Mr. Shaun Flanagan:

I can give a timeline. We can assume that the rare diseases technology review committee will provide a report relatively imminently, and there is a drugs group meeting in December which already has five items on the agenda because multiple medicines are going through the process, including multiple orphan drugs. In the past 12 weeks, for example, there were three meetings of the drugs group and 18 drugs were assessed and reviewed at the meetings, which means that we can process approximately six per meeting. At the moment, there are four items on the agenda. If it can be put on that agenda, it will be dealt with on that agenda but there are steps in the process and we have multiple other drugs and patients who also deserve responsibility.

To give context for the challenges the State faces, in 2018 to date the drugs group has made positive recommendations for medicines that will cost the State €300 million over the next five years. A significant amount of money, therefore, is flushing through in positive recommendations through that process. It is a very challenging position for the State to have to try to fund, and many orphan drugs with positive recommendations are included in that. From an evidence point of view, notwithstanding that SMA is an horrific disease and everyone recognises the unmet need of the patients, not least the type 1 patients, it is very challenging due to the lack of evidence evidence and maintaining cost effectiveness, even at the commercial offer.

It is public money and I would love to be able to put what the offer is into the public domain, but I am constrained by the company's constraints.