I propose to take Questions Nos. 439 and 454 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. 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, with a view to significantly reducing the cost of Orkambi. This process is on-going. A meeting was held in December and again in early January. Following completion of this process the HSE's Drugs Committee will make a recommendation on the cost-effectiveness of Orkambi to the HSE Directorate for a decision, taking into consideration the manufacturer's latest price offerings. Again, this decision will be made on objective, scientific and economic grounds in line with the 2013 Act.
I fully support the HSE in its efforts to reduce the price of this medicine and I would call on all public representatives, including the members of this house, to do the same.
