Patricia Ryan (Kildare South, Sinn Fein)
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277. To ask the Minister for Health the reason utrogesten 100ml tablets are no longer available under the DPS; and if he will make a statement on the matter. [21019/23]

Stephen Donnelly (Wicklow, Fianna Fail)
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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 licensed 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 by the taxpayer are made on objective, scientific and economic grounds, on the advice of the National Centre for Pharmacoeconomics (NCPE).

The HSE advise that Utrogestan 100mg capsules, which contain progesterone, is an Exempt Medicinal Product (EMP). However, due to the unmet clinical need, this product is reimbursable under an exceptional arrangement on the community drug schemes, including the Drug Payment Scheme (DPS). This arrangement enables practitioners to prescribe a EMP under that practitioner’s direct responsibility, in order to fulfil the special needs of that specific patient.

For reimbursement support under the community drug schemes, EMPs must be consultant initiated. The HSE will accept a GP prescription subsequent to the initial consultant’s prescription for approved patients.