New drugs on the horizon to treat fatty liver disease (written with Chantell Sell, PharmD)
March 7, 2024
Metabolic Associated Steatohepatitis (MASH), also known as non-alcoholic fatty liver disease (NAFLD) or non-alcoholic steatohepatitis (NASH), is both common and consequential. The prevalence of MASH is between 1.5-6% of the adult population, and this disease can cause inflammation and scarring (fibrosis) of the liver. In some cases, MASH can cause cirrhosis and liver failure, and it is the second most common reason for liver transplants (after alcoholic liver disease.) MASH is most common in those with obesity and diabetes.
Currently, weight loss is the primary way to treat MASH. Weight loss does not always improve liver function. Now, drug treatment for MASH appears to be right around the corner.
Resmetirom (Madrigal) is expected to the first drug approved by the Food and Drug Administration (FDA) for treatment of MASH later this month. Another drug, servodutide (an investigational drug from Boehringer Ingelheim and Zealand Pharmaceuticals) was shown to reduce fibrosis in a Phase 2 trial and is also being studied in obesity.
There are 105 drugs in the obesity treatment pipeline, and 20 of them are also being investigated for treatment of MASH. Semaglutide (Wegovy and Ozempic) has been shown to decrease liver fat accumulation but was not shown to decrease liver fibrosis. No word yet on MASH trials of tirzepatide (Zepbound and Mounjaro) or retatrutide (Lilly, experimental) an especially potent antiobesity treatment that acts on three different hormonal targets. There are multiple other drugs with different mechanisms which are in Phase 3 trials and could come to market in the coming years. Some of these candidate drugs are injectable, and others are oral.
MASH drugs are likely to cost $10-20,000 annually, and about a quarter of those with MASH are likely to be eligible for treatment. Some with MASH could be treated instead with GLP-1 medications, although some could be treated with both GLP-1s and MASH-specific medications. If research shows that GLP-1 and related drugs reduce fibrosis, the market for MASH-only medications could be much smaller.
Implications for employers:
Drugs to treat MASH have the potential to prevent many cases of liver failure, although they will likely be costly. It will be many years before researchers will know for sure that drug treatment will lead to longer lives.
The impact of this new group of drugs on pharmacy budgets will depend on FDA approved indications, and whether these medicines are used in conjunction with or instead of GLP-1 drugs.
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Illustration by Dall-E (prompt: Impressionist painting of a liver organ)
Tomorrow: Employers that cover abortion should consider adding Mifepristone to the outpatient formulary