Brendan Smith (Cavan-Monaghan, Fianna Fail)
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174. To ask the Minister for Health the position regarding negotiations between the HSE, the National Centre for Pharmacoeconomics and the manufacturer of Orkambi; if this drug will be made available for patients with cystic fibrosis; and if he will make a statement on the matter. [36441/16]

Simon 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.

In line with the 2013 Act, if a Company would like a medicine to be reimbursed by the HSE pursuant to the Community Drug Schemes or as a hospital medicine, the Company must first submit an application to the HSE to have the new medicine added to the Reimbursement List or to be priced as a hospital medicine.

Within 180 days of receiving the application (or such longer period which may arise if further information is sought from the Company), the HSE will decide to either:

- add the medicine to the Reimbursement List / agree to reimburse it as a hospital medicine, or,

- will refuse to reimburse the medicine.

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 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: www.ncpe.ie/wp-content/uploads/2015/12/Website-summary-orkambi.pdf.

The HSE has since had further engagements with the manufacturer in an effort to secure significant price reductions for Orkambi. The HSE will consider the outcome of these engagements and any other, together with the NCPE recommendation, in making a final decision on reimbursement. This decision will be made on objective, scientific and economic grounds by the HSE in line with the 2013 Act.