Michael Moynihan (Cork North West, Fianna Fail)
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321. To ask the Minister for Health if his Department has received a request for funding from the HSE for the reimbursement of the drug Tagrisso for the treatment of adult patients with locally advanced or metastatic EGRF T790M mutative-positive NSCLC; when he expects funding to be made available for same; and if he will make a statement on the matter. [38520/19]

John Curran (Dublin Mid West, Fianna Fail)
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366. To ask the Minister for Health further to Parliamentary Question No. 1309 of 6 September 2019, when the HSE received the further information from the manufacturer regarding Tagrisso; the length of time reimbursement has been under consideration by the HSE; when the HSE will make a final decision regarding reimbursement; and if he will make a statement on the matter. [38787/19]

Simon Harris (Wicklow, Fine Gael)
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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.