Medicinal Products

513. Deputy John Clendennen asked the Minister for Health for an update on the accessibility of Belzutifan (brand name Welireg) for the treatment of Von Hippel-Lindau syndrome; and if she will make a statement on the matter. [21311/26]

514. Deputy John Clendennen asked the Minister for Health for an update on the accessibility of Omaveloxolone (brand name Skyclarys) for the treatment of Friedreich’s ataxia; and if she will make a statement on the matter. [21312/26]

1661. Deputy Matt Carthy asked the Minister for Health whether she will review the current position to ensure that patients who are prescribed obesity medication such as Ozempic by their GPs can access it through the medical card or drug payment scheme; and if she will make a statement on the matter. [18264/26]

1680. Deputy Paul Murphy asked the Minister for Health if she will instruct her Department to review the current reimbursement scheme, making drugs such as vyloy available for reimbursement. [18372/26]

1686. Deputy Ciarán Ahern asked the Minister for Health whether an application for the inclusion of a cancer medicine (details supplied) in the HSE reimbursement scheme has been received; if she will expedite its inclusion when and if received; and if she will make a statement on the matter. [18391/26]

1713. Deputy John Brady asked the Minister for Health for an update on the application for reimbursement for the drug Skyclarys (omaveloxalone); and if she will make a statement on the matter. [18485/26]

1716. Deputy Pádraig Mac Lochlainn asked the Minister for Health the current status of the assessment, pricing negotiations and potential reimbursement approval for Skyclarys (omaveloxolone) for the treatment of Friedreich's Ataxia (FA) in Ireland; when patients can expect a decision on access to this medicine; and if she will make a statement on the matter. [18543/26]

1732. Deputy Micheál Carrigy asked the Minister for Health the steps being taken to ensure the HSE considers the "time-critical" nature of Friedreich's Ataxia during the current price negotiations for Skyclarys; the way in which the commitments in the National Rare Disease Strategy 2025-2030 and the 2026 IPHA Framework Agreement, which aims for a 180-day decision timeline, are being applied to thi…

1743. Deputy Rose Conway-Walsh asked the Minister for Health when she expects an outcome from the application for pricing and reimbursement of omaveloxolone (Skyclarys) for the treatment of Friedreich’s Ataxia in adults and adolescents aged 16 years and older; if not yet known, the efforts that will be made in the interim to support those diagnosed with Friedreich’s Ataxia who are waiting on the o…

1744. Deputy Rose Conway-Walsh asked the Minister for Health the specific steps being taken to ensure the HSE recognises the time-critical nature of Friedreich’s Ataxia during the current price negotiations for Skyclarys; how the commitments in the National Rare Disease Strategy 2025–2030 and the 2026 IPHA Framework Agreement are being applied to this case to prevent further delay for those with a…

1746. Deputy Seán Canney asked the Minister for Health when the drug Skyclarys will be reimbursed for patients with Friedreich’s Ataxia (details supplied); and if she will make a statement on the matter. [18731/26]

1750. Deputy Albert Dolan asked the Minister for Health the status of the HSE and Department of Health assessment of Omaveloxolone (Skyclarys) for the treatment of Friedreich’s Ataxia; the timeline for completing the reimbursement process; the engagement that has taken place with patient representatives and clinical experts; and if she will make a statement on the matter. [18744/26]

1751. Deputy Albert Dolan asked the Minister for Health the specific steps the HSE is taking to ensure that the time-critical nature of Friedreich’s Ataxia is fully recognised and reflected in the ongoing price negotiations for the reimbursement of Skyclarys; and if she will make a statement on the matter. [18745/26]

1752. Deputy Albert Dolan asked the Minister for Health the way in which the commitments set out in the National Rare Disease Strategy 2025–2030, particularly regarding timely access to approved therapies for rare disease patients, are being applied to the current reimbursement process for Skyclarys for the treatment of Friedreich’s Ataxia; and if she will make a statement on the matter. [18746/26…

1753. Deputy Albert Dolan asked the Minister for Health the way in which the 180-day decision timeline contained within the 2026 IPHA Framework Agreement is being implemented in the case of Skyclarys, given that over 570 days have now elapsed since the reimbursement application was submitted; and if she will make a statement on the matter. [18747/26]

1758. Deputy Louis O'Hara asked the Minister for Health if the drug Skyclarys (omaveloxolone), used for the treatment of Friedreich’s ataxia, will be made available under licence in Ireland; and if she will make a statement on the matter. [18769/26]

1759. Deputy Louis O'Hara asked the Minister for Health the specific steps that are being taken to ensure the HSE recognises the time-critical nature of Friedreich’s ataxia during the current price negotiations for Skyclarys; and if she will make a statement on the matter. [18770/26]

1760. Deputy Louis O'Hara asked the Minister for Health whether the 180-day reimbursement decision timeline mandated under the Health (Pricing and Supply of Medical Goods) Act 2013 was applied to the drug skyclarys (omaveloxolone); and if she will make a statement on the matter. [18771/26]

1791. Deputy Sorca Clarke asked the Minister for Health to outline the current status of the reimbursement application for skyclarys (omaveloxolone) for the treatment of Friedreich’s ataxia; if she will provide a detailed update of ongoing engagement between the HSE and the manufacturer; and the way in which the commitments contained within the National Rare Disease Strategy 2025–2030 are being ap…

1792. Deputy Sorca Clarke asked the Minister for Health the way in which the agreed timelines under the IPHA Framework Agreement 2026, including the stated 180-day decision target for reimbursement applications are being adhered to in the case of skyclarys, given that more than 570 days have elapsed since the initial application was submitted in August 2024. [18961/26]

1793. Deputy Sorca Clarke asked the Minister for Health if she will acknowledge concerns that Ireland continues to rank comparatively low in Europe for access to orphan medicines; the steps being taken to improve access rates; and if she will make a statement on the matter. [18962/26]

1818. Deputy Mairéad Farrell asked the Minister for Health the steps being taken to ensure that the HSE recognises and responds to the time-critical nature of Friedreich’s ataxia during the current price negotiations for skyclarys; the way in which the commitments, which are outlined in the National Rare Disease Strategy 2025–2030, and the 2026 IPHA Framework Agreement (which aims for a 180-day de…

1829. Deputy Sorca Clarke asked the Minister for Health if her attention has been drawn to the supply shortages affecting atropine eye drops used in the treatment of progressive myopia in children; the steps being taken to ensure continued access to this treatment; and if she will make a statement on the matter. [19150/26]

1855. Deputy Pádraig Rice asked the Minister for Health to respond to matters raised in correspondence (details supplied); if any of the specific actions outlined can, or will, be advanced; and if she will make a statement on the matter. [19307/26]

1859. Deputy Paul Lawless asked the Minister for Health the measures in place to ensure HSE price talks for skyclarys take account for Friedreich’s ataxia time-sensitive progression. [19311/26]