Written Answers Nos. 510-530
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. [15811/26]
View answerUnder the Health (Pricing and Supply of Medical Goods) Act 2013, the HSE has statutory responsibility for decisions on the pricing and reimbursement of medicines and medical devices; therefore, the matter has been referred to the HSE for attention and direct reply to the Deputy.
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. [15812/26]
View answerUnder the Health (Pricing and Supply of Medical Goods) Act 2013, the HSE has statutory responsibility for decisions on the pricing and reimbursement of medicines and medical devices; therefore, the matter has been referred to the HSE for attention and direct reply to the Deputy.
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]
View answerUnder the Health (Pricing and Supply of Medical Goods) Act 2013, the HSE has statutory responsibility for decisions on the pricing and reimbursement of medicines and medical devices; therefore, the matter has been referred to the HSE for attention and direct reply to the Deputy.
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]
View answerUnder the Health (Pricing and Supply of Medical Goods) Act 2013, the HSE has statutory responsibility for decisions on the pricing and reimbursement of medicines and medical devices; therefore, the matter has been referred to the HSE for attention and direct reply to the Deputy.
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]
View answerThe State has successfully negotiated a new Agreement in Principle on the Supply and Pricing of Medicines with IPHA and MFI, which will commence from this year and last until the end of 2029. The agreement provides a commitment and a structured process towards achieving a 180-day timeline, for completing health technology assessments (HTA) and reimbursement decisions. The structured process will be implemented over the lifetime of the Agreement.
The Mazars Review published in 2023 found that Ireland’s pricing and reimbursement system was operating as intended and within international norms however a number of key recommendations were made on foot of this review.
Along with increased resourcing across the pricing and reimbursement system (34 additional staff now hired) the development of a tracker was recommended to increase transparency for all stakeholders and subsequently launched in 2024. The HSE will continue the tracker’s development with the introduction of indicative timelines for each step of a medicine’s assessment process.
In terms of the pricing and reimbursement applications for tirzepatide (Mounjaro®), Under the Health (Pricing and Supply of Medical Goods) Act 2013, the HSE has statutory responsibility for decisions on the pricing and reimbursement of medicines and medical devices; therefore, the matter has been referred to the HSE for attention and direct reply to the Deputy.
515. Deputy Pádraig Rice asked the Minister for Health to outline how often the HSE’s National Women and Infants Health Programme meet; for an update on the application of a specific centre under the Endometriosis Surgery Abroad Interim Scheme (detailed supplied); and if she will make a statement on the matter. [15828/26]
View answerAs this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.
516. Deputy Michael Cahill asked the Minister for Health in addition to staff being transferred from Killarney District Hospital, how many new jobs will be created in the new Killarney Community Hospital, when will they be advertised; and will the Minister give a breakdown of how many under each category will be advertised; and if she will make a statement on the matter. [15829/26]
View answerAs this is a recruitment issue we have asked the HSE to respond directly to the Deputy.
517. Deputy Peter 'Chap' Cleere asked the Minister for Health when the new development in St. Columba's Hospital will be open and operational; and if she will make a statement on the matter. [15831/26]
View answerAs the Health Service Executive is responsible for the delivery of the public healthcare infrastructure projects, I have asked the HSE to respond to you directly in relation to this matter.
518. Deputy Ken O'Flynn asked the Minister for Health whether the provision of direct Exchequer funding by her Department to any non-statutory body is conditional upon the recipient maintaining a formally adopted safeguarding policy; a designated safeguarding officer; written mandatory reporting procedures in respect of safeguarding concerns; compliance with obligations under the Children First Act 2015 where applicable; and periodic certification or attestation of safeguarding compliance to her Department; the statutory, contractual or administrative basis for any such requirements; the monitoring and verification mechanisms operated by her Department to ensure compliance; and whether any funding has been suspended, withheld, reduced or subject to clawback in the past five years on grounds of safeguarding non-compliance. [15846/26]
View answerAs this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.
519. Deputy Ken O'Flynn asked the Minister for Health whether her Department maintains a central register or consolidated oversight framework identifying all non-statutory bodies in receipt of direct Exchequer funding; whether that register records safeguarding compliance status, including the existence of safeguarding policies, designated safeguarding officers and reporting procedures; whether her Department requires annual safeguarding compliance declarations from such bodies; and if she will provide the number of directly funded non-statutory bodies in each of the years 2022, 2023, 2024 and 2025, together with details of any compliance reviews, audits or inspections undertaken by her Department in respect of safeguarding governance during that period. [15847/26]
View answerAs this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.
520. Deputy Ken O'Flynn asked the Minister for Health whether she has received the completed report of the expert clinical group examining the implications for Ireland of the Cass Review; on what date it was received by her Department or the HSE CEO; whether she has requested a copy; whether she intends to publish the report in full; if not, the statutory or policy basis for withholding publication; and if she will make a statement on the matter. [15848/26]
View answerI propose to take Questions Nos. 520 and 612 together.
The Cass Report has been reviewed by clinical experts within the HSE at the request of the Chief Clinical Officer and the review is currently under consideration by the HSE.
The provision of proper, appropriate, and integrated gender healthcare services is something that I want to ensure is in place for those who are questioning their gender identity or are experiencing gender incongruence or dysphoria.
As per the Programme for Government 2025, the Government is committed to ensuring a transgender healthcare service based on clinical evidence, respect, inclusiveness, and compassion.
A clinical programme for gender healthcare has been initiated by the HSE and an updated clinical model for gender healthcare services is being developed. The Clinical lead is in place and recruitment is ongoing for the rest of the multi-disciplinary team.
Developing a Model of Care for Gender Healthcare Services is expected to be a complex process and the HSE and my department will work closely together to support the process, ensure transparency and keep the patient at the centre of the process.
It is important that the HSE is given time to develop a Model of Care that is based on the best clinical evidence and that will deliver the best outcomes for persons with gender incongruence or dysphoria. It is not possible to pre-empt the outcome of this process by determining at this stage what this model of care will look like once developed.
Regarding the HSE review of the Cass report, this was a specific and defined piece of work that was independent of the planned update of the HSE Clinical Model of Care for Gender Healthcare. It is the Model of Care that will ultimately make recommendations on the delivery of gender healthcare services in the HSE, for both adults and young people.
521. Deputy Ken O'Flynn asked the Minister for Health the formal interim clinical governance framework, written safeguards, or ministerial policy directions are currently in force governing the provision of gender-related healthcare services to children and adolescents pending completion of the updated National Model of Care; whether any elements of clinical practice have been paused, amended or restricted during this interim period; and if she will make a statement on the matter. [15849/26]
View answerAs this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.
522. Deputy Ken O'Flynn asked the Minister for Health whether her Department or the HSE has approved or mandated a national data collection framework, minimum dataset, or outcome monitoring system for gender identity services for children and young people; if not, when such a framework will be introduced; and how clinical outcomes, adverse events and long-term follow-up are currently monitored at national level. [15850/26]
View answerAs this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.
523. Deputy Ken O'Flynn asked the Minister for Health whether a formal methodological review, evidence appraisal, or structured policy evaluation of international clinical guidance, including the WPATH Standards of Care, was undertaken between 2018 and 2023 prior to adoption or application within Irish healthcare services; if so, to provide the title and date of such review; and if not, to explain the basis upon which those standards informed Irish clinical practice. [15851/26]
View answerAs this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.
524. Deputy Ken O'Flynn asked the Minister for Health the date on which the expert clinical group report examining the implications for Ireland of the Cass review was submitted to the HSE chief executive officer; whether the report has been furnished to her Department; whether she has received or reviewed the report; whether she intends to publish the report in full; and if she will make a statement on the matter. [15852/26]
View answerThe Cass Report has been reviewed by clinical experts within the HSE at the request of the Chief Clinical Officer and the review is currently under consideration by the HSE.
The provision of proper, appropriate, and integrated gender healthcare services is something that I want to ensure is in place for those who are questioning their gender identity or are experiencing gender incongruence or dysphoria.
As per the Programme for Government 2025, the Government is committed to ensuring a transgender healthcare service based on clinical evidence, respect, inclusiveness, and compassion.
A clinical programme for gender healthcare has been initiated by the HSE and an updated clinical model for gender healthcare services is being developed. The Clinical lead is in place and recruitment is ongoing for the rest of the multi-disciplinary team.
Developing a Model of Care for Gender Healthcare Services is expected to be a complex process and the HSE and my department will work closely together to support the process, ensure transparency and keep the patient at the centre of the process.
It is important that the HSE is given time to develop a Model of Care that is based on the best clinical evidence and that will deliver the best outcomes for persons with gender incongruence or dysphoria. It is not possible to pre-empt the outcome of this process by determining at this stage what this model of care will look like once developed.
Regarding the HSE review of the Cass report, this was a specific and defined piece of work that was independent of the planned update of the HSE Clinical Model of Care for Gender Healthcare. It is the Model of Care that will ultimately make recommendations on the delivery of gender healthcare services in the HSE, for both adults and young people.
525. Deputy Ken O'Flynn asked the Minister for Health the formal interim clinical governance arrangements, safeguards, or policy instructions currently apply to gender healthcare services for children and adolescents pending completion of the updated national Model of Care; whether any written direction, circular, or instruction has issued since publication of the Cass review; and if she will make a statement on the matter. [15853/26]
View answerAs this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.
526. Deputy Ken O'Flynn asked the Minister for Health to specify the statutory authority, national clinical guideline, or formally approved policy framework under which gender healthcare services for minors are currently delivered within the public health system; the date on which that framework was approved; and if she will make a statement on the matter. [15854/26]
View answerAs this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.
527. Deputy Ken O'Flynn asked the Minister for Health whether her Department has approved a national dataset, reporting framework, or outcome measurement standard for gender identity services provided to children and adolescents; if not, when such a framework is expected to be established; and if she will make a statement on the matter. [15855/26]
View answerAs this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.
528. Deputy Ken O'Flynn asked the Minister for Health to outline the formal methodology used by her Department and the HSE when evaluating international clinical guidance prior to consideration or incorporation into national healthcare policy; whether that methodology was applied in respect of the WPATH Standards of Care between 2018 and 2023; and if she will make a statement on the matter. [15856/26]
View answerAs this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.
529. Deputy Ken O'Flynn asked the Minister for Health whether any formal clinical risk assessment, patient safety review, or governance audit has been undertaken since publication of the final Cass review in respect of gender healthcare services for children and adolescents; and if she will make a statement on the matter. [15857/26]
View answerAs this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.
530. Deputy Ken O'Flynn asked the Minister for Health whether, under the Health Service Executive National Service Plan 2026 approved by her, her Department requires the HSE to collect, retain and report to the Department the number and percentage of clinical status 1 purple and red emergency calls in which the ambulance response time exceeded 30 minutes, 45 minutes, 60 minutes and 90 minutes in each of the years 2023, 2024 and 2025; if such reporting is not currently mandated, whether she will amend the 2026 or subsequent National Service Plan to require same; and if she will make a statement on the matter. [15858/26]
View answerAs this is a service matter, it has been referred to the Health Service Executive for attention and direct reply to the Deputy.
