Written answers

Thursday, 27 October 2016

Department of Health

Medicinal Products Prices

Photo of Richard Boyd BarrettRichard Boyd Barrett (Dún Laoghaire, People Before Profit Alliance)
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130. To ask the Minister for Health the action he is taking to address the delay in negotiating a price for the life-saving drug Orkambi; if he will put a cap on the price of newly released drugs in the national interest; the strategy the Government is taking to deal with the issue of overcharging for medication here in general, and for newly released drugs for specific conditions in particular; and if he will make a statement on the matter. [32394/16]

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.

These decisions are made on objective, scientific and economic grounds by the HSE. In reaching its decision, the HSE examines all the evidence which may be relevant in its view for the decision and will take into account such expert opinions and recommendations which may have been sought by the HSE, including, for example, advice from the National Centre for Pharmacoeconomics.

I am informed 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 in June 2016. 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 of the HTA has been published on the NCPE website and is available at: .

The HSE has since had further engagements with the manufacturer in an effort to secure significant price reductions for Orkambi. The HSE is considering the outcome of these engagements and any other, together with the NCPE recommendation, in making a final decision on reimbursement.

In relation to the cost of new medicines, the Health (Pricing and Supply of Medical Goods) Act 2013 sets out the conditions by which new medicines can be added to the reimbursement lists for the community drugs schemes. Before approving reimbursement of a new medicine the HSE is required to consider a number of criteria including: the potential or actual budget impact of a medicine, the cost-effectiveness of the medicine, the health needs of the public and the resources available to the HSE. The HSE therefore undertakes a robust analysis of the pricing points of new medicines and this is factored into negotiations with manufacturers. In the negotiation process the HSE will often seek significant price reductions so that medicines reimbursed are both cost-effective and affordable.

Under the new Framework Agreement on the Pricing and Supply of Medicines agreed between the State and the Irish Pharmaceutical Healthcare Association, medicines are now subject to an annual downward only price realignment. The price realignment is now based on an basket of 14 countries; this has been extended from 9 and also includes more lower cost countries. This will ensure that the State achieves better value for money on the cost of medicines as prices in the other reference countries are adjusted downwards over time. It also ensures that the prices paid by Ireland are not out of line with the other 13 EU Member States.

The issue of affordability and access to new and innovative medicines represents a major challenge to the health service in Ireland and indeed to health systems internationally.  I have said previously that I am willing to examine, with the Oireachtas, new ways in which this challenge might be addressed.

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