Lutetium (177Lu) Oxodotreotide (Lutathera®)

Assessment Status Assessment process complete
Drug Lutetium (177Lu) Oxodotreotide
Brand Lutathera®
Indication For the treatment of unresectable or metastatic, progressive, well differentiated (G1 and G2), somatostatin receptor (SSTR) positive gastroenteropancreatic neuroendocrine tumours (GEP-NETs) in adults.
Assessment Process
Rapid review commissioned 23/10/2018
Rapid review completed 16/11/2018
Rapid review outcome Full Pharmacoeconomic Assessment Recommended.
Full pharmacoeconomic assessment commissioned by HSE 21/11/2018
Pre-submission consultation with Applicant 17/12/2018
Full submission received from Applicant 23/05/2019
Preliminary review sent to Applicant 04/10/2019
NCPE assessment re-commenced 01/11/2019
Follow-up to preliminary review sent to Applicant 22/11/2019
NCPE assessment re-commenced 02/12/2019
Factual accuracy sent to Applicant 10/01/2020
NCPE assessment re-commenced 20/01/2020
NCPE assessment completed 07/02/2020
NCPE assessment outcome The NCPE recommends that lutetium (177Lu) oxodotreotide (Lutathera®) not be considered for reimbursement*.

*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 February 2021.