Costs pose hurdle for promising new hepatitis C lab test

A new rapid test for hepatitis C could help identify many more patients who could be cured of the deadly disease, but its use may be limited unless insurers’ reimbursement rises to cover its high cost, according to researchers from the University of Washington School of Medicine in Seattle.

Hepatitis C virus, also known as HCV, attacks the liver. While some people clear the virus without treatment, about 70% develop chronic infections that can cause cirrhosis, liver failure and cancer. Patients often have no symptoms, and most are unaware they are infected. The U.S. Centers for Disease Control and Prevention estimates that as many as 4 million Americans have chronic hepatitis C.

Available treatments, however, clear the infection in about 90% of patients. For this reason, the CDC recommends that every adult be tested for the virus at least once, and that testing be repeated for those in high-risk groups, such as people who inject drugs or are on hemodialysis.

Early screening efforts were highly successful, in part because when HCV tests became available, in the 1990s, older Americans had the highest rates of infection. These patients have been relatively easy to contact and bring in for follow-up care.

In recent years, however, the rate of acute and chronic infection has been rising among younger adults, largely due to the opioid and injection drug-use epidemic. These people, who are often seen in community clinics and emergency rooms, frequently do not get started on treatment.

“Our clinicians say that if they were able to go NIH with these lab results for these patients while they are still in the ER or clinic, they would be able to convince them to start treatment right on the spot,” said senior author Dr. Alexander Greninger, professor of laboratory medicine and pathology at the UW School of Medicine. 

The new finger-stick test, which detects the presence of the virus’s RNA, can be performed in a doctor’s office, clinic or emergency room, and provide results within an hour. The advantage of such “point-of-care” tests is that they make it possible to start patients on treatment while they are still in the clinic or emergency room, thereby making it much more likely they will be cured.

To assess the cost of implementing the new test, Greninger and his colleagues analyzed how HCV testing was done across the UW Medicine healthcare system from 2017 to 2024. 

The UW Medicine system includes a major medical center on the UW campus, a large public county hospital in downtown Seattle, a community hospital in north Seattle, and primary- and specialty-care clinics around King County. The data collected informed their projection of cost after the recently approved Cepheid Xpert HCV test was adopted in different scenarios.

Unlike older HCV tests, which can be run in large batches, the Cepheid tests are more expensive and, because they must be run one at a time, require more lab staff time. The researchers estimated that the cost of performing one Cepheid test was approximately $91.00.

“Even a minimal implementation of this test, such as restricting it to orders from the county hospital emergency room, would increase overall HCV testing lab costs by 22%, while broader implementation would cost millions of dollars, at a time of declining test reimbursements and challenging budgets throughout health care,” said first author Dr. Emily Helm, a UW Medicine resident in laboratory medicine and pathology. Dr. H. Nina Kim, professor of medicine, Division of Allergy and Infections Diseases at the UW School of Medicine was also a co-author of the study.

Restricting use of the test to settings where high-risk patients are most likely to be seen would be most cost-efficient, Helm said. For example, about one-third of the King County, Washington, cases are diagnosed in Harborview Medical Center’s emergency department, where more than 10% of HCV tests were positive. Limiting the new test to this emergency department would increase lab costs by about $550 per infection detected, Helm said. 

Testing hospitalized patients at Harborview (the public county hospital managed by UW Medicine) was also relatively cost-efficient compared to other approaches, the analysis found.

With new treatments, it is possible to essentially eradicate HCV if patients can be identified and started on treatment, Greninger said.

 “But eradicating HCV is about finding cases — the diagnostics — and the challenge is to find new ways to implement these tests that are affordable,” he said. “We’ve created entirely new models of paying for curative HCV antivirals and perhaps we need to be thinking the same thing for diagnostics.”

The study appears in the Journal of Clinical Microbiology. 

The study received no external funding and was supported by the Department of Laboratory Medicine and Pathology at the UW School of Medicine.

Written by Michael McCarthy.