| Assessment Status | Assessment process complete |
| HTA ID | – |
| Drug | Tolvaptan |
| Brand | Jinarc® |
| Indication | To slow the progression of cyst development and renal insufficiency of autosomal dominant polycystic kidney disease (ADPKD) in adults with CKD stage 1-3 at initiation of treatment with evidence of rapidly progressing disease. |
| Assessment Process | |
| Rapid review commissioned | 04/01/2016 |
| Rapid review completed | 12/01/2016 |
| Rapid review outcome | Full Pharmacoeconomic Assessment Recommended. |
| Full pharmacoeconomic assessment commissioned by HSE | 27/01/2017 |
| Full pharmacoeconomic assessment re-commissioned by HSE | 14/08/2017 |
| Pre-submission consultation with Applicant | 18/09/2017 |
| Full submission received from Applicant | 06/02/2018 |
| Preliminary review sent to Applicant | 03/04/2018 |
| NCPE assessment re-commenced | 14/05/2018 |
| Follow-up to preliminary review sent to Applicant | 03/07/2018 |
| NCPE assessment re-commenced | 23/07/2018 |
| Factual accuracy sent to applicant | 27/08/2018 |
| NCPE assessment re-commenced | 06/09/2018 |
| NCPE assessment completed | 13/09/2018 |
| NCPE assessment outcome | The NCPE recommends that tolvaptan not be considered for reimbursement unless cost effectiveness can be improved relative to existing treatments*. |
*This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Goods) Act 2013.
The HSE has approved reimbursement following confidential price negotiations; May 2019
