Léim ar aghaidh chuig an bpríomhábhar
Gnáthamharc

Medicinal Products Availability

Dáil Éireann Debate, Wednesday - 30 May 2018

Wednesday, 30 May 2018

Ceisteanna (164)

James Browne

Ceist:

164. Deputy James Browne asked the Minister for Health if his Department or the HSE has engaged with a company (details supplied) with regard to making Translarna available here; and if he will make a statement on the matter. [23976/18]

Amharc ar fhreagra

Freagraí scríofa

The Health Service Executive has statutory responsibility for decisions on pricing and reimbursement of medicines under the community drug schemes, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013. The 2013 Act does not give the Minister for Health any powers in this regard.

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.

In July 2017, the HSE informed the Department that, following an intensive process, the HSE decided not to reimburse Ataluren (Translarna) for the treatment of Duchenne Muscular Dystrophy.  The HSE in deciding not to reimburse Translarna did not consider the evidence for its clinical benefit to be sufficiently strong, in the context of the proposed cost and budget impact.

The HSE informed the applicant company of this decision, in keeping with the requirements of the 2013 Act. The applicant has appealed the HSE’s decision to the High Court, which is part of the statutory process under Section 27 of the 2013 Act.

A meeting took place on the 11 December 2017 with 2 representatives from Muscular Dystrophy Ireland, Dr O'Rourke and HSE and Departmental officials.

Following on from this meeting, the HSE advised the applicant that it is willing to complete a timely review of any new application.  It would be open to the company to make revised proposals in relation to pricing or access in this context. 

The HSE has notified the company that is ready and willing to review any new application irrespective of the on-going court proceedings.

Barr
Roinn