Medicinal Products Reimbursement

Dáil Éireann Debate, Wednesday - 5 December 2018

Wednesday, 5 December 2018

Questions (81, 143)

Caoimhghín Ó Caoláin

Question:

81. Deputy Caoimhghín Ó Caoláin asked the Minister for Health the position regarding the recent engagement with the representatives of a company (details supplied) in the context of securing an agreement for the provision of Spinraza for children and adults with spinal muscular atrophy and who would benefit from its properties; if the talks are ongoing; the timeframe in this regard; the outcome of same; and if he will make a statement on the matter. [50803/18]

John Curran

Question:

143. Deputy John Curran asked the Minister for Health if an access programme will be established to the drug Spinraza for children with spinal muscular atrophy; and if he will make a statement on the matter. [50616/18]

Written answers

Minister for Health

I propose to take Questions Nos. 81 and 143 together.

The HSE has statutory responsibility for medicine pricing and reimbursement decisions, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013. The Act specifies the criteria for decisions on the reimbursement of medicines. As Minister for Health, I do not have any statutory function in relation to reimbursement of medicines.

Nusinersen (Spinraza) is indicated for the treatment of 5q spinal muscular atrophy (SMA), a disorder characterised by progressive muscle atrophy and weakness.

In October 2017, the HSE received a reimbursement application for nusinersen. In December 2017, the National Centre for Pharmacoeconomics completed a health technology assessment of nusinersen and did not recommend reimbursement at the price submitted. The application is being considered by the HSE's Rare Diseases Medicinal Products/Technology Review Committee and the HSE Drugs Group and is due to be considered by the HSE Leadership Team shortly, following which a final decision will be notified.