HSE - PCRS

Application Details

HSE Application ID

HSE100101

HTA Number

26016

HTA Link

Drug

nusinersen

Brand

Spinraza®

Applicant

Biogen

Indication Applied For

High dose regimen (50/28mg) for the treatment of 5q Spinal Muscular Atrophy (SMA).

Application Date

02/04/2026

Marketing Authorisation Date

09/01/2026

Application Status

Proposal from Applicant Under Review

29/06/2026

Awaiting Proposal from Applicant

18/06/2026

Applicant Meeting Held with CPU

18/06/2026

Rapid Review Completed

12/05/2026

Rapid Review Commissioned

02/04/2026

Pricing and Reimbursement Application Complete

02/04/2026