National Centre for Pharmacoeconomics

National Centre for

NCPE Ireland

Obeticholic acid (Ocaliva®)

Obeticholic acid is indicated 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.

NCPE Assessment Process Ongoing
Rapid review received 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
Submission received from applicant 02/06/2017
Preliminary review sent to applicant 31/07/2017
NCPE assessment re-commenced 11/09/2017
Applicant factual accuracy check 09/10/2017
NCPE assessment re-commenced 24/10/2017
NCPE assessment completed 31/10/2017
Full pharmacoeconomic assessment outcome Reimbursement not recommended at the submitted price