Tuesday, 1 April 2014

Questions (567, 591)

Caoimhghín Ó Caoláin

Question:

567. Deputy Caoimhghín Ó Caoláin asked the Minister for Health if he will include Fampyra, a drug produced by Biogen and used in the treatment of multiple sclerosis, on the drugs payment scheme or long-term illness scheme; if due consideration will be given to the cost and effectiveness of this drug; and if he will make a statement on the matter. [15205/14]

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Kevin Humphreys

Question:

591. Deputy Kevin Humphreys asked the Minister for Health further to Parliamentary Question No. 1110 of 25 March 2014, if he will answer the issues raised in the questions, specifically if his attention has been drawn to the benefits the drug Fampyra has given sufferers of multiple sclerosis; if he will immediately make the drug available to persons who need it under the State schemes; if his attention has been drawn to the fact that the monthly costs for a patient on the LTI scheme who needs this drug are approximately €343; if he will ask the National Centre for Pharmacoeconomics to conduct another pharmacoeconomic evaluation of Fampridine; if he will arrange for the Health Service Executive to cover the costs of the drug in respect of a person (details supplied) in Dublin 8 as it has delivered a marked improvement in mobility, as answers to these points were not addressed in the reply; and if he will make a statement on the matter. [15358/14]

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Written answers (Question to Health)

I propose to take Questions Nos. 567 and 591 together.

The 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.

The HSE received an application for the inclusion of Fampridine (Fampyra®) in the GMS and community drugs schemes. The application was considered in line with the procedures and timescales agreed by the Department of Health and the HSE with the Irish Pharmaceutical Healthcare Association (IPHA) for the assessment of new medicines. In accordance with these procedures, the National Centre for Pharmacoeconomics (NCPE) conducted a pharmacoeconomic evaluation of Fampridine and concluded that, as the manufacturer was unable to demonstrate the cost effectiveness of Fampridine in the Irish healthcare setting, it was unable to recommend the reimbursement of the product. The report is available on the NCPE's website (www.ncpe.ie). The NCPE report is an important input to assist the HSE in its decision making process and informs further discussions between the HSE and the manufacturer of the drug. The HSE assessment process is intended to arrive at a decision on the funding of new medicines that is clinically appropriate, fair, consistent and sustainable. Due to the very difficult and challenging economic environment in which the Government targeted additional savings in health expenditure of €666 million in 2014, which must be achieved while protecting front line services to the most vulnerable to the greatest extent possible, the HSE has decided it was not in a position to add the drug to the List of Reimbursable Items supplied under the GMS and other community drug schemes.

It is open to the supplier, at any time, to submit a new application to the HSE incorporating evidence which demonstrates the cost effectiveness of Fampridine. The HSE will then re-consider the application to add this product to the List of Reimbursable Items, in line with the agreed procedures and timescales for the assessment of new medicines.