Tom Fleming (Kerry South, Independent)
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570. To ask the Minister for Health if he will make the drug MabCampath available to MS patients under the long-term illness scheme and the medical card scheme; and if he will make a statement on the matter. [6185/14]

Alex White (Dublin South, Labour)
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Alemtuzumab is no longer marketed under the trade name MabCampath. The manufacturer, Genzyme, withdrew the marketing authorisation for MabCampath in 2012. Genzyme subsequently has received a new marketing authorisation in Europe for Alemtuzumab under the brand name Lemtrada for the treatment of relapsing remitting multiple sclerosis. In the USA the FDA has refused marketing authorisation to date for the multiple sclerosis indication.

Alemtuzumab is a medicine which must be administered in a hospital. It is not suitable for administration in the community and therefore would not be provided through the Community Drug Schemes. Treatment can only be initiated and supervised by a neurologist experienced in the treatment of patients with MS. Specialists and equipment required for the timely diagnosis and management of the most frequent adverse reactions, especially autoimmune conditions and infections, should be available. Resources for the management of hypersensitivity and/or anaphylactic reactions must be available. This means in practise that the medicine could only be provided through the hospital system.

The HSE has confirmed that it has received a pricing application for Alemtuzumab / Lemtrada through its national pricing and reimbursement assessment process. The application will be assessed in line with the procedures and timescales agreed with the pharmaceutical industry under the 2012 Irish Pharmaceutical Healthcare Association agreement. 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.

The HSE cannot comment on the possible outcome of any individual assessment process whilst the actual assessment is ongoing. The assessment will be completed in as short a timeframe as possible subject to timely submission of relevant data by the applicant company.