Barry Heneghan (Dublin Bay North, Independent)
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550. To ask the Minister for Health if she will consider establishing an integrated care model for children with palliative care needs that would consolidate appointments and reduce the administrative workload on families, as survey data (details supplied) indicate that families are spending an average of 17.5 hours per week on related tasks and attending as many as 120 appointments annually; and if she will make a statement on the matter. [28560/25]

Barry Heneghan (Dublin Bay North, Independent)
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551. To ask the Minister for Health the targeted supports are in place to address the emotional and psychological strain experienced by parents providing full-time palliative care to children, particularly in light of survey findings (details supplied) which show high levels of isolation, exhaustion, and sleep deprivation among carers; and if she will make a statement on the matter. [28561/25]

Jennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)
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I propose to take Questions Nos. 550 and 551 together.

I would like to acknowledge the burden of care on families and carers of children with life limiting conditions. The government will continue to prioritise our children’s palliative care services, working towards the highest possible quality of end-of-life care and support for children with life limiting illnesses across the country.

Children’s palliative care is provided through a shared care approach involving GPs, Paediatricians, Community Specialist Palliative Care Teams and Clinical Nurse Coordinators. A key enabler of this model of care is the remote support provided by the Consultants in Paediatric Palliative Medicine at Children’s Health Ireland Crumlin and Temple Street. The voluntary sector including LauraLynn Children’s Hospice and Jack and Jill Foundation, support the statutory services with additional in-home nursing and respite supports for families. LauraLynn also provide inpatient Hospice care at their eight-bed facility in Leopardstown.

Palliative Care for Children with Life-limiting Conditions in Ireland – a National Policy guides provision of palliative care services for children and their families in Ireland. The Bee Wee Report recommended that Ireland continue the collaborative model of palliative care support to children in the community with input from primary care, community specialist palliative care paediatrics, and the voluntary sector. As of October 2023, all regions and services are implementing the model of care supporting children as outlined in the Bee Wee report.

Since 2021, the number of Clinical Nurse Coordinators has increased nationally from 12 to 19.5. There is now in place at least two CNCs in every region to cover for annual leave and sick leave. The CNCs work with the families, local HSE teams, voluntary organisations and Children’s Health Ireland Specialist Palliative Care Team to ensure children have a coordinated care plan that meets their needs. Clinicians working with these children are aware of the requirement to travel to hospital appointments. Every effort is made to coordinate care so children and their families can see different specialties on the one visit.

The CHI Specialist Palliative Care Team has increased from 2 to 4 consultants in palliative care medicine. This has ensured there is a 24/7 and 365 day on call service available to GPs, paediatricians and specialist palliative care teams providing palliative care to children throughout the country. The appointment of three Regional Paediatricians with Special Interest in Palliative Care in Cork, Galway and Limerick in 2025, will also reduce the need for families to travel to Dublin and provide additional expertise and support to children and families in the regions.

A further development has been the streamlined process for accessing Paediatric Home Care Packages based on the child’s medical needs. These packages include both home care support during the day and at night for children with life limiting conditions. Paediatric Home Care Packages are a home nursing service provided by HSE Primary Care when a child has complex healthcare nursing needs that cannot be met by existing Primary Care services and social services. As Minister, I recognise the challenge, that whilst comprehensive packages have been approved for funding, the home care agencies have not always been able to fill the hours.

The total national palliative care budget this year is over €184 million – a 15% increase on 2024 and a 50% increase on 2020. Our Programme for Government is committed to developing a new national policy on palliative care for children and to increase funding to children’s hospice care. This will enable us to further consider how best to support children with life limiting conditions and palliative care needs.

Shane Moynihan (Dublin Mid West, Fianna Fail)
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552. To ask the Minister for Health the actions her Department is taking to ensure equitable access to life-saving treatments for all adults with spinal muscular atrophy, given current aged-based disparities in treatment; and if she will make a statement on the matter. [28577/25]

Jennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)
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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.

Managed Access Protocol – Onasemnogene abeparvovec (Zolgensma®) for the treatment of 5q Spinal Muscular Atrophy (SMA)

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.