Dáil Éireann Debate, Tuesday - 11 July 2023
671. Deputy Ged Nash asked the Minister for Health if he will consider including testosterone cypionate in the drug payment scheme in view of the financial hardships being endured by patients (details supplied); and if he will make a statement on the matter. [33492/23]
View answerThe Health Service Executive (HSE) has statutory responsibility for decisions on pricing and reimbursement under the community drug schemes, in accordance with the provisions of 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 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. 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).
The HSE have advised that testosterone cypionate is an unlicensed product that is not reimbursable under the community drug schemes. However, there are a number of licensed testosterone products, including injections and gels, currently available on the formal reimbursement list.
