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.