Niamh Smyth
Ceist:271. Deputy Niamh Smyth asked the Minister for Health to review case (details supplied); and if she will make a statement on the matter. [48020/26]
Amharc ar fhreagraWednesday, 24 June 2026
Ceisteanna (271)
Freagraí scríofa
Under the Health (Pricing and Supply of Medical Goods) Act 2013, the Health Service Executive (HSE) has statutory responsibility for decisions on the pricing and reimbursement of medicines. The HSE assessed the pricing and reimbursement application for givinostat (Duvyzat®) in line with the criteria detailed in legislation.
As of the 1st July 2026, givinostat (Duvyzat®) is added to the list of reimbursable items under the High Tech Drug Arrangements for the treatment of Duchenne muscular dystrophy (DMD) in ambulant patients, aged 6 years and older, and with concomitant corticosteroid treatment. Reimbursement is restricted, and prescribers will be required to apply for reimbursement approval on an individual patient basis as per the HSE Managed Access Protocol, which can be found here: www.healthservice.hse.ie/staff/information-healthcare-workers/medicines-management-programme-mmp/managed-access-protocols