Dáil Éireann Debate, Tuesday - 14 July 2015
543. Deputy Caoimhghín Ó Caoláin asked the Minister for Health when a decision will be made on an application to the Health Service Executive by a company (details supplied) to have funding for the drug Fampyra reinstated. [28452/15]
View answerThe Health Service Executive (HSE) has statutory responsibility for decisions on pricing and reimbursement of medicinal products under the community drug schemes in accordance with the provisions of the Health (Pricing and Supply of Medical Goods) Act 2013. Prior to reimbursing any medicine, the HSE considers a range of statutory criteria including clinical need, cost-effectiveness and the resources available to the HSE.
The decisions on which medicines are reimbursed by the taxpayer are made on objective, scientific and economic grounds by the HSE on the advice of the National Centre for Pharmacoeconomics. They are not political or ministerial decisions.
In May 2013, the HSE decided that it could not approve the reimbursement of Fampridine under the GMS or other schemes, as the manufacturer (Biogen Idec) had failed to demonstrate or provide any formal justification for the prices proposed. The HSE decision was in line with many other European countries who have also, to date, not provided for the drug under their public health systems.
The HSE re-engaged with the company in July 2014 (and again in October 2014) seeking improved commercial offerings. The outputs of those commercial engagements were re-considered by the HSE Drugs Committee at its November 2014 meeting.
The Committee decided to seek additional detailed information from clinical experts as to how a responder-only reimbursement scheme (i.e. patients confirmed as positive responders to the medication) would operate for this product. The feasibility of this option is currently under consideration.
