Wednesday, 13 Jan 2021

Written Answers Nos. 787-807

Covid-19 Pandemic

Ceisteanna (787, 788, 942)

Peadar Tóibín

Ceist:

787. Deputy Peadar Tóibín asked the Minister for Health the number of Covid-19 outbreaks experienced in direct provision centres to date. [44774/20]

Peadar Tóibín

Ceist:

788. Deputy Peadar Tóibín asked the Minister for Health the number of direct provision centres currently experiencing outbreaks of Covid-19. [44775/20]

Seán Crowe

Ceist:

942. Deputy Seán Crowe asked the Minister for Health the number of Covid-19 infections of direct provision centre residents recorded; and the number of outbreaks recorded in direct provision centres. [1151/21]

Freagraí scríofa

Minister of State at the Department of Health

I propose to take Questions Nos. 787, 788 and 942 together.

The Health Protection Surveillance Centre (HPSC) reports on cases of Covid-19 in the population and is the official source of data in relation to cases, deaths and clusters based on confirmed figures.

The latest data as of 02/01/2021 indicate there are 7 open outbreaks in direct provision centres. Since the start of August 2020, there has been a total of 21 outbreaks, with 158 associated cases. Two residents have been hospitalised, with no resident admitted to ICU and no recorded death.

The HPSC is carrying out ongoing validation with the data and information. I have therefore, for the purpose of accuracy, referred this request for information to the HPSC for attention and direct reply to the Deputies.

The Department of Health and the HSE work closely with the Department of Children, Equality, Disability, Integration & Youth to ensure that the health and welfare of international protection applicants living in direct provision are protected. The HSE has provided specific COVID-19 guidance for Direct Provision settings. A range of measures are in place in direct provision centres to address any cases of COVID-19 if and when they arise.

The COVID-19 pandemic continues to have a major impact in Ireland and globally. It is imperative that residents in direct provision centres adhere strictly to public health advice at Level 5. By following the public health advice, we can reduce the spread of COVID-19 in our communities and support the provision of vital non-COVID healthcare services.

Psychological Assessments

Ceisteanna (789)

Seán Canney

Ceist:

789. Deputy Seán Canney asked the Minister for Health his plans to reinstate psychology services for children in the Headford and Lackagh primary care psychology service area of County Galway, given that the position has been vacant since June 2019 and children in this region of County Galway are losing out on vital psychology assessments; and if he will make a statement on the matter. [44778/20]

Freagraí scríofa

Minister for Health

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

Departmental Contracts

Ceisteanna (790)

Louise O'Reilly

Ceist:

790. Deputy Louise O'Reilly asked the Minister for Health if his Department or State agencies under the aegis of his Department have awarded contracts to a company (details supplied); if so, the value of such contracts; if the contracts were tendered for; and if he will make a statement on the matter. [44788/20]

Freagraí scríofa

Minister for Health

The Department itself has not made any payments to this company.

None of the agencies under the aegis of the Department have made any payments to this company.

Disability Services Provision

Ceisteanna (791)

Thomas Pringle

Ceist:

791. Deputy Thomas Pringle asked the Minister for Health the number of disabled persons in receipt of a personal assistance service in 2020; the hours received by each disabled person leading his or her own personal assistance service; and if he will make a statement on the matter. [44798/20]

Freagraí scríofa

Minister of State at the Department of Health

The area of disability services is a priority area for this Government. To support people with a disability, significant resources have been invested by the health sector in disability services, and the Government has ensured that an additional €100 million is being provided for new disability measures next year under Budget 2021. These measures will include an additional 80,000 personal assistant hours. The 2020 national service plan details that the HSE is seeking to deliver 1.67m hours of Personal Assistant Hours to over 2,550 people.

In preparing for and responding to COVID-19 and to fully align with Public Health guidance as recommended via the NPHET, the HSE and its partner service providers put in place a range of measures, which included the prioritisation of vital Residential and Home Support/PA services.

The Government is working to ensure that People with Disabilities be allowed to live an independent life of their own choosing, the same as any other person, and this is consistent with the disability reform policy - “transforming lives”.

The HSE provides a range of assisted living services including Personal Assistant (PA) services to support individuals to maximise their capacity to live full and independent lives.

Personal Assistance Services are accessed through an application process or through referrals from public health nurses or other community based staff. Individual’s needs are evaluated against the criteria for prioritisation for the particular services and then decisions are made in relation to the allocation of resources.

Resource allocation is determined by the needs of the individual, compliance with prioritisation criteria, and the level of resources available. It is important to note that the level of service delivered is varied to ensure that each client’s needs are reflected. Therefore there is no average agreed number of PA hours per person. PA and Home Support Services are provided either directly by the HSE or through a range of voluntary service providers. The majority of specialised disability provision (80%) is delivered through non-statutory sector service providers.

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

Covid-19 Pandemic

Ceisteanna (792, 1007, 1011, 1033)

Pádraig O'Sullivan

Ceist:

792. Deputy Pádraig O'Sullivan asked the Minister for Health the progress to date of the distribution of the Covid-19 vaccine; and if he will make a statement on the matter. [44800/20]

Patrick Costello

Ceist:

1007. Deputy Patrick Costello asked the Minister for Health the projected timeline of the Covid-19 vaccination plan. [1347/21]

Robert Troy

Ceist:

1011. Deputy Robert Troy asked the Minister for Health if further details will be provided regarding the Covid-19 vaccination roll-out; and if a company that is due to have employees vaccinated in phase 13 can pre-register with the HSE. [1367/21]

Marian Harkin

Ceist:

1033. Deputy Marian Harkin asked the Minister for Health the stage of the vaccination process; if the staff and residents of boarding out facilities for the elderly will receive the Covid-19 vaccine; and if he will make a statement on the matter. [1520/21]

Freagraí scríofa

Minister for Health

I propose to take Questions Nos. 792, 1007, 1011 and 1033 together.

The Government is committed to the timely implementation of a COVID-19 immunisation programme.

The National COVID-19 Vaccination Strategy, which was prepared by the High-Level Task Force on COVID-19 Vaccination, was signed off by Cabinet on 15 December 2020.

The vaccines will be rolled out in three phases - the initial roll out, a mass ramp-up and open access. The highest priority groups, those over the age of 65 living in long-term care facilities and frontline healthcare workers in direct patient contact, will receive the vaccine first.

The aim of the COVID-19 vaccination programme is to ensure, over time, that vaccine will become available to vaccinate all of those for whom the vaccine is indicated. Given that there will be initially limited vaccines available, it will take some time for all to receive those vaccines and that has necessitated an allocation strategy to ensure that those most at risk of death and serious illness receive the vaccine first.

The priority is to first vaccinate and protect directly the most vulnerable amongst us, that is, those most likely to have a poor outcome if they contract the virus. The priority is to directly use vaccines to save lives and reduce serious illness, hence the focus on the over 65 year old cohort in long term residential care facilities, and healthcare workers in frontline services often caring for the most vulnerable.

All of the groups will be covered as further vaccine supplies become available and the immunisation programme is rolled out nationally. This is wholly dependent on supply lines and on candidate vaccines obtaining approval. Therefore, it is not possible at this time to determine a timeframe for the full vaccination programme.

The evidence will be kept under review and the allocation groups may be updated, where necessary, in light of new evidence.

Further information on the Allocation Strategy can be found at:

https://www.gov.ie/en/publication/39038-provisional-vaccine-allocation-groups/.

Departmental Contracts

Ceisteanna (793)

Seán Canney

Ceist:

793. Deputy Seán Canney asked the Minister for Health the number of final accounts of capital project contracts that have exceeded the tender value by more than 20% in each of the years from 2010 to 2020; and if he will make a statement on the matter. [44817/20]

Freagraí scríofa

Minister for Health

As the Health Service Executive is responsible for the delivery of public healthcare infrastructure projects, I have asked the HSE to respond to you directly in relation to this matter.

Hospital Appointments Status

Ceisteanna (794)

Martin Kenny

Ceist:

794. Deputy Martin Kenny asked the Minister for Health the reason it will take 18 months to get an appointment for a MRI scan in Sligo University Hospital for a person (details supplied); and if he will make a statement on the matter. [44819/20]

Freagraí scríofa

Minister for Health

It is recognised that waiting times for scheduled appointments and procedures have been impacted in the last year as a direct result of the COVID-19 pandemic.

The HSE is currently recommending that only critical time dependent elective procedures are undertaken at this time due to the on-going and significant increased demand for bed capacity related to Covid-19.

This decision was made arising from the rapid increase in Covid-19 admissions and to ensure patient safety and that all appropriate resources were made available for Covid-19 related activity and time-critical essential work.

Patient safety remains at the centre of all hospital activity and elective care scheduling. To ensure services are provided in a safe, clinically-aligned and prioritised way, hospitals are following HSE clinical guidelines and protocols.

Under the Health Act 2004, the Health Service Executive (HSE) is required to manage and deliver, or arrange to be delivered on its behalf, health and personal social services. Section 6 of the HSE Governance Act 2013 bars the Minister for Health from directing the HSE to provide a treatment or a personal service to any individual or to confer eligibility on any individual.

The National Waiting List Management Policy is a standardised approach used by the HSE to manage scheduled care treatment for in-patient, day case and planned procedures. It sets out the processes that hospitals are to implement to manage waiting lists and was developed in 2014 to ensure that all administrative, managerial and clinical staff follow an agreed national minimum standard for the management and administration of waiting lists for scheduled care.

In relation to the particular query raised, 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 (795)

Niall Collins

Ceist:

795. Deputy Niall Collins asked the Minister for Health when the general practitioner visit card will be extended to children under eight years of age; and if he will make a statement on the matter. [44820/20]

Freagraí scríofa

Minister for Health

The Government is committed to increasing access to GP care without charges for children, an important healthcare measure that will remove a potentially prohibitive cost barrier to accessing GP care and will help to improve children’s health as they develop.

The Health (General Practitioner Service and Alteration of Criteria for Eligibility) Act 2020 provides, amongst other things, for the phased expansion of GP care without fees to all children aged 12 years and under. The initial stage of this phased expansion will be the provision of GP care without fees to all children aged between 6 and 8.

The appropriate date for commencing the expansion remains under consideration in light of COVID-19 and the additional pressures the expansion might place on general practice in that context and in anticipation of the usual increase in demand for healthcare services over the winter period. This date will be determined following consultation with the IMO. It is important to ensure that any additional pressures placed on general practice will not limit its capacity to meet the needs of all patients in the community.

Covid-19 Pandemic

Ceisteanna (796)

Seán Sherlock

Ceist:

796. Deputy Sean Sherlock asked the Minister for Health if research is being conducted by his Department on the physical and mental impacts on those diagnosed and recovered from Covid-19. [44822/20]

Freagraí scríofa

Minister of State at the Department of Health

A number of studies are taking place both within, and outside of, the Department of Health in relation to the impacts of covid-19 on the population.

The Healthy Ireland Survey is an annual interviewer-administered face-to-face survey commissioned by the Department of Health. It monitors the health and wellbeing of people living in Ireland. The survey was stopped at the commencement of Covid-19 restrictions as the survey method (face-to-face) was not compatible with Covid-19 restrictions. The survey fieldwork has restarted, using a new phone questionnaire with an emphasis on living with Covid-19. It includes a module on mental health and suicide. The results will be available next year.

The Department has partnered with Amárach Research for a series of monthly surveys in relation to the effects of covid-19 upon the population. The November Research Study showed that, while people’s happiness is still low and boredom has increased, stress, worry, anxiety and frustration have reduced since March (first survey).

Amárach opinion surveys can be found at:

https://www.gov.ie/en/collection/6b4401-view-the-amarach-public-opinion-survey/#may-august-2020

The CSO has published four rounds of their Social Impacts of Covid-19 in Ireland survey. The survey results provide data on people’s lifestyle and wellbeing at various stages of the pandemic and restrictions levels.

Results of the surveys can be found on the CSO website:

https://www.cso.ie/en/csolatestnews/presspages/2020/socialimpactofcovid-19surveynovember2020well-beingandlifestyleunderlevel5restrictions/

https://www.cso.ie/en/releasesandpublications/ep/p-covid19/covid-19informationhub/socialandwellbeing/

There have been a number of studies and research conducted by other organisations, including the National Suicide Research Foundation, Mental Health Reform and an International Covid-19 Psychological Research Consortium. The studies examined the impact of Covid-19 on people’s mental health and well-being. Results of these studies can be accessed by contacting the relevant organisation.

I recognise that the Covid pandemic may increase anxiety levels among the general population. The Government campaigns, “In this Together” and “Keep Well”, which encourage and offer practical advice on keeping our physical and mental health well, provide support for dealing with this issue.

We do not yet fully understand the impact of Covid-19 on mental health, the extent of subsequent supports that may be required or how this may affect longer term demand for services. However, the HSE already has a range of proactive responses for any rise in service need, including online and other telehealth psychosocial supports.

€2.2 million was provided to the HSE in 2020 for a mental health promotion and well-being campaign, through enhanced online supports to improve population health outcomes. Telehealth services were rapidly enhanced during the first wave and are now fully established to provide a broader service to clients. 7-day telehealth services include YourMentalHealth.ie, the information line 1800 111 888, the crisis textline and NGO partners’ online supports such as MYMind. Use of these services has increased significantly during Covid-19.

The Department and HSE continue to plan for any surge in demand as it arises and as services return to normal provision and capacity, subject to public health advice.

I am referring this PQ to the HSE for part response to inform on research being conducted at a service level.

Hospital Appointments Status

Ceisteanna (797)

Michael Healy-Rae

Ceist:

797. Deputy Michael Healy-Rae asked the Minister for Health the status of a hospital appointment for a person (details supplied); and if he will make a statement on the matter. [44824/20]

Freagraí scríofa

Minister for Health

It is recognised that waiting times for scheduled appointments and procedures have been impacted in the last year as a direct result of the COVID-19 pandemic.

The HSE is currently recommending that only critical time dependent elective procedures are undertaken at this time due to the on-going and significant increased demand for bed capacity related to Covid-19.

This decision was made arising from the rapid increase in Covid-19 admissions and to ensure patient safety and that all appropriate resources were made available for Covid-19 related activity and time-critical essential work.

Patient safety remains at the centre of all hospital activity and elective care scheduling. To ensure services are provided in a safe, clinically-aligned and prioritised way, hospitals are following HSE clinical guidelines and protocols.

Under the Health Act 2004, the Health Service Executive (HSE) is required to manage and deliver, or arrange to be delivered on its behalf, health and personal social services. Section 6 of the HSE Governance Act 2013 bars the Minister for Health from directing the HSE to provide a treatment or a personal service to any individual or to confer eligibility on any individual.

The National Waiting List Management Policy is a standardised approach used by the HSE to manage scheduled care treatment for in-patient, day case and planned procedures. It sets out the processes that hospitals are to implement to manage waiting lists and was developed in 2014 to ensure that all administrative, managerial and clinical staff follow an agreed national minimum standard for the management and administration of waiting lists for scheduled care.

In relation to the particular query raised, 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 (798, 903, 930, 938, 1003, 1019, 1053)

Duncan Smith

Ceist:

798. Deputy Duncan Smith asked the Minister for Health the plans his Department and the HSE have with regard to licensing the drug dupilumab for use by patients with severe eczema in Ireland; and if he will make a statement on the matter. [44840/20]

Brendan Griffin

Ceist:

903. Deputy Brendan Griffin asked the Minister for Health his views on a matter (details supplied); and if he will make a statement on the matter. [1010/21]

Róisín Shortall

Ceist:

930. Deputy Róisín Shortall asked the Minister for Health if a decision on the reimbursement of dupilumab, a drug to treat severe atopic eczema, was reached at the December 2020 HSE drugs group meeting; and if he will make a statement on the matter. [1116/21]

Michael Healy-Rae

Ceist:

938. Deputy Michael Healy-Rae asked the Minister for Health when the drug dupilumab will be made available here (details supplied); and if he will make a statement on the matter. [1133/21]

Eoin Ó Broin

Ceist:

1003. Deputy Eoin Ó Broin asked the Minister for Health the status of the assessment of the atopic eczema treatment known as dupilumab; and when the treatment will be available to eczema patients here. [1342/21]

David Cullinane

Ceist:

1019. Deputy David Cullinane asked the Minister for Health if the HSE drug group has met to date in January 2021; when the group will next meet; if the drug dupilumab will be approved for reimbursement; and if he will make a statement on the matter. [1444/21]

Gerald Nash

Ceist:

1053. Deputy Ged Nash asked the Minister for Health the status of the assessment of the drug dupilumab, which has been life-changing for many persons living with severe atopic eczema; when he expects this assessment to be completed; if he will ensure equitable access to dupilumab for eczema patients; and if he will make a statement on the matter. [1642/21]

Freagraí scríofa

Minister for Health

I propose to take Questions Nos. 798, 903, 930, 938, 1003, 1019 and 1053 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.

In line with the 2013 Health Act and the national framework agreed with industry, a company must submit an application to the HSE to have a new medicine added to the reimbursement list.

Reimbursement is for licensed indications which have been granted market authorisation by the European Medicines Agency or the Health Products Regulatory Authority.

HSE decisions on which medicines are reimbursed by the taxpayer are made on objective, scientific and economic grounds, on the advice of the National Centre for Pharmacoeconomics (NCPE). The NCPE conducts health technology assessments (HTAs) for the HSE and makes recommendations on reimbursement to assist HSE decisions.

The HSE has advised that it has received pricing and reimbursement applications for two indications of Dupilumab (Dupixent):

- For the treatment of moderate-to-severe atopic dermatitis in adult patients who are candidates for systemic therapy.

- For the treatment of moderate-to-severe atopic dermatitis in adolescents 12 years and older who are candidates for systemic therapy.

The HSE received an application for pricing / reimbursement of Dupilumab in November 2017 from the manufacturer for the treatment of moderate-to-severe atopic dermatitis in adult patients who are candidates for systemic therapy. The HSE commissioned a full HTA on 29 November 2017 as per agreed processes. This assessment was completed on 12 December 2019 with the NCPE recommending that Dupilumab be considered for reimbursement if cost-effectiveness could be improved relative to existing treatments.

Subsequently, the HSE received an application for the pricing / reimbursement of Dupilumab on 13 December 2019 for the treatment of moderate-to-severe atopic dermatitis in adolescents 12 years and older who are candidates for systemic therapy.

The HSE commissioned the rapid review process on the 17 December 2019. Following receipt of a rapid review dossier, the NCPE advised the HSE on the 17 January 2020 that a HTA was not recommended and that Dupilumab not be considered for reimbursement for this indication at the submitted price.

The HSE engaged in commercial negotiations with the company in February 2020 regarding both the adult and adolescent populations.

The HSE 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 and clinicians.

The final HTA report concerning Dupilumab was reviewed by the HSE Drugs Group, along with the outputs of commercial negotiations, and the patient group submission received during the HTA process. The HSE Drugs Group considered all the evidence and gave a recommendation to the HSE Executive Management Team (EMT) not to support reimbursement of Dupilumab for the treatment of moderate-to-severe atopic dermatitis in both adults and adolescents 12 years and older who are candidates for systemic therapy.

The HSE has confirmed that the applicant company was issued with notice of the proposed decision of the HSE EMT not to support reimbursement on 21 August 2020. On 18 September 2020, the applicant company submitted representations with respect to this application.

The HSE reviewed these representations, as is required in such circumstances under the 2013 Health Act, and engaged in a meeting in November 2020 with the applicant company to discuss the submission.

The HSE has advised that a Drugs Group meeting did take place in December 2020, at which point it was not possible to discuss Dupilumab due to time constraints.

The HSE has advised that a HSE Drugs Group’s meeting has been scheduled for the afternoon of 12th January 2020, subject to the confirmed quorum being achieved. The HSE has indicated that there is a risk that it will not be possible to achieve the necessary quorum, as contributing clinicians are under significant pressures with competing priorities due to the pandemic. In the event that the quorum is not maintained, this meeting will need to be rescheduled.

The HSE EMT will, on receipt of the outcome of the Drugs Group's deliberations, make the decision on whether Dupilumab will be reimbursed.

Covid-19 Pandemic

Ceisteanna (799)

Brendan Griffin

Ceist:

799. Deputy Brendan Griffin asked the Minister for Health his views on a matter (details supplied) regarding the roll-out of the Covid-19 vaccine; and if he will make a statement on the matter. [44843/20]

Freagraí scríofa

Minister for Health

A cross-Government High-Level Taskforce has been established to support and oversee the development and implementation of the COVID-19 immunisation programme. Government has agreed the prioritisation process that should apply to the vaccination of the population, based on the advice of national experts on immunisation and endorsed by the NPHET.

The rollout of the COVID-19 vaccination programme is underway. The vaccination programme is initially targeting those most at risk by focusing on Long Term Residential Care Facilities and front-line healthcare workers.

Following the initial phase, there will be a considerable scale up in the roll-out of vaccinations. This will be achieved through partnerships with Pharmacists in addition to GPs and other specialist staff and will be delivered through a range of Mass Vaccination Centres (MVCs). In this regard engagement has taken place between the HSE and representatives of community pharmacists.

A national and regional public information campaign about the COVID-19 vaccine has commenced. The campaign focuses on clear, transparent communication with the public around the vaccine rollout, its efficacy and addressing vaccine hesitancy.

HSE Reports

Ceisteanna (800)

Róisín Shortall

Ceist:

800. Deputy Róisín Shortall asked the Minister for Health further to Parliamentary Question No. 200 of 5 December 2019 and No. 843 of 24 November 2020 regarding the 2015 HSE report into the orthodontic service, if he will address issues (details supplied); and if he will make a statement on the matter. [44853/20]

Freagraí scríofa

Minister for Health

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

Question No. 801 answered with Question No. 767.

Treatment Abroad Scheme

Ceisteanna (802)

John Lahart

Ceist:

802. Deputy John Lahart asked the Minister for Health if patients have a right to travel to other EU countries to receive treatment with medicines that are not available on the HSE reimbursement list in Ireland but are available in public healthcare in other EU countries, such as gene or cell therapies indicated for certain rare diseases or types of cancer if these treatments are recommended by their medical practitioner in Ireland under the travel abroad scheme; the criteria, conditions and other considerations attached to this eligibility; and if he will make a statement on the matter. [44865/20]

Freagraí scríofa

Minister for Health

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

Hospital Appointments Status

Ceisteanna (803)

Seán Canney

Ceist:

803. Deputy Seán Canney asked the Minister for Health when a child (details supplied) who has been waiting for an urgent MRI since September 2020 will have an MRI conducted in University Hospital Galway; his views on whether treatment has been delayed by the lack of MRI facilities in County Galway; and if he will make a statement on the matter. [44871/20]

Freagraí scríofa

Minister for Health

It is recognised that waiting times for scheduled appointments and procedures have been impacted in the last year as a direct result of the COVID-19 pandemic.

The HSE is currently recommending that only critical time dependent elective procedures are undertaken at this time due to the on-going and significant increased demand for bed capacity related to Covid-19.

This decision was made arising from the rapid increase in Covid-19 admissions and to ensure patient safety and that all appropriate resources were made available for Covid-19 related activity and time-critical essential work.

Patient safety remains at the centre of all hospital activity and elective care scheduling. To ensure services are provided in a safe, clinically-aligned and prioritised way, hospitals are following HSE clinical guidelines and protocols.

Under the Health Act 2004, the Health Service Executive (HSE) is required to manage and deliver, or arrange to be delivered on its behalf, health and personal social services. Section 6 of the HSE Governance Act 2013 bars the Minister for Health from directing the HSE to provide a treatment or a personal service to any individual or to confer eligibility on any individual.

The National Waiting List Management Policy is a standardised approach used by the HSE to manage scheduled care treatment for in-patient, day case and planned procedures. It sets out the processes that hospitals are to implement to manage waiting lists and was developed in 2014 to ensure that all administrative, managerial and clinical staff follow an agreed national minimum standard for the management and administration of waiting lists for scheduled care.

In relation to the particular query raised, as this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.

Hospital Waiting Lists

Ceisteanna (804)

Seán Canney

Ceist:

804. Deputy Seán Canney asked the Minister for Health the longest time that children who are classified as semi-urgent, urgent and immediate are waiting for an MRI scan in University Hospital Galway; and if he will make a statement on the matter. [44872/20]

Freagraí scríofa

Minister for Health

It is recognised that waiting times for scheduled appointments and procedures have been impacted in the last year as a direct result of the COVID-19 pandemic.

The HSE is currently recommending that only critical time dependent elective procedures are undertaken at this time due to the on-going and significant increased demand for bed capacity related to Covid-19.

This decision was made arising from the rapid increase in Covid-19 admissions and to ensure patient safety and that all appropriate resources were made available for Covid-19 related activity and time-critical essential work.

Patient safety remains at the centre of all hospital activity and elective care scheduling. To ensure services are provided in a safe, clinically-aligned and prioritised way, hospitals are following HSE clinical guidelines and protocols.

In relation to the particular query raised, as this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.

Hospital Facilities

Ceisteanna (805)

Seán Canney

Ceist:

805. Deputy Seán Canney asked the Minister for Health the position regarding the availability of MRI facilities at University Hospital Galway; his views on the correct capacity; his plans to address the capacity shortfall and address the long waiting lists; and if he will make a statement on the matter. [44873/20]

Freagraí scríofa

Minister for Health

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 (806)

Bernard Durkan

Ceist:

806. Deputy Bernard J. Durkan asked the Minister for Health if the HSE drugs group met in December 2020; if not, if it is scheduled to meet; the drugs being considered for reimbursement, in tabular form; and if he will make a statement on the matter. [44880/20]

Freagraí scríofa

Minister for Health

The HSE has statutory responsibility for decisions on pricing and reimbursement of medicines under the community drug schemes, in accordance with the provisions of the Health (Pricing and Supply of Medical Goods) Act 2013. The matter has therefore been referred to the HSE for reply to the Deputy.

Medicinal Products

Ceisteanna (807)

Bernard Durkan

Ceist:

807. Deputy Bernard J. Durkan asked the Minister for Health the status of the reimbursement of Onpattro; when the drug will be made available to eligible patients; and if he will make a statement on the matter. [44881/20]

Freagraí scríofa

Minister for Health

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.

In line with the 2013 Health Act and the national framework agreed with industry, a company must submit an application to the HSE to have a new medicine added to the reimbursement list.

Reimbursement is for licensed indications which have been granted market authorisation by the European Medicines Agency or the Health Products Regulatory Authority.

HSE decisions on which medicines are reimbursed by the taxpayer are made on objective, scientific and economic grounds, on the advice of the National Centre for Pharmacoeconomics (NCPE).

The NCPE conducts health technology assessments (HTAs) for the HSE and makes recommendations on reimbursement to assist HSE decisions. The NCPE uses a decision framework to systematically assess whether a drug is cost-effective as a health intervention.

The HSE has advised that it received an application in December 2018 for the reimbursement of Patisiran (Onpattro) for the treatment of hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis) in adult patients with stage 1 or stage 2 polyneuropathy.

In January 2019, a full HTA with respect to this indication was commissioned by the HSE. This assessment was completed in February 2020, with the NCPE recommending that Patisiran not be considered for reimbursement unless cost-effectiveness could be improved relative to existing treatments.

The HTA report with respect to Patisiran was reviewed by the HSE Drugs Group, along with the outputs of commercial discussions with the applicant which took place in May 2020, and the patient group submission received during the HTA process.

The HSE 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 and clinicians.

The HSE Drugs Group requested patient and clinician input via the Rare Diseases Technology Review Committee (RDTRC) to assist the group in making its recommendation to the HSE Executive Management Team (EMT) regarding reimbursement of Patisiran.

In September 2020, The RDTRC convened and reviewed the clinical data previously submitted as part of the established pricing and reimbursement process. The Committee also heard from Consultants involved in the specialist management of patients with hATTR amyloidosis.

The RDTRC continued its review of Patisiran at its subsequent meeting on 5 November 2020 which included patient input on the impact of hATTR amyloidosis.

Following these meetings, the Committee finalised a statement summarising the clinician and patient engagement on Patisiran which was forwarded to the HSE Drugs Group for consideration.

The HSE has advised that additional information has been submitted by the manufacturer following engagements in December 2020 and January 2021. This information will be considered by the HSE Drugs Group along with the statement from the RDTRC.

The HSE has advised that a HSE Drugs Group’s meeting has been scheduled for the afternoon of 12th January 2020, subject to the confirmed quorum being achieved. The HSE has indicated that there is a risk that it will not be possible to achieve the necessary quorum, as contributing clinicians are under significant pressures with competing priorities due to the pandemic. In the event that the quorum is not maintained, this meeting will need to be rescheduled.

The application for Patisiran remains under consideration in line with the 2013 Health Act. The HSE Executive Management Team is the decision-making body for the reimbursement of medicines and it will make the decision on whether Patisiran will be reimbursed in line with the criteria contained in the 2013 Health Act.