Written answers

Tuesday, 10 March 2015

Department of Health

Drugs Payment Scheme Coverage

Photo of Derek NolanDerek Nolan (Galway West, Labour)
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364. To ask the Minister for Health when a decision will be made regarding the inclusion of fampridine, known as Fampyra, for funding under the Health Service Executive; and if he will make a statement on the matter. [10624/15]

Photo of Michelle MulherinMichelle Mulherin (Mayo, Fine Gael)
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384. To ask the Minister for Health the status of the revised application, submitted on 25 July 2014, to the Health Service Executive, by a company (details supplied), to add Fampyra to the list of reimbursable Items, supplied under the General Medical Services scheme or other community drug schemes; and if he will make a statement on the matter. [10040/15]

Photo of Kathleen LynchKathleen Lynch (Cork North Central, Labour)
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I propose to take Questions Nos. 364 and 384 together.

The 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.

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.

The HSE received an application for the inclusion of Fampridine 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 for the assessment of new medicines.

In accordance with these procedures, the National Centre for Pharmacoeconomics conducted a pharmacoeconomic evaluation of Fampridine and concluded that, as the manufacturer was unable to demonstrate sufficient effectiveness and a fair price for Fampridine in the Irish health care setting, it was unable to recommend the reimbursement of the product.

On foot of this, the HSE decided that 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 for the inclusion of Fampridine on the community drugs schemes incorporating new evidence which demonstrates the cost-effectiveness of the drug, by offering a reduced price or both. A revised application was received by the HSE on 25 July 2014. The HSE has since been engaging with the company seeking an improved commercial offering. These engagements have been completed and the HSE is now considering the outcome of those commercial engagements. The HSE has also had discussions with clinical experts regarding this drug, the outcome of which is also being considered.

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