Dáil Éireann Debate, Tuesday - 25 July 2023
1192. Deputy Duncan Smith asked the Minister for Health the timeline which he has given the HSE to complete its reimbursement process regarding the provision of enhertu for the treatment of breast cancer; if he is aware of the impact of delays in access to enhertu on outcomes for Irish patients; and if he will make a statement on the matter. [35998/23]
View answerThe 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 Trastuzumab deruxtecan (Enhertu®):
HER2-positive breast cancer
The HSE received an application for pricing and reimbursement of Trastuzumab deruxtecan (Enhertu®) on the 8th 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 11th July 2022.
• The NCPE Rapid Review assessment report was received by the HSE on the 27th July 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 31st August 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 Trastuzumab deruxtecan (Enhertu®) are available at 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 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.
HER2-low breast cancer
The HSE received an application for pricing and reimbursement of Trastuzumab deruxtecan (Enhertu®) on the 17th February 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 20th February 2023.
• The NCPE Rapid Review assessment report was received by the HSE on the 16th March 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 30th March 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 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.
Both applications remain under consideration with the HSE. The HSE cannot make any comment on possible outcomes from the ongoing processes.
