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Dáil
‹ Ceisteanna ar Reachtaíocht a Gealladh - Questions on Promised Legislation

Aduhelm approval and funding

Summary

Deputy Patricia Ryan asked for an update on Aduhelm’s approval process and whether it would be funded if approved. The Minister said medicines follow an established assessment process and he would ask the Department to reply in detail.

As the Minister will be aware, yesterday was World Alzheimer's Day. Earlier this year, we saw the US Food and Drug Administration give approval for Aduhelm, which has shown promise, particularly in the treatment of early onset dementia. The European Medicines Agency is currently considering an application for approval which was filed last year. Is there any update on this application? Will the Government commit to funding this drug, if approved, under the GMS and drugs payment scheme?

Comment on this

I thank Deputy Patricia Ryan. I do not have specific details of that particular drug. As the Deputy will be aware, there is an agreed process for the approval of medicines and the consideration of value for money through the National Centre for Pharmacoeconomics. I do not know exactly what stage in the process that particular drug is at but I will ask the Minister and his officials to revert to the Deputy with a detailed reply.

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