Bernard Durkan (Kildare North, Fine Gael)
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696. To ask the Minister for Health when sacituzumab-govitecan will be approved for use by the HSE to urgently assist patients with cancer treatment; and if he will make a statement on the matter. [59319/22]

Stephen Donnelly (Wicklow, Fianna Fail)
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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.

In terms of the specific details of the application for pricing and reimbursement of Sacituzumab govitecan (Trodelvy):

- The HSE received an application for pricing and reimbursement of Sacituzumab govitecan (Trodelvy®) on the 2nd February 2022 from Gilead Sciences Ltd. (the applicant) 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 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 7th February 2022.

- 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 Health Technology Assessment (HTA) on the 1st April 2022 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 Sacituzumab govitecan (Trodelvy®) are available at www.ncpe.ie/drugs/sacituzumab-govitecan-trodelvy-hta-id-22007/. The NCPE website reports that a full HTA was submitted by the Applicant company on the 10th August 2022 and the HTA assessment is ongoing.

- 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 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.

The application remains under consideration with the HSE. The HSE cannot make any comment on possible outcomes from the ongoing process.