Idebenone (Raxone®)

Assessment Status Assessment process complete
Drug Idebenone
Brand Raxone®
Indication For the treatment of visual impairment in adolescent and adult patients with Leber’s Hereditary Optic Neuropathy (LHON).
Assessment Process
Rapid review commissioned 10/02/2016
Rapid review completed 14/04/2016
Rapid review outcome Full Pharmacoeconomic Assessment Recommended
Full pharmacoeconomic assessment commissioned by HSE 28/06/2017
Pre-submission consultation with Applicant 25/07/2017
Full submission received from Applicant 17/11/2017
Preliminary review sent to Applicant 10/05/2018
NCPE assessment re-commenced 22/06/2018
Factual accuracy sent to Applicant 30/07/2018
NCPE assessment re-commenced 15/08/2018
NCPE assessment completed 28/08/2018
NCPE assessment outcome The NCPE recommends that idebenone 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 Medical Goods) Act 2013.

Technical Summary

Plain English Summary

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