Rheumatoid arthritis has a ribbon. It is purple and blue, the same as a bruise though the most visible sign of the condition is marked by the jagged angles of joints rather than discoloration. As far as disease ribbons come, RA was late to the game, but we could afford to be because we had a therapy on hand with the arrival of TNF-inhibitors (TNFi) in the 1990s.
TNFi may not sound familiar at first, but anyone who has watched a baseball game knows exactly what Humira is. This drug emerged in 2001 and has since become the most widely prescribed pharmaceutical class in the country. In a world begging for panaceas, Humira is as close as we can get. It treats everything from the skin (plaque psoriasis) to bones (rheumatoid arthritis) to the digestive tract (ulcerative colitis and Crohn’s Disease). It is why the biggest news in the pharmaceutical industry in 2023 is the expiration of Abbvie’s exclusive patent of Humira. There are already a handful of generic biosimilar alternatives to the drug approved by the Federal Drug Administration for prescription, with several more pending applications.
The emergence of competition for Humira is no doubt good news for the patients who have to shell out about $7,000 for a month’s supply absent insurance coverage. Humira’s biosimilars are generating savings for these patients. Amgen, for example, can deliver a two-supply of the therapy for between $1,557 and $3,288. As more biosimilars enter the market, one can expect these costs to go down as they compete for market access among the millions of sufferers who suffer from the autoimmune conditions that Humira and other TNFis effectively treat.
The key word is “effectively.” Rheumatoid arthritis is a stubborn condition. TNFis, whether brand name or biosimilar, are only effective in about one-out-of-three cases—great numbers if you are a baseball player or card sharp, but not so much when you are dealing with perpetual misery. Since the emergence of TNFis, patients have been forced to accept those odds because they were the best they could get. It takes months of expensive trial and error to determine whether or not they will respond to this treatment path before seeking alternatives. The arrival of biosimilars may ameliorate the wallet’s pain, but the joint will continue to degenerate.
The nature of patient-doctor conversations has changed in recent years. Instead of warnings about ineffectiveness, we have been able to discuss a blood test called PrismRA, which multiple clinical studies have shown can predict with 90 percent certainty an effective therapy program for those suffering from rheumatoid arthritis. I am not a mathematician or teacher, but in my clinical determination, an A- is better than an F when it comes to testing.
And yet the path to relief remains just where it was thirty years ago. Nearly every insurance company covers TNFis, and many patients ask for it by name after being inundated with all those baseball ads. They will spend thousands each month for this trusted hit-or-miss treatment path, but many insurance companies have yet to cover a simple blood test that can effectively identify when the standard care will miss.
The healthcare market takes its signals from the federal government. This is all well and good when it comes to determining a drug or therapy’s medicinal effectiveness, but it is also true when it comes to the finances. America’s largest health coverage platform is the Centers for Medicaid and Medicare Services (CMMS). The Biden administration has prided itself on expanding the agency’s ability to negotiate lower drug prices, though TNFi’s were exempted from the legislation. Just a month after Biden signed the measure into law, CMMS issued a preliminary ruling that rejected coverage for PrismRA, ignoring all of the clinical trials that demonstrated its effectiveness.
Patients benefit whenever there is competition in the healthcare marketplace, but competition alone is not enough—innovation is the key. And until the federal government embraces the innovation of precision medicine in the autoimmune space, patients will continue to suffer both physically and financially.
