Dáil Éireann Debate, Tuesday - 20 June 2023
674. Deputy Richard Boyd Barrett asked the Minister for Health if his Department or the HSE has plans to fund the drug, dupilumab which is used to treat a form of asthma, under the reimbursement scheme; if so, when; and if he will make a statement on the matter. [29408/23]
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 Dupilumab (Dupixent®):
The HSE received an application for pricing / reimbursement for Dupilumab (Dupixent®) on the 10th December 2021 from Sanofi (the applicant) indicated for adults and adolescents 12 years and older as add-on maintenance treatment for severe asthma with type 2 inflammation characterised by raised blood eosinophils and/or raised fraction of exhaled nitric oxide (FeNO), who are inadequately controlled with high dose inhaled corticosteroids (ICS) plus another medicinal product for maintenance treatment.
• 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 13th December 2021.
• The NCPE Rapid Review assessment report was received by the HSE on the 8th February 2022. The NCPE advised the HSE that a full HTA was not recommended and that Dupilumab (Dupixent®) not be considered for reimbursement at the submitted price. (www.ncpe.ie/dupilumab-dupixent-for-severe-asthma-hta-id-21063/)
• The HSE Corporate Pharmaceutical Unit (CPU) is the interface between the HSE and the Pharmaceutical Industry in relation to medicine pricing and reimbursement applications. CPU met with Sanofi in relation to their application for Dupilumab (Dupixent®) indicated for adults and adolescents 12 years and older as add-on maintenance treatment for severe asthma with type 2 inflammation characterised by raised blood eosinophils and/or raised fraction of exhaled nitric oxide (FeNO), who are inadequately controlled with high dose inhaled corticosteroids (ICS) plus another medicinal product for maintenance treatment.
• 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 totality of clinical and economic evidence for Dupilumab (Dupixent®) was comprehensively and extensively reviewed by the Drugs Group at the October 2022 meeting. The Group recommended in favour of reimbursement of Dupilumab (Dupilumab®) in this indication, subject to the establishment of a HSE managed access protocol (MAP).
• 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 uses 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 EMT supported reimbursement of Dupilumab (Dupixent®) indicated for adults and adolescents 12 years and older as add-on maintenance treatment for severe asthma with type 2 inflammation characterised by raised blood eosinophils and/or raised fraction of exhaled nitric oxide (FeNO), who are inadequately controlled with high dose inhaled corticosteroids (ICS) plus another medicinal product for maintenance treatment subject to a managed access protocol being implemented.
• As a condition of reimbursement, an individual patient approval system will be put in place by the HSE, to enable reimbursement for patients who meet the pre-defined criteria as per a HSE devised managed access protocol. The processes necessary to implement this required managed access protocol are currently being developed by the HSE.
The HSE cannot comment on the specific timeline for the HSE approval to be formalised while processes that involve a number of stakeholders and certain service development requirements to implement the managed access protocol are ongoing.
