Dáil Éireann Debate, Monday - 11 September 2023
1568. Deputy Sean Fleming asked the Minister for Health when romosozumab (Evenity) osteoporosis medication will be approved by the HSE and other relevant bodies; and if he will make a statement on the matter. [37527/23]
View answer1579. Deputy Brian Stanley asked the Minister for Health if his Department has made a decision on the approval of the drug, Evenity (manufacturer Amgen), for the treatment of osteoporosis, given that this has been approved at EU level. [37611/23]
View answerI propose to take Questions Nos. 1568 and 1579 together.
The 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 Romosozumab (Evenity®):
• The HSE received an application for pricing and reimbursement of Romosozumab (Evenity®) on the 20th April 2021 from UCB Pharma (the applicant) indicated for the treatment of severe osteoporosis in postmenopausal women at high risk of fracture.
• 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 21st April 2021.
• The NCPE Rapid Review assessment report was received by the HSE on the 27th May 2021. A full HTA was recommended to assess the clinical effectiveness and cost effectiveness of Romosozumab (Evenity®) compared with the current standard of care.
• The HSE commissioned a full Health Technology Assessment (HTA) on the 28th June 2021 as per agreed processes.
• The NCPE Health Technology Assessment report (ncpe.ie/wp-content/uploads/2021/05/Technical-summary-romosozumab-Evenity-21016.pdf) was received by the HSE on the 7th of March 2023. The NCPE recommended that Romosozumab (Evenity®), for the treatment of women who are postmenopausal with severe osteoporosis who have experienced a MOF (hip, vertebrae, distal radius, proximal humerus) within the previous 24 months and who are at imminent risk of another fragility fracture, be considered for reimbursement if cost-effectiveness can be improved relative to existing treatments.
• 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 met with UCB Pharma on the 18th May 2023 to discuss their application.
• 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 commercial negotiations, and any patient group submission(s) received. The HSE Drugs Group will consider all of the evidence and make 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 for Romosozumab (Evenity®) remains under consideration. The HSE cannot make any comment on possible outcomes from the ongoing process.
