Dáil Éireann Debate, Thursday - 8 September 2022
1702. Deputy Mary Lou McDonald asked the Minister for Health if he will provide an update on the recommendations by the HSE medicines management programme regarding the drug Cariban; his plans, if any, regarding the provision of affordable access to this treatment for persons suffering from hyperemesis who are prescribed this medication; and if he will make a statement on the matter. [42716/22]
Amharc ar fhreagraThe 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 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.
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 requested that the Medicines Management Programme 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.
