Written answers

Tuesday, 15 February 2022

Department of Health

Medicinal Products

Photo of James LawlessJames Lawless (Kildare North, Fianna Fail)
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689. To ask the Minister for Health if he will examine the use of a drug (details supplied) to help with a condition; and if he will make a statement on the matter. [7629/22]

Photo of Stephen DonnellyStephen Donnelly (Wicklow, Fianna Fail)
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The 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 Health 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.

Modified-release Hydrocortisone (Plenadren) is licensed for the treatment of adrenal insufficiency in Ireland and throughout the EU since 2011.

The HSE has advised that it received a pricing and reimbursement application for modified-release Hydrocortisone in 2016 for the treatment of adrenal insufficiency in adults. On 9 April 2019, following the assessment and deliberative process, the HSE determined that the application for modified-release Hyrdocortisone was refused, pursuant to Section 18 of the 2013 Act.

The HSE has not received a new pricing and reimbursement application for modified-release Hydrocortisone from the pharmaceutical company to date. If the company decides to submit a new pricing and reimbursement application, the HSE will assess this in accordance with the 2013 Act.

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