Written Answers Nos. 754-768
754. Deputy Pádraig O'Sullivan asked the Minister for Health if he could outline the extent of his Department and agencies under the remit of his Department have engaged with stakeholders regarding the implementation of the EU HTA regulation; and if he will make a statement on the matter. [33835/23]
View answer757. Deputy Pádraig O'Sullivan asked the Minister for Health to provide an update on the EU HTA regulation, his views on the value of the regulation; if he could outline the likelihood that efficiencies will arise from its implementation that may improve the assessment and reimbursement timelines in Ireland; and if he will make a statement on the matter. [33838/23]
View answer758. Deputy Pádraig O'Sullivan asked the Minister for Health whether his Department is preparing any amendments to the Health Act (Supply of Medical Goods) 2013 on foot of the EU HTA regulation; and if he will make a statement on the matter. [33839/23]
View answerI propose to take Questions Nos. 754, 757 and 758 together.
Health technology assessment (HTA) is a multidisciplinary process that summarises information about the medical, social, economic, and ethical issues related to the use of a health technology. Examples of health technologies include medicinal products, medical equipment, diagnostic and treatment methods, rehabilitation, and prevention methods. Its aim is to inform the formulation of safe and effective health policies, investment and reimbursement decisions that are patient focused and seek to achieve best value.
In Ireland, two agencies are primarily responsible for undertaking HTAs. The Health Information and Quality Authority (HIQA) undertakes HTA relating to medical devices/health technologies and the National Centre for Pharmacoeconomics (NCPE) undertakes HTA relating to medicinal products. The Department engages with relevant stakeholders with regards to HTA and implementation of Regulation (EU) 2021/2282 on HTA.
The Health Technology Assessment Regulation (HTAR) entered into force in January 2022 and will fully apply as of January 2025. Its purpose is to strengthen the quality of HTA in the European Union and ensure efficiency in the evaluation of new medicines and technologies in a consistent way across member states. The initial implementation from 2025 to 2027 will include medicinal products for oncology and advanced therapeutic medicinal products.
The HTAR contributes to improving the availability for EU patients of innovative technologies in the area of health, such as medicines and certain medical devices. It ensures an efficient use of resources and strengthens the quality of HTA across the EU. It provides a transparent and inclusive framework by establishing a Coordination Group of HTA national or regional authorities, a stakeholder network and by laying down rules on the involvement in joint clinical assessments and joint scientific consultations of patients, clinical experts and other relevant experts.
The HTAR will also reduce duplication of efforts for national HTA authorities and industry, facilitate business predictability and ensure the long-term sustainability of EU HTA cooperation.
Ireland has played a significant role to date both in the implementation through the consortium of EUnetHTA21 and the established HTAR Coordination Group. EUnetHTA21 was tasked by the European Commission (EC) with producing the procedures and guidelines to enable a smooth implementation. Experts from Ireland’s National Centre for Pharmacoeconomics (NCPE) were one of the most prominent contributors to this work.
Following the establishment of the HTA Coordination Group in 2022, which is the main governance body established under the HTA legislation, the NCPE’s Head of HTA Strategy and External Engagement was elected by other Member States as the Chair of the group. Ireland is now represented on the two configurations of the Co-ordination Group medicinal products and medical devices (and invitro diagnostic medical devices) and on all subgroups which are part of the HTAR governance structure.
The NCPE and HIQA are in the process of reviewing local procedures for any adaptations that are required to further enable the smooth implementation of the outputs of the HTAR. It is noted that the HTAR outputs will be a Joint Clinical Assessment report which will clearly outline the evidence and limitations for technologies relative to what is used in practice. Decisions in relation to reimbursement of technologies remain a national competency. In addition, early advice will be provided to Health Technology Developers on what evidence will be needed when they reach the stage of Joint Clinical Assessment.
Ireland will be part of an information day with its Beneluxa partners which aims to provide relevant information on the HTAR to stakeholders within those Member States of Beneluxa. In addition, the NCPE have in both 2021 and 2022 provided an update to stakeholders at the annual symposium attended by stakeholders including members from the pharmaceutical industry, patient representatives, and clinical experts.
The Department has also recently engaged with the European Commission to provide nominations to the Committee on HTA. This committee will further assist the Commission in the implementation of the Regulation.
The Department will continue to engage with experts from the NCPE and HIQA to progress implementations of the EU HTA Regulation and its application to Ireland.
755. Deputy Pádraig O'Sullivan asked the Minister for Health the level of drawdown on the €30 million announced for new medicines as part of Budget 2022, inclusive of acute spending and described on an in-year basis; and if he will make a statement on the matter. [33836/23]
View answerAs this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.
756. Deputy Pádraig O'Sullivan asked the Minister for Health if he could outline to what extent the work of the NCPE is subject to audit and review; how many audits have been carried out on the work of the NCPE; whether or not any third party has reviewed any NCPE output; and if he will make a statement on the matter. [33837/23]
View answerThe NCPE was subject to audit in 2019 as part of a review commissioned by the Department of Health and conducted by Mazars examining the governance arrangements to support the HSE’s drug reimbursement process. In relation to staffing and governance the report highlighted that: “As their roles are so specialist, we reviewed the qualifications of the staff at the NCPE. We noted that the assessors in the NCPE have all completed or are in the process of completing a PHD programme in Pharmacoeconomics. This is a highly unique skill set and these individuals are highly valuable to this process. The calibre of the staff resources employed in the NCPE is testament to the strong governance in this process”.
The NCPE is involved in multiple international collaborations and has completed two joint Health Technology Assessments (HTAs), Zolgensma® and Libmeldy®, as part of the Beneluxa Initiative. Collaboration on HTA requires that there is a peer review process. The NCPE contribution to the Joint Assessments is reviewed by HTA experts from other countries.
The NCPE is highly regarded internationally and is playing a leading role in three international initiatives: the Beneluxa Initiative, International Horizon Scanning Initiative, and the European HTA Regulation. The Regulation on HTA entered into force in January 2022 and will fully apply as of January 2025. Its purpose is to strengthen the quality of HTA in the European Union and ensure efficiency in the evaluation of new medicines and technologies in a consistent way across member states. The HTA Coordination Group is the main governance body established under the HTA legislation and under which Joint Clinical Assessments and Joint Scientific Consultations for both pharmaceutical technologies and medical devices will be undertaken following established methodological procedures. The NCPE’s Head of HTA Strategy and External Engagement is the Chair of this Group.
All NCPE HTAs are disseminated to the HSE’S Chief Clinical Officer on completion. Therefore, there is full oversight of all HTAs completed by the NCPE.
759. Deputy David Cullinane asked the Minister for Health the number of intensive homecare packages delivered in 2020, 2021, 2022 and to date in 2023, by CHO, in tabular form; the number of hours sought; the number of hours funded; and the funding allocated and spent in each year. [33841/23]
View answerAs these are operational matters, I have asked the Health Service Executive to respond to the deputy directly, as soon as possible
760. Deputy David Cullinane asked the Minister for Health the number of homecare packages delivered in 2020, 2021, 2022 and to date in 2023, by CHO, in tabular form; the number of hours sought; the number of hours funded; and the funding allocated and spent in each year. [33842/23]
View answerAs these are operational matters, I have asked the Health Service Executive to respond to the deputy directly, as soon as possible
761. Deputy David Cullinane asked the Minister for Health the number of people currently in receipt of the maximum hours of intensive homecare; the number of people in receipt of their full allocation; and the number of people not in receipt of their full allocation. [33843/23]
View answerAs these are operational matters, I have asked the Health Service Executive to respond to the deputy directly, as soon as possible
762. Deputy David Cullinane asked the Minister for Health the manner by which a person may apply for an intensive homecare package; and the maximum number of hours that may be allocated to a single individual. [33844/23]
View answerAs these are operational matters, I have asked the Health Service Executive to respond to the deputy directly, as soon as possible
763. Deputy Michael Healy-Rae asked the Minister for Health if an appointment for a person (details supplied) will be expedited; and if he will make a statement on the matter. [33846/23]
View answerAs this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.
764. Deputy Colm Burke asked the Minister for Health when he will publish the review of cardiac services in Ireland; and if he will make a statement on the matter. [33861/23]
View answerThe aim of the Cardiac Services Review is to recommend configuration for a national adult cardiac service to achieve optimal patient outcomes at population level with particular emphasis on the safety, quality and sustainability of the services that patients receive. This aligns with the Sláintecare reform programme. In terms of scope, the National Review covers scheduled and unscheduled hospital-based services for the diagnosis and treatment of cardiac disease in adults.
The Report is now finalised and is being prepared currently for my consideration. The Reviews recommendations will inform the future provision of cardiac services nationally
765. Deputy Colm Burke asked the Minister for Health to confirm that he will work towards publishing a new cardiovascular strategy, which Ireland has been without since 2019; and if he will make a statement on the matter. [33862/23]
View answerThe cardiovascular policy, “Changing Cardiovascular Health 2010-2019”, built on the first national cardiovascular health strategy, entitled “Building Healthier Hearts” (Department of Health 1999). The reorganisation of care was reflected in the national cardiovascular strategy in 2010 which proposed the centralisation of cardiovascular services in order to maximise access, expertise and population coverage which formed part of the consideration of the current National Review of Specialist Cardiac Services (NRCS).
The NRCS commenced in January 2018 under the Chairmanship of Professor Phillip Nolan and a Steering Group formed from nominations of interested stakeholders representing medical, professional/technical staff, nursing and patient representatives.
The aim of the Review is to recommend configuration for a national adult cardiac service to achieve optimal patient outcomes at population level with particular emphasis on the safety, quality and sustainability of the services that patients receive. This aligns with the Sláintecare reform programme. In terms of scope, the National Review covers scheduled and unscheduled hospital-based services for the diagnosis and treatment of cardiac disease in adults. The NRCS will inform recommendations for specialist cardiac services nationally. The Review is a key enabler for future policy and its recommendations will inform the future provision of services.
766. Deputy Colm Burke asked the Minister for Health to confirm that he will work towards the establishment of an early detection programme for people at risk of structural heart disease; and if he will make a statement on the matter. [33863/23]
View answerThe National Review of Specialist Cardiac Services commenced in January 2018 under the Chairmanship of Professor Phillip Nolan and a Steering Group formed from nominations of interested stakeholders representing medical, professional/technical staff, nursing and patient representatives.
The aim of the Cardiac Services Review is to recommend configuration for a national adult cardiac service to achieve optimal patient outcomes at population level with particular emphasis on the safety, quality and sustainability of the services that patients receive. This aligns with the Sláintecare reform programme. In terms of scope, the National Review covers scheduled and unscheduled hospital-based services for the diagnosis and treatment of cardiac disease in adults which includes structural heart disease.
The Report is now finalised and is being prepared currently for my consideration. The Reviews recommendations will inform the future provision of cardiac services nationally.
767. Deputy Colm Burke asked the Minister for Health if he will confirm that funding from the EU4Health Joint Action on diabetes and cardiovascular disease will be utilised to establish a pilot early detection programme for structural heart disease; and if he will make a statement on the matter. [33864/23]
View answerThe Department participates actively in the EU4Health Steering Group and Programme Committee, and together with its aegis bodies including the Health Service Executive (HSE) and Health Research Board (HRB), works to bring possible support measures under EU4Health to the attention of health authorities and eligible stakeholders.
Ireland joined a European consortium to prepare and apply for the direct grant to Member States on the prevention of NCDs. This application was submitted on the 15th of February and is now under review by the European Health and Digital Executive Agency (HaDEA), the results of which are expected July/August.
The joint action(s) on CVD and diabetes (JACARDI) supports the policy objective of reducing the burden of NCDs and implements the EU4Health Programme’s general objective of improving and fostering health in the Union. It aligns with our Sláintecare Reform Programme which is driving new investments in chronic disease management and CVD prevention.
Ireland is in the process of finalising the detail of our CVD priorities and we have undertaken a National Review of our cardiac services looking CVD prevention and related risk factors. The Review has identified innovative practices, including CVD screening, early diagnosis (which include structural heart disease) and CVD prevention which exemplify best practice for chronic disease management and care of older people, and empowers individuals to take charge of their own health care. The projects identified include an equity dimension aimed at reducing health inequalities. These practices align with the activities to be funded under JACARDI.
Once the EU grant agreement is finalised the expected start date for the identified projects is Sept/Oct 2023.
768. Deputy Holly Cairns asked the Minister for Health if his attention has been drawn to the financial and staffing difficulties currently experienced by private and voluntary nursing homes, including at a location (details supplied), under the fair deal scheme; and the measures his Department is taking to prevent further closures of private and voluntary nursing homes. [33872/23]
View answerFair Deal was designed to protect and support vulnerable older people, to ensure equal access to nursing home care based on what they could afford. This gives certainty to people and families. Government funding for Fair Deal is to support vulnerable older people at a time in their lives where full-time care is essential.Options to provide additional support to nursing homes are being explored, such as to help with the often costly nature of compliance for nursing homes under necessary HIQA regulations. I expect that proposed options in relation to this matter will be before me by the end of the year, though they are currently in the early stages of development.The Government is conscious of the financial challenges faced by the nursing home sector, especially smaller and voluntary nursing homes that may not have access to the same economies of scale as larger homes or groups. The Government has provided substantial support to the private and voluntary nursing home sector over the course of the pandemic. Over €150m of financial support has been provided to private and voluntary nursing homes through the COVID-19 Temporary Assistance Payment Scheme (TAPS) and the provision of free PPE and oxygen to private nursing homes continues, costing over €77 million to date.A new €10 million scheme (TIPS) was established last year to support private and voluntary nursing homes with increases in energy costs, covering 75% of year-on-year cost increases up to a monthly cap of €5,250 per nursing home. Following a recent review this scheme was extended for a second time to the end of June 2023.Budget 2023 saw an over €40 million in additional funding for the Nursing Home Support Scheme (NHSS) which will provide for an uplift in the maximum prices chargeable by private and voluntary nursing homes, as negotiated. Anyone who has had a scheduled renegotiation of their Deed of Agreement this year with the NTPF has seen a significant uplift. I am conscious of private and voluntary nursing homes that are not scheduled to renegotiate their Deed of Agreement in 2023 and other options are being considered. One of the options under consideration is for nursing home providers to agree to a shorter contract duration with the NTPF.Important strands of reform to the nursing home sector are being, or have been, brought forward. The Government remains committed to delivering on: •The nine recommendations that emerged from the Value for Money Review on Nursing Home Costs,•The 86 recommendations of COVID-19 Nursing Homes Expert Panel, especially those recommendations related to long-term sectoral reform, and•The four recommendations of the NTPF Review of Pricing System for Long Term Residential Care Facilities,Work continues within the Department of Health to deliver on all of these recommendations, as well as analysing the outcomes of the Skills Mix and Safe Staffing pilots which will serve to inform future policy.Given the size, complexity and cost of the NHSS, implementation is complex and any changes in policy direction need to be carefully assessed and kept under review. The Department of Health is consistently seeking to identify improvements and introduce enhancements to the scheme, where feasible, which aims to ensure that long-term nursing home care is sustainable, accessible and affordable for everyone and that people continue to be cared for in the most appropriate settings.In respect of staffing, to examine and address the significant workforce challenges in the homecare and nursing home sectors in Ireland, I established a cross-departmental Strategic Workforce Advisory Group (SWAG) in March 2022. The group was charged with identifying strategic workforce challenges in publicly and privately provided front-line carer roles in home support and nursing homes and with developing recommendations. Their report was published in October 2022 with 16 recommendations. I strongly endorse the Advisory Group’s recommendations. Implementation of the 16 recommendations is underway and is being overseen by a cross departmental implementation group, chaired by the Department of Health. One recommendation is fully delivered and 4 others at an advanced stage. Recommendation 9 has been implemented. The statutory instrument authorising the issuance of 1,000 employment permits for homecare workers was signed on 16th December 2022. As recommended by the Advisory Group, these permits will be for full-time positions with a minimum salary of €27,000 per year.
