Nearly 1 in 4 people with chronic hepatitis C (HCV) are denied initial approval of medications that treat the most common strain of the infection. Experts say this delay is creating a barrier to caring for patients.
In 2014 the FDA approved a new oral drug therapy, which has cure rates that exceed 90 percent. The new therapy offers an alternative to weekly injections that can cause severe side effects.
However, the high cost of care led insurers to impose new restrictions on drug authorization.
Researchers reviewed records of 129 patients who were prescribed a combination of two drugs (sofosbuvir and ledipasvir, or SOF/LED) between October and December 2014.
“The first key finding is that upon initial request for treatment, approximately one in four patients are denied,” says Albert Do, internal medicine resident at Yale Univeristy and co-first author with Yash Mittal. “That proportion is surprising.”
The researchers also found that certain subsets of patients were more likely to receive initial approval, including those with advanced liver disease such as cirrhosis and those on public insurance, either Medicare or Medicaid.
“It is significant that factors beyond disease state and medical necessity now affect one’s likelihood of accessing HCV treatment,” says Mittal.
While most patients in the study eventually received approval for treatment through the insurance appeals process, the delays are concerning, as time is critical for patients on the verge of developing cirrhosis or liver failure, says Joseph K. Lim, associate professor of medicine and director of the Yale Viral Hepatitis Program, who led the study.
“It could make the difference for those who can be treated and remain stable long-term, versus those who have gone past the point of no return and will require liver transplantation or succumb to their illness,” he adds.
This study, published in PLOS ONE, adds to a growing body of literature on the hepatitis C “cascade of care,” in which attrition occurs at every step from diagnosis, confirmation, linkage to care, and treatment, Lim explained. He hopes the study triggers further research and discussion about this new barrier to HCV care.
“Delay in access may further challenge our ability to cure hepatitis C in this country,” Lim says. “Some patients are told they must wait until they have advanced liver disease before they can undergo potentially curative treatment. We hope these data may help inform national policy discussions on promoting more rational, patient-centered approaches to HCV treatment access.”
Source: Yale University