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Medicinal Products

Dáil Éireann Debate, Tuesday - 18 April 2023

Tuesday, 18 April 2023

Questions (1513)

Duncan Smith

Question:

1513. Deputy Duncan Smith asked the Minister for Health his plans to move the drug eltroxin onto the long-term illness core list for people with Down syndrome, and other chromosomal abnormalities; and if he will make a statement on the matter. [17031/23]

View answer

Written answers

The Health Service Executive (HSE) has statutory responsibility for medicine pricing and reimbursement decisions, 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 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). I, as Minister for Health, have no role in these decisions.

The Long-Term Illness (LTI) scheme was established under Section 59(3) of the Health Act 1970 (as amended). Regulations were made in 1971, 1973 and 1975, prescribing 16 illnesses covered by the scheme. These are: acute leukaemia; mental handicap; cerebral palsy; mental illness (in a person under 16); cystic fibrosis; multiple sclerosis; diabetes insipidus; muscular dystrophies; diabetes mellitus; parkinsonism; epilepsy; phenylketonuria; haemophilia; spina bifida; hydrocephalus; and conditions arising from the use of Thalidomide.

Under the LTI scheme, patients receive drugs, medicines, and medical and surgical appliances directly related to the treatment of their illness, free of charge.

The HSE have advised that the drug Eltroxin (Levothyroxine Sodium) is included on the LTI scheme Core list under the category mental handicap.

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