I propose to take Questions Nos. 321 and 366 together.
The HSE has statutory responsibility for medicine pricing and reimbursement decisions, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013. The Act specifies the criteria for decisions on the reimbursement of medicines. The Minister for Health has no role in relation to reimbursement decisions.
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 current application for the reimbursement of Osimertinib (Tagrisso) for the treatment of adult patients with locally advanced or metastatic EGFR T790M mutation-positive NSCLC was received on 16 January 2018.
Following the NCPE’s assessment and after a number of rounds of commercial negotiations and HSE reviews, the HSE notified the applicant in February 2019 that it was minded not to approve reimbursement for this indication.
The 2013 Act provides for a period of representations after such notifications, before the HSE can make its final decision. The HSE have received representations from the manufacturer and they are under consideration by the HSE leadership team in advance of a final reimbursement decision.