Dáil Éireann Debate, Thursday - 8 September 2022
1576. Deputy Patrick Costello asked the Minister for Health if he will license cariban doxylamine pyridoxine under GMS and community drug schemes, recognising the great need of pregnant women suffering from hyperemesis gravidarum and the cost of which can be €50 per week; and if he will make a statement on the matter. [42282/22]
View answerThe 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.
In line with the 2013 Health 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 reimbursement list.
Reimbursement is for licensed 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.
Cariban (doxylamine / pyridoxine) is an unlicensed product that is not reimbursable under GMS and Community Drug Schemes. Only licensed products are added to the formal GMS Reimbursement List in line with the 2013 Act. It is a matter for the marketing company to apply for licensing in Ireland through the Health Products Regulatory Authority (HPRA).
However, the HSE has asked the Medicines Management Programme to examine the appropriateness and feasibility of a patient-specific arrangement for Cariban. The Medicines Management Programme assessment for Cariban has now been completed and its recommendation is under deliberation with the HSE at present.
