Risdiplam (Evrysdi™). HTA ID: 21006

Assessment Status Assessment Process Complete
HTA ID 21006
Drug Risdiplam
Brand Evrysdi™
Indication For the treatment of 5q spinal muscular atrophy (SMA) in patients 2 months of age and older, with a clinical diagnosis of SMA Type 1, Type 2 or Type 3 or with one to four SMN2 copies.
Assessment Process
Rapid review commissioned 15/03/2021
Rapid review completed 29/03/2021
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of risdiplam compared with the current standard of care.
Full pharmacoeconomic assessment commissioned by HSE 04/05/2021
Pre-submission consultation with Applicant 28/06/2021
Full submission received from Applicant 20/08/2021
Preliminary review sent to Applicant 01/10/2021
NCPE assessment re-commenced 29/10/2021
Follow-up to preliminary review sent to Applicant 26/11/2021
NCPE assessment re-commenced 20/12/2021
Factual accuracy sent to Applicant 18/02/2022
NCPE assessment re-commenced 25/02/2022
NCPE assessment completed 31/03/2022
NCPE assessment outcome The NCPE recommends that risdiplam not be considered for reimbursement until cost-effectiveness can be improved relative to existing treatments*.

Technical Summary

Plain English Summary

*This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.