How much does obeticholic acid cost in 2024?

Obeticholic acid is a synthetic bile acid that acts as a potent farnesoid X receptor (FXR) agonist, impairing bile acid synthesis and promoting bile acid secretion. It is the only approved second-line treatment for adult patients with primary cholangitis (PBC) in the United States and is recommended in combination with ursodeoxycholic acid (UDCA) in partial responders or as monotherapy in those intolerant to UDCA.

The drug was approved by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) based on the results of the 2016 POISE trial, which showed its therapeutic efficacy in improving biochemical markers in high-risk subgroups. Obeticholic acid is available in tablets ( 5 u200bu200band 10 mg) and is available by prescription only. The recommended starting dose is 5 mg once a day or 5 mg once a week, and the dosage for each individual depends on the patient's degree of liver damage (which should be determined before starting treatment with obeticholic acid). After a few months, if tolerated well, the dose can be increased. In patients who develop intolerable itching, the dose may be reduced or treatment discontinued (this may be a side effect).

Obeticholic acid has not yet been approved for marketing in China, so it cannot be included in medical insurance, and its domestic price is not clear. Overseas, obeticholic acid original medicine is usually available in two common specifications: 5 mg 30 tablets and 10 mg 30 tablets, and the price per box may exceed US$9,000 (the price may fluctuate due to exchange rates). Original medicines are expensive. Generic obeticholic acid drugs have been launched in overseas markets, and their pharmaceutical ingredients are basically the same as the original drugs. Suppliers include ASEAN Pharmaceuticals in Laos, Beacon Pharmaceuticals in Bangladesh, and Mylan Pharmaceuticals in India. The prices range from a few hundred to 1,000 yuan (the price may fluctuate due to exchange rates), which is more economical and affordable than the original drugs.