Tolvaptan (Jinarc®)

Assessment Status Assessment process complete
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.

Technical Summary

The HSE has approved reimbursement following confidential price negotiations; May 2019