The Race for the First NASH Approval

In this episode of IPD's Drug & Clinical Review, our Executive Clinical Pharmacy team discusses the pipeline for the nonalcoholic steatohepatitis (NASH) space, including:

- NASH Epidemiology and Prevalence
- Methods of Diagnosis
- Pipeline Treatments
- Ocaliva
- Drug Trial Results
- FDA Advisory Committee Meeting
- Resmetirom
- Drug Trial Results
- Potential Cost
- Potential Coverage and Uptake
- Sales Forecast
- Combination Therapies
- Primary Market Insights Discussions with Hepatologists and Payers

"So, if these medications are priced according to the assumptions you've laid out here, and there are as many as 5.5 million patients eligible for these therapies, what do you think the sales could be for obeticholic acid and resmetirom?

​That's the billion dollar question. The short answer is, if obeticholic acid gains FDA approval in June, and resmetirom is approved and launched by early 2024, we project that by 2027, obeticholic acid may generate annual net sales of over $450,000,000, and resmetirom may reach up to $1.7 billion. But there are a lot of variables that will impact our forecast. First and foremost, if obeticholic acid does not get approved by June 2023, then there is uncertainty that Intercept will complete the REGENERATE trial and resubmit its application with the complete trial data. Then, resmetirom will be the first to market and will not compete with any other agent. Then we need to consider if more NASH patients would be identified by primary care physicians and referred to specialists when there is a medication approved to treat their disease. We estimate less than 10% of NASH patients are currently being managed by specialists today, and a significant variable affecting the uptake of NASH therapies is how payers will manage this class. More significant management, such as requiring biopsy-confirmed NASH, and requiring certain lifestyle modifications be in place before becoming eligible [for] therapy, will significantly limit its uptake."