Hepatitis C patients are routinely being denied access to life-saving medication at a time when the liver disease is on the rise, especially among intravenous drug users, according to new analysis by researchers at the University of Pennsylvania's Perelman School of Medicine.

The number of new reported cases of acute hepatitis C in Pennsylvania soared 240 percent between 2012 and 2016, to 225, according to the U.S. Centers for Disease Control and Prevention, which the agency linked to a rise in injected-drug use. Yet according to the university study released Thursday, many patients may not be getting the treatment they need.

Half of patients with private insurance were denied coverage for the pill regimen, which can cost tens of thousands of dollars, according to a review of thousands of prescription claims between January 2016 and April 2017. Across all payers, including Medicare and Medicaid, 35 percent of prescriptions for the treatment were denied.

"Despite effective hepatitis C drugs and despite attention paid toward restrictions in access to drugs, denials are still common," said Vincent Lo Re III, an associate professor of infectious disease and epidemiology at Penn and a senior author of the study. "If we're going to hope to eliminate hepatitis C as a public health problem, we need to improve access to antiviral drugs."

"Eliminating hep C is a feasible goal but that's going to be hard to achieve if payers are not reimbursing for the treatment," he added in a statement.

The newest generation of hep C drugs, which debuted in 2014, has revolutionized treatment, making it far more successful. But the drugs' high cost has prompted insurers to restrict coverage to just patients with advanced stages of the liver infection.

Most treatments involve taking a pill once a day for 8 to 12 weeks, and cost $35,000 to $95,000.

In smaller studies shortly after the drugs became available in 2014, the researchers found that 8 percent to 16 percent of prescriptions were being denied.

Since then, several states — including Pennsylvania — have loosened restrictions for Medicaid patients in response to pressure from advocates and the threat of class-action lawsuits.

As of January, Medicaid covers hepatitis C treatment for all Pennsylvania patients. The program used to limit coverage to patients showing signs of liver damage.

Researchers had hypothesized that greater awareness, loosening of restrictions, and greater drug competition would improve access to treatment since their last study, Lo Re said. But it hasn't worked out that way.

Their analysis of prescriptions from 9,025 patients in 45 states over a 16-month period ending April 2017 submitted to Diplomat Pharmacy Inc., which provides pharmacy services across the country, showed otherwise:

  • Overall, 35.5 percent of prescriptions – a total of 3,200 prescriptions – were denied.
  • Commercial insurance had the highest denial rates, with 52.4 percent of patients denied coverage
  • Medicaid denied 34.5 percent of prescriptions and Medicare denied 14.7 percent of requests.

Pennsylvania accounted for about 31.5 percent of all prescriptions analyzed by researchers.

Here, 45.7 percent of prescriptions were denied. Medicaid denied 52.2 percent of prescriptions in Pennsylvania, far outpacing the national rate. The study period predated the state's new regulations.

Medicare and private insurance denial rates in Pennsylvania were in line with the national trend.

Lo Re said it was not clear in the data why prescriptions were denied because insurers did not report a reason to Diplomat.

Independence Blue Cross, the region's largest insurer, did not respond to a request for comment in time for publication.

Jack Hildick-Smith, co-chair of the Hepatitis C Allies of Philadelphia, said he's optimistic that the state's new Medicaid policy for hepatitis C treatment will improve access to patients, but there's still much work to be done, especially as infection rates rise in tandem with the city's opioid epidemic.

"Now that the policies have changed, it would be great to see hep C treatment become more integrated into primary care – which would make access much easier for patients," Hildick-Smith said in an email. "In particular, given the scope of Philadelphia's opioid crisis and the fact that stigma can make health care access challenging for many people with a history of drug use, having treatment available in settings where people feel comfortable is important."