Jackie Cahill (Tipperary, Fianna Fail)
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641. To ask 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]

Stephen Donnelly (Wicklow, Fianna Fail)
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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, 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.

Jackie Cahill (Tipperary, Fianna Fail)
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642. To ask 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]

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 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.

Paul Murphy (Dublin South West, RISE)
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647. To ask the Minister for Health in view of the NCPE's recent negative recommendation in relation to Evusheld, the action he will take on behalf of immunosuppressed people; if he will direct the HSE to make Evusheld available to all who need it; and if he will make a statement on the matter. [6729/23]

Stephen Donnelly (Wicklow, Fianna Fail)
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The National Centre for Pharmacoeconomics (NCPE) has responsibility for assessing evidence for comparative effectiveness and cost-effectiveness of technologies for use by patients in Ireland. This is done through assessment of evidence submitted by manufacturers and independent systematic review.

The NCPE has conducted a Health Technology Assessment (HTA) on Evusheld. This is a standard approval process for all new therapeutics, including those indicated for COVID-19. Following assessment of the submission made by AstraZeneca in respect of Evusheld, the NCPE has recommended that Evusheld not be considered for reimbursement unless cost-effectiveness can be improved relative to existing treatments.

In addition, available scientific evidence raises concerns in terms of the efficacy of Evusheld in light of emerging/increasing variants, and for that reason there is also significant risk around utilising the product as a potential contingency given the uncertainty around new variants, and the current evolutionary pattern towards sub-lineages of Omicron strains. The European Medicines Agency’s Emergency Task Force and the U.S. Food and Drug Administration have outlined concerns around the declining efficacy of these treatments and have cautioned that monoclonal antibodies currently authorised for COVID-19, including Evusheld, are unlikely to be effective against emerging strains of SARS-CoV-2.

The status of Evusheld and other existing and emerging COVID-19 therapeutics will continue to be monitored and assessed in order to ensure both the public interest and the capacity of the health system and service delivery is protected. Any individual who has concerns about an underlying condition or their level of risk in relation to COVID-19 should continue to seek advice from their GP or treating clinician.