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 making reimbursement decisions, which include the clinical and cost effectiveness of the product, the opportunity cost and the impact on resources available to the HSE.
In July 2017, the HSE informed the Department that, following an intensive process, it decided not to reimburse Ataluren (Translarna) for the treatment of Duchenne Muscular Dystrophy. The HSE, in deciding not to reimburse Altaluren, did not consider that the evidence for its clinical benefit was sufficiently strong, in the context of the proposed cost and budget impact.
The HSE informed the applicant of this decision, in keeping with 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.
As you are aware, a meeting took place on 11 December 2017 with two representatives from Muscular Dystrophy Ireland, Dr O'Rourke and HSE and Departmental officials.
Following from this meeting, the HSE advised the applicant that it is willing to complete a timely review of any new application. It is open to the company to make revised proposals in relation to pricing or access in this context.
The HSE has notified the company that it is ready and willing to review any new application, irrespective of the ongoing court proceedings.