Aengus Ó Snodaigh (Dublin South Central, Sinn Fein)
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557. To ask the Minister for Health the reason the drug Plenadren has not been licensed for use in Ireland despite being licensed by the European Medicines Agency nearly ten years ago; and his views on the matter. [44299/20]

Aengus Ó Snodaigh (Dublin South Central, Sinn Fein)
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558. To ask the Minister for Health if consideration will be given to requesting the National Centre for Pharmacoeconomics to re-evaluate its decision in 2013 not to recommend a full pharmacoeconomic evaluation and its decision in 2017 that reimbursement is not recommended at the submitted price, given that the price in two years may have substantially dropped since then, the number of patients in Ireland is low and Plenadren has a variety of prices in other EU states. [44300/20]

Aengus Ó Snodaigh (Dublin South Central, Sinn Fein)
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560. To ask the Minister for Health if there have been negotiations with the manufacture of the drug Plenadren to obtain a discount supply to threat the few patients in Ireland who would be able to avail of this life-changing drug if it was discounted, subsidised by the HSE or available on their medical cards; and if he will make a statement on the matter. [44302/20]

Aengus Ó Snodaigh (Dublin South Central, Sinn Fein)
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561. To ask the Minister for Health if he has had communications with health authorities in other EU states with a view to bulk purchasing the drug Plenadren from a pharmaceutical company (details supplied) to achieve a price reduction for national health services; and if he will make a statement on the matter. [44303/20]

Aengus Ó Snodaigh (Dublin South Central, Sinn Fein)
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562. To ask the Minister for Health if his attention has been drawn to the fact that the drug Plenadren is coming off licence in 2021; the steps that can be taken to encourage other pharmaceutical companies to commence production of the drug at a more affordable price for patients or their health services; and if he will make a statement on the matter. [44304/20]

Stephen Donnelly (Wicklow, Fianna Fail)
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I propose to take Questions Nos. 557, 558 and 560 to 562, inclusive, together.

The application, assessment and decision-making process for new medicines and new uses of existing medicines is underpinned by the Health (Pricing and Supply of Medical Goods) Act 2013.

In accordance with that Act, pharmaceutical companies are required to submit a formal pricing and reimbursement application to the HSE if they wish their medicine to be added to the list of reimbursable items.

On receipt of an application, the HSE are required to comply with the various provisions and criteria contained in the Act before reaching decisions on the pricing and reimbursement of medicines under the community drugs schemes.

The HSE has no role in encouraging companies to make applications for reimbursement under the 2013 Act and nor does the legislation support joint negotiating or bulk purchasing with other EU member countries.

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

I understand that the HSE received a pricing and reimbursement application for modified-release Hydrocortisone (Plenadren) in 2016 for the treatment of adrenal insufficiency in adults. In April 2019, following the assessment and deliberative process, the HSE made the decision to refuse the application, pursuant to Section 18 of the Health (Pricing and Supply of Medical Goods) Act 2013.

I am informed that the HSE does not currently have an open pricing and reimbursement application for modified-release Hydrocortisone. However, the HSE remains open to receiving and considering a new pricing and reimbursement application from the pharmaceutical company.