Skip to main content
Premium Trial:

Request an Annual Quote

Scipher Medicine to Expand Arthritis Therapy Response Test, Aiming to Maximize Medicare Coverage


NEW YORK – Scipher Medicine, one of the only companies to successfully develop a molecular test for therapy selection in rheumatoid arthritis, passed a major milestone last week with the finalization of a local coverage determination (LCD) by Medicare contractor Palmetto GBA that provides reimbursement for molecular biomarker tests to guide targeted therapy selection in the disease.

In its current form, the company's PrismRA assay uses a gene expression signature to predict which patients are unlikely to respond to tumor necrosis factor-ɑ inhibitors (TNFi). But the firm is already in the process of adding classifiers for JAK inhibitors and T-cell inhibitors that can be combined into a more comprehensive therapy selection test.

Scipher CEO Alif Saleh said this week that the company expects the new LCD to boost adoption of its test in coming months but stressed that the last 18 months have already seen significant uptake of the assay.

"Pre-Medicare, we already had about 20 percent of providers using the test … and we expect that to continue now at a faster clip," he said.

The new LCD mandates coverage for RA therapy selection testing in the Medicare population under certain conditions, including a diagnosis of moderately to severely active RA with a history of failure, contraindication, or intolerance for at least one first-line therapy.

In terms of test performance, the LCD also stipulates that assays must predict response or non-response to at least one class of targeted or biologic therapies for rheumatoid arthritis according to multiple validated response and remission criteria with a higher accuracy than a combination of existing clinical and other data. The test must also demonstrate reproducibility across clinical study cohorts. In the final LCD, PrismRA is the only technology described as having met these criteria thus far, but other assays could gain coverage in the future.

As it has been working to capture market share among rheumatologists, Scipher has also been building its evidence base for the validity and utility of PrismRA. A study published last November in Expert Review of Molecular Diagnostics compared a molecular testing arm to a control arm treated based on normal clinical assessment. The testing arm included 627 individuals, and the control arm recruited about 2,700.

According to the authors, 59 percent of the PrismRA-tested patients had a non-response result, 70 percent of whom received therapy aligned with that finding. In TNFi-treated patients, the test had an 88 percent positive predictive value, with 54 percent sensitivity.

Overall, test-guided treatment selection resulted in significantly superior outcomes relative to standard care with nearly three times more patients reaching remission.

Subsequent presentations at academic meetings have featured additional data from this ongoing real-world evidence cohort, which Scipher calls the Accelerate Information of Molecular Signatures (AIMS) study. One analysis indicated that RA patients' self-reported outcomes matched closely with the official clinical response criteria used in the trial, with responders reporting lower impacts of disease, less pain, and improved physical function.

Investigators also found that patients treated based on PrismRA results experienced less therapy discontinuation and switching than those who were treated with a TNFi despite being predicted to not respond.

Saleh said that the company has also been supporting decision impact studies and research around prescription behaviors. Physicians from a single rheumatology practice in Kentucky published a report this August on their real-world experience using the test in 150 RA patients, assessing the practical reality of payor reimbursement. Of the 150 patients, 65 received a TNFi-non-responder result and 41 were prescribed an alternative biologic or targeted drug.

Of these patients, 71 percent had their alternative treatment approved by their insurance without need for appeal. Overall, approval was significantly higher for Medicare-covered patients than those with private insurance, but two firms, United Healthcare and Aetna, approved alternative therapy for 100 percent of applicants.

The authors wrote that third-party payors' protocols have been a perceived obstacle for realizing the benefit of PrismRA testing, but that their real-world experience demonstrated that a significant majority of RA patients had their prescriber's intended therapy approved by their third-party payor without issue. They argued the results suggest that "even in the current landscape … rheumatologists are not impeded from implementing PrismRA results."

Saleh said that Scipher intentionally invested heavily in clinical studies early in its commercial development. "It's been expensive, obviously, but it's also allowed us to get Medicare coverage, so it kind of proves the point."

So far, the company hasn't won any private payor policies, but it is expecting the LCD to begin to influence commercial insurers moving forward.

Looking forward to next year, Saleh said that Scipher was particularly happy about the fact that Palmetto's LCD is a foundational coverage determination, applying not only to anti-TNF therapy prediction, but to prediction of therapy response across biologic and targeted therapies.

"We were hoping for that because we already have in our pipeline the addition of a T-cell test and a JAK test, as well, and we are hoping to launch both of them next year," he said. A broader test should also help to drive adoption, he added.

"We have manuscripts in process for T-cell [therapies], and I would say we are wrapping up our JAK study early next year, so we've been running studies while waiting for the Medicare decision," Saleh said.