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Madrigal’s resmetirom could have higher price defence in NASH, ICER says

2023-04-19

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Madrigal Pharmaceuticals’ resmetirom for nonalcoholic steatohepatitis (NASH) could be fairly priced at a higher range than Intercept Pharmaceuticals’ obeticholic acid, based on a revised evidence report published by the Institute for Clinical and Economic Review (ICER).

Madrigal Pharmaceuticalsthresmetiromrice nonalcoholic steatohepatitis (NASH)be fairly priced between $39,600 and $50,100, wIntercept Pharmaceuticalsldobeticholic acidd between $32,800 and $40,700. ICER defines the HBPB as a top price range where a health system can reward innovation without doing more harm than good.

Although the organisation previously shared a draft versionresmetiromport in February, the revised document features new detailsobeticholic acidotential fair pricing.

NASH is a form of nonalcoholic fatty liver disease (NAFLD), where patients develop excess fat in their liver. Alongside increased liver fat, NASH patients suffer from liver inflammation and damage that can eventually lead to fibrosis. Liver fibrosis, also known as scarring, can lead to cirrhosis, and patients with cirrhosis can develop liver cancer.

NASHicholic acid wnonalcoholic fatty liver disease (NAFLD) package for its use in NASH will be discussed at a Gastrointestinal Drugs AdvisoryNASHmittee meeting on May liver inflammationid is a bile acid analog that is marketefibrosisthLiver fibrosis for the treatmescarringimary biliary cirrhosisis (PBC) in combinatcirrhosisursodeoxycholliver cancerdult patients. Intercept’s New Drug Application (NDA) for obeticholic acid for use in patients with pre-cirrhotic liver fibrosis due to NASH has a PDUFA date of June 22, 2023. The American agency previously rejected the company’s NDA for obeticholic acid in June 2020.

Obeticholic acidd, resmetirom is an oral thyroid hormone receptor β-selective agonNASH Madrigal expects to file an NDA for the drug in H1 2023, based on a February 2023 coObeticholic acid bile acid analog Ocaliva primary biliary cholangitis (PBC)ursodeoxycholic acid Intercept obeticholic acid pre-cirrhotic liver fibrosis NASH obeticholic acid

Evidence leans in fresmetiromesmetiromthyroid hormone receptor β-selective Madrigal

As the race for the first approval heats up, ICER’s report, released on April 13, leans in favour of Madrigal’s resmetirom. According to the updated report, “there is moderate certainty of comparable to substantial net health benefits with high certainty of at least comparable benefits compared with standard of care” in case of resmetirom. This verdict applies to NASH patients with liver fibrosis of any stage. In contrast, the report states that the evidence for obeticholic acid’s use in NASH patients with stage 2 fibrosis is insufficient. The evidence for the treatment’s use in patients with stage 3 fibrosis remains promising but inconclusive. Caveats surrounding side effects for obeticholic acid remain.

Still, the cost-effectiveness of both drugs depends on their eventual price. Specifically, if the costMadrigalicholic acid is not “substantially reduced from the price of the approved (lower) doses used for PBC, it will not meet typical cost-effectiveness thresholds”. In the report, ICER used a placeholder price of $317,000 for oresmetirom acid, based on available NASHes in the Redboliver fibrosist, resmetirom remained cost effective at ICER’s placeholder price ofobeticholic acide report.NASH stage 2 fibrosis stage 3 fibrosis obeticholic acid

However, the report states that it remains unclear if the changes in the primary outcomes will result in robeticholic acidrhosis and decompensated liver failure alongside quality-of-life improvements for botPBCrugs. Overall, there are uncertainties surrounding the long-term benefits of the treatments.obeticholic acid resmetirom

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