One in four hepatitis C patients denied initial approval for drug treatment

Nearly one in four patients with chronic hepatitis C (HCV) are denied initial approval for a drug therapy that treats the most common strain of the infection, according to a Yale School of Medicine study.

The finding, published Aug. 27 in PLOS ONE, identifies a new barrier to caring for patients with this severe condition.

Prior to the FDA approval of novel antiviral therapies for HCV in 2014, treatment options for patients were limited, requiring weekly injections of interferon-based therapy that caused severe side effects. The new regimens revolutionized treatment and offered patients an oral therapy with cure rates exceeding 90%. However, the high cost of care led insurers to impose new restrictions on drug authorization.

In light of the new restrictions, the study authors hypothesized that while most patients would be able to access antiviral therapy, some would experience delays in approval and others would be denied. Led by Dr. Joseph K. Lim, associate professor of medicine and director of the Yale Viral Hepatitis Program, the investigators reviewed records of 129 patients who were prescribed a combination of two drugs (sofosbuvir and ledipasvir, or SOF/LED) between October and December 2014.

http://news.yale.edu/2015/08/27/one-four-hepatitis-c-patients-denied-initial-approval-drug-treatment#.VeiHbW4MoAc.facebook

This is insane!