Jennifer Murnane O'Connor (Carlow-Kilkenny, Fianna Fail)
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668. To ask the Minister for Health when funding and approval for the immunotherapy drug Osimertinib will become available for persons with lung cancer; and if he will make a statement on the matter. [13747/20]

Stephen Donnelly (Wicklow, Fianna Fail)
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The HSE has statutory responsibility for decisions on pricing and reimbursement of medicines under the community drugs schemes, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013.

In line with the 2013 Act and the national framework agreed with industry, a company must submit an application to the HSE to have a new medicine added to the reimbursement list.

Reimbursement is for licensed indications which have been granted market authorisation by the European Medicines Agency or the Health Products Regulatory Authority.

In making a relevant reimbursement decision, the HSE is required under the Act to have regard to a number of criteria including the health needs of the public, cost effectiveness, potential or actual budget impact and efficacy.

I can confirm that the HSE has approved the application for reimbursement of Osimertinib (Tagrisso) for non small cell lung cancer, the specific recommendation is for second-line use for the treatment of adult patients with locally advanced or metastatic EGFR T790M mutation-positive non small cell lung cancer.

Reimbursement will commence from the 1st July 2020.