Challenges Associated With Biosimilars

EP: 1.Clinical Overview of Inflammatory Diseases

EP: 2.Humanistic and Economic Impact of Inflammatory Diseases

EP: 3.Cost Drivers Contributing to the Economic Impact of Inflammatory Diseases

EP: 4.Biologics Used in Inflammatory Diseases

EP: 5.Barriers to Biologics Access

EP: 6.Savings Potential With Biosimilars

EP: 7.Opportunities Provided By Biosimilars

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EP: 8.Challenges Associated With Biosimilars

EP: 9.Challenges Payers Face With Biosimilars

EP: 10.Existing FDA-Approved Biosimilars

EP: 11.Interchangeability In Biosimilars

EP: 12.Patient and Provider Education on Biosimilars

EP: 13.Cost and Time Benefits of Interchangeable Biosimilars

EP: 14.Challenges of Biosimilars With Interchangeable Designations

EP: 15.Interchangeable Biosimilar Automatic Substitution

EP: 16.Addressing the Increased Amount of Interchangeable Biosimilars in the Market

EP: 17.Future Opportunities With Interchangeable Biosimilars

Ryan Haumschild, PharmD, MS, MBA: And with those great opportunities biosimilars provide, there are also challenges. Dr Kay, I don't want to come to you for just challenges, but I feel like I'd love to hear your perspective of some of the challenges that you've experienced as a provider related to biosimilars and inflammatory conditions.

Jonathan Kay, MD: The biggest challenge is that the patient needs to share in the savings. A patient accepting a biosimilar, which is equivalent in effectiveness and comparable and safety is not giving up anything, they're gaining treatment with effective medication. But to make that change for the sake of saving the payer money, or the pharmacy benefit manager money, and not sharing in those cost savings, really doesn't make sense. So the success of biosimilars is dependent upon including the patient in the economic advantage of the biosimilars. In terms of challenges, a patient who's doing well on reference biologic medication, when faced with the suggestion of changing to a biosimilar, is going to ask why; [they might say] “I'm doing very well on the medication that I'm taking. What's in it for me?” In Europe, in countries where there's a strong social commitment, such as the Netherlands or Scandinavian countries, the individual patient follows the Enlightenment concept of the social contract and is willing to give up a little bit of something themselves for the good of society. So biosimilars have been very successful, especially in the Scandinavian countries, but also in European countries, such as the Netherlands, where there's a strong sense of social responsibility among the population. In the United States, it's a bit more complicated and patient education is critical. In the Netherlands, there was a study done in Nijmegen, where patients switched from reference infliximab to biosimilar infliximab and they found that although there was no change in disease activity over 6 months, 25% of patients discontinued the biosimilar after 6 months for reasons that were mostly subjective. The same groupconducted another study in which they switched patients from reference to etanercept to biosimilar etanercept and this time, they involve the pharmacists and nurses in the clinic to provide the patients with education. This was not a controlled study because patients were only provided with information about biosimilars. But patients who are educated about biosimilars had about an 8% to 10% discontinuation rate at 6 months, which compared to a historical cohort was within 2% of the historical cohort. So, first of all, there was a much lower discontinuation rate, and it was comparable to the discontinuation rate from patients who had previously been treated with reference products. So, education is incredibly important when initiating treatment with a biosimilar. And it's important to educate the patient initiating a reference product, but with a biosimilar to educate the patient that biosimilars have been studied extensively developed very carefully, and shown to be equivalent in efficacy and comparable in safety and immunogenicity with that education. If the other component of sharing in the financial savings benefits the patient, then we can be quite successful in using biosimilars in the United States.

Maia Kayal, MD, MS: I agree with Dr Kay 100%. I think taking the time and spending it on education is imperative because I think especially with the injectable biosimilars, it's difficult for patients to be cruising on the reference product injectable, and then all of a sudden in 1month, get a new package with new packaging, a new form of administration, especially with adalimumab. Adalimumab reference product is citrate-free and patients really enjoy them because it doesn't cause burning or stinging when they inject. But some of the new adalimumab biosimilars might still have citrate, and patients might not be aware. They also may not be comfortable with the packaging. Do they have to pull it up into a syringe? Is it still an easily employed pen? I think taking that time upfront to understand what the patient’s perspective is on switching to a biosimilar, allay their concerns, and then understand even on a deeper level which biosimilar will they be prescribed, what that looks like, how can they use that, is really key to get them to buy into the idea of a biosimilar. And then you're right. The cost savings have to rally onto the patient because otherwise, you worry what's it all for?

Jonathan Kay, MD: There's a big difference between the self-administered biosimilars and the infusible biosimilar. Infliximab is an infusible biosimilar. And the uptake of biosimilar infliximab initially when it was first released in 2017 was very low in the United States largely because it was not on the formulary in most institutions. But as institutions became more aware of biosimilars, and especially with 340B institutions, the savings became quite significant. Institutions started to use biosimilars and found them to be quite successful. For the patient sitting in an infusion chair, unless they read very carefully the writing on the bag, they're not going to notice that they're getting biosimilar infliximab compared to reference infliximab or even which biosimilar. And the experience that we've had is that when the biosimilar has changed to a different biosimilar there's been no increase in adverse effects. As you pointed out, the self-injectable biosimilars come in either a syringe or a pen and the autoinjectors are patented and proprietary to the manufacturer of the reference product. So each biosimilar comes up with its own autoinjector, which is visible to the patient. Some of these might actually be better than the reference product. And the reference product has a 3-step autoinjector, whereas a 2-step autoinjector just involves pushing it down on your skin, and everything else happens, you can't stop it. You just inject and then you hold it there and make sure that the injections have gone in completely for 10 seconds, and then you're done. So there are autoinjectors that are not cylindrical that are shaped with a flat surface on 1 side so they don't roll off the table. There are autoinjectors that have wider grips for patients with arthritis and compromised hand function. So the autoinjector is actually an opportunity for a competitive advantage over a biosimilar since the patient doesn't really feel the economic impact that much. And how do you differentiate yourself? You can't say that [they’re] more effective because a biosimilar cannot be more effective than the reference product. It can be a little bit safer. There's a biosimilar, etanercept, which has 3.7% injection site reactions in clinical trials compared to 17.2% with the reference product. The etanercept biosimilars won't be released in the United States until 2028, but there can be advantages as you pointed out. Reference adalimumab in the low concentration contains citrate and the high concentration does not contain citrate. And the citrate buffer contributes to the burning sensation. Some of the biosimilar adalimumab in the low concentration are citrate free, so that can be an advantage. The needle can be a smaller gauge. It can also be sharper. Some needles, patients reported, [are] somewhat dull and hurt a little bit more when they go in. So, there are plenty of opportunities for competitive advantages of biosimilars. But you also point out that education should be done by the provider, which is very important. When you have a patient with inflammatory bowel disease, comorbidities, compliance with medication, or activity of the disease, all of these things have to be included in a very brief, relatively brief appointment during which you don't have a lot of extra time to counsel the patient adequately about the differences between a biosimilar and a reference product. So the challenge to the provider is, how to educate the patient adequately about biosimilars while still addressing all of their medical needs.

Ryan Haumschild, PharmD, MS, MBA: One thing to build off of that with provider challenges is also many large practices and health systems have their own integrated specialty pharmacies that they can utilize for patient education and coordination through the EMR [electronic medical records]. And one thing that's going to be really interesting is we have more biosimilars. We've already had this, but it's a biosimilar to be managed to the pharmacy benefit, so there's restrictive payer coverage. Only certain pharmacies can dispense. We actually ran a study that was published in the American Society of Health-System Pharmacy of the Emory Specialty Pharmacy [Atlanta, Georgia] that when we dispense internally, same provider, we had 22.5% better adherence when it was filled internally vs a PBM [pharmacy benefit managers]-owned specialty pharmacy. So that's another thing that we're definitely going to have to tug and pull on. How do we work with our payers if we're unable to fill internally as a provider to make sure that we've got good adherence data to have these patients be successful on the product.product?

Jonathan Kay, MD: I couldn't agree with you more. At UMass Memorial Medical Center [Worcester, Massachusetts], we have our own internal specialty pharmacy. And we have pharmacy liaisons that help us with prior authorization and interface with the patients. They follow up with the patient. Pharmacists speak with the patient, address concerns, and enhance compliance. But the problem is that if a patient changes insurance, then they're no longer able to use our internal specialty pharmacy. Unless all pharmacies were created equal, there is a difference among pharmacies, and I would use this platform to advocate, payers, that you'd be more liberal in supporting specialty pharmacies and allowing institutional specialty pharmacies to dispense these medications because so much of the direct involvement of the pharmacy liaison with the patient and with the provider is important in compliance. And compliance with the payer is going to result less in the way of comorbidities and consequences of inadequately treated disease. So, there should be an increase in the number and use of institutional specialty pharmacies. But the problem is that the PBMs typically own their own specialty pharmacies. And the PBM is also on the payers. PBMs are becoming all-powerful and have many different aspects, which makes it difficult for the institutional control of specialty pharmacy distribution of drugs, which is actually optimal for the patient to be widely available.

Transcript edited for clarity.

This activity is supported by an educational grant from Boehringer Ingelheim.