Niamh Smyth (Cavan-Monaghan, Fianna Fail)
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356. To ask the Minister for Health if a person (details supplied) can access a drug for their condition; if so, if they will be reimbursed for same; if it can be accessed under the cross-border health directive; and if he will make a statement on the matter. [11363/18]

Simon Harris (Wicklow, Fine Gael)
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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.

The HSE received separate applications for the reimbursement of Nivolumab (Opdivo) for eight separate indications, including for use as a combination therapy in 2017.

In October 2017, Nivolumab was approved by the HSE for the treatment of:

- melanoma (monotherapy);

- renal cell carcinoma, and

- Hodgkins Lymphoma.

The HSE decided not to support the use of Nivolumab in the treatment of locally advanced or metastatic non-small cell lung cancer. The HSE Drugs Group did not consider the evidence for clinical benefit to be sufficiently robust in the context of the proposed price and budget impact.

The company is welcome to submit a new reimbursement application which will be assessed in line with the 2013 Act.

The EU Directive 2011/24/EU on Patients’ Rights in Cross Border Healthcare aims to ensure EU citizens may access safe and good quality healthcare services across EU borders. The Directive establishes a framework for cross border healthcare between EU/EEA states to facilitate patients to access care in another Member State in accordance with their entitlements in their own country. Under the Directive, known as the Cross Border Healthcare Directive (CBD), insured patients are entitled to have the costs of cross-border healthcare services reimbursed if the healthcare service in question is among the benefits to which they are entitled in their Member State of affiliation. As such, it allows Irish residents to avail of healthcare in other EU or EEA (excluding Switzerland) Member States that they would be entitled to within the public health system in Ireland, which is not contrary to Irish legislation.

As Nivolumab is not currently available within the public health system in Ireland for use for people with lung cancer, it would not be possible to avail of it abroad under the Cross Border Directive.