Catherine Murphy (Kildare North, Social Democrats)
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585. To ask the Minister for Health if he has engaged with a person (details supplied) in respect of their request. [21224/23]

Réada Cronin (Kildare North, Sinn Fein)
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596. To ask the Minister for Health if the case of a person (details supplied) will be urgently examined and the executive's discretion used urgently in view of the circumstances; and if he will make a statement on the matter. [21275/23]

Stephen Donnelly (Wicklow, Fianna Fail)
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I propose to take Questions Nos. 585 and 596 together.

The Health Service Executive (HSE) has statutory responsibility for medicine pricing and reimbursement decisions, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013.

In line with the 2013 Act and the national framework agreed with industry, a company must submit an application to the HSE to have a new medicine added to the reimbursement list. Reimbursement is for licenced indications which have been granted market authorisation by the European Medicines Agency or the Health Products Regulatory Authority.

In making a relevant reimbursement decision, the HSE is required under the Act to have regard to a number of criteria including efficacy, the health needs of the public, cost effectiveness and potential or actual budget impact. 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). The Minister for Health has no role in these decisions.

The HSE considers the NCPE assessment, the outputs from commercial engagements, patient interest group submissions, and any other pertinent information in advance of making a reimbursement decision.

Sacituzumab govitecan (Trodelvy®) is indicated as monotherapy for the treatment of adult patients with unresectable or metastatic triple-negative breast cancer who have received two or more prior systemic therapies, including at least one of them for advanced disease.

The NCPE Rapid Review assessment report was received by the HSE on the 8th March 2022.

The NCPE advised the HSE that a full Health Technology Assessment (HTA) was recommended to assess the clinical effectiveness and cost effectiveness of Sacituzumab govitecan (Trodelvy®) compared with the current standard of care.

The HSE commissioned a full HTA on the 1st April 2022 as per agreed processes.

The NCPE completed the HTA on the 23 March 2023 and recommended that Sacituzumab govitecan (Trodelvy®) be considered for reimbursement if cost-effectiveness can be improved relative to existing treatments (see www.ncpe.ie/drugs/sacituzumab-govitecan-trodelvy-hta-id-22007/).

The provision of medicines which are not on the reimbursement list can be made by the HSE under Discretionary Hardship Arrangements, as provided for in Section 23 of the 2013 Act.

However, the HSE must be satisfied that:

• The patient requires that item for clinical reasons, and
• There is no listed item which is a suitable alternative for that item in so far as that patient is concerned.