Results from a recent study entitled “Drug Authorization for Sofosbuvir/Ledipasvir (Harvoni) for Chronic HCV Infection in a Real-World Cohort: A New Barrier in the HCV Care Cascade“, published in the journal PLOS ONE showed that 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. The study conducted by a team of researchers from the Yale School of Medicine identifies a new barrier in HCV patient care.
Treatment of chronic HCV infection in the United States has been revolutionized with the development of novel direct-acting antiviral (DAA) therapies. DAA therapy has demonstrated better tolerability, adherence, as well as rates of sustained virologic response (SVR) and cure compared to antecedent interferon (IFN)-based therapies
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 the study, the team led by Joseph K. Lim, M.D., associate professor of medicine and director of the Yale Viral Hepatitis Program, preformed a retrospective review in patients that received sofosbuvir/ledipasvir (SOF/LED) from October 11-December 31, 2014. The study intended to determine rates and timings of drug authorization, but also the predictors of approval and factors associated with faster decision and approval times.
“The first key finding is that upon initial request for treatment, approximately one in four patients are denied,” said in a news release Albert Do, M.D., internal medicine resident and co-first author with Yash Mittal, M.D. “That proportion is surprising.”
The results revealed that for the 174 patients prescribed HCV therapy during this period, 129 requests were made for SOF/LED, of which 100 (77.5%) received initial approval, and an additional 17 patients (13.9%) ultimately received approval through appeal processes.
Faster approval times were seen in patients with Child-Pugh Class B disease. Also, a higher proportion of patients were initially approved if they had Medicare/Medicaid coverage and a baseline viral load ≥6 million IU/mL. The authors determined that predictors of shorter decision and approval times were advanced fibrosis, high Model of End Stage Liver Disease (MELD) score, and female gender.
“It is significant that factors beyond disease state and medical necessity now affect one’s likelihood of accessing HCV treatment,” said Dr. Mittal.
Although the majority of patients received approval for treatment through insurance appeal processes, the delays are concerning. “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,” Dr. Lim noted. He further mentioned that the results add to current evidence on the hepatitis C “cascade of care,” in which attrition occurs at every step from diagnosis, confirmation, linkage to care, and treatment.
According to researchers further studies are necessary to investigate the impact of evolving drug authorization policies by Medicare/Medicaid and private payers on access to curative HCV therapies such as SOF/LED. “Delay in access may further challenge our ability to cure hepatitis C in this country,” Dr. Lim said. “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.”