Cysteamine bitartrate delayed-release (Procysbi®)

Assessment Status NCPE Assessment process complete
Drug Cysteamine bitartrate delayed-release
Brand Procysbi®
Indication For the treatment of proven nephropathic cystinosis.
Assessment Process
Rapid review commissioned 01/12/2015
Rapid review completed 15/12/2015
Rapid review outcome Full pharmacoeconomic assessment recommended at the submitted price
Full pharmacoeconomic assessment commissioned by HSE 23/12/2015
Pre-submission consultation with Applicant 22/05/2017
Full submission received from Applicant 13/07/2017
Preliminary review sent to Applicant 22/08/2017
NCPE assessment re-commenced 29/08/2017
Factual accuracy sent to Applicant 17/10/2017
NCPE assessment re-commenced 15/11/2017
NCPE assessment completed 15/11/2017
NCPE assessment outcome Reimbursement not recommended at the submitted price

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

Technical Summary