Questions

527. Deputy Ken O'Flynn asked the Minister for Health whether any formal analysis has been conducted comparing decision-making outcomes across the six Health Regions; if so, to provide the metrics used, the findings, and any identified regional disparities. [29321/26]

528. Deputy Ken O'Flynn asked the Minister for Health what formal mechanisms exist to intervene where a Health Region's decisions materially diverge from national policy or from other regions; and whether any such interventions have occurred since the establishment of the Health Regions. [29322/26]

529. Deputy Ken O'Flynn asked the Minister for Health whether any independent audit or internal review has been conducted on consistency of decision-making across Health Regions since 2022; and to provide the dates and findings of such audits. [29323/26]

530. Deputy Ken O'Flynn asked the Minister for Health whether patients have a formal right to review or appeal decisions where similar cases are treated differently across Health Regions; and if so, the structure of such a mechanism. [29324/26]

531. Deputy Ken O'Flynn asked the Minister for Health how "consistency" is defined within the Health Regions model; whether measurable benchmarks exist; and how compliance with such benchmarks is monitored. [29325/26]

239. Deputy Ken O'Flynn asked the Minister for Health whether an application has been received for the reimbursement of the drug skyclarys for the treatment of Friedreich’s ataxia; if so, the current status of that application; the date on which it was submitted to the National Centre for Pharmacoeconomics; and the expected timeline for a final reimbursement decision. [29078/26]

240. Deputy Ken O'Flynn asked the Minister for Health the average and median time taken for reimbursement decisions for orphan or rare disease medicines over the past five years; the specific timelines applicable in the case of treatments for Friedreich’s ataxia; and whether any delays have arisen in the assessment process for this category of medicines. [29079/26]

241. Deputy Ken O'Flynn asked the Minister for Health whether any interim access schemes, compassionate use programmes, or early access pathways are currently available in the State for patients with Friedreich’s ataxia; and whether consideration is being given to enabling access to skyclarys pending a full reimbursement decision. [29080/26]

242. Deputy Ken O'Flynn asked the Minister for Health whether standard cost-effectiveness thresholds applied by the National Centre for Pharmacoeconomics are adjusted in the case of rare diseases; if not, whether the Minister will consider reforming these thresholds to reflect the unique clinical and ethical context of low-prevalence conditions. [29081/26]

243. Deputy Ken O'Flynn asked the Minister for Health the estimated number of patients diagnosed with Friedreich’s ataxia in the State; the number currently under active neurological care; and whether a national clinical pathway or specialised service model exists for this condition. [29082/26]

244. Deputy Ken O'Flynn asked the Minister for Health whether skyclarys has been approved or reimbursed in other EU Member States or comparable jurisdictions; and whether such decisions are considered in Ireland’s reimbursement process. [29083/26]

245. Deputy Ken O'Flynn asked the Minister for Health whether the current national rare disease strategy provides for expedited access pathways to disease-modifying therapies; and whether any review of this policy framework is underway. [29084/26]

745. Deputy Ken O'Flynn asked the Minister for Health the factors underlying the increase in expenditure by the Primary Care Reimbursement Service on salbutamol nebules dispensed under the general medical services scheme between 2024 and 2025; and if she will provide a breakdown of the extent to which this increase is attributable to volume of items dispensed, reimbursement price per item, and any changes to dispensi…

746. Deputy Ken O'Flynn asked the Minister for Health the total number of salbutamol nebule items dispensed under the general medical services scheme in each month from January 2024 to date in 2026; and if she will provide the corresponding average reimbursement cost per item for each month. [28033/26]

747. Deputy Ken O'Flynn asked the Minister for Health the reimbursement price per unit applicable to salbutamol nebules under the Primary Care Reimbursement Service in each month from January 2024 to date in 2026; whether any changes to pricing arrangements, reference pricing, or reimbursement rules occurred during this period; and if she will detail same. [28034/26]

748. Deputy Ken O'Flynn asked the Minister for Health the clinical guidelines, prescribing controls, and audit mechanisms in place governing the prescribing of salbutamol nebules under the general medical services scheme; and whether any review has been conducted in light of increased expenditure in 2025. [28035/26]

749. Deputy Ken O'Flynn asked the Minister for Health the reason the Primary Care Reimbursement Service does not capture or retain data on the clinical indication associated with medicines reimbursed under the general medical services scheme, including salbutamol nebules; and whether there are plans to introduce such data capture to support expenditure oversight and value-for-money assessment. [28036/26]

750. Deputy Ken O'Flynn asked the Minister for Health whether analysis has been undertaken by her Department or the Health Service Executive into the change in seasonal expenditure patterns for salbutamol nebules between 2024 and 2025; and if she will provide the findings of any such analysis. [28037/26]

751. Deputy Ken O'Flynn asked the Minister for Health whether any internal audit, external audit, or value-for-money review has been conducted in respect of expenditure by the Primary Care Reimbursement Service on salbutamol nebules under the general medical services scheme since January 2024; if so, to provide the dates and findings of such reviews; and if not, the reason none has been undertaken. [28038/26]

752. Deputy Ken O'Flynn asked the Minister for Health whether any expenditure thresholds, alerts, or variance triggers exist within the Primary Care Reimbursement Service to identify significant increases in spend on specific medicines, including salbutamol nebules; and if she will outline the governance arrangements in place when such increases occur. [28039/26]

753. Deputy Ken O'Flynn asked the Minister for Health the total expenditure by the Primary Care Reimbursement Service on respiratory medicines under the general medical services scheme in each month from January 2024 to date in 2026; and the proportion of this expenditure attributable to salbutamol nebules. [28040/26]

754. Deputy Ken O'Flynn asked the Minister for Health whether benchmarking has been carried out comparing expenditure and utilisation of salbutamol nebules in Ireland with other EU member states; and if so, to provide the findings of such benchmarking. [28041/26]

755. Deputy Ken O'Flynn asked the Minister for Health whether the Primary Care Reimbursement Service or the Health Service Executive has identified any risks relating to over-prescribing, inappropriate prescribing, or dependency in respect of salbutamol nebules; and if she will outline any mitigation measures in place. [28042/26]

756. Deputy Ken O'Flynn asked the Minister for Health whether any changes to prescribing guidance, reimbursement criteria, or clinical pathways for respiratory care were introduced between January 2024 and February 2026 which may have influenced the level of prescribing of salbutamol nebules; and if she will detail same. [28043/26]

757. Deputy Ken O'Flynn asked the Minister for Health the average cost per individual procedure funded under the treatment abroad scheme in respect of gender affirmation surgeries in each year from 2020 to 2025; the methodology used to calculate or monitor such costs; and the financial control or value-for-money mechanisms in place to assess these expenditures. [28044/26]