A Medicare & Biosimilars “WIN”

Dr. Angus Worthing
Angus Worthing, MD

Greetings from Washington, DC where I, as chairman of the American College of Rheumatology’s Government Affairs Committee, had the honor to organize rheumatologists from around the country holding more than 100 meetings on Capitol Hill on Thursday supporting reforms to step therapy (“fail first”) and prior authorization, increased screening for osteoporosis, solutions to the rheumatology workforce shortage, and rheumatology-specific research at the Pentagon. We’re already hearing great news about our successes: hours after our visit, Reps Schakowski and Burgess introduced a bill to repay med school loans for pediatric rheumatologists (and other specialists), to help solve a critical need for kids with arthritis. Also, we generated interest in the Senate to introduce a companion bill to the House’s Safe Step Act to allow patients to be exempted from step therapy in cases where their doctor can predict that the insurance company’s “preferred” drug will be ineffective, cause side effects, reduce adherence, or other commonsense reasons. 

Please keep the momentum going by taking 1 minute right now to send a pre-written email to Congress at the ACR website (for rheumatologists and rheum professionals) or at Simple Tasks (for patients and families). Your emails will help convince your elected leaders that our initiatives matter! And follow the fun at #Act4Arthritis.

A Medicare “win”

On Thursday, the American College of Rheumatology (ACR) logged another victory for patients who receive in-office medications through Medicare. You may remember that the ACR strenuously objected last August to the Trump administration’s announcement allowing Medicare Advantage plans to force our patients through step therapy before getting in-office infusion or injection medicines. This week, although the plan unfortunately remains in effect, Medicare heeded ACR’s request to protect patients currently receiving therapies (“grandfathering/grandmothering”) from going through step therapy. Instead of looking back only 108 days to check if patients are currently taking a medicine, plans must look back 365 days, where they will find many of our patients being treated at less-frequent intervals.

A Biosimilars “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 and was endorsed by the ACR. As you may know, Congress created 2 FDA approval pathways for biosimilars, which are akin to “generic” versions of biologic drugs: the “biosimilar” pathway — which has produced the two currently available drugs, Inflectra and Reflexis, and the “interchangeability” pathway — which would designate which biosimilars could be substituted by a pharmacist for a bio-originator or “name brand biologic” prescription. FDA wisely decided that in order to be interchangeable, a drug will need to be proven to work in patients who switch back and forth 3 times between the bio-originator and biosimilar. This plan for 3-switch studies should maximize the chance that pharmacists will only be able to substitute safe, effective drugs for 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 US. Many of my patients are doing well on biosimilar infliximab, which is more than 30% less expensive than Remicade was. But if our patients don’t have access to safe, effective biosimilars — because of problems with regulations or the marketplace — the promise 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. You can read more about biosimilars in the ACR’s open access white paper here.

Ongoing Challenges

Pharmacy benefits managers (“PBMs”) still control our prescriptions using a scheme of kickbacks and opaque anti-competitive practices through step therapy and prior authorization. But ACR’s advocacy efforts at ATAP, together with other provider and patient groups, has 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 unfortunately continues to threaten the viability of rheumatology practices, particularly small and rural practices, with potential cuts through penalties, and also recent Trump administration proposals to cut reimbursement for seeing patients (so-called “evaluation and management” or E/M codes) — the core of rheumatologists’ work — and to cut ultrasound diagnostic exams which offer more information than MRI using less expensive and more patient-friendly technology. As the volunteer Government Affairs chair, I became the “starting gun” on NPR and in the NY Times for the campaign against the E/M cuts last summer, and the campaign is working. In November, Medicare announced they would not go forward with the cuts as proposed, and last month a Medicare official told me that they plan to increase (not decrease) E/M reimbursements. Our arguments against cutting ultrasound have also been warmly received in meetings at Medicare. Stay tuned for this summer’s Medicare Physician Fee Schedule announcement; if these cuts aren’t reversed, I’ll tell you about your opportunity to raise your voice at regulations.gov.

As I wrap up, a reminder to stay up-to-date and join the conversation to raise your voice by following me on Twitter here. Even though I don’t have my own member of Congress yet (since I live in DC), I love giving you brief, actionable tweets about what you can do to exercise your first amendment rights for the rheumatology community!

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