Dáil Éireann Debate, Tuesday - 14 February 2023
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]
View answer574. 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]
View answer610. 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]
View answer626. 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]
View answer632. 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]
View answer653. 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]
View answer666. 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]
View answer669. 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]
View answer738. 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]
View answer748. 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]
View answer750. 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]
View answer753. 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]
View answer791. 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]
View answer792. 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]
View answer858. 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]
View answerI 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/.
