to pick the agent.

CfB: And lastly, are there any thoughts that you want to get across that have not yet been addressed?

Koeller: I guess, just the thought that this is all new to everyone. We're only a couple of years into biosimilars. A lot of these are cancer agents. We're just now getting into therapeutic cancer agents and clinicians are always interested in the drugs that treat the disease versus the supportive care agents. So, I think it's just a tincture of time for everyone to get trained. Education is extremely important. We still have a lot of people to train that don't actually understand the process and don't really know recombinant DNA technology, they don't know protein chemistry, and they don't understand manufacturing. They don't understand what all needs to be done to make a biosimilar. So, there's still a lot of education that needs to take place. Hopefully the industries will be helping us do that and help us, again, provide the information to our workers that we need so they feel good about what they're doing when they're administering these products to the patients they're taking care of.

CfB: To learn more, visit our website at centerforbiosimilars.com. I'm Matthew Gavidia. Thanks for joining us.