Wednesday, 15 May 2019

Ceisteanna (29, 42, 146)

Gino Kenny

Ceist:

29. Deputy Gino Kenny asked the Minister for Health if his attention has been drawn to the wait that families of children with SMA have been facing while the approval of Spinraza has yet to be resolved; if he will intervene on behalf of children such as a child (details supplied); if he will deliver a positive outcome for all children with SMA and their families by announcing the approval of Spinraza; and if he will make a statement on the matter. [20497/19]

Amharc ar fhreagra

Caoimhghín Ó Caoláin

Ceist:

42. Deputy Caoimhghín Ó Caoláin asked the Minister for Health the status of the protracted engagement between representatives of the Health Service Executive and a company (details supplied); if the most recent offer from the company presents an acceptable package to allow for approval to issue for reimbursement of Spinraza; his views on whether a further delay in reaching an agreement would be unacceptable to a caring child healthcare conscious society; and if he will make a statement on the matter. [20857/19]

Amharc ar fhreagra

Gino Kenny

Ceist:

146. Deputy Gino Kenny asked the Minister for Health the status of the decision on the approval of Spinraza; and if he will make a statement on the matter. [20844/19]

Amharc ar fhreagra

Freagraí scríofa (Ceist ar Health)

I propose to take Questions Nos. 29, 42 and 146 together.

As the Deputies are aware, the Oireachtas put in place a strong legal framework, in the Health (Pricing and Supply of Medical Goods) Act 2013, to give full statutory powers to the HSE to assess and make decisions on reimbursement of medicines, taking account of a range of objective factors and expert opinion as appropriate.

I fully recognise that this debilitating and progressive condition places enormous strain on SMA sufferers and their families and carers, and I can understand their wish to have access to potentially beneficial drug treatments.

However, because of the significant monies involved, the HSE must ensure that the best price is achieved for all medicines, as these commitments are often multi-million euro investments on an on-going basis. This can lead to a protracted deliberation process, where suppliers commence the negotiation process with a pricing proposal that does not reflect affordability or the evaluation of clinical effectiveness.

In the case of Spinraza, following detailed consideration of an application for reimbursement and lengthy engagement with the company, the HSE decided that it was unable to reimburse Nusinersen (Spinraza). The HSE concluded that the evidence for clinical effectiveness was still quite limited and that the price proposed by the manufacturer was not a cost-effective use of resources.

On 21 February 2019, the HSE wrote to the manufacturer involved and informed them of the proposal to refuse reimbursement at the current price offering. Under the requirements of the Health (Pricing and Supply of Medical Goods) Act 2013 the company had 28 days to respond or make representations to the HSE’s proposed decision.

I am advised by the HSE that the manufacturer submitted additional information and that the matter remains under consideration by the HSE.