Patisiran (Onpattro®)

Assessment Status Assessment process complete
Drug Patisiran
Brand Onpattro®
Indication For the treatment of hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis) in adult patients with stage 1 or stage 2 polyneuropathy.
Assessment Process
Rapid review commissioned 07/12/2018
Rapid review completed 03/01/2019
Rapid review outcome Full Pharmacoeconomic Assessment Recommended.
Full pharmacoeconomic assessment commissioned by HSE 09/01/2019
Pre-submission consultation with Applicant 26/02/2019
Full submission received from Applicant 28/06/2019
Preliminary review sent to Applicant 18/10/2019
NCPE assessment re-commenced 15/11/2019
Follow-up to preliminary review sent to Applicant 22/11/2019
NCPE assessment re-commenced 06/12/2019
Factual accuracy sent to applicant 31/01/2020
NCPE assessment re-commenced 13/02/2020
Factual Accuracy #2 sent to Applicant 18/02/2020
NCPE assessment re-commenced 19/02/2020
NCPE assessment completed 20/02/2020
NCPE assessment outcome The NCPE recommends that patisiran (Onpattro®) is not 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

Plain English Summary

The HSE has approved reimbursement following confidential price negotiations October 2021