Obeticholic acid (Ocaliva®)

Assessment Status Assessment process complete
Drug Obeticholic acid
Brand Ocaliva®
Indication For the treatment of primary biliary cirrhosis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA or as monotherapy in adults unable to tolerate UDCA.
Assessment Process
Rapid review commissioned 18/11/2016
Rapid review completed 21/12/2016
Rapid review outcome Full Pharmacoeconomic Assessment Recommended
Full pharmacoeconomic assessment commissioned by HSE 17/01/2017
Pre-submission consultation with Applicant 27/02/2017
Full submission received from Applicant 02/06/2017
Preliminary review sent to Applicant 31/07/2017
NCPE assessment re-commenced 11/09/2017
Factual accuracy sent to Applicant 09/10/2017
NCPE assessment re-commenced 24/10/2017
NCPE assessment completed 31/10/2017
NCPE assessment outcome Reimbursement not recommended at the submitted price

Technical Summary

The HSE has approved reimbursement following confidential price negotiations – October 2022.