Michael Ring (Mayo, Fine Gael)
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556. To ask the Minister for Health the process by which pregnant women experiencing extreme nausea and vomiting can obtain a drug (details supplied); and if he will make a statement on the matter. [6526/23]

Stephen Donnelly (Wicklow, Fianna Fail)
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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 licenced 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 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 indicates 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/

Martin Browne (Tipperary, Sinn Fein)
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558. To ask the Minister for Health if he is aware that requiring a consultant prescription for pregnant women suffering from hyperemesis gravidarum to access cariban effectively limits the reimbursement scheme to those women with private healthcare given the vast majority of pregnant women in the public system do not see their consultant. [6528/23]

Claire Kerrane (Roscommon-Galway, Sinn Fein)
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596. To ask the Minister for Health the reason that cariban cannot be prescribed by a GP under the drugs payment scheme to ensure easier access to it for pregnant women. [6593/23]

Jackie Cahill (Tipperary, Fianna Fail)
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627. To ask the Minister for Health the reason cariban cannot be prescribed by GPs on the DPS; and if he will make a statement on the matter. [6685/23]

Niamh Smyth (Cavan-Monaghan, Fianna Fail)
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640. To ask the Minister for Health if matters (details supplied) in relation to cariban will be addressed in the interest of pregnant women in Ireland experiencing extreme nausea; and if he will make a statement on the matter. [6721/23]

Stephen Donnelly (Wicklow, Fianna Fail)
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I propose to take Questions Nos. 558, 596, 627 and 640 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 licenced 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/

Martin Browne (Tipperary, Sinn Fein)
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559. To ask the Minister for Health if he will provide in full the instructions given to consultants and midwives on the prescription of Cariban. [6529/23]

Stephen Donnelly (Wicklow, Fianna Fail)
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As this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.

Michael Ring (Mayo, Fine Gael)
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560. To ask the Minister for Health the reason GPs cannot prescribe a drug (details supplied) on the drugs payment scheme considering that the majority of women in need of the medication would not be seen by their consultant until well into their second trimester; and if he will make a statement on the matter. [6530/23]

David Stanton (Cork East, Fine Gael)
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565. To ask the Minister for Health if he will allow GPs to prescribe cariban to patients under the community drugs scheme, the general medical services scheme and the drug payment scheme without it being consultant initiated; and if he will make a statement on the matter. [6537/23]

Richard O'Donoghue (Limerick County, Independent)
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588. To ask the Minister for Health the drug cariban cannot be prescribed by a GP on the drugs payment scheme; and if he will make a statement on the matter. [6582/23]

Éamon Ó Cuív (Galway West, Fianna Fail)
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609. To ask the Minister for Health the limitations on the availability of a drug (details supplied) under the drugs payment scheme; if it can be prescribed by a general practitioner; if it requires prescription by a consultant; if so, the reasons for this; and if he will make a statement on the matter. [6635/23]

Michael Moynihan (Cork North West, Fianna Fail)
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611. To ask the Minister for Health the reasons that a GP cannot prescribe cariban to their patients through the drugs payment scheme, given that many women do not see a consultant until after 12 weeks into pregnancy and suffer from extreme nausea and vomiting in this time; and if he will make a statement on the matter. [6640/23]

Jackie Cahill (Tipperary, Fianna Fail)
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628. To ask the Minister for Health the other options that are available to pregnant people who experience Hyperemesis Gravidarum in the first 12 weeks of pregnancy given the current inability to obtain a prescription for cariban without first being seen by a consultant; and if he will make a statement on the matter. [6686/23]

Neasa Hourigan (Dublin Central, Green Party)
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633. To ask the Minister for Health the reason cariban is only available under the community drug schemes when consultant obstetrician initiated as opposed to a general practitioner; and if he will make a statement on the matter. [6692/23]

Róisín Shortall (Dublin North West, Social Democrats)
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654. To ask the Minister for Health if he will amend the reimbursement scheme for cariban in order that it can be prescribed by a GP; the reason only consultant obstetricians can prescribe this treatment under the drugs payment scheme, given that the majority of women do not see a consultant until they are at least 12 weeks pregnant; and if he will make a statement on the matter. [6766/23]

Pa Daly (Kerry, Sinn Fein)
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667. To ask the Minister for Health his views on allowing GPs to prescribe a drug (details supplied). [6811/23]

Thomas Pringle (Donegal, Independent)
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670. To ask the Minister for Health if a general practitioner will be able to make a determination and recommend the prescription of cariban; and if he will make a statement on the matter. [6814/23]

Thomas Pringle (Donegal, Independent)
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671. To ask the Minister for Health the reason cariban is not being made available under the drugs payment scheme; and if he will make a statement on the matter. [6815/23]

Paul Murphy (Dublin South West, RISE)
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749. To ask the Minister for Health the reason cariban cannot be prescribed by a GP on the drug payment scheme; if he agrees with these reasons; and if he will make a statement on the matter. [7101/23]

Stephen Donnelly (Wicklow, Fianna Fail)
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I propose to take Questions Nos. 560, 565, 588, 609, 611, 628, 633, 654, 667, 670, 671 and 749 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 licenced 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/

Michael Ring (Mayo, Fine Gael)
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562. To ask the Minister for Health the current standard practice in other EU countries in relation to the prescribing of a specific drug (details supplied); and if he will make a statement on the matter. [6534/23]

Jackie Cahill (Tipperary, Fianna Fail)
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629. To ask the Minister for Health the current standard of practice in other EU countries for the prescription of cariban; and if he will make a statement on the matter. [6687/23]

Stephen Donnelly (Wicklow, Fianna Fail)
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I propose to take Questions Nos. 562 and 629 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 licenced 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.

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/