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. Reimbursement for medicines under the community drugs schemes is for licensed indications which have been granted market authorisation by the European Medicines Agency or the Health Products Regulatory Authority (HPRA).
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. The Minister for Health has no role in these decisions.
Esbriet® (pirfenidone) for the treatment of mild to moderate idiopathic pulmonary fibrosis has been on the HSE's Reimbursement List since 2015. It is available under the General Medical Services (medical card) Scheme and the Drug Payment Scheme for that indication.
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 LTI scheme will be included as part of a review of the current eligibility framework, including the basis for existing hospital and medication charges, to be carried out under commitments given in the Sláintecare Implementation Strategy.
In the meantime, for people who are not eligible for the LTI scheme, there are other arrangements which protect them from excessive medicine costs.
Under the Drug Payment Scheme, no individual or family pays more than €80 a month towards the cost of approved prescribed medicines. The scheme significantly reduces the cost burden for families and individuals with ongoing expenditure on medicines.
People who cannot, without undue hardship, arrange for the provision of medical services for themselves and their dependants may be eligible for a medical card. In accordance with the provisions of the Health Act 1970 (as amended), eligibility for a medical card is determined by the HSE. Medical card eligibility is primarily based on an assessment of means and is not granted on the basis of any particular condition.
In certain circumstances the HSE may exercise discretion and grant a medical card, even though an applicant exceeds the income guidelines, where he or she faces difficult financial circumstances, such as extra costs arising from illness.
In circumstances where an applicant is still over the income limit for a medical card, they are then assessed for a GP visit card, which entitles the applicant to GP visits without charge.
Individuals may also be entitled to claim tax relief on the cost of their medical expenses, including medicines prescribed by a doctor, dentist, or consultant. Relief is at the standard tax rate of 20%.
