Medicare will now cover a molecular diagnostic test to predict treatment response for certain patients with rheumatoid arthritis (RA).
The blood test, PrismRA, is the first and only commercially available test that can help predict which patients with RA are unlikely to respond to tumor necrosis factor inhibitor (TNFi) therapy, according to the test manufacturer, Scipher Medicine.
“Precision medicine will now be accessible to many patients suffering from RA, a potentially debilitating disease if not treated with the right therapy,” Alif Saleh, the company’s chief executive officer, said in a press release on September 7. “This coverage decision not only represents a significant benefit for patients today but also ushers in a new era of precision medicine in autoimmune diseases.”
PrismRA was first made available in December 2021 for commercial billing. The test costs about $5,000, but most patients with insurance coverage pay less than $75 out-of-pocket after insurance, according to Scipher.
On September 1, 2022, the Medicare administrative contractor Palmetto GBA published a draft recommendation that the test should not be covered by the national health insurance program, stating that biomarker tests “have not yet demonstrated definitive value above the combination of available clinical, laboratory, and demographic data.”
During the comment period, clinicians urged the contractor to reconsider.
“I do not have a test or clinical assessment to inform me of the right biologic for my patients. I utilize the PrismRA test to inform me which biologic is the best start. Without this valuable tool, I am left with prescribing based on what is dictated by the patient’s insurance,” wrote one commenter.
These responses and additional data published during the comment period resulted in Palmetto GBA revising their decision.
“We agree that despite the many limitations of predictive biomarker tests, a review of the evidence supports their limited use given their demonstrated validity and utility,” the company wrote in response. “Specifically, when a nonresponse (NR) signature is obtained by the molecular signature response classifier (MSRC), nearly 90% of those patients will prove to not clinically respond to TNFi therapies using multiple validated disease response criteria including the ACR50 and CDAI. For these patients, a change in management would ultimately serve to avoid time on an unnecessary therapy and shorten the time to an appropriate therapy.”
The local coverage determination (LCD) provides Medicare coverage nationally for patients who have a confirmed diagnosis of moderate to severely active RA, have failed first-line therapy for RA treatment, and have not started biologic or targeted synthetic therapy for RA or who are being considered for an alternative class of targeted therapy due to failure of an initially targeted therapy despite adequate dosing.
The LCD becomes effective for tests performed on or after October 15, 2023.
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Publish date : 2023-09-07 17:25:20
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