Access to and Challenges to Biosimilar use in Clinical Practice

EP: 1.What is a Biosimilar?

EP: 2.Comparison of Biosimilar Products and Reference Products

EP: 3.Approval Process for Biosimilars

EP: 4.Immunogenicity of Biosimilars

EP: 5.Cost Savings with Biosimilars and Use in Multiple Sclerosis

EP: 6.Natalizumab Biosimilar in Development in Multiple Sclerosis

EP: 7.Comparison of AFFIRM (Reference Natalizumab) and Antelope (Biosimilar Natalizumab) Trials

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EP: 8.Access to and Challenges to Biosimilar use in Clinical Practice

EP: 9.Implementing Biosimilars in Clinical Practice

EP: 10.Biosimilar Discussion With Patients and Biosimilar Resources

EP: 11.Concluding Thoughts on Biosimilars in Multiple Sclerosis

Amy Perrin Ross, MSN, MSCN, APN, CNRN: I’ll go back to you John, and ask what do we know about getting access to a biosimilar? I mean, we’ve talked a lot about using it, how we’d use it, and when we’d use it, but what about access?

John Kramer, PA-C: Access obviously is always a top-of-mind issue for all of us working in the field of MS [multiple sclerosis]. At our institution, a lot of the access to these biosimilars has really been driven by the payers. There clearly is some economic efficiency not only for the payers, but hopefully that translates down to the patient level as well. So that has been our experience in terms of gaining access to these biosimilars that really in the beginning has been driven strictly by the payers.

Amy Perrin Ross, MSN, MSCN, APN, CNRN: Any thoughts about step therapy or have you had the experiences in your rituximab biosimilars with step therapy?

John Kramer, PA-C: With step therapy. as it relates to patients who are considered for anti-CD20 therapy, there have been several payers that have requested that patients start initially with a rituximab biosimilar first before then potentially move on to another anti-CD20 therapy first, either due to lack of efficacy or safety concerns with the rituximab biosimilar product.

Amy Perrin Ross, MSN, MSCN, APN, CNRN: You know, you bring up a good point because my colleagues in the clinic and I would just sort of scratch our heads because we have a payer who, [in the past], actually told us, no, we can’t use rituximab because it’s not FDA approved. We needed to go to treatment, whatever it was. Although that wasn’t our first choice, we went ahead with it. Now we want to make a change to yet another therapy. Once again, the new therapy was denied and the rationale was because we hadn’t used the rituximab that they had denied 2 years earlier. And so, I think we as clinicians need to be mindful of what’s going on in terms of the payer issues and the payer population, and not just take a no on a prior authorization and move on. Think about where this fits in our practice and in the treatment landscape for our patient population. Pat, let’s think about challenges. What kind of challenges could we face when incorporating biosimilars into practice specifically for MS?

Patricia Melville, MSCN, RN, NP-C, CCRC: I think there are challenges from various areas. I think we as providers and prescribers have our own challenges in becoming familiar with biosimilars. We need to educate ourselves and our peers and our colleagues about biosimilars, about the science of biosimilars, and about the safety and efficacy. We then in turn need to educate our patients…. When patients, using the example that Aliza spoke about earlier, were switching from the brand to the generic form of glatiramer acetate, that created quite a bit of controversy among many patients. Patients were insisting that they wanted to remain on the brand drug as opposed to the generic. I suspect that, as we move into the world of biosimilars, we may have some discussions about that as well.

We also are going to have challenges with insurance companies, payers, and pharmacy benefit managers getting these drugs approved. In preparation for today’s discussion, there were a few editorials that I read about situations where there’s concern that pharmacy benefit managers may actually remove the reference product from their formulary in favor of the biosimilar. This is going to impact our prescribing habits and is going to impact our patients.... Last but not least, I sort of mentioned it in the beginning: hesitancy. Hesitancy on the part of the prescribers, hesitancy on the part of the patients. Is the biosimilar good enough or as good as the reference product? I think we have a long road ahead of us in terms of educating our colleagues, our peers, and our patients.

Amy Perrin Ross, MSN, MSCN, APN, CNRN: …. Pat, you bring up a good point about the possibility of removing a reference product from a formulary in favor of the biosimilar. That takes us back to our earlier discussion today about immunogenicity and where we’re at with that. We have patients who may not have a problem with the actual active ingredients, but there may be something in the inactive ingredients, and we have seen that. For whatever reason in our practice, there’s a local pharmacy that tends to use a generic for one of the birth control medications that our patients use. That specific generic has caused a tremendous number of problems with our patients. So it’s not that we are antigeneric, it’s just the version that is used. If the reference product is pulled as you suggested or as the editorial suggested, what would we be left with in terms of options for patients? Again, I don’t expect there to be a high preponderance of those issues, but that certainly is something that could come up in the way of making these things available for our patient population.

Transcript Edited for Clarity