| Assessment Status | Assessment process complete |
| HTA ID | - |
| 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 |
The HSE has approved reimbursement following confidential price negotiations – October 2022.
