Time to Access Pediatric/Adolescent vs. Adult Medicinal Products in Greece
Author(s)
Margetis A1, Kani C1, Chantzaras A1, Koutsiouris V2, Bacopoulou F1
1Health Technology Assessment and Reimbursement Committee, Hellenic Ministry of Health, Athens, Greece, 2Hellenic Ministry of Health, Athens, Greece
Presentation Documents
OBJECTIVES:
The aim of the present study was to evaluate the time lag between marketing authorization, submission to the Greek Health Technology Assessment (HTA) Committee, and inclusion in the National Positive Reimbursement List of medicinal products intended for adult vs. pediatric/adolescent use in Greece, from January 2018 until December 2021.METHODS:
Data were collected from the European Medicines Agency (EMA), the Greek Ministry of Health websites as well as from the Greek HTA Committee’s database. The dataset included all medicinal products which received a marketing authorization/indication extension from EMA over the study period. Median times for medicinal products with adult vs. pediatric/adolescent indications were calculated in calendar days.RESULTS:
A total of 385 and 213 products with adult or pediatric/adolescent indications respectively, were authorised by EMA, from which 146 and 43 medicinal products, respectively, were submitted to the Greek HTA Committee, over the 4-year study period. The median time (25th–75th percentile) from EMA approval to submission to the Greek HTA Committee was 312 (199-458) and 365 (246-508) days, for medicinal products with adult or pediatric/adolescent indications, respectively. Among medicinal products submitted to the Greek HTA Committee, almost a third (n=54) with adult and a fourth (n=11) with pediatric/adolescent indications were included in the National Positive Reimbursement List during 4 years. The median time (25th–75th percentile) from EMA approval to inclusion in the National Positive Reimbursement List was 836 (598-982) and 738 (616-1015) days, for products with adult or pediatric/adolescent indications, respectively.CONCLUSIONS:
The time interval from EMA approval to submission to the Greek HTA Committee was longer for pediatric/adolescent products, while the respective gap to inclusion in the National Positive Reimbursement List was shorter, compared to medicinal products for adults.Conference/Value in Health Info
2022-11, ISPOR Europe 2022, Vienna, Austria
Value in Health, Volume 25, Issue 12S (December 2022)
Code
HTA182
Topic
Health Policy & Regulatory, Health Technology Assessment
Topic Subcategory
Decision & Deliberative Processes, Reimbursement & Access Policy
Disease
SDC: Pediatrics