Stephen Donnelly (Wicklow, Fianna Fail)
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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.

In line with the 2013 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 formal 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. HSE decisions on which medicines are reimbursed by the taxpayer are made on objective, scientific and economic grounds, on the advice of the National Centre for Pharmacoeconomics (NCPE).

There are formal processes which govern applications for the pricing and reimbursement of medicines, and new uses of existing medicines, to be funded and/or reimbursed.

The HSE Corporate Pharmaceutical Unit (CPU) is the interface between the HSE and the Pharmaceutical Industry in relation to medicine pricing and reimbursement (P&R) applications and the operation of the national pricing framework agreements. The role of the CPU is to manage the process around pricing and reimbursement applications for new medicines received by the HSE from industry and to lead on pricing negotiations with individual companies around specific medicines.

With respect to Fenfluramine (Fintepla):

Fenfluramine (Fintepla) received a marketing authorisation (MA) from the European Medicines Agency (EMA) in December 2020.

As per the Summary of Product Characteristics (SmPC), Fenfluramine (Fintepla) is indicated for the treatment of seizures associated with Dravet syndrome and Lennox-Gastaut syndrome as an add-on therapy to other anti-epileptic medicines for patients 2 years of age and older.

The HSE CPU has confirmed that, as of the 26th May 2023, it has not received a P&R application from UCB Pharma (the MA holder) for Fenfluramine (Fintepla).