Wednesday, 1 February 2017
Department of Health
Medicinal Products Availability
266. To ask the Minister for Health the timeframe for approval of the provision of Orkambi to cystic fibrosis patients in view of ongoing negotiations between a company (details supplied) and the HSE; and if he will make a statement on the matter. [4784/17]
267. To ask the Minister for Health when the drugs committee will conclude its deliberations (details supplied); when the drugs committee recommendations will be considered by the HSE board; when the Cabinet will consider the HSE recommendations on the provision of Orkambi in terms of sanction of the necessary resources to facilitate its provision to patients; and if he will make a statement on the matter. [4785/17]
I propose to take Questions Nos. 266 and 267 together.
The HSE's Drugs Committee met last week where it considered the latest price offering by Vertex for the drug Orkambi. The matter will now progress to HSE Leadership where it will be considered at the next available HSE Leadership meeting.
It is important to note that in considering an application for reimbursement, the HSE will have regard to Part 1 and Part 3 of Schedule 3 of the Health (Pricing and Supply of Medical Goods) Act 2013. 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.
Where the HSE decides that it cannot fund a new medicine from within existing resources, it may inform the Department of its decision in this respect. The Department may, as it deems appropriate, bring a memorandum to Government in relation to the funding implications and requesting consideration of same.