Eoin Ó Broin
Ceist:413. Deputy Eoin Ó Broin asked the Minister for Health if she will meet with families of children living with a medical condition (details supplied). [33381/25]
Amharc ar fhreagraThursday, 19 June 2025
Ceisteanna (413)
Freagraí scríofa
I have indicated to my officials that I would like to meet with some of the families of children with Duchenne muscular dystrophy to hear their concerns about access to the new medicines. I would hope that a meeting can be organised soon.
As I outlined in the Dáil last week I am closely following the developments in relation to the medicine givinostat (Duvyzat®), which was authorised by the European Commission for the treatment of Duchenne Muscular Dystrophy on the 6th of June 2025.
The HSE has statutory responsibility for decisions on the pricing and reimbursement of medicines and devices. As of the 17th of June 2025, the HSE has advised that it has not received a pricing and reimbursement application for givinostat (Duvyzat®) from Italfarmaco S.p.A., the Marketing Authorisation Holder. The national assessment and decision process for the medicine cannot commence in the absence of this application.
I encourage the company to submit a pricing and reimbursement application to the HSE, in early course, to allow the national assessment and decision process to commence. The HSE cannot assess any new medicine for reimbursement until an application is received.