Results 2,001-2,009 of 2,009 for speaker:Maria Byrne
- Joint Oireachtas Committee on Health: Treatment of Rare Diseases: Discussion (15 Oct 2025)
Maria Byrne: If the National Centre for Pharmacoeconomics is happy with the information, does that mean the drug will become readily available and what are the next steps?
- Joint Oireachtas Committee on Health: Treatment of Rare Diseases: Discussion (15 Oct 2025)
Maria Byrne: Is Professor Barry hopeful that the NCP will hear within the next month from the company?
- Joint Oireachtas Committee on Health: Treatment of Rare Diseases: Discussion (15 Oct 2025)
Maria Byrne: I want to discuss rare diseases and orphan drugs. Why is there a long waiting time of 710 days compared with other countries that seem to have a faster process? Is the process fit for purpose? Does it need a review or changes to be made to fast-track the process?
- Joint Oireachtas Committee on Health: Treatment of Rare Diseases: Discussion (15 Oct 2025)
Maria Byrne: Professor Barry referred to the whole transparency side and decision-making. What steps should be taken or are there more steps that should be taken to improve that whole area?
- Joint Oireachtas Committee on Health: Treatment of Rare Diseases: Discussion (15 Oct 2025)
Maria Byrne: Great. I have one other question to do with the oncology and the non-oncology orphan medicines that are not available in Ireland. What proportion have seen an application made to the reimbursement assessment process by the marketing authorised holders?
- Joint Oireachtas Committee on Health: Treatment of Rare Diseases: Discussion (15 Oct 2025)
Maria Byrne: On the orphan drugs that fail the HTA due to restrictive cost-effectiveness, is the Department considering a different valuation framework or just a threshold for these medicines?
- Joint Oireachtas Committee on Health: Treatment of Rare Diseases: Discussion (15 Oct 2025)
Maria Byrne: How are patient organisations and clinicians meaningfully involved in the HSE reimbursement process for orphan drugs?
- Joint Oireachtas Committee on Health: Treatment of Rare Diseases: Discussion (15 Oct 2025)
Maria Byrne: I thank the witnesses.
- Joint Oireachtas Committee on Health: Treatment of Rare Diseases: Discussion (15 Oct 2025)
Maria Byrne: I, too, want to raise the same issue. I have had dealings with a family whose grandchild lives in Wexford. The child is six years of age and is badly in need of givinostat. It is a fact that in April 2025 the European Medicines Agency granted conditional approval and on 6 June the European Commission granted conditional approval.