249. Deputy Ciarán Ahern asked the Minister for Health the reason Skyclarys has not yet been approved for reimbursement despite being authorised for use by the European Medicines Agency; and if she will make a statement on the matter. [17273/26]
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 under the heading Medicinal Products.
1,228 questions match, newest first.
250. Deputy Ciarán Ahern asked the Minister for Health the specific steps being taken to ensure the HSE considers the "time-critical" nature of FA during the current price negotiations for Skyclarys; and if she will make a statement on the matter. [17274/26]
251. Deputy Ciarán Ahern asked the Minister for Health 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 the HSE’s consideration of Skyclarys, to prevent further delays; and if she will make a statement on the matter. [17275/26]
257. Deputy Catherine Ardagh asked the Minister for Health the reason all melatonin products require a prescription in Ireland; if she will consider allowing availability without prescription for products with a lower dosage of the product (details supplied) in order that it could be classified as a food supplement; and if she will make a statement on the matter. [17309/26]
260. Deputy Ryan O'Meara asked the Minister for Health if she will intervene to ensure that the HSE prioritises a conclusion to the Skyclarys reimbursement negotiations, given that it is the only available treatment for this progressive disease, which can currently be classed as having an ‘unmet need’ as outlined in the National Rare Disease Strategy 2025 – 2030; if the current delay aligns with the "equitable access…
274. Deputy Johnny Guirke asked the Minister for Health regarding the reimbursement of Skyclarys (omaveloxolone), the only approved treatment for Friedreich’s Ataxia (details supplied), the specific steps being taken to ensure the HSE considers the "time-critical" nature of FA during the current price negotiations for Skyclarys; and if she will make a statement on the matter. [17394/26]
275. Deputy Johnny Guirke asked the Minister for Health regarding the reimbursement of Skyclarys (omaveloxolone), the only approved treatment for Friedreich’s Ataxia (details supplied), 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 this specific case, to prevent further delays in …
292. Deputy Shay Brennan asked the Minister for Health the specific steps being taken to ensure the HSE considers the “time-critical” nature of FA during the current price negotiations for Skyclarys. [17453/26]
293. Deputy Shay Brennan asked the Minister for Health the commitments in the National Rare Disease Strategy 2025-2030 and the 2026 IPHA Framework Agreement (which aims for a 180-day decision timeline) which are being applied to a specific case, to prevent further delays in addressing the ‘unmet need’ with FA. [17454/26]
349. Deputy Michael Lowry asked the Minister for Health if she will intervene to ensure that the HSE prioritises a conclusion to the Skyclarys reimbursement negotiations, given that it is the only available treatment for a progressive disease (details supplied) which currently can be classed as having an ‘unmet need’ as outlined in the National Rare Disease Strategy 2025 – 2030; her views on whether the current delay…
350. Deputy Willie O'Dea asked the Minister for Health if she will provide an update on the process to allow for the reimbursement of Skyclarys, the only approved treatment for Friedreich’s Ataxia (FA); the specific steps being taken to ensure the HSE considers the "time-critical" nature of FA during the current price negotiations for Skyclarys; the way in which the commitments in the National Rare Disease Strategy 2…
812. Deputy Louis O'Hara asked the Minister for Health if the HSE has plans to reimburse omaveloxolone, a drug used to treat Friedrichs ataxia; and if she will make a statement on the matter. [16376/26]
875. Deputy Paul McAuliffe asked the Minister for Health if she will consider the inclusion of plenadren, a life-saving medication for adrenal insufficiency, under the HSE hardship fund; if she will consider the appeal case of a person (details supplied); and if she will make a statement on the matter. [16674/26]
876. Deputy Richard Boyd Barrett asked the Minister for Health if she will consider making the drug Omaveloxolone available to the approximately 200 people in Ireland currently living with Friedreich's Ataxia, given the life-changing impact this drug can have; if she will reconsider her position that the drug is not ‘economically viable’, in light of the relatively small number of people whose lives can be changed by…
899. Deputy Denise Mitchell asked the Minister for Health if consideration will be given to making the medication Skyclarys (omaveloxolone) available to Irish Friedreich’s Ataxia patients under the current drugs reimbursement process; if she recognises the clinical necessity of this request as this drug is the only proven treatment to slow the progression of this debilitating condition; and if she will make a stateme…
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…
920. Deputy John Paul O'Shea asked the Minister for Health when she intends 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. [16948/26]
921. Deputy John Paul O'Shea 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. […
931. Deputy James O'Connor asked the Minister for Health if she will outline her Department’s current position on measures to support the availability of new and existing antimicrobials in Ireland; the way in which Ireland’s approach aligns with EU level initiatives on antimicrobial resistance, including provisions under the revised EU pharmaceutical legislation; if any consideration has been given to national or EU …
932. Deputy James O'Connor asked the Minister for Health if antimicrobial resistance (AMR) will be a focus under Ireland’s health agenda during its upcoming EU Presidency; if she will outline any planned initiatives, events or policy discussions on AMR at EU level during the presidency; if she will indicate how this agenda will align with Ireland’s national AMR strategy and ongoing EU pharmaceutical reform; and if sh…
933. Deputy James O'Connor asked the Minister for Health if she will outline the approach adopted when processing medicine reimbursement applications for combination therapies for cancer patients in the public system; and if she will make a statement on the matter. [16984/26]
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]
938. Deputy Colm Burke asked the Minister for Health the approach adopted when processing medicine reimbursement applications for combination therapies for cancer patients in the public system; and if she will make a statement on the matter. [17031/26]
943. Deputy Barry Heneghan asked the Minister for Health when Skyclarys (omaveloxolone), the first approved treatment for Friedreich’s ataxia, will be made available to patients in Ireland through reimbursement; if she will prioritise the assessment and reimbursement process given the urgent clinical need for the approximately 200 people living with this progressive condition; and if she will make a statement on the …