I propose to take Questions Nos. 1309 and 1355 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.
In line with the 2013 Act and the national framework agreed with industry, if a company would like a medicine to be reimbursed by the HSE, the company must submit an application to the HSE to have the new medicine added to the reimbursement list.
Reimbursement is for licenced indications which have been granted market authorisation by the European Medicines Agency or the Health Products Regulatory Authority.
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).
I am advised by the HSE that it has received two applications for the reimbursement of osimertinib:
1) The treatment of adult patients with locally advanced or metastatic EGFR T790M mutation-positive NSCLC.
In respect of this indication, the HSE received a health technology assessment (cost utility analysis) for this application in May 2018. Following the 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 to not 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.
2) The first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer with activating epidermal growth factor receptor (EGFR) mutations.
In respect of the second indication, a health technology assessment was completed on 6 August 2019 with the NCPE recommending that 'osimertinib not be considered for reimbursement unless cost effectiveness can be improved relative to existing treatments.' The HSE will assess this application for reimbursement in line with the 2013 Health Act.