Medicinal Products

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 liv…

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…

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 mak…

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 o…

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 statem…

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 give…

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 pharmaceutic…

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…

945. Deputy Joe Cooney asked the Minister for Health the reasons the drug acarizax is not included in either the medical card scheme or the drugs payment scheme; if she will consider the inclusion of the drug; and if she will make a statement on the matter. [17057/26]

949. Deputy John Lahart asked the Minister for Health the approval process for bempedoic acid (nilemdo) under the drugs payment scheme; the reason for delays in processing individual applications for this medication; if she will ensure that applicants who have exceeded the monthly DPS threshold while awaiting approval will be reimbursed in full; and if she will make a statement on the matter. [170…

951. Deputy Cian O'Callaghan asked the Minister for Health if she will commit to prioritising the reimbursement process for omaveloxolone to ensure that it is made available to the approximately 200 people in Ireland living with Friedreich’s ataxia; if she recognises the clinical necessity of this treatment for a community that currently has no other therapeutic options; and if she will make a sta…

959. Deputy John McGuinness asked the Minister for Health if versatis pain patches will be made available to a person (details supplied); and if she will make a statement on the matter. [17156/26]

966. Deputy John Brady asked the Minister for Health for an update on the use of the drug xolair for allergies; the status of applications to the HSE to fund the use of this drug in limited circumstances for allergies; and if she will make a statement on the matter. [17186/26]

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 eit…

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 ba…

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 ha…