Billy Kelleher (Cork North Central, Fianna Fail)
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341. To ask the Minister for Health to set down the number of drugs in the past two years and to date in 2017 that have been referred from the HSE to the Department of Health for further consideration after being passed for reimbursement; the names of these drugs; the reason each was referred to his Department; if this was outside the industry agreement and-or the statutory process; and if he will make a statement on the matter. [29554/17]

Billy Kelleher (Cork North Central, Fianna Fail)
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342. To ask the Minister for Health to outline the reason that Brintellix was referred to his Department for further consideration for reimbursement after being approved; the length of time this process takes; and if he will make a statement on the matter. [29557/17]

Simon Harris (Wicklow, Fine Gael)
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I propose to take Questions Nos. 341 and 342 together.

The Health Service Executive (HSE) has statutory responsibility for decisions on the pricing and reimbursement of medicines in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013. The 2013 Act specifies the criteria to be applied in the making of decisions on the reimbursement of medicines.

Part 4 of the 2013 Act provides, inter alia, for the establishment and maintenance of a "Reimbursement List" for the purposes of section 59 of the Health Act 1970.

Section 18 of the 2013 Act allows a supplier of an item to apply to the HSE requesting the HSE to add the item to the Reimbursement List.

In considering an application, the HSE will also have regard to Part 1 and Part 3 of Schedule 3 of the 2013 Act.

Section 19(4) of the 2013 Act prohibits the HSE from making a relevant decision under section 18 "except in accordance with the criteria specified in Schedule 3". Schedule 3 sets out nine general criteria, of which one is the resources available to the Executive.

Under the 2016 Framework Agreement on the Supply and Pricing of Medicines, in a situation where the HSE wishes to reimburse a medicine but cannot do so from within existing resources, it may inform my Department of its decision in this respect. The Minister for Health may, as he deems appropriate, bring a Memorandum to Government in relation to the funding implications and requesting consideration of same.

In line with the Framework Agreement and since its introduction in July 2016, the HSE has referred four treatments to my Department for consideration: Orkambi (including Kalydeco), Eviredge, Entresto and Britellix.

Prior to the introduction of the Framework Agreement one treatment, Ibrutinib, was referred to my Department in 2016.

The reason each treatment was referred to my Department was because the HSE decided to support the reimbursement application but considered that this could not be funded from within its current budgetary envelope and also taking account of the cumulative costs over a 5 year period.

Following consideration by my Department and Government of the funding implications, the HSE decided, in line with the 2013 Act to reimburse Ibrutinib and Orkambi (including Kalydeco).

The remaining three treatments are currently under consideration by my Department.

In addition to this, the HSE has informed my Department on 21 June that there are 6 other medicines approved to date in 2017 which may have additional budgetary implications outside the 2017 Service Plan. However, the HSE have stated that it would be difficult to predict precisely at this stage as to whether these medicines can be funded from within the existing HSE allocation.

It should be noted that the final decision in relation to the reimbursement of all medicines remains the statutory responsibility of the HSE.