Dáil Éireann Debate, Monday - 7 September 2026
3144. Deputy Barry Ward asked the Minister for Health the position regarding any engagement that she has had with advocacy groups in relation to the introduction of the medication called Givinostat to treat patients with Duchenne Muscular Dystrophy; the actions she will take to expedite this issue; and if she will make a statement on the matter. [59961/26]
View answer3145. Deputy Barry Ward asked the Minister for Health the position regarding the outcome of any meetings of the HSE drug approval group in relation to a medication (details supplied) to treat patients with Duchenne muscular dystrophy; the actions she will take to expedite this issue; and if she will make a statement on the matter [59965/26]
View answer3332. Deputy Barry Ward asked the Minister for Health the position regarding the introduction of a medication (details supplied) to treat patients with Duchenne muscular dystrophy; the actions she will take to expedite this issue; and if she will make a statement on the matter. [59956/26]
View answer3336. Deputy Barry Ward asked the Minister for Health if her attention has been drawn to the approval by the European Medicines Agency of a medication (details supplied) to treat patients with Duchenne muscular dystrophy; the actions she will take to engage with the HSE to ensure that any delays to its approval in Ireland are expedited; and if she will make a statement on the matter. [59963/26]
View answerI propose to take Questions Nos. 3144, 3145, 3332 and 3336 together.
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.
The applicant's commercial proposal along with other relevant information was progressed to the HSE's Drugs Group on 9th June 2026, who assessed all the information, including submissions by patient representative organisations, and prepared a recommendation for the HSE Senior Management Team.
Givinostat (Duvyzat®) which is indicated for the treatment of Duchenne Muscular Dystrophy in ambulant patients, aged 6 years and older, and with concomitant corticosteroid treatment was added to the HSE Reimbursement List under the High Tech Scheme on the 1st July 2026.
