Joan Collins (Dublin South Central, Independent)
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197. To ask the Minister for Health if the HSE high level officials group has made a recommendation on the reimbursement of Orkambi and the extension of Kalydeco for the two to five age group and the R117h group of persons with cystic fibrosis eligible for these vital drugs; and if he will make a statement on the matter. [8974/17]

Joan Collins (Dublin South Central, Independent)
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198. To ask the Minister for Health if the HSE approval on the reimbursement of Orkambi and the extension of Kalydeco for the two to five age group and the R117h group contingent on additional funding is being provided by government to the HSE. [8975/17]

Joan Collins (Dublin South Central, Independent)
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199. To ask the Minister for Health if the Cabinet will be making the final decisions relating to the reimbursement of Orkambi and the extension of Kalydeco for the two to five age group and the R117h group; if so, when; and if not, the body that is making the final decision. [8976/17]

Simon Harris (Wicklow, Fine Gael)
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I propose to take Questions Nos. 197 to 199, inclusive, together.

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 reaching its decision, the HSE examines all the evidence which may be relevant in its view for the decision (including the information /dossier submitted by the Company) and will take into account such expert opinions and recommendations which may have been sought by the HSE at its sole discretion (for example, from the National Centre for Pharmacoeconomics).

In considering an application, the HSE will also have regard to Part 1 and Part 3 of Schedule 3 of the 2013 Act. Part 3 requires the HSE to have regard to the following criteria:

1. the health needs of the public;

2. the cost-effectiveness of meeting health needs by supplying the item concerned rather than providing other health services;

3. the availability and suitability of items for supply or reimbursement;

4. the proposed costs, benefits and risks of the item or listed item relative to therapeutically similar items or listed items provided in other health service settings and the level of certainty in relation to the evidence of those costs, benefits and risks;

5. the potential or actual budget impact of the item or listed item;

6. the clinical need for the item or listed item;

7. the appropriate level of clinical supervision required in relation to the item to ensure patient safety;

8. the efficacy (performance in trial), effectiveness (performance in real situations) and added therapeutic benefit against existing standards of treatment (how much better it treats a condition than existing therapies); and

9. the resources available to the HSE.

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 Orkambi and Kalydeco. This dossier included details on all relevant costs and relevant cost offsets including those associated with hospitalisation, disease management costs, intravenous antibiotics, adverse events and any additional costs arising in patients not taking Orkambi or Kalydeco.

The NCPE has completed its Health Technology Assessment and this is available on its website. It was submitted 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. In line with the HSE's assessment process, the HSE Drugs Committee considered the NCPE recommendation, the manufacturers submissions and commercial offer and other information. Following this consideration the Drugs Committee did not recommend reimbursement at the current price. The HSE Directorate considered the Drugs Committee’s recommendation in December and the Directorate took the decision not to reimburse at the current price offered by the company.

The HSE has since re-entered into negotiations with Vertex, the manufacturer of Orkambi and Kalydeco, with a view to significantly reducing the cost of both drugs. A meeting was held in December and again in early January. Following completion of the negotiation process, I am advised that the HSE’s Drugs Committee met at the end of January and considered the manufacturer's latest price offerings. No decision has been reached regarding Orkambi and discussions are ongoing with regard to Kalydeco. The matter is currently under consideration by the HSE Directorate.

I understand how patients and their families must feel in these circumstances, as they await the decisions by the HSE in relation to reimbursement. However, as with all new drugs developed, the HSE must follow a statutory process, as set out in the 2013 Act.