Sorca Clarke (Longford-Westmeath, Sinn Fein)
Link to this: Individually | In context

184. To ask the Minister for Health for an update on the review of atropine 0.01%; if consideration has been given to making it available for myopia control; and if she will make a statement on the matter. [26316/25]

Sorca Clarke (Longford-Westmeath, Sinn Fein)
Link to this: Individually | In context

185. To ask the Minister for Health the criteria for which atropine 0.01% eye drops, prescribed for myopia, to limit the risk of damage to eyes and potentially detached retinas is not on licence, and therefore not covered by the drug payment scheme. [26317/25]

Jennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)
Link to this: Individually | In context

I propose to take Questions Nos. 184 and 185 together.

The Health Service Executive (HSE) has statutory responsibility for medicine pricing and reimbursement decisions, in accordance with the provisions of the Health (Pricing and Supply of Medical Goods) Act 2013. Reimbursement is for licenced indications which have been granted market authorisation by the European Medicines Agency (EMA) or the Health Products Regulatory Authority (HPRA). 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.

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 are made on objective, scientific and economic grounds, on the advice of the National Centre for Pharmacoeconomics (NCPE).

There are currently two applications for atropine products under evaluation by the EMA:

- Atropine sulfate - EMEA/H/C/006324 treatment of progression of myopia in children aged 3 to 18 years.

- Atropine sulphate PH. EUR. - EMEA/H/C/006385, PUMA treatment of myopia in children aged 3 years and older.

Until such time as a product is licensed for the reduction of myopia progression, and the Marketing Authorisation Holder subsequently applies to the HSE for reimbursement through the formal pricing and reimbursement application process, a reimbursement recommendation cannot be made by the HSE.