Dáil Éireann Debate, Tuesday - 19 June 2018
318. Deputy Niamh Smyth asked the Minister for Health further to Parliamentary Question No. 158 of 23 May 2018, the timeframe for the introduction of the drug; if the latest correspondence will be reviewed; and if he will make a statement on the matter. [26314/18]
Amharc ar fhreagraThe 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.
Translarna (Atlauren) is a high cost medicine manufactured by PTC Therapeutics for the treatment of a subgroup of patients with Duchene Muscular Dystrophy – a rare disease. The medicine 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 were considered by the HSE Drugs Committee and Leadership Team in 2016 and 2017. The applications were considered carefully, however the final decision was that the HSE was not in a position to fund the medicine on the basis of the current clinical evidence of effectiveness and the prices being charged by the pharmaceutical company.
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.
The HSE has informed the company that any new information it may have in relation to clinical benefits or evidence (or in relation to price) can be considered as part of a new application. The HSE has confirmed that there will also be no delay in bringing such an application to a speedy conclusion and decision stage.
