Written answers

Tuesday, 10 June 2025

Department of Health

Medicinal Products

Photo of Albert DolanAlbert Dolan (Galway East, Fianna Fail)
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1352. To ask the Minister for Health the rationale for excluding evorel 100mcg patches from the new hormone replacement therapy (HRT) scheme, given its widespread use as a substitute for estradot, which has been in long-term short supply; the measures being taken to ensure continuity of HRT care for those impacted by the supply shortages of estradot, including the potential inclusion of alternatives such as evorel in the scheme; and if her Department or the HSE is reviewing the classification or coverage of unlicensed but clinically necessary HRT alternatives to ensure equitable access to treatment for all women. [29291/25]

Photo of Louis O'HaraLouis O'Hara (Galway East, Sinn Fein)
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1380. To ask the Minister for Health the reason evorel patches, which are being dispensed in place of estradot due to an ongoing shortage, are not covered under the new free hormone replacement therapy scheme; and if she will make a statement on the matter. [29459/25]

Photo of Louis O'HaraLouis O'Hara (Galway East, Sinn Fein)
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1381. To ask the Minister for Health the steps being taken to ensure hormone replacement therapy (HRT) medicine alternatives such as evorel are included in the free HRT scheme, especially given the possible long-term unavailability of estradot; if her Department or the HSE plans to reassess the coverage of such alternative HRT medication under the free HRT scheme to ensure continuity of care; and if she will make a statement on the matter. [29460/25]

Photo of Shane MoynihanShane Moynihan (Dublin Mid West, Fianna Fail)
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1479. To ask the Minister for Health to outline the availability of estradot in Ireland, and if an alternative to this drug can be funded as part of the free HRT programme. [29831/25]

Photo of Jennifer Carroll MacNeillJennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)
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I propose to take Questions Nos. 1352, 1380, 1381 and 1479 together.

The Health Service Executive (HSE) has statutory responsibility for decisions on pricing and reimbursement of medicines and medical items, in accordance with 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 or the Health Products Regulatory Authority (HPRA). In line with the 2013 Act and the national framework agreed with industry, a company must apply to the HSE to have a new medicine added to the formal Reimbursement list.

The Hormone Replacement Therapy (HRT) arrangement commenced on 1st June 2025. The list of reimbursable items is set out in pharmacy circular 08/2025 (available at: ). Pharmacists can contact the HSE for any HRT related reimbursement support queries by emailing .

The HSE advise that Evorel 100 patches are not licensed in Ireland with the HPRA and therefore cannot be added to the reimbursement list. Evorel 50 patches and Evorel Conti patches are both available on the reimbursement list and are therefore included in the HRT arrangement. The HSE also advise that they do sometimes see reimbursement applications for Evorel 25 patches and Evorel 75 patches, and these would be reimbursed as Exempt Medicinal Products (EMPs).

The HPRA has been notified of current shortages in respect of all four Estradot patches on the reimbursement list (the 37.5, 50, 75, and 100 dosages). These shortages are due to a manufacturing delay which is impacting multiple countries. The HPRA has been notified that the supply of the Estradot 37.5 patches and Estradot 100 patches would resume in May 2025, while the resumption of the supply of Estradot 50 patches and Estradot 75 patches would be later in the year. The HPRA maintains a list of current and resolved shortages on its website. The webpage is updated daily as the HPRA receives new information.

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