Stephen Donnelly (Wicklow, Fianna Fail)
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I propose to take Questions Nos. 684 and 686 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.

HSE decisions on which medicines are reimbursed by the taxpayer are made on objective, scientific and economic grounds, on the advice of the National Centre for Pharmacoeconomics (NCPE). There are formal processes which govern applications for the pricing and reimbursement of medicines, and new uses of existing medicines, to be funded and/or reimbursed.

The HSE-Drugs Group is the national committee which the HSE has in place to make recommendations on the pricing and reimbursement of medicines. The membership of the HSE-Drugs Group includes public interest members. The totality of clinical and economic evidence for a new medicine is comprehensively and extensively reviewed by the HSE-Drugs Group and a recommendation is then made. In cases where there is a high drug cost or a high potential budget impact or where only a subset of the licensed population has been put forward for consideration, the HSE-Drugs Group may recommend reimbursement subject to the establishment of a HSE-Medicines Management Programme (MMP)-led managed access protocol, in line with Section 20 of the Health (Pricing and Supply of Medical Goods) Act 2013.

The decision-making authority in the HSE is the HSE-Executive Management Team (EMT). The HSE-EMT decides on the basis of all the demands it is faced with (across all services) whether it can fund a new medicine, or new uses of an existing medicine, from the resources that have been provided to it in line with the Health (Pricing and Supply of Medical Goods) Act 2013. The HSE-EMT will make the final reimbursement recommendation.

When a managed access protocol is recommended the HSE-MMP will develop an individual patient approval system based on EMT recommendation and Drugs Group considerations and will ensure it is in line with the reimbursement approval agreement. This will ensure that reimbursement is available for patients who meet the pre-defined criteria as per a HSE-MMP devised managed access protocol.

Managed access protocols may be considered for amendment if the Marketing Authorisation Holder (MAH) submits additional information to the HSE for consideration (e.g. different subgroup(s) from those submitted with the initial pricing and reimbursement application) or if clinical evidence emerges which may impact on the approved HSE reimbursement criteria. In such cases the HSE can consider the updated information, along with information including cost-effectiveness evidence available and the potential budget impact to facilitate an informed decision.

Stephen Donnelly (Wicklow, Fianna Fail)
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As this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.

Stephen Donnelly (Wicklow, Fianna Fail)
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As this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.