Access Barriers to Rifaximin May Increase Risk of Hospitalization from Overt Hepatic Encephalopathy

Access barriers that prevent or delay treatment with rifaximin (Xifaxan; Bausch Health Companies Inc, Salix Pharmaceuticals) for overt hepatic encephalopathy (OHE) recurrence may increase the risk of OHE-related hospitalization, according to findings from a recent retrospective study presented at the AMCP Nexus 2023 meeting in Orlando, Florida, in a session titled "Assessment of Access Barriers to Rifaximin Among Patients with Overt Hepatic Encephalopathy Using Adjudicated Claims Data."

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“The study results highlight that rejection of [rifaximin] claims led to delay in treatment initiation as well as gaps in active treatment,” said study lead Arun Jesudian, MD, director of Inpatient Liver Services at NYPH/Weill Cornell in New York, in a press release. “Such access barriers to [rifaximin] may result in increased rates of OHE-related hospitalizations."

During the study, investigators conducted a retrospective database analysis of claims data made by commercially insured patients at risk of OHE recurrence to identify access barriers to rifaximin. Rifaximin is the only FDA-approved treatment that can reduce the risk of OHE recurrence in adult patients, according to Nicola Kayel, senior vice president, Marketing, Salix.

The claims data were filed over a 12-month period, which began when a patient made their first attempt to access rifaximin—attempts were then categorized as paid, reversed, or rejected prescription claims. Findings showed that almost every single patient (97%) reported an experience during which they were delayed treatment by at least 1 day, according to study findings; however, the average treatment gap (per patient) was 2.9 days.

“This analysis shows that many OHE patients continue to face barriers in receiving the vital care they may require," Kayel said in the press release.

Investigators found that 34.8% of patients had to delay treatment initiation because of a holdup in receiving rifaximin. Further, the reason that 77.7% of these patients had to delay the treatment start date is because their claims were rejected. Prior authorization requirements (61.8%) was the most common reason that a claim was rejected.

On average, every patient had 1.5 claims rejected, 0.9 reversed, and 6.4 paid. But, despite the higher number of paid claims, most patients (72.7%) who made an initial paid claim still experienced an average treatment gap of 22.9 days in the 12-month period.

The most common adverse events (AEs) associated with rifaximin include hepatic encephalopathy, peripheral edema, nausea, dizziness, fatigue, and ascites. Other AEs may include irritable bowel syndrome with diarrhea, or increased alanine transaminase.

This medication is also contraindicated in certain patients, including those who are hypersensitive to rifaximin or any of its ingredients. Concomitant treatment with a P-glycoprotein and/or OATPs inhibitor may also significantly increase the systemic exposure of rifaximin.

“Patients living with OHE continue to be at risk for recurrence and we are committed to understanding and improving the patient journey," Kayel concluded in the press release.

Reference

New Analysis Indicates That a Majority of Overt Hepatic Encephalopathy (OHE) Patients May Face Delays in Treatment Initiation and Gaps During Treatment for Access to Treatment Indicated to Reduce Risk for OHE Recurrence. News Release. October 17, 2023. Accessed on October 17, 2023. https://www.accesswire.com/viewarticle.aspx?id=793209