Wednesday, 13 May 2020

Questions (547, 548, 550)

Thomas Byrne

Question:

547. Deputy Thomas Byrne asked the Minister for Health if osimertinib will be reimbursed for patients suffering from non-small cell lung cancer; and if he will make a statement on the matter. [4382/20]

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Thomas Byrne

Question:

548. Deputy Thomas Byrne asked the Minister for Health if he has received an update from the NCPE on the reimbursement of osimertinib. [4383/20]

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Thomas Byrne

Question:

550. Deputy Thomas Byrne asked the Minister for Health the reason for the delay in reimbursing osimertinib for patients suffering from non-small cell lung cancer; and the reason Ireland is not reimbursing the drug in line with other European countries. [4385/20]

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Written answers (Question to Health)

I propose to take Questions Nos. 547, 548 and 550 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 which specifies the criteria for decisions on the reimbursement of medicines.

In line with the 2013 Health 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.

In making a relevant reimbursement decision, the HSE is required under the 2013 Health Act to have regard to a number of criteria. These reimbursement criteria are comprehensive and must all be carefully considered by the HSE when reimbursement decisions are under consideration, particularly as many of these reimbursement decisions represent multi-million euro investments by the State.

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

I am advised by the HSE that it has received two applications for the reimbursement of osimertinib (Tagrisso):

1) The treatment of adult patients with locally advanced or metastatic EGFR T790M mutation-positive non-small cell lung cancer (NSCLC). In May 2018, the NCPE recommended that osimertinib not be considered for reimbursement for this indication unless cost-effectiveness can be improved relative to existing treatments. The application has had a positive recommendation from the HSE Drugs Committee and is currently under consideration by the HSE in line with the 2013 Health Act.

2) The first-line treatment of adult patients with locally advanced or metastatic NSCLC with activating epidermal growth factor receptor (EGFR) mutations.

In respect of this 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.