“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
“The first key finding is that upon initial request for treatment, approximately one in four patients are denied,” said Albert Do, M.D., internal medicine resident and co-first author with Yash Mittal, M.D. “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.”
Source: MedicalXpress.com – August 26, 2015