Dáil Éireann Debate, Tuesday - 26 May 2009
165 Deputy Joe Carey asked the Minister for Health and Children if there has been guidance issued to the Health Service Executive in relation to the provision of the drug Tysabri to multiple sclerosis sufferers here; if the cost of provision of this drug has been established; and if she will make a statement on the matter. [21000/09]
View answerThe Summary of Product Characteristics for Tysabri, which was approved as part of the procedure for its product authorisation, contains specific information regarding the safe and effective use of the product. In addition, specific "Physician Information and Management Guidelines" have been issued for the use of Tysabri and all physicians who prescribe Tysabri should be familiar with these guidelines.
Tysabri is indicated for two specific categories of Multiple Sclerosis patients, i.e. patients with high disease activity despite treatment with beta-interferon and patients with rapidly evolving severe relapsing remitting form of the condition. In the past 12 months the manufacturer has sent two letters to health care professionals in Ireland, following approval by the Irish Medicines Board, outlining specifically the risk of liver toxicity and the risk of progressive multifocal leukoencephalopathy (progressive damage of the white matter in the brain).
The provision of this drug to patients is currently a matter for decision by the hospital concerned. The issue of access to the drug in question is also under consideration by the Health Service Executive. Arising from a recent review of neurology services, a clinician led review group is to advise on how best to ensure that there is fair and equitable access to this drug and other agents used to treat this particular condition, taking account of clinical need, benefits and cost. The group is to include patient representation.
The current maximum ex-factory price of Tysabri is €1636.85 per 300mg infusion. However, individual hospitals can negotiate revised arrangements with pharmaceutical manufacturers. I have asked the Health Service Executive to respond directly to the Deputy with regard to the cost of the provision of this drug to patients in Ireland.
