Medicinal Products

Dáil Éireann Debate, Thursday - 9 February 2023

Thursday, 9 February 2023

Ceisteanna (282, 283, 302, 305)

Michael Healy-Rae

Ceist:

282. Deputy Michael Healy-Rae asked the Minister for Health if his Department will provide persons with access to a drug (details supplied); and if he will make a statement on the matter. [6319/23]

Brendan Griffin

Ceist:

283. Deputy Brendan Griffin asked the Minister for Health if his Department will provide a person (details supplied) with access to a medication; and if he will make a statement on the matter. [6333/23]

Bríd Smith

Ceist:

302. Deputy Bríd Smith asked the Minister for Health if he will clarify the reason exactly a GP cannot prescribe cariban on the drugs payment scheme; if he will acknowledge that the majority of women do not see a consultant until after 12 weeks of pregnancy and it is the case that a GP would be qualified to prescribe the drug and be automatically covered on the DPS; if he will clarify the reason that a GP would not be qualified to do so if this is not permissible; if he will clarify the standard practice of the prescription of the drug that exists in other EU member states; if he will further outline his Department’s recommendations to help with extreme nausea and vomiting for the first 12 weeks of pregnancy or until the drug can be accessed; and if he will make a statement on the matter. [6375/23]

Paul Kehoe

Ceist:

305. Deputy Paul Kehoe asked the Minister for Health the reason the drug cariban cannot be prescribed by a GP on the drugs payment scheme, given that the majority of women do not see a consultant until after 12 weeks; if this is the current standard practice in other EU member states; his Department’s recommendations, in the meantime, to help with the extreme nausea and vomiting for the first 12 weeks, or until the drug can be accessed; and if he will make a statement on the matter. [6383/23]

Freagraí scríofa

Minister for Health

I propose to take Questions Nos. 282, 283, 302 and 305 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 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.

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 schemes eligibility – either the General Medical Services (GMS) Scheme or the Drugs Payment Scheme (DPS) – and submits the claim using the relevant administrative code in their monthly submission to PCRS.

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. The number of applications received by the Primary Care Reimbursement Service (PCRS), as of 8th February 2023, are 357.

Finally, the HSE provides general advice on treatments for hyperemesis gravidarum at:

www2.hse.ie/conditions/hyperemesis-gravidarum/treatment/

Question No. 283 answered with Question No. 282.