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Formulary Approval and Challenges for Payers


Hope S. Rugo, MD: Will a health plan approve a biosimilar or not? If there are 5 trastuzumab biosimilars approved in the United States, or 3 filgrastims, how do you decide? My guess is that health plans will just contract with different companies. Or they’ll say, “You can use any biosimilar.” It won’t really matter because they’re all going to be about the same price point lower. So I don’t know that there will be a key factor, other than approval by a regulatory agency and a price difference.

Cornelius F. Waller, MD: In the hospital, we have a commission for the use of pharmacologic agents. It is led by a physician, and his deputy is the hospital pharmacist. To get into a hospital from the outside, as a manufacturer, you have to convince the physician that this drug is good to use. And then gastroenterologists or rheumatologists or oncologists, together with the pharmacist and the physician, can determine the pros and cons of using these drugs. Then it’s decided. Of course, having 3 or 4 different drugs with the same compound is not wanted. And so this has to be decided on. This is how it’s being handled here. I know that in practices outside hospitals, these regulatory agencies, on the national and regional levels, are a part of this decision making because they actually ask for certain amounts of use of biosimilars.

Hope S. Rugo, MD: Whether biosimilars will be a first-line, first-tier biologic or not is an interesting question. If you’ve shown that an agent is similar and that there are no clinically meaningful differences, we can consider that a first-tier biologic. It can be the first one you take off the shelf when you’re treating your patient in early-stage disease. So much care is taken with the production and assessment of these agents that we can be very certain that they’re safe and [very certain] of their clinical endpoints, at least the short-term clinical endpoints.

I think we can feel secure in using these drugs. It’s not like we’re going to save them for the incurable patient, you know? We can feel safe in using these agents with curative intent. I’m speaking primarily about therapeutic agents for cancer, particularly trastuzumab, but many others will be coming down the pike. I think the rheumatologic area is sort of a separate case that we’re not really involved with. We certainly have been embracing the supportive care drugs, and I don’t think any of us have seen any appreciable differences there, as were shown in clinical trials as well.

People are always a bit nervous about it, and it’s going to take a while to percolate in, but with the cost savings and the availability, I think it is an inevitable shift over time, and a very important one in our competitive atmosphere. The cost savings can be translated into spending money on drug development and spending money on giving patients newer drugs that are not yet biosimilars. New immunotherapies are a fortune of cancer therapy at the moment. So by ratcheting down some, by moving on to the biosimilars, we’re really improving things.

Cornelius F. Waller, MD: To get access to biosimilars in Germany, it is important that the physician know about it. If there’s more experience in the use of biosimilars in rheumatology, for example, where they have been used longer than other antibodies in oncology or hematology, I think this information needs to be spread.

Hope S. Rugo, MD: It’s difficult to know what the payer challenges are, but I think some of it is going to be deciding how to contract for these drugs. Are they going to say that you’re obliged to get the biosimilar if there’s a biosimilar available for your insurance plan?

Biosimilars are intravenous drugs, so you have to get approval. As providers, our offices send in approval. “I want to get trastuzumab for my patient.” The insurer could come back and say, “Yes, you can use trastuzumab, but you need to use a biosimilar.” It’s going to be a fascinating thing. Let’s say that my institution contracts with 1 biosimilar. We usually contract to get delivery of specific agents, right? We can’t just give a different one because the company says, “I want you to use Company X’s biosimilar.” Why should they care whether a physician uses Company X’s or Z’s biosimilar? They’re not going to specifically contract with that company. So it’s interesting. With so many people jumping into the biosimilar market, will the insurers simply say, “We will only pay for a biosimilar, but we don’t care whose it is”? Will the cost differentials be big? My guess is no. The whole field will see this big shift and price down, but there are a lot of interesting challenges ahead.

Cornelius F. Waller, MD: Substitution means that the pharmacist can distribute a biosimilar or the reference product no matter what the physician has prescribed. It is important that there is contact between the physician and the pharmacist. If the physician does not want substitution, it’s important that it’s not performed. However, legislation is not yet clear-cut. For example, in the European Union, to my knowledge, it’s a matter of the national institutions rather than of Europe or the [European Medicines Agency, EMA]. In the following years, I think we will see how this is going to happen. Substitution for other drugs outside biologics is something that happens on a regular basis. With biologics, I think it’s a more complex issue. What needs to be assured is that there is knowledge to the physician and the patient as to whether he or she receives what has been prescribed.

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