Obinutuzumab (Gazyvaro®) for previously untreated advanced follicular lymphoma

Assessment Status Assessment process complete
Drug Obinutuzumab
Brand Gazyvaro®
Indication In combination with chemotherapy, followed by obinutuzumab maintenance therapy in patients achieving a response, for the treatment of patients with previously untreated advanced follicular lymphoma.
Assessment Process
Rapid review commissioned 08/08/2017
Rapid review completed 13/09/2017
Rapid review outcome Full Pharmacoeconomic Assessment Recommended
Full pharmacoeconomic assessment commissioned by HSE 25/09/2017
Pre-submission consultation with Applicant 10/10/2017
Full submission received from Applicant 21/11/2017
Preliminary review sent to Applicant 26/02/2018
NCPE assessment re-commenced 08/03/2018
Factual accuracy sent to Applicant 27/03/2018
NCPE assessment re-commenced 13/04/2018
NCPE assessment completed 03/05/2018
NCPE assessment outcome The NCPE recommends that obinutuzumab (Gazyvaro®) in combination with chemotherapy followed by obinutuzumab maintenance therapy for this indication should 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

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