Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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233. To ask the Minister for Health the reason the Government and the HSE has decided not to grant access to the Orkambi drug which has proved to be a game changer in the lives of those cystic fibrosis sufferers that are suitable to receive it; the reason the cost of this drug is being prioritised over the value of lives saved not least the savings in reduced acute care needs as a result of improved health of those that receive treatment with orkambi; if he will reverse this decision and grant access to Orkambi for CF sufferers; and if he will make a statement on the matter. [38152/16]

Clare Daly (Dublin Fingal, Independent)
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238. To ask the Minister for Health if he will ensure that Orkambi is made available to cystic fibrosis persons that urgently require same as their access to the drug from the trial concludes [38161/16]

Simon Harris (Wicklow, Fine Gael)
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I propose to take Questions Nos. 233 and 238 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. 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.

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.

The HSE has recently completed its most recent round of negotiations with the manufacturer. On foot of this, the HSE’s Drugs Committee, having considered the NCPE recommendation and other expert advice, is in the process of sending its latest recommendation on the cost-effectiveness of Orkambi to the HSE Directorate. The HSE Directorate will then make a decision taking into consideration the manufacturer’s latest price offer. This decision will be made on objective, scientific and economic grounds in line with the 2013 Act.

I share the HSE's disappointment that the manufacturer in this case has maintained a very high price in the course of negotiations in relation to the potential reimbursement of Orkambi for Irish patients.

I appreciate that this is a very stressful time for Cystic Fibrosis patients and their families. However, I want to assure them that I do not consider this to be the end of the process. I would strongly urge Vertex, as the manufacturer in this case, to fundamentally reconsider its position and to table a pricing proposal which can facilitate the provision of Orkambi at a price that will represent value for money for the Irish health service, patients and the taxpayer.