Tuesday, 17 July 2012

Questions (813)

Mary Lou McDonald


822 Deputy Mary Lou McDonald asked the Minister for Health if his attention has been drawn to the fact that the Health Service Executive continues to refuse cancer patients Yondelis Trabectedin treatment, a chemotherapy drug given to patients when other chemotherapy drugs have failed or are not suitable due to side effects; and the reason the HSE refuses to provide this treatment to cancer patients. [35214/12]

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Written answers (Question to Minister for Health)

Yondelis® or trabectedin was licensed by the European Medicines Agency in September 2007. It is an orphan drug and the licence was granted under the "exceptional circumstances" clause. This happens when the applicant for a licence cannot provide comprehensive data on the efficacy and safety of the medicine for which authorisation is being sought, due to the rarity of the condition it is intended for, limited scientific knowledge in the area concerned, or ethical considerations involved in the collection of such data.

Yondelis® trabectedin is indicated for the treatment of patients with advanced soft tissue sarcoma. It is also indicated in combination with another drug for the treatment of patients with relapsed platinum-sensitive ovarian cancer. http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/000773/human_med_001165.jsp&mid=WC0b01ac058001d124. The original licence for soft tissue sarcoma was granted in Ireland in 2007, and the licence for ovarian cancer was granted in 2009, with pricing approval being given by the HSE for this drug in January, 2008.

The HSE is not aware of any issue with supply of this drug. If the Deputy has information about a particular case she should relay this to the HSE, which will investigate the matter.

Question No. 823 answered with Question No. 801.