Louise O'Reilly (Dublin Fingal, Sinn Fein)
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366. To ask the Minister for Health the medicines that his Department has approved but are not in a position to purchase as a result of a lack of funding; the number of persons these medicines would benefit; the illnesses for which they are prescribed; the reason these medicines have not yet been purchased; the funding issues associated with same; and if he will make a statement on the matter. [30991/17]

Margaret Murphy O'Mahony (Cork South West, Fianna Fail)
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434. To ask the Minister for Health if the timelines in the IPHA agreement regarding the reimbursement process for new medicines are being met; and if he will make a statement on the matter. [31352/17]

Margaret Murphy O'Mahony (Cork South West, Fianna Fail)
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435. To ask the Minister for Health the number of medicines that have been submitted for reimbursement to the HSE that are now exceeding timelines as set out in the IPHA agreement; and if he will make a statement on the matter. [31353/17]

Margaret Murphy O'Mahony (Cork South West, Fianna Fail)
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436. To ask the Minister for Health the number of medicines that have been referred by the HSE leadership team to his Department for reimbursement approval; and if he will make a statement on the matter. [31354/17]

Simon Harris (Wicklow, Fine Gael)
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I propose to take Questions Nos. 366 and 434 to 436, inclusive, 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.

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

In line with the Framework Agreement and since its introduction in July 2016, the HSE has referred ten treatments to my Department for consideration, one of which was Orkambi (including Kalydeco).

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 funding implications of the other nine treatments are currently under consideration by my Department. These are outlined in Table 1.

Table 1: Treatments referred to the Department of Health

Each of these treatments were referred to my Department 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. The HSE advise that the cumulative cost over 5 years of these treatments is approximately €120 million.

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

The National Centre for Pharmacoeconomics (NCPE) conducts health technological assessments on behalf of the HSE, a summary of which are available on the NCPE website www.ncpe.ie. These assessments include details of the estimated patient numbers and costs associated with each of these treatments.

As outlined in the IPHA agreement, and in line with the 2013 Act, 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.

While the HSE strives to reach a decision regarding drug approval in as timely a manner as possible and within the 180 days, because of the significant monies involved, there is an onus on the HSE to ensure that the best price is achieved as these commitments often feature multi million euro investments on an ongoing basis. The achievement of more successful price negotiations also allows for further drugs to be approved within the finite budget available.

I have asked the HSE to refer directly to the Deputy in relation to the timelines for the individual medicines.