Bríd Smith (Dublin South Central, People Before Profit Alliance)
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663. To ask the Minister for Health the current status of the drug vyepti (details supplied), following its completion of the approval process; if he will acknowledge that there are many migraine sufferers who are resistant to current drugs available and who are desperate to access this new drug in an effort to relieve their pain; the proposed timeline for the drug to be available to those who need it; and if he will make a statement on the matter. [25684/23]

Stephen Donnelly (Wicklow, Fianna Fail)
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The Health Service Executive (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.

In terms of the specific details of the application for pricing and reimbursement of Eptinezumab (Vyepti®):

The HSE received an application for pricing / reimbursement for Eptinezumab (Vyepti®) on the 20^thJuly 2022 from Lundbeck (the applicant) indicated for the prophylaxis of migraine in adults who have at least four migraine days per month.

• The first step in the process is the submission of a Rapid Review dossier (a clinical and economic dossier) to the National Centre for Phamacoeconomics (NCPE) for assessment. The HSE commissioned the Rapid Review process on the 20 July 2022.
• The NCPE Rapid Review assessment report was received by the HSE on the 16 September 2022. The NCPE advised the HSE that a full HTA was recommended to assess the clinical effectiveness and cost effectiveness of Eptinezumab (Vyepti®) compared with the current standard of care, on the basis of the proposed price relative to currently available therapies. (See www.ncpe.ie/e-2/)
• The HSE commissioned a full Health Technology Assessment (HTA) on the 28 September 2022 as per agreed processes.
• The HSE Corporate Pharmaceutical Unit (CPU) is the interface between the HSE and the Pharmaceutical Industry in relation to medicine pricing and reimbursement applications. CPU met with Lundbeck in October 2022 and January 2023 in relation to their application for Eptinezumab (Vyepti®) for the prophylaxis of migraine in adults who have at least four migraine days per month.
• The 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 pharmacoeconomic report will be reviewed by the HSE Drugs Group along with the outputs of commercial negotiations, and any patient group submission(s) received. The HSE Drugs Group will consider all of the evidence and make a recommendation to the HSE Executive Management Team.
• The decision making authority in the HSE is the HSE Executive Management Team. The HSE Executive Management Team decides on the basis of all the demands it is faced with (across all services) whether it can fund a new medicine, or new use 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.
• As a condition of reimbursement, an individual patient approval system will be put in place by the HSE, to enable reimbursement for patients who meet the pre-defined criteria as per a Medicines Management Programme (MMP) devised managed access protocol. The processes necessary to implement this required managed access protocol (MAP) are currently being developed by the HSE MMP.

Jennifer Murnane O'Connor (Carlow-Kilkenny, Fianna Fail)
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664. To ask the Minister for Health the considerations his Department is giving to the inclusion of the drugs saxenda and ozempic, both now recognised as valuable medications in the treatment of obesity, to the drugs payment scheme for non-diabetic patients; if there are plans to widen the prescription of saxenda and ozempic to medical card holders with a BMI of greater than 35 as a preventative medicine; and if he will make a statement on the matter. [25689/23]

Stephen Donnelly (Wicklow, Fianna Fail)
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The Health Service Executive (HSE) has statutory responsibility for pricing and reimbursement decisions under the community drug schemes, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013. Therefore, this matter has been referred to the HSE for attention and direct reply to the Deputy.