Dáil Éireann Debate, Wednesday - 19 March 2025
1755. Deputy Marie Sherlock asked the Minister for Health if durvalumab is being considered for use by the HSE as part of the first-line treatment of patients with cholangiocarcinoma (bile duct cancer) as is now the case in the United Kingdom; and if she will make a statement on the matter. [11901/25]
Amharc ar fhreagraUnder the Health (Pricing and Supply of Medical Goods) Act 2013, the HSE has statutory responsibility for decisions on the pricing and reimbursement of medicines therefore I have reached out to them on this matter.
The HSE has advised it 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 must robustly assess 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 Durvalumab (Imfinzi®):
The HSE received a complete application for pricing and reimbursement on the 16th February 2023 from AstraZeneca (the applicant) for Durvalumab (Imfinzi®) in combination with gemcitabine and cisplatin indicated for the first-line treatment of adults with unresectable or metastatic biliary tract cancer (BTC).
• 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 HTA was recommended to assess the clinical effectiveness and cost effectiveness of durvalumab used in combination with gemcitabine and cisplatin compared with the current standard of care (SOC) (gemcitabine and cisplatin).
• The HSE commissioned a full HTA on the 29th March 2023 as per agreed processes.
• The NCPE Health Technology Assessment Report was received by the HSE on the 19th December 2024. The NCPE recommended that Durvalumab (Imfinzi®) not be considered for reimbursement unless cost-effectiveness can be improved relative to existing treatments. (www.ncpe.ie/durvalumab-imfinzi-2/).
• 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 the applicant to discuss this application and awaits formal submission of a commercial proposal by the applicant.
• 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.
Regarding next steps, the HSE CPU awaits submission of a commercial proposal from the applicant. The HSE cannot make any comment on possible outcomes from the ongoing process.
