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Gnáthamharc

Tuesday, 17 Jun 2025

Written Answers Nos. 741-763

Medicinal Products

Ceisteanna (741, 807)

Cathal Crowe

Ceist:

741. Deputy Cathal Crowe asked the Minister for Health when the medication known as givinostat will be made available in Ireland, given its potential role in the treatment of Duchenne muscular dystrophy; and if she will make a statement on the matter. [31801/25]

Amharc ar fhreagra

Shane Moynihan

Ceist:

807. Deputy Shane Moynihan asked the Minister for Health when medication known as givinostat will be made available in the State, given the role it can play in treating Duchenne muscular dystrophy in young boys. [32084/25]

Amharc ar fhreagra

Freagraí scríofa

I propose to take Questions Nos. 741 and 807 together.

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 devices; therefore, I have asked the HSE for an update in this matter.

The HSE has advised that there is a National Application, Assessment & Decision Process for new medicines which is underpinned by Primary Legislation (Health (Pricing and Supply of Medical Goods) Act 2013) put in place by the Oireachtas. The HSE must comply with the relevant legislation when considering investment decisions around new medicines.

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.

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.

Pharmaceutical companies are required to submit formal applications to the HSE if they wish for their medicines to be added to the list of reimbursable items / funded via hospitals. The decision of pharmaceutical companies to market licensed medicines i.e. whether or not to submit a formal application, is outside the control of the HSE.

In terms of the specific details of an application for pricing and reimbursement of Givinostat (Duvyzat®):

On 25th April 2025, the EMA’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a conditional marketing authorisation for Givinostat (Duvyzat®) for the treatment of Duchenne muscular dystrophy (DMD) in ambulant patients, aged 6 years and older, and with concomitant corticosteroid treatment. On the 6th June 2025 the European Commission granted EU conditional marketing authorisation for Givinostat (Duvyzat®) for the treatment of Duchenne muscular dystrophy (DMD).

A pricing and reimbursement application has not yet been received by the HSE for Givinostat (Duvyzat®).

As outlined above, the national assessment and decision process cannot commence in the absence of a pricing and reimbursement application submission to the HSE.

Health Services

Ceisteanna (742)

Sorca Clarke

Ceist:

742. Deputy Sorca Clarke asked the Minister for Health in relation to the physiotherapist service in a care centre (details supplied) in Longford, following the noncompliance finding by HIQA in October 2024, and the ongoing attempts to source permanent location, the work that has been undertaken in terms of relocation to the primary care centre in Ballyminnion; and if any findings have indicated it's not suitable. [31813/25]

Amharc ar fhreagra

Freagraí scríofa

As this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.

Medical Cards

Ceisteanna (743)

Thomas Gould

Ceist:

743. Deputy Thomas Gould asked the Minister for Health if she will amend the means test relating to over 70's medical card entitlement to take account of increases to the State pension in recent years; and if she will make a statement on the matter. [31819/25]

Amharc ar fhreagra

Freagraí scríofa

Eligibility for a Medical Card is primarily based on a financial assessment which is conducted by the HSE in accordance with the Health Act 1970 (as amended). The HSE assesses each medical card application on a qualifying financial threshold. This is the amount of money that an individual can earn a week and still qualify for a card. It is specific to the individual’s own financial circumstances.

Persons aged 69 and under are assessed under the general means tested medical card thresholds which are based on an applicant’s household income after tax and the deduction of PRSI and the Universal Social Charge. Certain expenses are also taken into account. Examples of allowable expenses include rent, mortgage, certain insurance costs, childcare, maintenance, nursing home net costs which help to increase the amount a person can earn and still qualify for a medical card. Detailed guidelines are available at: https://www2.hse.ie/services/schemes-allowances/medical-cards/applying/assessment/.

Persons aged 70 or older are assessed under medical card income thresholds which are based on gross income. The weekly gross medical card income thresholds for people aged 70 and over are currently €550 per week for a single person and €1050 for a couple. However, it should be noted that those aged over 70 can also be assessed under the general means tested scheme where there are particularly high costs, e.g., medication, nursing home fees. Furthermore, the Deputy may be aware that, since 2015, every individual aged 70 and over has automatic eligibility for a GP visit card.

Every effort is made by the HSE, within the framework of the legislation, to support applicants in applying for a medical card - in particular, to take full account of difficult circumstances in the case of applicants who may be in excess of the income guidelines. In such circumstances, the HSE may exercise discretion and grant a medical card, for example:

• Discretionary medical cards issued to patients with significant medical expenses but who do not satisfy the means test.

• Emergency medical cards are issued to patients that are terminally ill, or are seriously ill, and in urgent need of medical care that they cannot afford.

Where a person's sole income is derived from a social protection payment, he/she will be awarded a medical card.

To ensure the medical card system is responsive and sensitive to people's needs, my Department keeps medical card issues under review and any changes are considered in the context of any potential broader implications for Government policy, the annual budgetary estimates process and legislative requirements arising.

Health Service Executive

Ceisteanna (744)

Cathy Bennett

Ceist:

744. Deputy Cathy Bennett asked the Minister for Health further to Parliamentary Question No. 307 of 15 May 2025, if the HSE has compiled the requested information regarding the number of GPs by county or smallest geographic region available; the number per capita; and if she will make a statement on the matter. [31824/25]

Amharc ar fhreagra

Freagraí scríofa

I understand that the HSE issued a reply to the question under reference on 11 June.  However, as I further understand that the Deputy is seeking additional clarification in relation to the information sought, and as this is a service matter, I have asked the Health Service Executive to issue a further response to the Deputy directly, as soon as possible.

Health Services Waiting Lists

Ceisteanna (745)

Donna McGettigan

Ceist:

745. Deputy Donna McGettigan asked the Minister for Health the number of people left the waiting list for CAHMS in county Clare for each of the past four years; the reasons they left the list, in tabular form; and if she will make a statement on the matter. [31825/25]

Amharc ar fhreagra

Freagraí scríofa

As this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.

Medicinal Products

Ceisteanna (746)

Richard Boyd Barrett

Ceist:

746. Deputy Richard Boyd Barrett asked the Minister for Health whether she will intervene to ensure that a person (details supplied) with Duchenne muscular dystrophy can be prescribed givnostat as a matter of urgency. [31826/25]

Amharc ar fhreagra

Freagraí scríofa

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 devices; therefore, I have asked the HSE for an update in this matter.

The HSE has advised that there is a National Application, Assessment & Decision Process for new medicines which is underpinned by Primary Legislation (Health (Pricing and Supply of Medical Goods) Act 2013) put in place by the Oireachtas. The HSE must comply with the relevant legislation when considering investment decisions around new medicines.

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.

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.

Pharmaceutical companies are required to submit formal applications to the HSE if they wish for their medicines to be added to the list of reimbursable items / funded via hospitals. The decision of pharmaceutical companies to market licensed medicines i.e. whether or not to submit a formal application, is outside the control of the HSE.

In terms of the specific details of an application for pricing and reimbursement of Givinostat (Duvyzat®):

On 25th April 2025, the EMA’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a conditional marketing authorisation for Givinostat (Duvyzat®) for the treatment of Duchenne muscular dystrophy (DMD) in ambulant patients, aged 6 years and older, and with concomitant corticosteroid treatment. On the 6th June 2025 the European Commission granted EU conditional marketing authorisation for Givinostat (Duvyzat®) for the treatment of Duchenne muscular dystrophy (DMD).

A pricing and reimbursement application has not yet been received by the HSE for Givinostat (Duvyzat®).

As outlined above, the national assessment and decision process cannot commence in the absence of a pricing and reimbursement application submission to the HSE.

Medicinal Products

Ceisteanna (747, 773)

Michael Healy-Rae

Ceist:

747. Deputy Michael Healy-Rae asked the Minister for Health if the drug givinostat will be approved in Ireland (details supplied); and if she will make a statement on the matter. [31827/25]

Amharc ar fhreagra

John Brady

Ceist:

773. Deputy John Brady asked the Minister for Health if she will make the drug givinostat available to all who are diagnosed with Duchenne Muscular Dystrophy; if so, whether she will provide a timeline for the rollout of this drug; and if she will make a statement on the matter. [31934/25]

Amharc ar fhreagra

Freagraí scríofa

I propose to take Questions Nos. 747 and 773 together.

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 devices; therefore, I have asked the HSE for an update in this matter.

The HSE has advised that there is a National Application, Assessment & Decision Process for new medicines which is underpinned by Primary Legislation (Health (Pricing and Supply of Medical Goods) Act 2013) put in place by the Oireachtas. The HSE must comply with the relevant legislation when considering investment decisions around new medicines.

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.

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.

Pharmaceutical companies are required to submit formal applications to the HSE if they wish for their medicines to be added to the list of reimbursable items / funded via hospitals. The decision of pharmaceutical companies to market licensed medicines i.e. whether or not to submit a formal application, is outside the control of the HSE.

In terms of the specific details of an application for pricing and reimbursement of Givinostat (Duvyzat®):

On 25th April 2025, the EMA’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a conditional marketing authorisation for Givinostat (Duvyzat®) for the treatment of Duchenne muscular dystrophy (DMD) in ambulant patients, aged 6 years and older, and with concomitant corticosteroid treatment. On the 6th June 2025 the European Commission granted EU conditional marketing authorisation for Givinostat (Duvyzat®) for the treatment of Duchenne muscular dystrophy (DMD).

A pricing and reimbursement application has not yet been received by the HSE for Givinostat (Duvyzat®).

As outlined above, the national assessment and decision process cannot commence in the absence of a pricing and reimbursement application submission to the HSE.

Nursing Homes

Ceisteanna (748)

Michael Fitzmaurice

Ceist:

748. Deputy Michael Fitzmaurice asked the Minister for Health whether it is possible for a brother-in-law of the person receiving long-term care in a nursing home to be named as a 'family successor”, in order to qualify for the three-year cap on family farms under the fair deal programme; and if she will make a statement on the matter. [31835/25]

Amharc ar fhreagra
Reply not received from Department.

Departmental Legal Cases

Ceisteanna (749)

David Cullinane

Ceist:

749. Deputy David Cullinane asked the Minister for Health for confirmation that the legal instructions issued by her predecessor and contained in a letter titled ‘Directions from Minister of Health to the Executive under section 10 of the Health Act 2004’, which issued in January 2025, were carried out in full; and if she will make a statement on the matter. [31837/25]

Amharc ar fhreagra
Reply not received from Department.

Departmental Legal Cases

Ceisteanna (750)

David Cullinane

Ceist:

750. Deputy David Cullinane asked the Minister for Health whether she has received any update from the HSE Board on its response to the legal instructions that issued from her predecessor in January 2025, and were contained in a letter titled ‘Directions from Minister of Health to the Executive under section 10 of the Health Act 2004’; and if she will make a statement on the matter. [31838/25]

Amharc ar fhreagra

Freagraí scríofa

Paediatric spinal services are a priority under the Waiting List Action Plan and are overseen by the Waiting List Action Plan Taskforce.

In recent years significant investment of over €30m has been allocated to help tackle waiting lists for spinal procedures. Several initiatives are underway to help improve access to services including a ringfenced theatre, additional outpatient clinics, and national and international outsourcing to maximise capacity.

The Paediatric Spinal Services Management Unit, led by a Consultant Orthopaedic Surgeon, and supported by wider Multi-Disciplinary Teams, ensures patients are prioritised correctly for surgery and works to reduce waiting times.

On 21 January 2025, under Section 10 of the Health Act, the former Minister directed the HSE to ensure that all children on the active waiting list at the end of 2024, who were waiting more than 4 months, are to be offered treatment abroad. International outsourcing arrangements are in place with Morgan Stanley Children’s Hospital in New York and Great Ormond Street Hospital in London. Since these initiatives started, 16 patients that were considered suitable have had surgery completed outside of Ireland. CHI has advised that a further 8 procedures are due to be internationally outsourced this year, and additional patients may be deemed clinically suitable for surgery abroad as the year progresses.

My Department remains actively engaged with the HSE and CHI to ensure that activity is maximised to the fullest extent possible.

Departmental Data

Ceisteanna (751)

David Cullinane

Ceist:

751. Deputy David Cullinane asked the Minister for Health the number of the 54 children who were waiting longer than four months for their paediatric spinal surgery at the end of December 2024 that were offered the opportunity to get their spinal surgery abroad; and if she will make a statement on the matter. [31839/25]

Amharc ar fhreagra

Freagraí scríofa

As this is an operational matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.

Departmental Data

Ceisteanna (752)

David Cullinane

Ceist:

752. Deputy David Cullinane asked the Minister for Health the total number of children who have travelled abroad for spinal surgery since her appointment in January 2025; and if she will make a statement on the matter. [31840/25]

Amharc ar fhreagra

Freagraí scríofa

As this is an operational matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.

Departmental Data

Ceisteanna (753)

David Cullinane

Ceist:

753. Deputy David Cullinane asked the Minister for Health the total number of paediatric orthopaedic surgeons who carry out spinal procedures and are employed across CHI since 2020 to date, by year, by hospital and by total CHI number; and if she will make a statement on the matter. [31841/25]

Amharc ar fhreagra

Freagraí scríofa

As this is an operational matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.

Departmental Data

Ceisteanna (754)

David Cullinane

Ceist:

754. Deputy David Cullinane asked the Minister for Health the total number of spinal surgeries performed by each orthopaedic surgeon who performs spinal surgery, to date this year, in tabular form; and if she will make a statement on the matter. [31842/25]

Amharc ar fhreagra

Freagraí scríofa

As this is an operational matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.

Departmental Data

Ceisteanna (755)

David Cullinane

Ceist:

755. Deputy David Cullinane asked the Minister for Health to provide a breakdown of the total number of outpatient clinics across all areas of paediatric orthopaedics provided by each of paediatric spinal surgeon, to date this year, in tabular form; and if she will make a statement on the matter. [31843/25]

Amharc ar fhreagra

Freagraí scríofa

As this is an operational matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.

Departmental Data

Ceisteanna (756)

David Cullinane

Ceist:

756. Deputy David Cullinane asked the Minister for Health to confirm the total number of paediatric surgeries carried out in CHI to date this year versus the same period in 2024; and if she will make a statement on the matter. [31844/25]

Amharc ar fhreagra

Freagraí scríofa

As this is an operational matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.

Departmental Data

Ceisteanna (757, 758)

Erin McGreehan

Ceist:

757. Deputy Erin McGreehan asked the Minister for Health the number of appointments available per year under the free contraception scheme. [31845/25]

Amharc ar fhreagra

Erin McGreehan

Ceist:

758. Deputy Erin McGreehan asked the Minister for Health whether an additional consultation is provided free of charge when a person needs to review her prescription under the free contraception scheme. [31846/25]

Amharc ar fhreagra

Freagraí scríofa

I propose to take Questions Nos. 757 and 758 together.

The free contraception scheme was launched in September 2022, initially for those aged 17-25. It has been gradually expanded and now includes women aged 17-35 from July 1st, 2024. The scheme is open to women, girls and other people identifying as transgender or non-binary, who are ordinarily resident in Ireland and for whom prescription contraception is deemed suitable by their doctors.

The scheme covers the cost of consultations with GPs, primary care, student health and family planning centres and prescriptions for the wide range of contraceptive options available on the HSE Re-Imbursement List, including long-acting reversible contraception (LARCs: injections, intra-uterine devices and systems (coils) and implants) and emergency contraception in addition to the contraceptive Pill, patch and ring. LARC fittings, removals, injections and check-ups are also free of charge under the scheme.

Women who have had coils, IUDs, IUSs or implants inserted while eligible under the scheme remain eligible for subsequent checks and free removal of any devices inserted prior to reaching the eligibility limit (currently their 36th birthday), to ensure continuity of care.

The Programme for Government, Securing Ireland's Future, 2025, commits to continuing to extend access to free contraception.

The FCS works through GPs, primary care, student health and family planning centres and community pharmacies most of which are private sector and deliver services under contract with the HSE which are re-imbursed retrospectively via the Primary Care Re-Imbursement Service (PCRS). Approximately 2,400 GPs and 2,050 pharmacies have signed up to provide services and products under the scheme to date.

The availability of appointments are a matter for GPs and other services delivering the scheme. The HSE reports on these retrospectively. The Department, HSE, PSI, IPU and other key stakeholders are working to enable contraceptive prescribing by pharmacists, in order to extend or continue a prescription for contraception, as part of the work of the Community Pharmacy Expansion Implementation Oversight Group. The work on contraception is accompanying wider work to expand the role of community pharmacies to also deliver a common conditions service. More information about the group can be found here - www.gov.ie/en/department-of-health/collections/community-pharmacy-expansion-implementation-oversight-group/#:~:text=The%20Minister%20for%20Health%20has%20established%20a%20Community,Support%20the%20Expansion%20of%20the%20Role%20of%20Pharmacy%E2%80%9D.

It should be noted that the number of appointments per individual per year is not limited; a contraception appointment should be free for women who fall within the eligible age range and are ordinarily resident in Ireland. Should an initially prescribed contraceptive method need to be changed or checked, for example as a result of side effects, women will be re-imbursed for subsequent appointments under the scheme.

In terms of the total number of appointments with GPs and other service providers delivered under the FCS in 2024 and previous years, as this is a service matter, I have asked the HSE to respond directly to the Deputy as soon as possible.

Medicinal Products

Ceisteanna (759)

Erin McGreehan

Ceist:

759. Deputy Erin McGreehan asked the Minister for Health if she will provide details regarding the prescribing of antidepressants to patients who are covered under the medical card scheme and the drugs payment scheme; and if she will make a statement on the matter. [31852/25]

Amharc ar fhreagra

Freagraí scríofa

The medical decision to prescribe or not prescribe any treatment for an individual patient is strictly a decision for the treating clinician, in consultation with their patient. The Minister for Health has no role in this clinical decision-making process. As this also raises an operational matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.

Nursing Homes

Ceisteanna (760)

Erin McGreehan

Ceist:

760. Deputy Erin McGreehan asked the Minister for Health the number of public nursing home beds created by the State each year from 2020 to 2024, by county, in tabular form; and if she will make a statement on the matter. [31853/25]

Amharc ar fhreagra

Freagraí scríofa

As this is a service matter I have asked the Health Service Executive to respond to the Deputy as soon as possible.

Health Services

Ceisteanna (761)

Donna McGettigan

Ceist:

761. Deputy Donna McGettigan asked the Minister for Health if she can confirm that funding for a psychologist in Ennis day hospital was stopped in September 2024 when the previous psychologist retired, and was not resumed until this February when the process of replacement began; the reason the process was delayed for the intervening months and if lack of funding contributed to the delay; the reason the transition from one psychologist to a replacement was not planned in advance to make it seamless (given that it was retirement, not an unexpected occurrence); and if she will make a statement on the matter. [31872/25]

Amharc ar fhreagra

Freagraí scríofa

As this is a service matter, I have asked the Health Service Executive to respond direct to the Deputy as soon as possible.

Health Services

Ceisteanna (762, 942)

Mattie McGrath

Ceist:

762. Deputy Mattie McGrath asked the Minister for Health if she will give an update on equal access to treatments for adults living with spinal muscular atrophy; when a review of fair criteria for age-based assessment is expected, so that all individuals with SMA are treated equally under the healthcare system; and if she will make a statement on the matter. [31878/25]

Amharc ar fhreagra

Micheál Carrigy

Ceist:

942. Deputy Micheál Carrigy asked the Minister for Health if she will provide an update on the ongoing review of access to approved spinal muscular atrophy (SMA) treatments; if she is aware that approximately 20 adults continue to be excluded from treatment on the basis of having been over 18 years of age at the time of initial HSE approval; if she will outline the steps being taken to address this age-based exclusion and ensure fair and equal access to treatment for all patients living with SMA in Ireland; and if she will make a statement on the matter. [32831/25]

Amharc ar fhreagra

Freagraí scríofa

I propose to take Questions Nos. 762 and 942 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 over 18 years of age.

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.

Ambulance Service

Ceisteanna (763)

Alan Kelly

Ceist:

763. Deputy Alan Kelly asked the Minister for Health when she last met with the National Ambulance Service; and who the attendees were. [31881/25]

Amharc ar fhreagra

Freagraí scríofa

Since taking up office, I have not yet had the opportunity to meet with the National Ambulance Service (NAS). However, I want to take this opportunity to acknowledge the vital role the NAS plays in the delivery of urgent and emergency care right across the country. I look forward to engaging directly with the National Ambulance Service in the near future to discuss their work, and how we can continue to support and strengthen pre-hospital emergency care for patients.

Roinn