Gerry Adams (Louth, Sinn Fein)
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100. To ask the Minister for Health if any patient not involved in the ongoing clinical trial is currently receiving combined Nivolumab/Ipilimumab therapy; his plans to make combined Nivolumab/Ipilimumab therapy available to all suitable cancer patients; and if he will make a statement on the matter. [13711/16]

Simon Harris (Wicklow, Fine Gael)
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I am aware that various clinical trials are ongoing and I welcome the opportunity for Irish patients to be involved in such trials. However, my Department is not privy to information on the number of people recruited to particular trials, or to detailed information on the progress of these trials.

The HSE has statutory responsibility for decisions on pricing and reimbursement of medicinal products under the community drug schemes, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013. Prior to reimbursing any item, the HSE considers a range of statutory criteria, including clinical need, cost-effectiveness and the resources available.

I have been informed by the manufacturer of the drug Nivolumab that they have provided the medicine to over 200 advanced lung cancer patients to date through Clinicians in a number of hospitals throughout the country under what is known as a compassionate access programme. While such schemes are Clinician driven and are not subject to the same regulations and standards of a clinical trial, I understand that companies engaging in such programmes continue to provide the treatment to patients for the duration of their treatment programme and that access to the medicine for such patients is not impacted by the reimbursement decisions of the HSE or an ending of the compassionate programme by the manufacturer.

I welcome the decision announced yesterday by the manufacturer of this drug to extend this compassionate access programme for patients with advanced lung cancer for a period of 30 days to the end of June 2016.