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 |