Dáil Éireann Debate, Wednesday - 17 October 2018
174. Deputy James Browne asked the Minister for Health the position regarding the provision of access to Spinraza in view of a fresh price offer by the drug company in July 2018; and if he will make a statement on the matter. [42669/18]
View answer177. Deputy Eamon Scanlon asked the Minister for Health when the drug Spinraza will be approved for spinal muscular atrophy sufferers; and if he will make a statement on the matter. [42676/18]
View answerI propose to take Questions Nos. 174 and 177 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. The Minister for Health does not have any statutory power or function in relation to reimbursement of medicines.
For a medicine to be considered for reimbursement by the HSE, it must first have a marketing authorisation from the European Medicines Agency (EMA) or the Health Products Regulatory Authority (HPRA), before being assessed under the 2013 Act.
Nusinersen (Spinraza) is indicated for the treatment of 5q spinal muscular atrophy (SMA), a disorder characterised by progressive muscle atrophy and weakness.
In May 2017, the EMA granted market authorisation for nusinersen and in October 2017, the HSE received a reimbursement application for nusinersen.
In December 2017, the NCPE completed a HTA of nusinersen and did not recommend reimbursement at the price submitted. The application is being considered by the 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 the final decision will be notified.
