Niamh Smyth (Cavan-Monaghan, Fianna Fail)
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588. To ask the Minister for Health the status of his negotiations regarding the provision of the drug Orkambi; if there is a timeframe for its introduction; and if he will make a statement on the matter. [11730/17]

Simon Harris (Wicklow, Fine Gael)
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The HSE has statutory responsibility for decisions on pricing and reimbursement of medicines in 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 information submitted by the company). It will take into account such expert opinions and recommendations which it may have sought at its sole discretion, for example from the National Centre for Pharmacoeconomics (NCPE).

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 eats a condition than existing therapies).

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

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 has 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 manufacturer’s submissions and commercial 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 negotiations with the manufacturer of Orkambi and Kalydeco. Meetings were held in December and in early January.

This process is now reaching a crucial stage, and it is expected that this will be concluded in a period of weeks. However, given the scale of the investment and the potential benefits for Irish patients I continue to call on all parties to support the HSE in their engagement and to provide the space for this process to be concluded.

I am acutely aware of how difficult this is for CF patients and their families, there is no doubt that the last number of months have been a stressful and worrying time and I understand that people feel they don’t have time to wait. However, the Government’s priority is to achieve the best outcome for Irish CF patients and the health system overall.