Medicinal Products

2109. Deputy Ken O'Flynn asked the Minister for Health the total expenditure incurred by the Primary Care Reimbursement Service on salbutamol nebules dispensed under the General Medical Services Scheme in each month from January 2024 to date in 2026. [20299/26]

2110. Deputy Ken O'Flynn asked the Minister for Health the number of claims submitted for salbutamol nebules or equivalent short-acting bronchodilator nebules under the General Medical Services Scheme, the Drugs Payment Scheme, and the Long-Term Illness Scheme, in each of the years 2024 and 2025. [20300/26]

2111. Deputy Ken O'Flynn asked the Minister for Health the number of claims for salbutamol nebules rejected or unpaid by the Primary Care Reimbursement Service in 2024 and 2025, and the reasons for rejection. [20301/26]

2112. Deputy Ken O'Flynn asked the Minister for Health whether the Department or the HSE issued any clinical or reimbursement guidance to pharmacists relating to salbutamol nebule shortages during 2024 or 2025, and if so to provide the details. [20302/26]

2113. Deputy Ken O'Flynn asked the Minister for Health whether the HSE has analysed prescribing substitution patterns for salbutamol nebules during supply shortages, including increased dispensing of inhalers or alternative bronchodilators. [20303/26]

2114. Deputy Ken O'Flynn asked the Minister for Health whether a national governance framework exists within her Department or the Health Service Executive for the monitoring and management of shortages of essential medicines; the statutory or policy basis for that framework; the units responsible for maintaining national oversight; and if she will make a statement on the matter. [20305/26]

2115. Deputy Ken O'Flynn asked the Minister for Health whether the Department receives regular national reports or aggregated data from the Health Products Regulatory Authority or the Health Service Executive relating to shortages of medicines in the State; the frequency of such reporting; and whether the Department maintains a national register or monitoring system for medicines supply disruption…

2116. Deputy Ken O'Flynn asked the Minister for Health whether a formal risk-assessment or prioritisation system exists within the Department or the Health Service Executive for identifying medicines considered clinically critical, including respiratory medicines such as salbutamol nebules, where supply disruptions may pose patient safety risks; and if she will outline the governance arrangements …

2117. Deputy Ken O'Flynn asked the Minister for Health whether her Department maintains a national strategy or policy framework for the prevention, monitoring, and management of shortages of essential medicines in the State; when such a strategy was last reviewed or updated; whether it includes defined governance arrangements between her Department, the Health Products Regulatory Authority, and th…

2118. Deputy Ken O'Flynn asked the Minister for Health whether her Department has issued any written policy guidance, circular, direction or framework to the Health Service Executive or to the National Centre for Pharmacoeconomics regarding the appropriate time horizon to be applied in health technology assessments used to inform pricing and reimbursement decisions for medicines; if such guidance …

2119. Deputy Ken O'Flynn asked the Minister for Health whether national policy guidance exists governing the methodological standards to be applied in health technology assessments used to support decisions under the Health (Pricing and Supply of Medical Goods) Act 2013, including assumptions relating to modelling time horizons, discount rates and long-term cost-effectiveness analysis; and if she …

2120. Deputy Ken O'Flynn asked the Minister for Health whether her Department has issued guidance to ensure that health technology assessments of medicines intended to prevent or reduce the long-term incidence of chronic diseases, including type 2 diabetes or cardiovascular disease, appropriately account for long-term health outcomes and downstream health system savings; and if she will make a sta…

2121. Deputy Ken O'Flynn asked the Minister for Health what oversight role her Department exercises in relation to the methodological frameworks used by the National Centre for Pharmacoeconomics when conducting health technology assessments that inform reimbursement decisions by the Health Service Executive; and if she will make a statement on the matter. [20313/26]

2122. Deputy Ken O'Flynn asked the Minister for Health whether her Department has reviewed whether the health technology assessment methodology applied in Ireland is aligned with that used by comparable agencies internationally, including NICE in the United Kingdom, CADTH in Canada, or PBAC in Australia, particularly regarding the time horizons applied in cost-effectiveness modelling for preventiv…

2123. Deputy Ken O'Flynn asked the Minister for Health whether her Department has undertaken any review of whether the methodological assumptions applied in health technology assessments used in Ireland may disadvantage medicines intended to prevent long-term chronic illness by applying short-term modelling horizons; and if she will make a statement on the matter. [20315/26]

2124. Deputy Ken O'Flynn asked the Minister for Health whether her Department intends to establish a national policy framework or guidance governing the methodological standards used in health technology assessments for medicines seeking reimbursement by the Health Service Executive, including standards relating to modelling time horizons for chronic disease prevention therapies; and if she will m…

2177. Deputy Erin McGreehan asked the Minister for Health the specific steps the HSE is taking to ensure that the time critical and progressive nature of Friedreich's Ataxia is fully recognised and acted upon during the ongoing price and reimbursement negotiations for skyclarys, given the significant risk of irreversible decline for patients during prolonged delays. [20488/26]

2178. Deputy Erin McGreehan asked the Minister for Health the way in which the commitments outlined in the National Rare Disease Strategy 2025-2030 particularly those relating to timely access to innovative therapies are being applied in the case of skyclarys. [20489/26]

2179. Deputy Erin McGreehan asked the Minister for Health the way in which the 180 day decision timeline set out in the 2026 IPHA Framework Agreement is being implemented in practice for rare disease medicines; and the reason this timeline has not been met in the case of skyclarys for Friedreich's Ataxia patients. [20490/26]

2180. Deputy Erin McGreehan asked the Minister for Health whether her Department or the HSE has considered establishing an Early Access Programme for skyclarys, in light of the progressive and time sensitive nature of Friedreich's Ataxia, so that patients can access the treatment while reimbursement negotiations are ongoing. [20491/26]

2199. Deputy Maeve O'Connell asked the Minister for Health the position regarding the current reimbursement process for Omaveloxolone, considering the time-sensitive nature of the condition for those with Friedreich's ataxia; and if she will make a statement on the matter. [20597/26]

2219. Deputy Niall Collins asked the Minister for Health if she will ensure that the HSE prioritises a conclusion to the Skyclarys reimbursement negotiations, given that it is the only available treatment for a progressive disease Friedreich's Ataxia (FA), which currently can be classed as having an ‘unmet need’, as outlined in the National Rare Disease Strategy 2025 – 2030; whether she believes t…

2221. Deputy Aengus Ó Snodaigh asked the Minister for Health the reason access to Friedreich's Ataxia is not available on the medical card or licenced for the drug reimbursement scheme for patients in the State; and if she will make a statement on the matter. [20816/26]

2225. Deputy Cathal Crowe asked the Minister for Health the reason the HSE no longer provides funding for Novofine autocover needles; whether an alternative product will be considered for funding (details supplied); and if she will make a statement on the matter. [20860/26]

22. Deputy Peter Roche asked the Minister for Health if her Department has considered introducing an early access scheme for people living with rare diseases to access EMA-approved orphan medicines; if such an early access scheme will include orphan medicines products licensed for non-oncology conditions; and if she will make a statement on the matter. [17621/26]