SAN FRANCISCO – Surprising no one, progression to cirrhosis in patients with nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH) cirrhosis in the U.S. is associated with increased health care resource utilization (HCRU) and costs, a Bristol-Myers Squibb Co.-sponsored study has found. The analysis could provide critical ammunition for drug developers such as BMS seeking to deploy economic arguments for the role of pharmaceutical intervention in reducing the condition's contribution to the upward march of health care costs.

Presented by BMS manager Dhaval Patil, from the company's Center for Observational Research and Data Science, the data were reported during the American Association for the Study of Liver Diseases (AASLD) meeting on Friday.

Patil and his colleagues looked at both pre- and post-cirrhosis diagnosis in patients with NAFLD/NASH to determine the impact of progression on total health care costs as well as all-cause drug costs. Their analysis found that, in patients with NAFLD/NASH, total per-patient, per-month (PPPM) health care cost increased by more than threefold following cirrhosis diagnosis, rising to $8,525 from $2,555 pre-diagnosis.

Patients with NAFLD/NASH who had type 2 diabetes and coronary heart disease presented even higher costs pre- and post-cirrhosis diagnosis, with all-cause PPPM medical costs rising to $10,357 following a cirrhosis diagnosis vs. $3,224 prior to diagnosis.

All-cause PPPM drug costs for the total study population, more than 68,000 patients with NAFLD/NASH and cirrhosis, rose to $432 per month post-cirrhosis diagnosis vs. $293 per month pre-diagnosis.

The retrospective cohort study was completed with data from Truven Marketscan Commercial and Medicare databases based on information available from Jan. 1, 2006, to March 31, 2017. Most patients were privately insured.

Amid an epidemic of obesity and metabolic syndrome, one recent study estimated that there has been a 2.5-fold increase in the prevalence of NASH cirrhosis in 2009-2012 vs. 1999-2002. As the problem grows, future analyses are needed to understand the impact of co-variates on the HCRU and costs of patients with advanced NASH and co-morbid type 2 diabetes and/or coronary heart disease, Patil and his colleagues concluded. Additional research is also warranted to further understand the impact of those conditions within the context of each stage of liver disease progression in patients with advanced NASH, they said.

BMS, under license from Ambrx Inc., is developing BMS-986036, a pegylated FGF-21-like protein developed using Ambrx's Recode technology for the potential treatment of metabolic and fibrotic disorders. According to Cortellis, in October, it initiated an open-label, parallel-group, single-dose, phase II trial in Hungary and Czechia in patients with NAFLD and NASH, to assess the pharmacokinetics, safety and tolerability of the candidate. The trial is expected to complete in May 2019.

At AASLD, the company is presenting data from a phase I study showing that 20-mg and 40-mg once-weekly dosing of the drug was generally well-tolerated among healthy adults.

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