Written answers

Tuesday, 11 November 2014

Department of Health

General Medical Services Scheme Administration

Photo of Robert TroyRobert Troy (Longford-Westmeath, Fianna Fail)
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119. To ask the Minister for Health if he will provide an update on whether the Health Service Executive will include sofosbuvir or Sovaldi in the general medical scheme and community drugs schemes. [42775/14]

Photo of Kathleen LynchKathleen Lynch (Cork North Central, Labour)
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The 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 HSE received an application in February 2014 for the inclusion of Sofosbuvir, the first of a new generation of drugs for the treatment of Hepatitis C, in the GMS and community drugs schemes. The application is being 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 HSE asked the National Centre for Pharmacoeconomics to conduct a pharmacoeconomic evaluation of the new product in June 2014. This evaluation will provide detailed information on the potential budget impact of the medicine.It will also assess whether the product is cost effective at the price quoted by the manufacturer. The Report by the National Centre for Pharmacoeconomics, which is expected to be published shortly, is an important input to assist the HSE in its decision making process.

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. In advance of this decision the HSE has engaged with the pharmaceutical companies regarding an early access programme for a cohort of individuals with advanced liver disease and who require immediate treatment.

The Department has also established an advisory group to examine the feasibility and cost implications of a multi-annual approach to the clinical and public health management of hepatitis C. This group will furnish a report to the Minister for Health on this issue when it has completed its work.

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