Medicinal Products

1184. Deputy Martin Daly asked the Minister for Health if she will intervene to ensure that the Health Service Executive urgently prioritises the conclusion of reimbursement negotiations for skyclarys for the treatment of Friedreich’s ataxia, given that it is currently the only available treatment for this progressive and life-limiting rare disease and that Friedreich’s ataxia may be considered as…

1185. Deputy Martin Daly asked the Minister for Health her views on whether the ongoing delay in concluding reimbursement negotiations for skyclarys for patients with Friedreich’s ataxia is consistent with the commitment to “equitable access” set out in the recently launched National Rare Disease Strategy 2025–2030; and if she will make a statement on the matter. [30202/26]

1274. Deputy Roderic O'Gorman asked the Minister for Health the reason imvaggis is not covered by the free HRT scheme; if consideration can be given to its inclusion in the scheme; and if she will make a statement on the matter. [30897/26]

1276. Deputy Pádraig O'Sullivan asked the Minister for Health whether her Department has identified which of the medicines currently in shortage across the European Union may pose a risk of shortage in Ireland; the measures in place to ensure continuity of supply and minimise patient impact; and if she will make a statement on the matter. [30904/26]

1278. Deputy Cormac Devlin asked the Minister for Health if she will provide an update on the NCPE appraisal of ritlecitinib (litfulo) for severe alopecia areata, including current stage, any ongoing HSE pricing and reimbursement engagement with the applicant, expected timelines for a decision, and proposed prescribing setting if approved (details supplied); and if she will make a statement on the…

1279. Deputy Cormac Devlin asked the Minister for Health if an application has been received by the HSE for pricing and reimbursement of baricitinib for the alopecia areata indication; if not, whether the HSE or her Department has engaged with the marketing authorisation holder regarding a submission (details supplied); and if she will make a statement on the matter. [30915/26]

1280. Deputy Cormac Devlin asked the Minister for Health whether her Department, the HSE or the HPRA has engaged with the manufacturer of deuruxolitinib (leqselvi) regarding plans for EU submission and availability in Ireland; whether any named-patient or compassionate access requests have been received (details supplied); and if she will make a statement on the matter. [30916/26]

1281. Deputy Cormac Devlin asked the Minister for Health if she will outline whether JAK inhibitor treatments for severe alopecia areata, where reimbursed, will be provided via the High Tech Arrangement; the intended initiation and monitoring setting; the proposed stop rules; the estimated annual budget impact and eligible patient numbers (details supplied); and if she will make a statement on the…

1282. Deputy Cormac Devlin asked the Minister for Health the number of patients treated for alopecia areata with JAK inhibitors in public hospitals in each of the past three years, by CHO and by medicine, including any named-patient access, and associated monitoring protocols; and if she will make a statement on the matter. [30918/26]

554. Deputy Gillian Toole asked the Minister for Health the reason drug companies are indemnified if vaccines are presented to the public as being safe and effective. [29477/26]

558. Deputy Gillian Toole asked the Minister for Health the reason drug companies indemnified are if vaccines are presented to the public as being safe and effective. [29492/26]

565. Deputy Eoghan Kenny asked the Minister for Health if her Department has considered the inclusion of skyclarys (omaveloxolone) which is a treatment for Friedreich's ataxia in a reimbursement scheme given the cost of the drug and the fact that other European countries provide this scheme to patients; and if she will make a statement on the matter. [29555/26]

221. Deputy Niamh Smyth asked the Minister for Health if she will review matters raised in correspondence (details supplied); if she will provide an update on the HSE's decision regarding the reimbursement of skyclarys for the treatment of Friedreich's ataxia; if she will note that 619 days have elapsed since the application for reimbursement was submitted by the pharmaceutical company; the timeli…

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]

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]

129. Deputy Marie Sherlock asked the Minister for Health the steps her Department is taking to urgently regulate the administration of dermal fillers as committed to in the programme for Government; when such regulation or legislation will be introduced; if she and her Department will engage with stakeholders regarding the best way to protect the public; if her Department received research from th…

149. Deputy Catherine Callaghan asked the Minister for Health for an update on the measures being taken to provide treatments such as skyclarys (omaveloxolone) to patients with Friedrich's ataxia in Carlow and Kilkenny, and across the country; and if she will make a statement on the matter. [28381/26]

183. Deputy Aindrias Moynihan asked the Minister for Health the measures being taken by the Health Products Regulatory Authority to control the illegal sales of prescription medications; and if she will make a statement on the matter. [28385/26]

184. Deputy David Cullinane asked the Minister for Health if she will review the approval process for reimbursement of orphan medicines; her plans for providing access to life changing, high cost medical products for people with rare diseases who currently cannot access medicines which have regulatory approval but do not have a reimbursement arrangement; and if she will make a statement on the mat…

190. Deputy Shay Brennan asked the Minister for Health if her Department has assessed the potential national cost savings associated with weight based dosing of pembrolizumab (keytruda), in light of the Cork University Hospital study indicating a saving of €635,417.50 for 28 patients over two years. [28352/26]

207. Deputy Micheál Carrigy asked the Minister for Health for an update on the price negotiations regarding Skyclarys; the steps being taken to support those with Friedrich’s ataxia in the time critical interim; and if she will make a statement on the matter. [28226/26]

211. Deputy Shay Brennan asked the Minister for Health the mechanisms that are in place to ensure that high cost oncology medicines are prescribed in the most cost effective manner without compromising patient outcomes. [28353/26]

732. Deputy John Connolly asked the Minister for Health the reason long-term cancer medications, including hormone therapies used in cancer treatment and recurrence prevention, are not currently covered under the long-term illness scheme; whether consideration is being given to extending eligibility under the scheme to include such medications for cancer patients; whether consideration has been gi…

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…