Inotersen (Tegsedi®). HTA ID: 19034

Assessment Status Assessment process complete
HTA ID 19034
Drug Inotersen
Brand Tegsedi®
Indication For the treatment of Stage 1 or Stage 2 polyneuropathy in adult patients with hereditary transthyretin (TTR) amyloidosis (hATTR).
Assessment Process
Rapid review commissioned 26/08/2019
Rapid review completed 07/10/2019
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of inotersen compared with the current standard of care.
Full pharmacoeconomic assessment commissioned by HSE 09/10/2019
Pre-submission consultation with Applicant 08/12/2020
Full submission received from Applicant 23/07/2021
Preliminary review sent to Applicant 05/10/2021
NCPE assessment re-commenced 02/11/2021
Factual accuracy sent to Applicant 22/12/2021
NCPE assessment re-commenced 10/01/2022
NCPE assessment completed 11/02/2022
NCPE assessment outcome The NCPE recommends that inotersen 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

Plain English Summary

The HSE has approved reimbursement following confidential price negotiations – August 2022.