Abdullah Mubarak, a gastroenterologist at the Liver Center of Texas, says one in 10 of his NASH patients is able to lose weight and keep it off for more than a year or two. Lifestyle changes, though, aren't always easy for people to maintain. Still, such a cost may be unattractive to payers when lined up against diet and exercise. For that indication, Ocaliva's list price clocks in at nearly $70,000.Īt least two investment banks expect Intercept to set the drug's price much lower in NASH - Steven Seedhouse of Raymond James models a gross list price of around $10,000, while analysts at Credit Suisse anticipate a higher $18,000 price tag.
Obeticholic acid is actually on the market already, sold under the brand name Ocaliva for another liver disease called primary biliary cirrhosis. Intercept Pharmaceuticals is the only drugmaker to have scored positive results in a late-stage NASH trial, and even that study found 75% of patients didn't experience significant fibrosis improvement without NASH worsening after 18 months of treatment with the company's medicine, obeticholic acid. Most advanced NASH drugs haven't wowed on efficacy Company "If insurance providers wanted to create a hurdle to access these drugs, they will biopsy," said Manal Abdelmalek, a professor of medicine at Duke University. The tests are invasive and relatively pricey, and there aren't enough hepatologists to perform them - a problematic combination for patients who want or could benefit from drug therapy. Among 411 patients, the analysis determined 15% were at the two highest stages of fibrosis, whereas nearly 70% were at the two lowest.ĭata on the NASH population is far from conclusive, because the best way to define liver inflammation and scarring is through biopsy. Payers stand to save a lot of money through that strategy, as research has found just a small percentage of NASH patients ever develop advanced fibrosis.Ī meta-analysis published in 2015, for example, looked at studies of adults who had either NASH or more general fatty liver disease. Only the sickestĭoctors, analysts and industry executives foresee the sickest patients - those with the greatest liver scarring - as the most likely to get coverage and reimbursement in the nascent NASH market. "Payers are going to balk and try to be very selective in who we could prescribe to," Tetri told BioPharma Dive. That's spurring apprehension among payers, leading healthcare providers to expect barriers to drug therapy for a majority of the estimated 10 million to 30 million NASH patients in the U.S. Based on Wall Street estimates and clinical data released thus far, the earliest drugs are likely to come with limited efficacy and price tags of $10,000 or more.
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