Medicinal Products Expenditure

Dáil Éireann Debate, Wednesday - 8 June 2016

Wednesday, 8 June 2016

Questions (490)

Noel Grealish

Question:

490. Deputy Noel Grealish asked the Minister for Health if he has undertaken an assessment of the savings to the State that can be made if a suitable person with cystic fibrosis is placed on a course of Orkambi; if so, the potential annual savings, in monetary terms, from their improved health, in terms of reduced hospitalisation costs, reduced costs of other services such as physiotherapy and so on and reduced costs of other medications; if such an assessment has not been made, if he will undertake to have such a study carried out immediately to determine the savings which could be off-set against the cost of purchasing Orkambi; the status of the latest negotiations to secure a reduction in the price being sought by the manufacturer; and if he will make a statement on the matter. [14949/16]

Written answers

Minister for Health

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. Prior to deciding whether to reimburse a medicine, the HSE considers a range of statutory criteria, including clinical need, cost-effectiveness and the resources available.

The decisions on which medicines are reimbursed by the taxpayer are made on objective, scientific and economic grounds by the HSE, on the advice of the National Centre for Pharmacoeconomics (NCPE). The NCPE conducts health technology assessments (HTAs) of pharmaceutical products for the HSE, and can make recommendations on reimbursement to assist the HSE in its decision-making process. The NCPE used a decision framework to systematically assess whether the drug is cost-effective as a health intervention

I am informed by the NCPE that following a request from the HSE, the NCPE carried out an assessment of the manufacturer's economic dossier submitted in March 2016 on the cost effectiveness of lumacaftor/ivacaftor (Orkambi). This dossier included details on all relevant costs and relevant cost offsets including hospitalisation, disease management costs, intravenous antibiotics, adverse events and any additional costs arising in patients not taking Orkambi.

The NCPE has completed its HTA and submitted it to the HSE. The NCPE determined, following an evaluation of the economic dossier, that the manufacturer failed to demonstrate cost-effectiveness or value for money from using the drug. The NCPE have confirmed that all relevant costs were included in the analysis.

A summary has been published on the NCPE website and is available at:http://www.ncpe.ie/wp-content/uploads/2015/12/Website-summary-orkambi.pdf.

The HSE will now enter into negotiations with the manufacturer, to seek very significant price reductions. The HSE will then consider the outcome of these negotiations, together with the NCPE recommendation, in making a final decision on reimbursement.