Written Answers Nos. 626-643
635. Deputy Neasa Hourigan asked the Minister for Health the medicines available under the drug payment scheme to treat hyperemesis gravidarum; the medicines available on the medical card to treat same; and if he will make a statement on the matter. [6694/23]
Amharc ar fhreagra705. Deputy Frankie Feighan asked the Minister for Health if his Department has any update on medications for hyperemesis (details supplied); and if he will make a statement on the matter. [7029/23]
Amharc ar fhreagraI propose to take Questions Nos. 635 and 705 together.
The Health Service Executive (HSE) has statutory responsibility for decisions on pricing and reimbursement of medicines and medical items, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013.
In line with the 2013 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 formal Reimbursement list. Reimbursement is for licenced indications which have been granted market authorisation by the European Medicines Agency or the Health Products Regulatory Authority.
In making a relevant reimbursement decision, the HSE is required under the Act to have regard to a number of criteria including efficacy, the health needs of the public, cost effectiveness and potential or actual budget impact. 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). I, as the Minister for Health, have no role in these decisions.
As part of Budget 2023, I announced €32.2 million in funding for Women’s Health Initiatives in 2023, to include dedicated funding for Cariban® (doxylamine/pyridoxine).
The dedicated funding for Cariban® will 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.
Cariban® is an Exempt Medicinal Product, i.e., it is not licensed with the Health Products Regulatory Authority (HPRA) in Ireland. Only licensed products are added to the formal HSE Reimbursement List in line with the 2013 Act.
There are three products containing doxylamine/pyridoxine licensed in Ireland:
- Xonvea® gastro-resistant tablets.
- Exeltis® gastro-resistant tablets.
- Navalem® modified-release hard capsules.
To date the market authorisation holder of Xonvea® has not progressed the pricing and reimbursement application further with the HSE. The market authorisation holders for Exeltis® and Navalem® have not submitted pricing and reimbursement applications to the HSE.
However, following the recommendations of the HSE Medicines Management Programme, and to address the unmet need of patients with hyperemesis gravidarum, an exceptional arrangement was put in place to support the reimbursement of Cariban®.
Cariban® is now available under the community drug schemes – the General Medical Services (GMS) and the Drugs Payment Scheme (DPS) – on an individual patient basis for those patients who meet the criteria for the treatment of nausea and vomiting in pregnancy.
Under the community drug schemes, Exempt Medicinal Products such as Cariban, 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.
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 applications being processed for Cariban® are in line with expectations.
If a licensed product was subsequently approved for reimbursement, this exceptional arrangement could then be reviewed or revised. The HSE therefore encourages clinicians, along with the Institute of Obstetricians and Gynaecologists and the National Clinical Programme for Obstetrics and Gynaecology, and other healthcare professionals 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.
636. Deputy Rose Conway-Walsh asked the Minister for Health the ratio of clinicians working in prosthetics and orthotics to their clerical and administrative staff; and if he will make a statement on the matter. [6704/23]
Amharc ar fhreagraAs this is a service matter, I have asked the Health Service Executive to respond directly to the Deputy, as soon as possible.
637. Deputy Rose Conway-Walsh asked the Minister for Health if he will outline any plans to introduce regional rehabilitation services for amputees; and if he will make a statement on the matter. [6705/23]
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.
638. Deputy Rose Conway-Walsh asked the Minister for Health the number of CAMHS intellectual disability teams in CHO2; and if he will make a statement on the matter. [6706/23]
Amharc ar fhreagraAs this is a service matter, I have asked the Health Service Executive to respond directly to the Deputy as soon as possible.
639. Deputy Niamh Smyth asked the Minister for Health the reason a person (details supplied) is waiting so long for an appointment with Enable Ireland; and if he will make a statement on the matter. [6720/23]
Amharc ar fhreagraAs this question refers to service matters, I have asked the Health Service Executive (HSE) to respond to the Deputy directly, as soon as possible.
641. Deputy Jackie Cahill asked the Minister for Health if he is aware that pregnant people affected by hyperemesis gravidarum are currently forced to present at emergency departments in order to obtain consultant prescriptions for Cariban; if his Department has identified the unnecessary delays and additional cost burden this has caused in emergency departments; and if he will make a statement on the matter. [6722/23]
Amharc ar fhreagraAs part of Budget 2023, I announced €32.2 million in funding for Women’s Health Initiatives in 2023, to include dedicated funding for Cariban® (doxylamine/pyridoxine). The dedicated funding for Cariban® will help women who experience hyperemesis gravidarum, aa 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 Goods) 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.
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.
Following the recommendations of the HSE Medicines Management Programme, Cariban® is now available on an individual patient basis for those patients who meet the criteria under the community drug schemes – the General Medical Services scheme (GMS) and the Drugs Payment Scheme (DPS) – 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.
This exceptional arrangement has been put in place since 1st of January 2023 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. Any potential additional costs arising from patients presenting at emergency departments to access this arrangement were not included in the estimates.
642. Deputy Jackie Cahill asked the Minister for Health the engagement the Department has made with Hyperemesis Ireland, the ICGP, and other expert bodies, regarding the implementation of reimbursement of cariban for hyperemesis gravidarum sufferers; his future plans to engage with relevant bodies; and if he will make a statement on the matter. [6723/23]
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. 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.
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 those patients with hyperemesis gravidarum, reimbursement support for 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.
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.
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).
This arrangement has been put in place to ensure that those patients suffering from hyperemesis gravidarum have access to Cariban®. The number of approved applications to date is in line with expectations and indicates that the budget allocated will be used in 2023.
