Journal of pharmaceutical policy and practice · 2026
Do conditional marketing authorisations actually accelerate patient access? Time-to-access of conditional vs. standard marketing authorisations in Italy, Spain, and Germany.
СтатьяНазвание и аннотация: Перевод в очереди
Обработка статьи · этапы, ошибки и управление
Загрузка состояния…
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Ardito Vittoria, Falk Lasse, Gasol Boncompte Montserrat, Pontes Caridad, Robinson James, Schreyögg Jonas, Ciani Oriana
Аннотация
BACKGROUND: The European Medicines Agency (EMA) implemented 'fast-track' programmes, like conditional marketing authorisations (CMA), where the benefits of immediate drugs' availability outweigh the risks associated with incomplete evidence. However, payers in the European Union (EU) decide on medicines' coverage based on clinical benefits assessment, cost-effectiveness and/or budget impact. We investigated differences in the time-to-access of drugs approved via CMA vis-à-vis standard marketing authorisation (SMA) in Italy, Germany, and Spain.
METHODS: CMA-licenced drugs from 2006 to 2022 were retrieved and matched with comparable SMA drugs. Collected data were as follows: marketing authorisation details, drug characteristics, pivotal trials' characteristics and national reimbursement decision dates. Data sources included European Public Assessment Reports, and country-specific databases (Farmadati®, Lauer-Taxe®, BIFIMED).
RESULTS: CMA drugs take longer, in days, to reach reimbursement compared to SMA drugs both in Italy (CMA: median 523, mean 635, standard deviation (SD 364; SMA: median 455, mean 497, SD 242) and Spain (CMA: median 691, mean 779, SD 456; SMA: median 534, mean 568, SD 273). Cox regressions and Kaplan-Meier survival analyses corroborate these findings.
CONCLUSIONS: The EMA's intent to accelerate access to promising medicines may be offset by longer timelines to secure national reimbursement in major EU nations.
METHODS: CMA-licenced drugs from 2006 to 2022 were retrieved and matched with comparable SMA drugs. Collected data were as follows: marketing authorisation details, drug characteristics, pivotal trials' characteristics and national reimbursement decision dates. Data sources included European Public Assessment Reports, and country-specific databases (Farmadati®, Lauer-Taxe®, BIFIMED).
RESULTS: CMA drugs take longer, in days, to reach reimbursement compared to SMA drugs both in Italy (CMA: median 523, mean 635, standard deviation (SD 364; SMA: median 455, mean 497, SD 242) and Spain (CMA: median 691, mean 779, SD 456; SMA: median 534, mean 568, SD 273). Cox regressions and Kaplan-Meier survival analyses corroborate these findings.
CONCLUSIONS: The EMA's intent to accelerate access to promising medicines may be offset by longer timelines to secure national reimbursement in major EU nations.