Pat Buckley (Cork East, Sinn Fein)
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631. To ask the Minister for Health if her Department has considered creating a statutory right to timely mental health care for children under 18. [26875/25]

Mary Butler (Waterford, Fianna Fail)
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It is a priority for me, and indeed for Government, to ensure that children who need services can access them and access them on time. This is in line with our national mental health policy Sharing the Vision, our suicide reduction strategy Connecting for Life, and the HSE Annual Service Plan 2025.

Year-on-year funding for mental health services increased from €1.3 billion announced in Budget 2024 to almost €1.5 billion in 2025. This represents a 10.7% annual increase. CAMHS nationally receives approximately €167 million annually, with a further €110 million provided to NGOs, many of which focus on youth mental health. Under Budget 2025, an additional €2.9 million will support CAMHS to increase core staffing, develop a new CAMHS Emergency Liaison Service and expand CAMHS Hubs to improve crisis cover for services.

CAMHS is a secondary care specialist service for those aged up to 18 years, who have a moderate to severe mental health difficulty. Access to CAMHS is on the basis of prioritised clinical assessment, in line with the CAMHS Operational Guidelines which are available on the HSE website. All referrals to CAMHS are assessed by a multidisciplinary team. Approximately 2% of the population require support from this specialist service with over 90% of mental health needs requiring treatment in a primary care setting.

I established the National Office for Child and Youth Mental Health in the HSE to improve leadership and all aspects of care across youth mental health. The Office published its new Youth Mental Health Action Plan in February last. This ambitious plan for comprehensive reform across all youth mental health services, including the specialist CAMHS service, will deliver services which are safer, effective, easier to access and which offers appropriate support at all levels when needed.

The three-year Plan sets out a clear roadmap for the Department and HSE to ensure children and families have equitable and timely access to high-quality mental health care, including better links with Primary Care and Disability Services, and greater use of e-mental health responses. My aim is that services will be better connected and easier to navigate, with increased focus on the rights of young people and their families.

The development of a Single Point of Access for all child and youth mental health referrals in partnership with disabilities, primary care, and voluntary and statutory agencies is a key priority within the new Action Plan. This action will ensure children and young people will have improved access to timely, integrated and appropriate mental health services through streamlined referrals and simplified care pathways which will reduce waiting lists.

I recently commenced a series of visits to all HSE Regional Health Areas to meet with the Regional Executive Officers and their staff to focus on improvements to all aspects of Youth Mental Health care, to identify areas where increased activity is needed, and also areas of innovative and positive service delivery. This includes improving access and reducing CAMHS waiting lists particularly for those waiting over 12 months. I have stressed also, the importance of filling all approved posts for each CAMHS team to ensure the effective and timely delivery of services.

The Deputy will appreciate that the provision of health and personal social care services, including entitlement as legislated for, in Ireland is governed by a wide range of Health legislation, and reflected as appropriate in various policies and services. The revision of the Mental Health Act 2001 and the development of a new Mental Health Bill is a longstanding priority of mine and features in the current Programme for Government. It is also a major component of Recommendation 92 of our national mental health policy, Sharing the Vision, and a priority project under Sláintecare.

The regulation of mental health services, adult and children, inpatient and community, is a core policy contained within the Bill. In addition, the Bill provides for an overhauled approach to mental health legislation, providing a more person-centric, human rights-based approach. A new Part of the Bill is also dedicated to the care and treatment of children and young people, which includes the presumption of capacity for young people aged 16 and 17 years to consent to or refuse admission and treatment.

In light of the above, it is not planned to progress the type of proposal raised by the Deputy.

Pat Buckley (Cork East, Sinn Fein)
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632. To ask the Minister for Health her response to recent data showing over 4,200 children on CAMHS waiting lists, with over 620 waiting longer than one year; and the policy changes she intends to pursue. [26876/25]

Mary Butler (Waterford, Fianna Fail)
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It is a priority for me, and for Government, to ensure that children who need services can access them and access them on time. This is in line with our national mental health policy Sharing the Vision, our suicide reduction strategy Connecting for Life, and the HSE Annual Service Plan 2025.

Year-on-year funding for mental health services increased from €1.3 billion announced in Budget 2024 to almost €1.5 billion in 2025. This represents a 10.7% annual increase. CAMHS nationally receives approximately €167 million annually, with a further €110 million provided to NGOs, many of which focus on youth mental health. Under Budget 2025, an additional €2.9 million will support CAMHS to increase core staffing, develop a new CAMHS Emergency Liaison Service and expand CAMHS Hubs to improve crisis cover for services.

CAMHS is a secondary care specialist service for those aged up to 18 years, who have a moderate to severe mental health difficulty. Access to CAMHS is on the basis of prioritised clinical assessment, in line with the CAMHS Operational Guidelines which are available on the HSE website. All referrals to CAMHS are assessed by a multidisciplinary team. Approximately 2% of the population require support from this specialist service with over 90% of mental health needs requiring treatment in a primary care setting.

I established the National Office for Child and Youth Mental Health in the HSE to improve leadership and all aspects of care across youth mental health. The Office published its new Youth Mental Health Action Plan in February last. This ambitious plan for comprehensive reform across all youth mental health services, including the specialist CAMHS service, will deliver services which are safer, effective, easier to access and which offers appropriate support at all levels when needed.

The three-year Plan sets out a clear roadmap for the Department and HSE to ensure children and families have equitable and timely access to high-quality mental health care, including better links with Primary Care and Disability Services, and greater use of e-mental health responses. My aim is that services will be better connected and easier to navigate, with increased focus on the rights of young people and their families. The development of a Single Point of Access for all child and youth mental health referrals in partnership with disabilities, primary care, and voluntary and statutory agencies is a key priority within the new Action Plan.

I recently commenced a series of visits to all HSE Regional Health Areas to meet with the Regional Executive Officers and their staff to focus on improvements to all aspects of Youth Mental Health care, to identify areas where increased activity is needed, and also areas of innovative and positive service delivery. This includes improving access and reducing CAMHS waiting lists particularly for those waiting over 12 months. I have stressed also, the importance of filling all approved posts for each CAMHS team to ensure the effective delivery of services.

I will, in conjunction with the HSE, continue to keep this matter under close review for the remainder of this year.

Robert Troy (Longford-Westmeath, Fianna Fail)
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633. To ask the Minister for Health if her Department will commit to providing equal access to treatment of spinal muscular atrophy for patients of all ages (details supplied). [26877/25]

Barry Ward (Dún Laoghaire, Fine Gael)
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700. To ask the Minister for Health if her attention has been drawn to the campaign by an organisation (details supplied) and other organisations in relation to the treatment of patients with SMA over the age of 18 and the inability to access treatment; and if she will make a statement on the matter. [27092/25]

Ruth Coppinger (Dublin West, Solidarity)
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777. To ask the Minister for Health if she will review the policy that excludes adults with spinal muscular atrophy from treatments that are available to those under 18; and if she will make a statement on the matter. [27628/25]

Jennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)
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I propose to take Questions Nos. 633, 700 and 777 together.

The HSE has statutory responsibility for decisions on pricing and reimbursement of medicines under the community drugs schemes, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013. Therefore, I have asked the HSE to provide an update in relation to treatments for SMA patients.

The HSE has advised that once a medicine is approved by the European Medicines Agency, the HSE is dependent on a pharmaceutical company making an application to Ireland for its drug or new indication to be assessed for reimbursement. All medicines are considered for pricing of reimbursement in order of application.

While many companies engage proactively with the HSE, Ireland, by virtue of its size and market share, may not always be prioritised by some companies in the first stages of marketing a new medicine. Reports describing timelines for reimbursement from EMA approval to HSE reimbursement approval do not consider this important factor, as statutorily the HSE are not able to add a new medicine to the reimbursement list until an application is received.

The HSE has advised that it is committed to providing access to as many medicines as possible, in as timely a fashion as possible, from the resources available (provided) to it.

The HSE must robustly assess applications for pricing and reimbursement to make sure that it can stretch available resources as far as possible and to deliver the best value in relation to each medicine and ultimately more medicines to Irish citizens and patients. HSE decisions on which medicines are reimbursed by the taxpayer are made on objective, scientific and economic grounds. There are formal processes which govern applications for the pricing and reimbursement of medicines, and new uses of existing medicines, to be funded and / or reimbursed.

In terms of the specific details of the application for pricing and reimbursement of risdiplam (Evrysdi®):

Reimbursement approval is in place for risdiplam (Evrysdi®) for the treatment of 5q spinal muscular atrophy (SMA) under the High Tech arrangements from the 1st September 2023. Reimbursement support is for a subgroup of the licensed indication.

As a condition of reimbursement, an individual patient approval system has been put in place by the HSE, to enable reimbursement for patients who meet the pre-defined criteria as per a HSE devised managed access protocol.

If the manufacturer of Risdiplam(Evrysdi® (Roche) submits a de novo application for adult patients with a clinical diagnosis of SMA Type 1, Type 2 or Type 3, that application will be duly progressed through the formal processes governing the pricing and reimbursement of medicines.

In terms of the specific details of the application for pricing and reimbursement of onasemnogene abeparvovec (Zolgensma®):

In October 2021, onasemnogene abeparvovec (Zolgensma®) was approved for reimbursement in Ireland following joint assessment and negotiations under the Beneluxa initiative for the treatment of patients with spinal muscular atrophy (SMA) with a bi-allelic mutation in the SMN1 gene and a clinical diagnosis of SMA type 1, or pre-symptomatic patients with 5q SMA with a bi-allelic mutation in the SMN1 gene and up to 3 copies of the SMN2 gene.

As a condition of reimbursement, an individual patient approval system has been put in place by the HSE, to enable reimbursement for patients who meet the pre-defined criteria as per a HSE devised managed access protocol. www.hse.ie/eng/about/who/cspd/medicines-management/managed-access-protocols/onasemnogene-abeparvovec-zolgensma/managed-access-protocol-onasemnogene-abeparvovec-zolgensma.pdf.

In terms of the specific details of the application for pricing and reimbursement of nusinersen (Spinraza®) for adult patients (>18 years):

The HSE approved funding of nusinersen (Spinraza®) effective 1st July 2019 for the treatment of 5q Spinal Muscular Atrophy (SMA) Type I, Type II and Type III in children under 18 years.

The first step in the process is the submission of a Rapid Review dossier (a clinical and economic dossier) to the National Centre for Pharmacoeconomics (NCPE) for assessment. The HSE commissioned the Rapid Review process on the 28th September 2020.

The NCPE Rapid Review assessment report was received by the HSE on the 29th October 2020. The NCPE advised the HSE that a full Health Technology Assessment (HTA) was recommended for Nusinersen (Spinraza®) to assess the clinical and cost-effectiveness compared to the current standard of care for adult patients (>18 years).

www.ncpe.ie/nusinersen-spinraza-hta-id-20044/.

The HSE commissioned a full Health Technology Assessment on the 9th November 2020 as per agreed processes.

The HSE Corporate Pharmaceutical Unit (CPU) is the interface between the HSE and the Pharmaceutical Industry in relation to medicine pricing and reimbursement applications. The CPU met with Biogen regarding their application for Nusinersen (Spinraza®).

The Drugs Group is the national committee which the HSE has in place to make recommendations on the pricing and reimbursement of medicines. The membership of the HSE Drugs Group includes public interest members. The pharmacoeconomic report will be reviewed by the HSE Drugs Group along with the outputs of commercial negotiations, and any patient group submission(s) received. The HSE Drugs Group will consider all of the evidence and make a recommendation to the HSE Senior Leadership Team.

The decision-making authority in the HSE is the HSE Senior Leadership Team. The HSE Senior Leadership Team decides on the basis of all the demands it is faced with (across all services) whether it can fund a new medicine, or new use of an existing medicine, from the resources that have been provided to it in line with the Health (Pricing and Supply of Medical Goods) Act 2013.

A completed HTA is required from the applicant (Biogen) to progress this application, as per the formal processes governing the pricing and reimbursement of medicines. In the absence of a completed HTA the pricing and reimbursement application cannot progress.

The application remains under consideration with the HSE. The HSE cannot make any comment on possible outcomes from the ongoing assessment processes.