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]
Parliamentary questions
Questions
TDs ask ministers questions to get answers on the record, most of them in writing. Here is every one asked in the 34th Dáil, by the department it went to and the subject heading it was filed under. How questions work
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Showing questions asked by Ken O'Flynn under the heading Medicinal Products.
196 questions match, newest first.
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 disruptions. [20306/26]
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 for managing such ri…
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 the Health Service Exe…
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 exists, to provide t…
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 will make a statemen…
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 statement on the matter…
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 preventive medicines; and if …
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 make a statement on t…
917. Deputy Ken O'Flynn asked the Minister for Health the date on which the review of the medicines reimbursement process, as committed to in the Programme for Government, will commence; whether terms of reference has been agreed; whether those terms will explicitly include the assessment and reimbursement framework for orphan medicines; when the review is expected to conclude; and if she will make a statement on the…
918. Deputy Ken O'Flynn asked the Minister for Health in light of Rare Disease Day taking place on 28 February, if she will commit to introducing an early access scheme in Ireland for people living with rare diseases to access EMA-approved orphan medicines; if such an early access scheme will include orphan medicines products licenced for non-oncology conditions; and if she will make a statement on the matter. [16944…
934. Deputy Ken O'Flynn asked the Minister for Health her plans to commence a review of the reimbursement process, as committed to in the Programme for Government; whether such a review will specifically include the way in which orphan medicines are assessed and reimbursed; and if she will make a statement on the matter. [16987/26]
510. Deputy Ken O'Flynn asked the Minister for Health the incremental cost-effectiveness ratio, cost per QALY gained, time horizon applied, and discount rate used in the full health technology assessments conducted by the National Centre for Pharmacoeconomics in respect of tirzepatide for type 2 diabetes mellitus and weight management; and whether lifetime modelling assumptions were applied in either assessment. [158…
511. Deputy Ken O'Flynn asked the Minister for Health whether the health technology assessments conducted in respect of tirzepatide included modelling of downstream healthcare cost offsets arising from reductions in incidence of type 2 diabetes; cardiovascular events; hospital admissions; and obesity-related complications; and to provide the percentage reductions assumed in each case within the base-case analysis. [1…
512. Deputy Ken O'Flynn asked the Minister for Health the projected gross and net annual budget impact, and five-year cumulative budget impact, of reimbursement of tirzepatide for weight management under the current eligibility criteria outlined by the HSE; and the estimated eligible patient population used in the budget impact model. [15813/26]
513. Deputy Ken O'Flynn asked the Minister for Health whether one-way or probabilistic sensitivity analyses were conducted as part of the pharmacoeconomic evaluations of tirzepatide and semaglutide; and if so, the key variables identified as having the greatest impact on cost-effectiveness outcomes. [15814/26]
514. Deputy Ken O'Flynn asked the Minister for Health the reasons for the duration between commissioning and completion of the full health technology assessment of tirzepatide for type 2 diabetes; and whether her Department has conducted any review of timelines in the medicines assessment process since 2023. [15815/26]
548. Deputy Ken O'Flynn asked the Minister for Health further to Parliamentary Question No. 315 of 11 February 2025, and noting that the National Centre for Pharmacoeconomics completed a full health technology assessment of tirzepatide for the treatment of adults with insufficiently controlled type 2 diabetes mellitus on 9 February 2026, and for weight management on 3 December 2025, whether she has been notified of t…
549. Deputy Ken O'Flynn asked the Minister for Health whether her Department or the HSE has prepared or received any gross and net budget impact analysis in respect of the proposed reimbursement of tirzepatide and semaglutide for diabetes and weight management indications; the estimated annual gross cost to the Exchequer in each of the first five years of potential reimbursement; any estimated downstream cost offsets…
550. Deputy Ken O'Flynn asked the Minister for Health the estimated number of adults nationally who meet the clinical eligibility thresholds outlined in the completed HTAs for tirzepatide for diabetes and weight management indications; the estimated number of adolescents who would meet the subpopulation criteria proposed for semaglutide reimbursement; whether her Department has been advised of projected uptake rates;…
551. Deputy Ken O'Flynn asked the Minister for Health whether her Department has undertaken any comparative assessment of the timeframe from marketing authorisation to reimbursement decision for GLP-1 receptor agonists in Ireland relative to other EU Member States; whether she considers the current pharmacoeconomic assessment and negotiation timeline proportionate to the scale of the public health burden posed by obe…