Angus Worthing, MD, FACR, FACP, describes policy changes that are needed in the biosimilars space.
Policy and Biosimilars
Do you think there is a certain policy needed in the biosimilars market that is not currently in place?
I think, first and foremost, we want an interchangeability guidance from the FDA and that’s in progress right now. What that will do is help manufacturers come up with the right clinical trials design to give doctors, patients, and payers, the data that we need to be confident and learn about drugs that the patients can be moved from a reference biologic to a biosimilar confidently, and knowing that it’s going to work and there aren’t going to be any safety problems in switching.
Another important issue is the reform of cost-sharing that Medicare beneficiaries have in the Part D system. So, these are drugs that patients can give themselves at home, often with a subcutaneous shot. Right now, as the regulations are written, patients will be actually paying a higher percentage or a higher amount of money for a biosimilar drug than they will for a reference biologic drug. Unfortunately—and this is only until 2020 but the first few years of this era of biosimilars is critically important—for now the ways the laws are written, patients might be paying more for switching to these follow-on biosimilar drugs. I think that might stifle the system of biosimilars and create a barrier towards uptake.
Next, as I represent the American College of Rheumatology and our members—the rheumatologists across the country—we would like to have the suffix that’s attached on the end of biosimilar names, and it appears to the reference biologic name, we want those to be meaningful and memorable. Right now, as it stands, it’s 4 letters that might be a palindrome or might be interest looking, but they’re not memorable. So now that we have 5 of these drugs in our rheumatology space that are FDA-approved, it’s difficult to remember one from the next. We’d like the FDA to issue a guidance that either expands the number of letters that can be used so that something can be meaningful, or somehow makes it more memorable.
Lastly, we’d like for the reimbursement for biosimilars that are given by providers’ offices or in hospitals to be individualized. Right now, the regulations are written such that any biosimilar in a family that refers to one originator drug—all of those drugs are reimbursed at the same rate, which means that it might be difficult for a provider, group, or hospital to give a patient the best drug for them on an individual basis because one biosimilar might cost more than the other biosimilar in that family. If the reimbursement is all equal or the same, it might be difficult, financially, for that practice or hospital to give the drug that they’d like to give to the patient. So, we’re in favor of breaking down each individual drug to have its own reimbursement code.