Dáil Éireann Debate, Thursday - 12 July 2018
482. Deputy Catherine Murphy asked the Minister for Health the position regarding the reimbursement of the drug Translarna; if he has received a submission regarding same from a group (details supplied); the timeframe in which the submission will be reviewed; and if he will make a statement on the matter. [32236/18]
View answerThe 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 that are available to the HSE.
Ataluren (Translarna) is a high cost medicine for the treatment of a subgroup of patients with Duchene muscular dystrophy, a rare disease. Ataluren has conditional market authorisation from the European Medicines Agency for Europe - the condition being that the company carries out further clinical trials to determine the clinical efficacy of the drug.
Applications for reimbursement of ataluren were considered by the HSE Drugs Committee and Leadership Team in 2016 and 2017. The HSE's final decision was that it was not in a position to fund the medicine on the basis of the current clinical evidence of effectiveness and the prices being sought by the applicant company.
The HSE informed the applicant of this decision, in keeping with the requirements of the 2013 Act. The applicant appealed the decision to the High Court, as part of the statutory process under Section 27 of the 2013 Act.
On 6 July 2018, my Department was informed by the HSE that a settlement of the High Court action had been reached.
The Terms of Settlement stipulate that, in the event that the applicant submits a new reimbursement application for ataluren, it would be reviewed by the HSE in a timely fashion, having regard to the relevant statutory framework.
