Written answers

Tuesday, 28 February 2017

Department of Health

Medicinal Products Availability

Photo of Dessie EllisDessie Ellis (Dublin North West, Sinn Fein)
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516. To ask the Minister for Health his plans to roll-out the use of the drug Abiraterone (details supplied). [9572/17]

Photo of Simon HarrisSimon Harris (Wicklow, Fine Gael)
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The HSE has statutory responsibility for decisions on pricing and reimbursement of medicines under the community drugs schemes, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013.

In line with the 2013 Act, if a company would like a medicine to be reimbursed by the HSE pursuant to the community drug schemes or as a hospital medicine, the company must first submit an application to the HSE to have the new medicine added to the reimbursement list or to be priced as a hospital medicine.

Abiraterone has been reimbursed under the community drugs scheme since 2012 for the treatment of metastatic castration resistant prostate cancer (mCRPC) which has progressed on or after a docetaxel-based chemotherapy regimen and has been reimbursed since May 2015 for the treatment of mCRPC in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated.

The company must submit a separate application to extend a treatment to a new cohort of patients or for a different indication of the drug. Each application is considered separately on its merits and in line with the 2013 Act.

For a medicine to be considered for reimbursement by the HSE it must first have a marketing authorisation from the European Medicines Agency or the Health Products Regulatory Authority, before being assessed under the 2013 Act.

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