Dáil Éireann Debate, Wednesday - 3 June 2020
563. Deputy Pádraig Mac Lochlainn asked the Minister for Health if his attention has been drawn to the ongoing campaign by families of persons with amyloidosis here to be provided with the drug patisiran as is the case in Northern Ireland; and if he will make a statement on the matter. [8576/20]
View answerThe 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.
In line with the 2013 Act and the national framework agreed with industry, a company must submit an application to the HSE to have a new medicine added to the reimbursement list.
Reimbursement is for licenced indications which have been granted market authorisation by the European Medicines Agency or the Health Products Regulatory Authority.
In making a relevant reimbursement decision, the HSE is required under the Act to have regard to a number of criteria including the health needs of the public, cost effectiveness, potential or actual budget impact and efficacy.
I am advised by the HSE that it has received an application for the reimbursement of Patisiran (Onpattro®) for the treatment of hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis) in adult patients with stage 1 or stage 2 polyneuropathy.
In January 2019, a full health technology assessment was commissioned by the HSE. This assessment was completed in February 2020 with the NCPE recommending that patisiran (Onpattro®) is not considered for reimbursement unless cost-effectiveness can be improved relative to existing treatments. The HSE will assess this application for reimbursement in line with the 2013 Health Act.
I can confirm that I have received representations in relation to the reimbursement of patisiran (Onpattro®).
