Osimertinib (Tagrisso®)

Assessment Status Assessment process complete
Drug Osimertinib
Brand Tagrisso®
Indication For the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor [EGFR] T790M mutation positive non-small cell lung cancer [NSCLC].
Assessment Process
Rapid review commissioned 26/02/2016
Rapid review completed 22/03/2016
Rapid review outcome Reimbursement not recommended at this point in time
Updated clinical evidence submitted by the Applicant 21/12/2016
Rapid Review completed 10/01/2017
Rapid Review outcome Full pharmacoeconomic assessment recommended
Full pharmacoeconomic assessment commissioned by HSE 30/01/2017
Pre-submission consultation with Applicant 20/03/2017
Full submission received from Applicant 02/06/2017
Preliminary review sent to Applicant 28/07/2017
NCPE assessment re-commenced 24/11/2017
Factual accuracy sent to Applicant 21/12/2017
NCPE assessment re-commenced 16/01/2018
NCPE assessment completed 16/01/2018
NCPE assessment outcome An updated submission incorporating new clinical evidence, a new cost-effectiveness model and budget impact model was submitted by the applicant at the end of the NCPE assessment process, during the factual accuracy check of the NCPE’s final report. This submission will be considered following a re-commissioning of the full pharmacoeconomic assessment by the HSE.
Full pharmacoeconomic assessment re-commissioned by HSE 18/01/2018
NCPE assessment commenced 19/01/2018
Preliminary review sent to Applicant 23/02/2018
NCPE assessment re-commenced 06/03/2018
Factual accuracy sent to Applicant 06/04/2018
NCPE assessment re-commenced 13/04/2018
NCPE assessment completed 03/05/2018
NCPE assessment outcome The NCPE recommends that osimertinib (Tagrisso®) 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; July 2020.