US and EU Biosimilar Pricing and Stakeholder Education

Cornelius F. Waller, MD: The pricing of biosimilars is an important issue. Everybody, of course, hopes that costs can be saved by using biosimilars. On the other hand, to consider that, the production process of a biosimilar should be equal to the reference product. What has been seen over the past is that if the price reduction is in a low percentage, the likelihood of changing to or using a biosimilar is not as high as if you have a bigger price difference. This has been seen for antibodies in rheumatology, and I’ve heard that with trastuzumab, which is going to be marketed sometime this year, there might be a difference of 30%, for example, to the reference product. If price is an issue in the health care system, and if the trastuzumab biosimilar is, pricewise, cheaper than the reference product, it might actually enter the market more easily than if you had a small margin. However, I think you have to take into consideration that there are different systems in different countries.

Rebates are being made for using the reference product. I think this whole decision-making process needs to be understood to actually value the chances for cost reduction by using biosimilars. If there is a price difference between Europe and the United States, for example, from 30% to 15% by using biosimilars, the likelihood of using biosimilars might be higher in Europe than in the United States. However, the reimbursement of drug costs needs to be taken into consideration because this is different between countries. It may even be different between states and health insurers. Therefore, to have a complete picture, you have to have this information.

Hope S. Rugo, MD: The United States has a funny market in this because insurers pay for biologics and pay for patients to receive biologics for years and years based on the studies that we have. People may have private insurance and other insurance that allows for that process. In other countries, insurance may be owned by a government. The government sets forth guidelines, and you can only get the drug through those means, unless you have other means of paying for it.

In Europe, there’s more chance for cost savings because people are going to contract broadly and push to get a bigger cost decrease. In the United States, insurers don’t contract directly with the companies in order to get the drugs, and there aren’t those same kinds of restrictions based on the cost of the government paying for your health care. So, we have a different situation.

The cost savings have been estimated to be about 15% to 30%, overall. My guess is that, just like many drugs that are marketed for much higher prices in the United States versus other countries, the same will be true of the biosimilars. The cost will be lower than the reference product, but it will still be more than we would like it to be. It’s not going to be rock bottom because insurers will still cover it. There will still be a discount.

Then it depends on people making deals. The reference biologic stakeholders may say “Only buy our product and we’ll give you this amount of discount.” The biosimilar stakeholders might say something very similar.

Cornelius F. Waller, MD: In Europe, there are countries like Germany or Great Britain where you have a high-impact of use of biosimilars. In Great Britain, this is partly driven by the advice of [the National Institute for Health and Care Excellence, NICE] as an institution—it’s involvement in drug costs and use. There are other countries with much less market share, also in Europe. In other regions, like in South America, biosimilars have been taken up quickly because originator products like trastuzumab, for example, are not available. I think the use of biosimilars, at reasonable costs, will catch up in the market.

In Germany, insurance companies are not the ones that decide whether to use a biosimilar or reference product. If there is an indication—a patient has a certain disease and the drug is approved—it’s up to the physicians, together with pharmacists, to decide which drug to use. Furthermore, in Germany, on the national and regional levels, there are certain institutions that play a part in the decision-making process, whether or not to use a biosimilar. I think the high rates of the use of a filgrastim biosimilar in Germany is partly due to the fact that these institutions are a part of the process.

Hope S. Rugo, MD: I don’t think that the difference in the cost of the drug will change the copay. For some people, certainly those with Medicare plans where you’re paying for some parts of the drug, or whatever it is, if the drug is less expensive, the patient will pay less. If they have a lifetime cap, they’ll have less money. There are a lot of important points.

Cornelius F. Waller, MD: The issue of copays, to my knowledge, doesn’t play a role in Germany because insurance pays if the drug is indicated. If you are outside an indication for a drug, you have to ask whether cost reimbursement is being granted. If not, the patient has to pay for it on his or her own. The likelihood is low, but this does happen. I think it’s different in the United States.

My experience, over the past 10-plus years, is that many people don’t really have an idea of what we are talking about when we talk about biosimilars. I think a major issue is educating prescribers, but also nurses, on what it means to produce a biosimilar. They need to understand the approval process and what types of studies are needed to address issues related to treatment. Few patients are being treated with a biosimilar and still this drug has been approved. Prescribers need to understand how it came to approval.

Also very important to prescribers, in my opinion, is this postmarketing strategy for biosimilars. You have these pharmacovigilance and safety plans. After the drug is on the market, they need to recognize how to react when a patient has an adverse event to a biosimilar or the reference product. It should be as easy as possible to track what kind of drug this patient has received.