Written answers

Thursday, 5 March 2020

Department of Health

Medicinal Products Reimbursement

Darren O'Rourke (Meath East, Sinn Fein)
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685. To ask the Minister for Health the status of the approvals process for Osimertinib; the date on which the drug will be approved for reimbursement; if his attention has been drawn to the case of a person (details supplied) in County Meath spending €5,270 per month on the medication; and if he will make a statement on the matter. [3273/20]

Photo of Simon HarrisSimon Harris (Wicklow, Fine Gael)
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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.  The 2013 Act does not give the Minister for Health any powers in this regard.  The HSE does not require approval or consent from the Minister or Government when making a reimbursement decision.  As Minister for Health, it would be inappropriate for me to comment on individual cases.

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.

Reimbursement is for licenced 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 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.

I am advised by the HSE that it has received two applications for the reimbursement of osimertinib (Tagrisso). The application received for osimertinib for the treatment of adult patients with locally advanced or metastatic EGFR T790M mutation-positive non-small cell lung cancer (NSCLC) has had a positive recommendation from the Drugs Committee and is currently under consideration by the HSE in line with the 2013 Health Act.

The HSE has confirmed that it is in contact with the applicant company and will keep them updated of all developments in relation to this matter.

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