Brendan Griffin (Kerry, Fine Gael)
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2069.To ask the Minister for Health if the case of a patient (details supplied) will be examined; and if he will make a statement on the matter. [31379/24]

Stephen Donnelly (Wicklow, Fianna Fail)
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Under the Health (Pricing and Supply of Medical Goods) Act 2013, the HSE has statutory responsibility for decisions on the pricing and reimbursement of medicines. I have asked the HSE to provide an update in relation to the Deputy’s question. The HSE have provided the following update:

The HSE is committed to providing access to as many medicines as possible, in as timely a fashion as possible, from the resources available (provided) to it.

The HSE robustly assesses applications for pricing and reimbursement to make sure that it can stretch available resources as far as possible and to deliver the best value in relation to each medicine and ultimately more medicines to Irish citizens and patients.

HSE decisions on which medicines are reimbursed by the taxpayer are made on objective, scientific and economic grounds.

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 considers the following criteria prior to making any decision on pricing / reimbursement in line with the Health (Pricing and Supply of Medical Goods) Act 2013:

(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

In terms of the specific details of the application for pricing and reimbursement of Trastuzumab deruxtecan (Enhertu®):

HER2-positive breast cancer

The HSE received an application for pricing and reimbursement of Trastuzumab deruxtecan (Enhertu®) on the 8^th July 2022 from AstraZeneca (the applicant) as monotherapy indicated for the treatment of adult patients with unresectable or metastatic HER2- positive breast cancer who have received one or more prior anti-HER2-based regimens.

• The first step in the process is the submission of a Rapid Review dossier (a clinical and economic dossier) to the National Centre for Pharmacoeconomics (NCPE) for assessment. The HSE commissioned the Rapid Review process on the 11^thJuly 2022.
• The NCPE Rapid Review assessment report was received by the HSE on the 27^thJuly 2022. The NCPE advised the HSE that a full Health Technology Assessment (HTA) was recommended to assess the clinical effectiveness and cost effectiveness of Trastuzumab deruxtecan (Enhertu®) compared with the current standard of care.
• The HSE commissioned a full Health Technology Assessment (HTA) on the 31^stAugust 2022 as per agreed processes.
• The NCPE Health Technology Assessment Report was received by the HSE on the 12^thDecember 2023. The NCPE recommended that Trastuzumab deruxtecan (Enhertu®) be considered for reimbursement if cost-effectiveness can be improved relative to existing treatments. www.ncpe.ie/drugs/trastuzumab-deruxtecan-enhertu-hta-id-22050/
• The HSE Corporate Pharmaceutical Unit (CPU) is the interface between the HSE and the Pharmaceutical Industry in relation to medicine pricing and reimbursement applications. The HSE CPU has met with AstraZeneca to discuss this application.
• 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 any commercial negotiations, and any patient group submission(s) received. The HSE Drugs Group considers all of the evidence and makes a recommendation to the HSE Senior Leadership Team.
• The decision making authority in the HSE is the HSE Senior Leadership Team. The HSE Senior Leadership 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.

The HSE received an application for pricing and reimbursement of Trastuzumab deruxtecan (Enhertu®) on the 17^thFebruary 2023 from AstraZeneca (the applicant) as monotherapy indicated for the treatment of adult patients with unresectable or metastatic HER2 low breast cancer who have received prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy.

• The first step in the process is the submission of a Rapid Review dossier (a clinical and economic dossier) to the National Centre for Pharmacoeconomics (NCPE) for assessment. The HSE commissioned the Rapid Review process on the 20^thFebruary 2023.
• The NCPE Rapid Review assessment report was received by the HSE on the 16^thMarch 2023. The NCPE advised the HSE that a full Health Technology Assessment (HTA) was recommended to assess the clinical effectiveness and cost effectiveness of Trastuzumab deruxtecan (Enhertu®) compared with the current standard of care.
• The HSE commissioned a full Health Technology Assessment (HTA) on the 30^thMarch 2023 as per agreed processes.
• The NCPE publishes details of medicines where the HSE has commissioned a Rapid Review assessment and/or a full health technology assessment on their website. The website is updated at regular intervals and includes assessment outcomes and updates on reimbursement for each individual medicine and indication listed. Details of the assessment(s) of Trastuzumab deruxtecan (Enhertu®) are available at: www.ncpe.ie/trastuzumab-deruxtecan-enhertu/
• The HSE Corporate Pharmaceutical Unit (CPU) is the interface between the HSE and the Pharmaceutical Industry in relation to medicine pricing and reimbursement applications.
• 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 any commercial negotiations, and any patient group submission(s) received. The HSE Drugs Group considers all of the evidence and makes a recommendation to the HSE Senior Leadership Team.
• The decision making authority in the HSE is the HSE Senior Leadership Team. The HSE Senior Leadership 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.