A Biosimilar Win
Good news here, too. On May 10, the FDA finalized the approval pathway for interchangeable biosimilars in a way that balances biosimilar uptake and patient safety and provider confidence. The plan was endorsed by the ACR. As you may know, Congress created two FDA approval pathways for biosimilars: the biosimilar pathway, which has produced some currently available drugs, and the interchangeability pathway, to designate which biosimilars could be substituted by a pharmacist for a bio-originator or name brand biologic prescription. The FDA wisely decided that in order to be interchangeable, a drug will need to be proved to work in patients who switch back and forth three times between the bio-originator and biosimilar. This plan for three-switch studies should maximize the chance that pharmacists will only be able to substitute safe, effective drugs for our biologic prescriptions in the future.
In my personal view, biosimilars are the most medically acceptable and politically feasible way to lower drug prices and improve access to biologics for rheumatology patients in the U.S. Many of my patients are doing well on a biosimilar that is 20–30% less expensive than the originator drug. But if our patients don’t have access to safe, effective biosimilars—because of problems with regulations or the marketplace—the promises of lower costs and improved access will be foiled. The FDA has done its part to require rigorous clinical studies of interchangeable biosimilars to set the stage for substitution. Read more about biosimilars in the ACR’s open access white paper.
Pharmacy benefit managers (PBMs) still control our prescriptions using a scheme of kickbacks and opaque anti-competitive practices. But the ACR’s advocacy efforts at ATAP, together with CSRO, AWIR and other provider and patient groups have educated Congress about how PBMs incentivize price hikes through step therapy by preferring the drug with the most lucrative rebate package. And Congress is listening: House and Senate hearings have exposed how manufacturers and PBMs are both at fault for the high cost of drugs, and legislation to bring transparency and needed reforms is on the way.
Medicare reimbursement continues to threaten viability of rheumatology practices, with potential cuts through MACRA penalties, as well as recent Trump administration proposals to cut reimbursement for seeing patients (E/M codes)—the core of rheumatologists’ work—and to cut ultrasound diagnostic exams, which offer more information using less expensive and more patient-friendly technology. As your volunteer Government Affairs Committee chair, I became the starting gun on NPR and in The New York Timesfor the campaign against the E/M cuts last summer, and the campaign is working. In November, Medicare announced it would not go forward with the cuts as proposed, and last month a Medicare official told me that it favors an AMA plan to increase (not decrease) E/M reimbursements. Our arguments against cutting ultrasound reimbursement have also been warmly received in meetings at Medicare.