Dáil Éireann Debate, Thursday - 25 June 2026
421. Deputy Albert Dolan asked the Minister for Health if she will provide an update on the consideration by the HSE senior leadership team of the reimbursement application for givinostat; whether a decision has now been reached following the recommendation submitted by the Drugs Group on 9 June 2026; and if she will make a statement on the matter. [48421/26]
Amharc ar fhreagraUnder 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 commercial proposal along with other relevant information was progressed to the 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 Leadership Team.
On foot of the Drugs Group recommendation, the HSE Senior Management Team, which holds final decision-making authority on the reimbursement of a medicine in line with the Health (Pricing and Supply of Medical Goods) Act 2013, has made a positive reimbursement decision and commissioned a Managed Access Protocol for givinostat.
All efforts will be made to expedite the implementation of the Managed Access Protocol and to ensure that an adequate stock of the medicine is available and delivered to patients as quickly as possible.
