Written Answers Nos. 532-551
532. Deputy Sean Sherlock asked the Minister for Health if he will provide an update under Housing for All to an amended fair deal scheme to remove disincentives for sale and rental of vacant properties. [7132/23]
Amharc ar fhreagraProceeds of Sale
The Nursing Homes Support Scheme (Amendment) Act 2021, which was signed into law on 22 July 2021, and commenced on 20 October, introduces further safeguards in the NHSS to further protect the viability and sustainability of family farms and businesses. It also includes an amendment in relation to applying the 3-year cap to the proceeds of sale of a house while a resident is in long-term care. This addresses the first relevant commitment in the Housing for All Strategy (action 19.7).
Within the NHSS, the asset value of a resident's home, known in the Scheme as the "principal residence", is assessed for 3 years, with 7.5% of its value going towards the cost of care (3.75% in the case of a couple). After a person has been in care for 3 years , the value of this property is no longer assessed. In practice, this generally reduces the nursing home fees of those maintaining their home, from year four onwards. The 2021 Act now extends the 3-year cap to cover the proceeds of sale, so that a person will be able to sell their home without incurring additional fees from their fourth year in long-term residential care onwards. This applies even if the home is sold before 3 years in care; the proceeds of sale will be assessed up to the 3-year point, but excluded from assessment after that. Further details can be found here: www2.hse.ie/services/fair-deal-scheme/the-3-year-cap.html
Rental in NHSS
Effective from 1 November, the amount of rental income that nursing home residents can retain under the Fair Deal from renting their principle private residence increases from 20% to 60%.
Prior to the change outlined above being implemented, participants in the Fair Deal scheme were able to rent out their homes or other assets, but rental income was subject to assessment at 80% like all other income (such as pension income).Recognising that this may act as a disincentive against renting out a property, the Government approved a policy change to the Nursing Homes Support Scheme “Fair Deal”, to remove a disincentive for applicants to the Scheme to rent out their principal residence after they have entered long term residential care. The rate of assessment for rental income from a principal residence is reduced from 80% to 40%. This will be reviewed after six months of operation, with the potential for further amendment after that point. It should be noted that rental income accrued from property that is not a principal private residence will continue to be assessed at 80%.
This policy change addresses the commitments made under Housing For All Action 19.8. The change was made through a Committee-Stage amendment to the Department of Housing, Local Government and Heritage’s Regulation of Providers of Building Works and Building Control (Amendment) Bill 2022 which is in operation as of 1 November.
Further details are available at: www2.hse.ie/services/schemes-allowances/fair-deal-scheme/financial-assessment/#rental-income-for-your-home
These measures will allow residents in Fair Deal to keep more of their income and will also help address pressures on the rental market. It is important that residents who choose to rent out their homes do so in a safe and supported way. The well-being, safety and comfort of nursing home residents remains a priority for me.
533. Deputy Paul Kehoe asked the Minister for Health the justification for a patient with private health insurance being asked to authorise a hospital to charge their private insurance provider for a private room, even though they may be staying in a public ward in the event of a private room not being available, and that they would be admitted to a public ward; and if he will make a statement on the matter. [6423/23]
Amharc ar fhreagraAnyone who is ordinarily resident in Ireland is entitled to access hospital services as a public patient. When a patient is admitted to hospital, they have the option of whether they wish to be treated privately or publicly.
Should a patient opt to be treated privately, this does not necessarily include access to single or limited occupancy wards as access to accommodation is based on clinical need.
Hospitals charge for private in-patient services under section 55 of the Health Act. Private health insurance coverage includes the amounts payable under section 55 and consultant professional fees.
534. Deputy David Cullinane asked the Minister for Health the number and details of compensation or redress schemes put in place by his Department since 1998, in tabular form; the number of claims made; the total cost of the scheme; and if he will make a statement on the matter. [6464/23]
Amharc ar fhreagraThe information requested by the Deputy is not immediately available, a full response is being collated and will be forwarded to the Deputy as soon as possible.
535. Deputy Eoin Ó Broin asked the Minister for Health further to Parliamentary Question Nos. 295 and 296 of 30 June 2022, if he will provide an update on the Public Health (Tobacco and Nicotine Inhaling Products) Bill 2019; if a timeframe for enactment can be indicated; and if he will make a statement on the matter. [6474/23]
Amharc ar fhreagra536. Deputy Eoin Ó Broin asked the Minister for Health if the Public Health (Tobacco and Nicotine Inhaling Products) Bill 2019 will address the packaging and advertisement of tobacco and nicotine inhaling products. [6475/23]
Amharc ar fhreagraI propose to take Questions Nos. 535 and 536 together.
The Public Health (Tobacco and Nicotine Inhaling Products) Bill is prioritised for publication in the current session.
The Bill will address the advertising of nicotine inhaling products but not packaging.
The advertising of e-cigarettes on television, radio and online is already prohibited by the Tobacco Product Directive Regulations S.I. No. 271/2016. The Bill will prohibit such advertising within 200 metres of a school or playground, in cinemas, on public transport and at public transport stops.
537. Deputy Rose Conway-Walsh asked the Minister for Health the process by which pregnant women experiencing extreme nausea and vomiting can obtain medication cariban; the reason GP’s are not able to prescribe cariban on the drug payment scheme given that the majority of women do not see their consultant until well into second trimester and it is the current standard practice in other EU member states; and if he will make a statement on the matter. [6479/23]
Amharc ar fhreagra553. Deputy Réada Cronin asked the Minister for Health if he will clarify the situation on the availability of, and access to, the hyperemesis gravidarum drug, cariban; how access in Ireland compares to that of other countries; the reason it cannot be prescribed by a GP when the majority of pregnant women can get to see a consultant only after the twelfth week of pregnancy; the number of scripts for cariban processed through the drugs payment scheme to date, in tabular form; and if he will make a statement on the matter. [6521/23]
Amharc ar fhreagra557. Deputy Martin Browne asked the Minister for Health the process for pregnant women suffering from hyperemesis gravidarum to access cariban under the redress scheme. [6527/23]
Amharc ar fhreagra578. Deputy Jim O'Callaghan asked the Minister for Health the process by which pregnant women experiencing extreme nausea can obtain the drug Cariban which is available on the drugs payment scheme; the reason the drug cannot be prescribed by a GP on the drugs payment scheme; the number of Cariban prescriptions that have been processed through the drugs payment scheme to date in tabular form; and if he will make a statement on the matter. [6558/23]
Amharc ar fhreagra595. Deputy Claire Kerrane asked the Minister for Health the process in writing by which pregnant women experiencing extreme nausea and vomiting can obtain the drug cariban. [6592/23]
Amharc ar fhreagra600. Deputy Joe O'Brien asked the Minister for Health the process in writing by which pregnant women experiencing extreme nausea and vomiting can obtain the drug cariban; the reason that the drug cannot be prescribed by a GP on the DPS (details supplied); if he will outline the current standard practice in other EU member states; his Department’s recommendations to help with the extreme nausea and vomiting for the first 12 weeks or until the drug can be accessed; and the number of cariban prescriptions that have been processed through the DPS to date, in tabular form. [6617/23]
Amharc ar fhreagra606. Deputy Seán Haughey asked the Minister for Health the process by which pregnant women experiencing hyperemesis gravidarum can obtain the drug cariban; the reason this drug is not prescribed initially by a GP as part of the drugs payment scheme; if his attention has been drawn to the fact that the majority of women do not see a consultant until after 12 weeks of pregnancy; the measures that can be taken regarding this in the first 12 weeks of pregnancy or until an appointment can be made with a consultant; and if he will make a statement on the matter. [6632/23]
Amharc ar fhreagra620. Deputy Cian O'Callaghan asked the Minister for Health the current process for women accessing cariban; the standard practice within the European Union for treating hyperemesis; if the number of prescriptions for cariban that have been processed through the drugs payment scheme can be provided in tabular form; and if he will make a statement on the matter. [6668/23]
Amharc ar fhreagraI propose to take Questions Nos. 537, 553, 557, 578, 595, 600, 606 and 620 together.
As part of Budget 2023, funding of €32.2 million was announced for Women’s Health Initiatives in 2023.
This included dedicated funding of €1.3m for Cariban® (doxylamine/pyridoxine) to help women who experience hyperemesis gravidarum, a severe form of nausea and vomiting, during pregnancy. Hyperemesis gravidarum is expected to affect about 1% of the pregnant population.
The Health Service Executive (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 Good s) Act 2013. Only licensed indications which have been granted market authorisation by the European Medicines Agency (EMA) or the Health Products Regulatory Authority (HPRA) can be added to the formal reimbursement list.
Within the European Union (EU), the pricing and reimbursement of medicines is a national competence. As EU Member States operate different pharmaceutical reimbursement systems across the EU, a direct comparison of the reimbursement of products is not possible. The competent authority for pricing and reimbursement in Ireland is the HSE.
Cariban® is an Exempt Medicinal Product (EMP), i.e., it is not licensed in Ireland and, therefore, cannot be added to the formal reimbursement list.
However, following the recommendations of the HSE Medicines Management Programme, and to address the unmet need of patients with hyperemesis gravidarum, reimbursement support for Cariban® (doxylamine/pyridoxine), an unlicensed Exempt Medicinal Product, has now been made available on an individual patient basis for those patients who meet the criteria and where Consultant Obstetrician initiated.
Under the community drug schemes, Exempt Medicinal Products must be Consultant initiated. However, whilst the original prescriber of Cariban® must be a consultant and specialist in the relevant field, the HSE will accept a GP prescription subsequent to the initial hospital prescription for approved patients.
The relevant HSE circular regarding the exceptional arrangement for Cariban® is available at:
www.hse.ie/eng/staff/pcrs/circulars/pharmacy/pharmacy-circular-001-23-cariban.pdf.
In order to obtain reimbursement support for Cariban® under this exceptional arrangement, the prescribing consultant must confirm whether the following apply:
- The individual has nausea and vomiting of pregnancy (NVP) which requires systemic treatment.
- The individual has been assessed using the pregnancy unique quantification of emesis and nausea (PUQE) assessment tool and the appropriate treatment algorithm has been followed.
- The individual has not responded to conservative management.
The consultant must also make an Unlicensed Product Declaration and submit the completed application form by email to the Primary Care Reimbursement Service (PCRS).
Once reviewed by the PCRS, the prescriber and dispensing pharmacy are emailed (via secure email) with the reimbursement decision. The community pharmacy then dispenses the product under the specific patient’s community drug schemes eligibility and submits the claim using the relevant administrative code in their monthly submission to PCRS.
While reimbursement support is offered on the basis of the patient’s eligibility under the General Medical Services (GMS) Scheme or the Drugs Payment Scheme (DPS), Cariban® is not on the formal reimbursement list.
This exceptional arrangement has been put in place to ensure that those patients suffering from hyperemesis gravidarum have access to Cariban®. The dedicated funding that has been allocated is based on 1% of the pregnant population requiring treatment for hyperemesis gravidarum. The number of approved applications to date is in line with expectations and indicate that the budget allocated will be used in 2023. As of 10th February 2023, the number of applications received by the Primary Care Reimbursement Service (PCRS) stands at 384.
There are three other products containing doxylamine/pyridoxine, which are licensed in Ireland:
- Xonvea® gastro-resistant tablets.
- Navalem® modified-release hard capsules.
- Exeltis® gastro-resistant tablets.
The market authorisation holder of Xonvea® has not progressed the pricing and reimbursement application further with the HSE at this stage. The market authorisation holders for Exeltis® and Navalem® have not submitted pricing and reimbursement applications to the HSE.
The HSE therefore encourages clinicians, along with the Institute of Obstetricians and Gynaecologists and the National Clinical Programme for Obstetrics and Gynaecology, other healthcare professionals, and relevant representative bodies to encourage the market authorisation holders of the licensed medicinal products (Xonvea®, Exeltis® and Navalem®) to progress with the formal pricing and reimbursement process in Ireland.
Finally, the HSE provides general advice on treatments for hyperemesis gravidarum at:
www2.hse.ie/conditions/hyperemesis-gravidarum/treatment/.
538. Deputy Denis Naughten asked the Minister for Health the reason hospital contract staff who interacted with patients are being excluded from payment of the pandemic bonus; and if he will make a statement on the matter. [6481/23]
Amharc ar fhreagraAs this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly.
539. Deputy Dara Calleary asked the Minister for Health if he will provide an update on the pandemic payment of €1,000 for a person (details supplied). [6488/23]
Amharc ar fhreagraAs this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly.
I would also like to remind the Deputy that it is against Department policy to comment on individual cases.
540. Deputy Pádraig O'Sullivan asked the Minister for Health if he will clarify the cost of cariban; the reason only consultant prescriptions for cariban are reimbursable; if reimbursement can also be given if prescribed by someone’s GP; and if he will make a statement on the matter. [6490/23]
Amharc ar fhreagraAs part of Budget 2023, funding of €32.2 million was announced for Women’s Health Initiatives in 2023. This included dedicated funding for Cariban® (doxylamine/pyridoxine) to help women who experience hyperemesis gravidarum, a severe form of nausea and vomiting, during pregnancy.
The Health Service Executive (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.
Only licensed indications which have been granted market authorisation by the European Medicines Agency (EMA) or the Health Products Regulatory Authority (HPRA) can be added to the formal reimbursement list.
Cariban® is an Exempt Medicinal Product, i.e., it is not licensed in Ireland and, therefore, cannot be added to the HSE's formal reimbursement list. Therefore, there is currently no formal pricing agreement in place for Cariban®.
However, following the recommendations of the HSE Medicines Management Programme, and to address the unmet need of patients with hyperemesis gravidarum, Cariban® has now been made available on an individual patient basis for those patients who meet the criteria and where Consultant Obstetrician initiated.
The relevant HSE circular regarding the exceptional arrangement for Cariban® is available at: www.hse.ie/eng/staff/pcrs/circulars/pharmacy/pharmacy-circular-001-23-cariban.pdf.
The HSE circular sets a reimbursement price for a pack of 24 Cariban 10mg/10mg modified release hard capsules at €34.90.
Under the community drug schemes, Exempt Medicinal Products must be Consultant initiated.
However, whilst the original prescriber of Cariban® must be a Consultant and specialist in the relevant field, the HSE will accept a GP prescription subsequent to the initial hospital prescription for approved patients.
Finally, reimbursement support is offered on the basis of the patient’s eligibility under the General Medical Services (GMS) Scheme or the Drugs Payment Scheme (DPS).
541. Deputy Pádraig O'Sullivan asked the Minister for Health the number of cariban prescriptions that have been processed through the DPS to date; and if he will make a statement on the matter. [6491/23]
Amharc ar fhreagra561. Deputy Martin Browne asked the Minister for Health the number of cariban prescriptions that have been processed through the drugs payment scheme to date. [6531/23]
Amharc ar fhreagra564. Deputy Michael Ring asked the Minister for Health the number of prescriptions for a drug (details supplied) that have been processed through the DPS to date in tabular form; and if he will make a statement on the matter. [6536/23]
Amharc ar fhreagra577. Deputy Patricia Ryan asked the Minister for Health the number of prescriptions for the drug cariban that have been processed through the drug payment scheme to date; and if he will make a statement on the matter. [6557/23]
Amharc ar fhreagra592. Deputy Joe O'Brien asked the Minister for Health if he will provide details of the number of prescriptions for cariban which have been processed by the HSE through the general medical services and drugs payment schemes to date. [6588/23]
Amharc ar fhreagra607. Deputy Seán Haughey asked the Minister for Health the number of cariban prescriptions that have been processed through the drug payment scheme to date, in tabular form; and if he will make a statement on the matter. [6633/23]
Amharc ar fhreagra612. Deputy Michael Moynihan asked the Minister for Health the number of cariban prescriptions that have been processed through the drugs payment scheme to date; and if he will make a statement on the matter. [6641/23]
Amharc ar fhreagra630. Deputy Jackie Cahill asked the Minister for Health the number of cariban prescriptions processed through DPS to date; and if he will make a statement on the matter. [6688/23]
Amharc ar fhreagra634. Deputy Neasa Hourigan asked the Minister for Health the number of cariban prescriptions that have been processed through the drugs payment scheme since it was made available under the community drug schemes. [6693/23]
Amharc ar fhreagra655. Deputy Róisín Shortall asked the Minister for Health the number of cariban prescriptions that have been processed through the drugs payment scheme to date and by month, in tabular form. [6767/23]
Amharc ar fhreagra668. Deputy Pa Daly asked the Minister for Health if he will provide a breakdown of the number of prescriptions of a drug (details supplied) through the drugs payment scheme to date.; and if he will make a statement on the matter. [6812/23]
Amharc ar fhreagra672. Deputy Thomas Pringle asked the Minister for Health the number of cariban prescriptions that have been processed since 1 January 2023; and if he will make a statement on the matter. [6816/23]
Amharc ar fhreagra740. Deputy Barry Cowen asked the Minister for Health the number of cariban prescriptions that have been processed through the DPS to date in tabular form. [7079/23]
Amharc ar fhreagra751. Deputy Paul Murphy asked the Minister for Health to provide details of the number of cariban prescriptions that have been processed through the drug payment scheme to date; and if he will make a statement on the matter. [7103/23]
Amharc ar fhreagra793. Deputy Colm Burke asked the Minister for Health the number of cariban prescriptions that have been processed through the drugs payment scheme to date in tabular form; and if he will make a statement on the matter. [7210/23]
Amharc ar fhreagraI propose to take Questions Nos. 541, 561, 564, 577, 592, 607, 612, 630, 634, 655, 668, 672, 740, 751 and 793 together.
Since 1st January 2023, reimbursement support for Cariban® (doxylamine/pyridoxine) has been available under an exceptional arrangement on an individual patient basis where consultant initiated.
As of 10th February 2023, the number of applications received by the Primary Care Reimbursement Service (PCRS) stands at 384.
542. Deputy Ged Nash asked the Minister for Health if he will confirm that the Drogheda area will be provided with the resources as committed to by his Department to undertake the drug-related intimidation and violence engagement programme; when this programme will commence; the resources that will be made available to the programme in the Drogheda area; and if he will make a statement on the matter. [6492/23]
Amharc ar fhreagraIn Budget 2023 the Department of Health provided €250,000 for the roll-out of the inter-agency DRIVE initiative (Drug-Related Intimidation and Violence Engagement).
It is intended that funding from this allocation will be provided for a Drive coordinator in Drogheda, as part of the Department's commitment to the implementation of the Drogheda report.
It is understood that the DRIVE Steering Committee is preparing a business plan to submit to the HSE for the drawdown of the funding.
543. Deputy Ged Nash asked the Minister for Health when the north-east drugs task force will be provided with the details of its 2023 annual budget allocation; if this allocation will be increased to take account of inflation-driven cost rises; if so, the additional amount of funding in percentage terms to be allocated to the task force compared to 2022; and if he will make a statement on the matter. [6493/23]
Amharc ar fhreagraAs this is a service matter, I have asked the Health Service Executive to respond to the deputy directly, as soon as possible.
544. Deputy Brendan Howlin asked the Minister for Health if he will arrange to have a mammogram provided for a person (details supplied) who was first called for a mammogram in November 2019, and due to Covid delays, has still not received this test; and if he will make a statement on the matter. [6494/23]
Amharc ar fhreagraAs this is a service matter, it has been referred to the Health Service Executive for attention and direct reply to the Deputy.
545. Deputy John McGuinness asked the Minister for Health if the Farrelly Commission has submitted its final report; and if so, when the report will be published. [6495/23]
Amharc ar fhreagraThe Farrelly Commission, which commenced work on the 15th May 2017, was established to investigate the care and protection of 'Grace' (pseudonym) and others in a former foster home in the South East, which has been the subject of abuse allegations. The Farrelly Commission is a statutory Commission of Investigation and is independent in its functions.
The Farrelly Commission has submitted a series of interim reports and two substantive interim reports, all of which are published on the Department's website. A final report has not been submitted but progress is reviewed regularly by the Minister for Health.
546. Deputy Sorca Clarke asked the Minister for Health the total number of people on outpatient waiting lists at Midland Regional Hospital Mullingar in 2022. [6496/23]
Amharc ar fhreagra547. Deputy Sorca Clarke asked the Minister for Health the number of children on outpatient waiting lists at Midland Regional Hospital Mullingar in 2022. [6497/23]
Amharc ar fhreagraI propose to take Questions Nos. 546 and 547 together.
It is recognised that waiting times for many scheduled appointments and procedures were too long before and have been made worse by the Covid-19 pandemic. While significant work continues to positively impact on waiting times and improve pathways to elective care, acute hospitals are still impacted by operational challenges arising from the pandemic and the current pressures on Emergency Departments.
The Health Service Executive (HSE) has confirmed to the Department that 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.
The Department of Health continues to work with the HSE and the National Treatment Purchase Fund (NTPF) to identify ways to improve access to care, including through increased use of private hospitals, funding weekend and evening work in public hospitals, funding “see and treat” services, providing virtual clinics, and increasing capacity in the public hospital system.
The 2022 Waiting List Action Plan set targets to reduce both the number of people waiting for care and the length of time they are waiting. Positive progress was made in 2022 in relation to both targets, despite negative impacts throughout the year on scheduled care from continued COVID-19 surges, emergency department pressures and other operational factors, including staff hiring. In 2022, there were c.1.56m patients removed from the Waiting list and c.1.53m patients added to the waiting list – a net reduction of c.30k (4%). Long waiters were significantly reduced in 2022: the number of patients exceeding the 18-month maximum wait time target for new outpatient (OPD) appointments target decreased by c.59.0k (38.5%) and the number of patients exceeding the 12-month maximum wait time target for in-patient day case (IPDC) procedures and GI Scopes has decreased by c3.8k (22.6%) and c.3.5k (86.5%) respectively.
Through the 2022 Plan, €350m funding was allocated to the HSE and the NTPF to provide additional public and private activity to reduce the waiting list backlogs that were exacerbated during the Pandemic, but also as the first stage of an ambitious multi annual approach, to lay the foundations for important reforms that will deliver sustained reductions in waiting lists.
For 2023, funding of €443 million is being allocated to tackle Waiting Lists, some €360m of which is targeted at acute hospital waiting lists. The plan to utilise this part of the funding is being developed by the Department of Health in conjunction with the HSE and NTPF. This will include details of new capacity planned for 2023 as well as important reforms that will improve capacity in the public hospital system.
In relation to the particular queries raised by the Deputy, adult and child waiting list information by hospital is published monthly and is available on the NTPF website at: www.ntpf.ie/home/nwld.htm
548. Deputy Fergus O'Dowd asked the Minister for Health if he will respond to concerns raised from a person (details supplied) in respect of access to cariban; and if he will make a statement on the matter. [6501/23]
Amharc ar fhreagra752. Deputy Paul Murphy asked the Minister for Health if he will ensure that access to cariban is made readily available to all pregnant women prescribed the drug through the drugs payment scheme without the need for additional documentation in order to prevent situations (details supplied); and if he will make a statement on the matter. [7104/23]
Amharc ar fhreagraI propose to take Questions Nos. 548 and 752 together.
As part of Budget 2023, funding of €32.2 million was announced for Women’s Health Initiatives in 2023.
This included dedicated funding for Cariban® (doxylamine/pyridoxine) to help women who experience hyperemesis gravidarum, a severe form of morning sickness, during pregnancy. Hyperemesis gravidarum is expected to affect about 1% of the pregnant population.
The Health Service Executive (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 Good s) Act 2013. Only licensed indications which have been granted market authorisation by the European Medicines Agency (EMA) or the Health Products Regulatory Authority (HPRA) can be added to the formal reimbursement list.
Cariban® is an Exempt Medicinal Product (EMP), i.e., it is not licensed in Ireland and, therefore, cannot be added to the formal reimbursement list.
The pricing and reimbursement of medicines is a national competence. Different pharmaceutical reimbursement systems are currently in place across the EU. As Member States operate different systems, a direct comparison of the reimbursement of products is not possible. The competent authority for pricing and reimbursement in Ireland is the HSE.
However, following the recommendations of the HSE Medicines Management Programme, and to address the unmet need of patients with hyperemesis gravidarum, reimbursement support for Cariban® (doxylamine/pyridoxine), an unlicensed Exempt Medicinal Product, has now been made available on an individual patient basis for those patients who meet the criteria and where Consultant Obstetrician initiated.
Under the community drug schemes, Exempt Medicinal Products must be Consultant initiated. However, whilst the original prescriber of Cariban® must be a consultant and specialist in the relevant field, the HSE will accept a GP prescription subsequent to the initial hospital prescription for approved patients.
The relevant HSE circular regarding the exceptional arrangement for Cariban® is available at:
www.hse.ie/eng/staff/pcrs/circulars/pharmacy/pharmacy-circular-001-23-cariban.pdf.
In order to obtain reimbursement support for Cariban® under this exceptional arrangement, the prescribing consultant must confirm whether the following apply:
- The individual has nausea and vomiting of pregnancy (NVP) which requires systemic treatment;
- The individual has been assessed using the pregnancy unique quantification of emesis and nausea (PUQE) assessment tool and the appropriate treatment algorithm has been followed;
- The individual has not responded to conservative management.
The consultant must also make an Unlicensed Product Declaration and submit the completed application form by email to the Primary Care Reimbursement Service (PCRS).
Once reviewed by the PCRS, the prescriber and dispensing pharmacy are emailed (via secure email) with the reimbursement decision. The community pharmacy then dispenses the product under the specific patient’s community drug schemes eligibility and submits the claim using the relevant administrative code in their monthly submission to PCRS.
While reimbursement support is offered on the basis of the patient’s eligibility under the General Medical Services (GMS) Scheme or the Drugs Payment Scheme (DPS), Cariban® is not on the formal reimbursement list.
This exceptional arrangement has been put in place to ensure that those patients suffering from hyperemesis gravidarum have access to Cariban®. The dedicated funding that has been allocated is based on 1% of the pregnant population requiring treatment for hyperemesis gravidarum. The number of approved applications to date indicate that the budget allocated will be used in 2023.
549. Deputy Jackie Cahill asked the Minister for Health the estimated cost of purchasing an ambulance and staffing it with an appropriate team of paramedics in order to provide transport services from Nenagh General Hospital to local nursing homes, to transport patients who are leaving Nenagh Hospital and are being moved to local nursing homes in north Tipperary; the estimated cost for this one-off capital expenditure; the estimated running costs of this on an annual basis thereafter; and if he will make a statement on the matter. [6502/23]
Amharc ar fhreagraAs the Deputy may or may not be aware funding and responsibility for the provision of non-emergency patient transportation was distributed to individual service providers (Hospitals and Community Healthcare Organisation (CHOs) ) some years ago, on the basis that they are the service provider and not the National Ambulance Service. The responsibility for determining if non-emergency patient transport is to be provided, and the cost of that transport, therefore rests with the local service provider, that is the hospital, or the CHO concerned. Otherwise, such transportation arrangements are normally funded by the individual.
I have asked the Health Service Executive to respond to the Deputy directly on this matter with any further pertinent information they may have on this topic.
550. Deputy Aodhán Ó Ríordáin asked the Minister for Health the process in writing by which pregnant women experiencing extreme nausea and vomiting during pregnancy can obtain the drug cariban on the drugs payment scheme (details supplied); and if he will provide details of the standard practice in other EU member states. [6510/23]
Amharc ar fhreagra574. Deputy Patricia Ryan asked the Minister for Health the process by which pregnant women experiencing extreme nausea and vomiting can obtain the drug cariban through the drug payment scheme; and if he will make a statement on the matter. [6554/23]
Amharc ar fhreagra610. Deputy Michael Moynihan asked the Minister for Health if he will provide details of the process for women to obtain the medication cariban through the drugs payment scheme; and if he will make a statement on the matter. [6639/23]
Amharc ar fhreagra626. Deputy Jackie Cahill asked the Minister for Health the process by which pregnant people with Hyperemesis Gravidarum may obtain the drug cariban; and if he will make a statement on the matter. [6684/23]
Amharc ar fhreagra632. Deputy Neasa Hourigan asked the Minister for Health if he will outline the process by which pregnant people experiencing extreme nausea and vomiting can obtain cariban (doxylamine/pyridoxine); and if he will make a statement on the matter. [6691/23]
Amharc ar fhreagra653. Deputy Róisín Shortall asked the Minister for Health the process by which pregnant women experiencing extreme nausea and vomiting can obtain cariban via the drugs payment scheme, following reports that the process is very unclear and acts as a barrier to obtaining the drug in a timely manner; the steps he is taking to address these access issues; and if he will make a statement on the matter. [6765/23]
Amharc ar fhreagra666. Deputy Pa Daly asked the Minister for Health the process in writing by which pregnant women experiencing extreme nausea and vomiting can obtain a drug (details supplied); the availability of said drug; and if he will make a statement on the matter. [6810/23]
Amharc ar fhreagra669. Deputy Thomas Pringle asked the Minister for Health if he will outline the process in writing by which pregnant women experiencing extreme nausea and vomiting can obtain cariban; and if he will make a statement on the matter. [6813/23]
Amharc ar fhreagra738. Deputy Barry Cowen asked the Minister for Health the process in writing by which pregnant women experiencing extreme nausea and vomiting can obtain cariban. [7077/23]
Amharc ar fhreagra748. Deputy Paul Murphy asked the Minister for Health to details the process by which pregnant women experiencing extreme nausea and vomiting can obtain cariban; and if he will make a statement on the matter. [7100/23]
Amharc ar fhreagra750. Deputy Paul Murphy asked the Minister for Health the alternative treatments for extreme nausea and vomiting for the first 12 weeks of pregnancy he recommends for pregnant women given the lack of access to cariban during that time period for many pregnant women who do not see an obstetrician until after 12 weeks; and if he will make a statement on the matter. [7102/23]
Amharc ar fhreagra753. Deputy Seán Canney asked the Minister for Health if he can provide clarity for pregnant women on the process of how to obtain cariban through the drugs payment scheme, given that the drug is necessary to prevent extreme nausea and vomiting; and if he will make a statement on the matter. [7138/23]
Amharc ar fhreagra791. Deputy Colm Burke asked the Minister for Health the process in writing by which pregnant women experiencing extreme nausea and vomiting can obtain the drug known as cariban; and if he will make a statement on the matter. [7208/23]
Amharc ar fhreagra792. Deputy Colm Burke asked the Minister for Health the reason the drug known as cariban cannot be prescribed by a GP on the drugs payment scheme as the majority of women who need this medication do not see a consultant until after 12 weeks; the other alternatives that are available for women to assist with nausea and vomiting prior to 12 weeks; and if he will make a statement on the matter. [7209/23]
Amharc ar fhreagra858. Deputy Verona Murphy asked the Minister for Health the steps his Department is taking to ease current access difficulties to cariban being experienced by expectant mothers; and if he will make a statement on the matter. [7361/23]
Amharc ar fhreagraI propose to take Questions Nos. 550, 574, 610, 626, 632, 653, 666, 669, 738, 748, 750, 753, 791, 792 and 858 together.
As part of Budget 2023, funding of €32.2 million was announced for Women’s Health Initiatives in 2023.
This included dedicated funding of €1.3m for Cariban® (doxylamine/pyridoxine) to help women who experience hyperemesis gravidarum, a severe form of nausea and vomiting, during pregnancy. Hyperemesis gravidarum is expected to affect about 1% of the pregnant population.
The Health Service Executive (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 Good s) Act 2013. Only licensed indications which have been granted market authorisation by the European Medicines Agency (EMA) or the Health Products Regulatory Authority (HPRA) can be added to the formal reimbursement list.
Within the European Union (EU), the pricing and reimbursement of medicines is a national competence. As EU Member States operate different pharmaceutical reimbursement systems across the EU, a direct comparison of the reimbursement of products is not possible. The competent authority for pricing and reimbursement in Ireland is the HSE.
Cariban® is an Exempt Medicinal Product (EMP), i.e., it is not licensed in Ireland and, therefore, cannot be added to the formal reimbursement list.
However, following the recommendations of the HSE Medicines Management Programme, and to address the unmet need of patients with hyperemesis gravidarum, reimbursement support for Cariban® (doxylamine/pyridoxine), an unlicensed Exempt Medicinal Product, has now been made available on an individual patient basis for those patients who meet the criteria and where Consultant Obstetrician initiated.
Under the community drug schemes, Exempt Medicinal Products must be Consultant initiated. However, whilst the original prescriber of Cariban® must be a consultant and specialist in the relevant field, the HSE will accept a GP prescription subsequent to the initial hospital prescription for approved patients.
The relevant HSE circular regarding the exceptional arrangement for Cariban® is available at:
www.hse.ie/eng/staff/pcrs/circulars/pharmacy/pharmacy-circular-001-23-cariban.pdf.
In order to obtain reimbursement support for Cariban® under this exceptional arrangement, the prescribing consultant must confirm whether the following apply:
- The individual has nausea and vomiting of pregnancy (NVP) which requires systemic treatment.
- The individual has been assessed using the pregnancy unique quantification of emesis and nausea (PUQE) assessment tool and the appropriate treatment algorithm has been followed.
- The individual has not responded to conservative management.
The consultant must also make an Unlicensed Product Declaration and submit the completed application form by email to the Primary Care Reimbursement Service (PCRS).
Once reviewed by the PCRS, the prescriber and dispensing pharmacy are emailed (via secure email) with the reimbursement decision. The community pharmacy then dispenses the product under the specific patient’s community drug schemes eligibility and submits the claim using the relevant administrative code in their monthly submission to PCRS.
While reimbursement support is offered on the basis of the patient’s eligibility under the General Medical Services (GMS) Scheme or the Drugs Payment Scheme (DPS), Cariban® is not on the formal reimbursement list.
This exceptional arrangement has been put in place to ensure that those patients suffering from hyperemesis gravidarum have access to Cariban®. The dedicated funding that has been allocated is based on 1% of the pregnant population requiring treatment for hyperemesis gravidarum. The number of approved applications to date is in line with expectations and indicate that the budget allocated will be used in 2023. As of 10th February 2023, the number of applications received by the Primary Care Reimbursement Service (PCRS) stands at 384.
There are three other products containing doxylamine/pyridoxine, which are licensed in Ireland:
- Xonvea® gastro-resistant tablets.
- Navalem® modified-release hard capsules.
- Exeltis® gastro-resistant tablets.
The market authorisation holder of Xonvea® has not progressed the pricing and reimbursement application further with the HSE at this stage. The market authorisation holders for Exeltis® and Navalem® have not submitted pricing and reimbursement applications to the HSE.
The HSE therefore encourages clinicians, along with the Institute of Obstetricians and Gynaecologists and the National Clinical Programme for Obstetrics and Gynaecology, other healthcare professionals, and relevant representative bodies to encourage the market authorisation holders of the licensed medicinal products (Xonvea®, Exeltis® and Navalem®) to progress with the formal pricing and reimbursement process in Ireland.
Finally, the HSE provides general advice on treatments for hyperemesis gravidarum at: www2.hse.ie/conditions/hyperemesis-gravidarum/treatment/.
551. Deputy James Lawless asked the Minister for Health if he will confirm the pandemic payment to a person (details supplied); and if he will make a statement on the matter. [6511/23]
Amharc ar fhreagraAs this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly.
