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 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 reaching its decision, the HSE examines all the evidence which may be relevant in its view for the decision, including the dossier submitted by the Company. The HSE will take into account such expert opinions and recommendations which may have been sought by the HSE at its sole discretion, for example, from the National Centre for Pharmacoeconomics – the NCPE. This ensures that reimbursement decisions are made on objective scientific and economic grounds.
In July 2017, the HSE informed my 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.
I appreciate that Duchene Muscular Dystrophy is a serious condition and that the families of children diagnosed with this illness are extremely anxious to obtain any treatment which they believe will alleviate its symptoms. I have met with some of the families and can appreciate their predicament.
The HSE has 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.
That offer to review any new application is irrespective of the ongoing court proceedings.
