“It was difficult to come up with the exact number … [but] the groups that are generally under that size would have a lot less buying power and a lot less ability to get the drug under the average sales price in this country than groups that are bigger than that,” Dr. Worthing says.
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The ACR is also pushing for exemptions based on biologics themselves. The society is pushing to exempt drugs/biologics that have no alternative with a more than 20% ASP differential and where there are less three of fewer members of the drug/biologic class.
“The biologics that we’ve got in rheumatology are all similarly very expensive, and so the way that demonstration proposes to save money is to stop incentivizing doctors to prescribe more expensive drugs,” Dr. Worthing says. “The reality for us is that we don’t have less expensive drugs.”
The Part B proposal not only covers established biologics, but will also have jurisdiction over infliximab-dyyb, the first biosimilar approved to treat RA (in combination with methotrexate), ankylosing spondylitis and psoriatic arthritis.
But biosimilars have not been the price savior rheumatologists have hoped for. Dr. Worthing says biosimilars are not expected to reduce price more than “maybe 30 to 40%. In addition to that, biologic prices seem to have risen about 30% this year. So even if biosimilars were a 30–40% discount to biologics that would just have drug pricing even with a year ago.
“While we hope for improved access because of lower price,” he says, “the price went up right before it went down and so we’re back to square one.”
Dr. Worthing’s big fear with the nascent state of biosimilars and the proposed Part B rule is that anything that limits access to “revolutionary” treatments is doing a disservice to rheumatologists and, more importantly, their patients.
“It’s one of the most difficult moments in practicing medicine … to get to a place where we’ve diagnosed a condition in a patient, we’ve figured out the right treatment for them and we’re lucky enough to have access to these revolutionary treatments but then suddenly realize that the person can’t get access to the treatment because of a systematic problem,” he says. “It’s really just heartbreaking.”
Richard Quinn is a freelance writer in New Jersey.