Stephen Donnelly (Wicklow, Fianna Fail) | Oireachtas source

I thank Mr. Hennessy. The Spinraza process has been ongoing for some time. In May 2017 it was approved by the European Medicines Agency and an application was received in October last year. In December last year we were told the National Centre for Pharmacoeconomics, NCPE, completed its health technology assessment and said "No" at the current price. My understanding is we have a "Yes" on the impact of the drug at a clinical level but a "No" on the price based on the analysis of the NCPE. Responses to parliamentary questions from October - we are getting the same response now - was that it is now with the rare diseases review committee, the HSE drugs group and the HSE leadership. I have the same question as earlier, as a number of men, women and children are desperately waiting for an answer and hoping for a positive reply on this. When will they expect to hear either way from all the different groups? If it is a "Yes", when can they expect access to the drug?

The rare diseases technology review committee first met on 15 October, when it was high on our agenda. We met again on 8 November. We also met patients and families, who presented well to the group and demonstrated what living with SMA is like. The committee is putting together a report which will be sent to the drugs group within weeks and it will outline how one might decide on the prescribing areas, who would be prescribed for, what the criteria to start prescribing nusinersen would be and whether there would be criteria to discontinue it if it did not work, as some of the trials show that up to 50% of people will not respond. That is the kind of document that is being prepared. I anticipate that a draft will be sent to the drugs group in the next two or three weeks, and that is the task of the rare diseases committee.

Mr. Flanagan might comment further on the drugs group. I imagine it will be taken into consideration before the end of the year.