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One in Four Patients with HCV Denied Initial Request for Treatment

A new study published in PLoS ONE showed that one in four patients with hepatitis C virus infection who apply for treatment of the infection is initially denied.

“Delay in access may further challenge our ability to cure hepatitis C in this country,” Joseph K. Lim, MD, associate professor of medicine and director of the Yale Viral Hepatitis Program at Yale University, said in a press release. “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.”

Lim and colleagues, including Albert Do, MD, internal medicine resident at Yale University, analyzed data of 129 patients at Yale Liver Center who had an insurance pre-authorization request for sofosbuvir/ledipasvir (Harvoni, Gilead Sciences) between October and December 2014. The researchers recorded the insurance provider of pre-authorization request for each patient. Approval, denial or pending status of each patient’s pre-authorization initial request and appeal as of March 1, 2015 was also recorded. In addition, if a patient was denied treatment and were appealing, the date of the appeal request and date of the appeal decision were recorded and included in the analyses. Various patient characteristics were recorded and included for analysis as well.

Of 128 patients whose pre-authorization status was determined, 77.5% received initial approval for pre-authorization (n = 100). Of all 129 patients, 91.4% received approval (n = 117), which included patients who required an appeal. At the initial treatment request, 14.7% of patients were required to file an appeal (n = 19), of which 4.7% were denied (n = 6).

“[This] proportion is surprising,” Do said in the release.

As of March 1, 2015, the pre-authorization status of 3.9% of patients is still pending (n = 6) and for one patient is unknown. The average time to receiving approval or denial was 26.1 ± 25.2 days. In the requests that were approved, the average time to decision was 22.9 ± 21.2 days.

Patients with Medicare or Medicaid had a shorter average time-to-decision (22.6 days vs. 28.7 days; P = .18) and time-to-approval (19.2 days vs. 25.9 days; P = .08), but was insignificant.

More patients with Medicare or Medicaid were initially approved compared with patients with private insurance (92.2% vs. 71.4%; P = .002). Also, more patients with a viral load of at least 6 million were initially approved compared with patients with viral load less than 6 million (84.1% vs. 62.5%; P = .04).

Pre-authorization requests from the Yale liver transplant clinic were found to have a faster average time-to-decision (17.9 days vs. 28.9 days; P = .03) and time-to-approval (14.8 vs. 25.6 days; P = .02) compared with pre-authorization requests from other clinics.

Univariate analysis showed psychiatric disease, high FIB-4 score and pre-authorization request from the transplant clinic to be associated with shorter times-to-decision and times-to-approval. Additionally, this analysis showed that having Medicare or Medicaid and a high viral load were associated with increased odds of initial approval compared with private insurance and low viremia, according to the research.

Multivariate analysis showed that MELD score, female gender and advanced fibrosis predicted a shorter time-to-decision and time-to-approval, whereas psychiatric disease was a predictor of a shorter time-to-approval.

“This is the first study to our knowledge assessing real-world access to interferon-free [direct-acting antiviral] regimens in established cohorts of patients with chronic HCV seeking antiviral therapy,” the researchers wrote. “These results contribute to the limited data available addressing proportion of patients successfully obtaining drug authorization through public and private insurance carriers, time to approval, and predictors for approval. ... Further studies are warranted to investigate the impact of evolving drug authorization policies by Medicare/Medicaid and private payers on access to curative HCV therapies such as [sofosbuvir and ledipasvir].”

• Reference:
• Do A, et al. PLoS One. 2015;doi:10.1371/journal.pone.0135645.

Disclosures: Lim reports consulting for Boehringer Ingelheim, Bristol-Myers Squibb, Gilead Sciences, Glaxo SmithKline, Janssen and Merck; and has received research contracts from Abbott, Achillion, Boehringer Ingelheim, Bristol-Myers Squibb, Gilead Sciences, Globeimmune, Hologic, Janssen and Vertex. Please see the full study for a list of all other researchers’ relevant financial disclosures.