Cholic acid (Orphacol®). HTA ID: 21062

Assessment Status Rapid Review complete
HTA ID 21062
Drug Cholic acid
Brand Orphacol®
Indication For the treatment of inborn errors in primary bile acid synthesis due to 3β-Hydroxy-Δ5-C27-steroid oxidoreductase deficiency or Δ4-3-Oxosteroid-5β-reductase deficiency in infants, children and adolescents aged one month to 18 years, and adults.
Assessment Process
Rapid review commissioned 13/12/2021
Rapid review completed 12/01/2022
Rapid review outcome A full HTA is not recommended. The NCPE recommends that cholic acid (Orphacol®) not be considered for reimbursement at the submitted price*.

*This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.

The HSE has approved reimbursement following confidential price negotiations, December 2022.