Inotuzumab ozogamicin (Besponsa®)

Assessment Status Assessment process complete
Drug Inotuzumab ozogamicin
Brand Besponsa®
Indication As monotherapy for the treatment of adults with relapsed or refractory (R/R) CD22-positive B cell precursor acute lymphoblastic leukaemia (ALL). Adult patients with Philadelphia chromosome positive (Ph+) relapsed or refractory B cell precursor ALL should have failed treatment with at least 1 tyrosine kinase inhibitor (TKI).
Assessment Process
Rapid review commissioned 03/07/2017
Rapid review completed 08/09/2017
Rapid review outcome Full Pharmacoeconomic Assessment Recommended.
Full pharmacoeconomic assessment commissioned by HSE 11/09/2017
Pre-submission consultation with Applicant 02/10/2017
Full submission received from Applicant 08/03/2018
Preliminary review sent to Applicant 13/07/2018
NCPE assessment re-commenced 02/08/2018
Factual accuracy sent to Applicant 31/08/2018
NCPE assessment re-commenced 07/09/2018
NCPE assessment completed 14/09/2018
NCPE assessment outcome The NCPE recommends that inotuzumab should be considered for reimbursement if 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

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