Tuesday, 19 February 2019

Ceisteanna (328, 383, 388, 395, 415, 434)

Willie O'Dea

Ceist:

328. Deputy Willie O'Dea asked the Minister for Health the status of the approval of the drug Spinraza for availability under the general medical services system; and if he will make a statement on the matter. [7727/19]

Amharc ar fhreagra

Seán Haughey

Ceist:

383. Deputy Seán Haughey asked the Minister for Health if the drug known as Spinraza will be made available to persons with spinal muscular atrophy; and if he will make a statement on the matter. [8009/19]

Amharc ar fhreagra

Peadar Tóibín

Ceist:

388. Deputy Peadar Tóibín asked the Minister for Health when Spinraza treatment will be rolled out to persons with spinal muscular atrophy; and if he will make a statement on the matter. [8028/19]

Amharc ar fhreagra

Seán Sherlock

Ceist:

395. Deputy Sean Sherlock asked the Minister for Health when a drug (details supplied) will be made available. [8119/19]

Amharc ar fhreagra

Denis Naughten

Ceist:

415. Deputy Denis Naughten asked the Minister for Health when a decision will be made on making Spinraza available to children with spinal muscular atrophy; and if he will make a statement on the matter. [8205/19]

Amharc ar fhreagra

Robert Troy

Ceist:

434. Deputy Robert Troy asked the Minister for Health the status of the application for reimbursement for Nusinersen for the treatment of spinal muscular atrophy; if he has engaged with the HSE in an effort to advance this process; and if he will make a statement on the matter. [8324/19]

Amharc ar fhreagra

Freagraí scríofa (Ceist ar Health)

I propose to take Questions Nos. 328, 383, 388, 395, 415 and 434 together.

The Health Service Executive has statutory responsibility for decisions on pricing and reimbursement of medicines, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013.

The Act specifies the criteria to be applied in the making of reimbursement decisions which include the clinical and cost effectiveness of the product, the opportunity cost and the impact on resources that are available to the HSE.

I am advised by the HSE that the application for the reimbursement of Nusinersen (Spinraza) was considered by HSE Leadership at a meeting on 12 February 2019 and that the HSE is in the process of communicating its decision to the relevant company.