APPLICATIONS FOR ROMOSOZUMAB (EVENITY) UNDER A MANAGED ACCESS PROTOCOL IN IRELAND
Author(s)
Lisa Kelly, BSc1, Bernard Duggan, BSc1, Sinead Lucey, MSc1, Amelia Smith, PhD2, Claire Gorry, PharmD, PhD3.
1Trinity College Dublin, Dublin, Ireland, 2Pharmacology and Therapeutics, Trinity College Dublin, Dublin 8, Ireland, 3School of Medicine, Trinity College Dublin, Ireland.
1Trinity College Dublin, Dublin, Ireland, 2Pharmacology and Therapeutics, Trinity College Dublin, Dublin 8, Ireland, 3School of Medicine, Trinity College Dublin, Ireland.
OBJECTIVES: Romosozumab (Evenity®) is reimbursed in Ireland on the High Tech Arrangement since 1 November 2024, subject to a Health Service Executive (HSE)-Managed Access Protocol (MAP), for a subgroup of the licensed population: the treatment of severe osteoporosis in postmenopausal women, who have experienced a major osteoporotic fracture within the previous 24 months and who are at imminent risk of another fragility fracture. The MAP outlines the eligibility criteria that must be satisfied for reimbursement support, with designated specialist doctors (‘approved consultants’) provided with access to an online application system. This study provides an overview of applications for romosozumab reimbursement and utilisation in the first year of the protocol.
METHODS: All applications submitted via the HSE-Primary Care Reimbursement Service (PCRS) online application system between 1 November 2024 and 31 October 2025 were reviewed. Data relevant to the study period was also extracted from the HSE-PCRS national pharmacy claims database. Data was compiled and analysed in Microsoft Excel™.
RESULTS: A total of 283 applications were received from 34 approved consultants. The mean age of applicants was 72.4 years (range 44-98 years). Reimbursement was approved for 94.7% (n=268) of applications received. In the case of the remaining applications (n=15, 5.3%), a positive reimbursement recommendation has not been progressed to date, as information was not provided to demonstrate that the reimbursement criteria were satisfied. Rheumatologists submitted the majority of applications (75.3%, n=213), followed by geriatricians (20.1%, n=57). The number of applications received in Year 1 was significantly greater than that estimated by the supplier in their budget impact model as part of their Health Technology Assessment dossier (4 estimated versus 283 applications). In October 2025, 211 individuals accessed romosozumab treatment.
CONCLUSIONS: The MAP ensures drug reimbursement is in line with the agreed terms by the HSE. Data collected may inform future Health Technology Assessment and reimbursement decisions.
METHODS: All applications submitted via the HSE-Primary Care Reimbursement Service (PCRS) online application system between 1 November 2024 and 31 October 2025 were reviewed. Data relevant to the study period was also extracted from the HSE-PCRS national pharmacy claims database. Data was compiled and analysed in Microsoft Excel™.
RESULTS: A total of 283 applications were received from 34 approved consultants. The mean age of applicants was 72.4 years (range 44-98 years). Reimbursement was approved for 94.7% (n=268) of applications received. In the case of the remaining applications (n=15, 5.3%), a positive reimbursement recommendation has not been progressed to date, as information was not provided to demonstrate that the reimbursement criteria were satisfied. Rheumatologists submitted the majority of applications (75.3%, n=213), followed by geriatricians (20.1%, n=57). The number of applications received in Year 1 was significantly greater than that estimated by the supplier in their budget impact model as part of their Health Technology Assessment dossier (4 estimated versus 283 applications). In October 2025, 211 individuals accessed romosozumab treatment.
CONCLUSIONS: The MAP ensures drug reimbursement is in line with the agreed terms by the HSE. Data collected may inform future Health Technology Assessment and reimbursement decisions.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
HSD7
Topic
Health Policy & Regulatory, Health Service Delivery & Process of Care
Disease
Musculoskeletal Disorders (Arthritis, Bone Disorders, Osteoporosis, Other Musculoskeletal)