Differences in time to patient access to innovative cancer medicines in six European countries.

Europe access early access programs off-label use oncology reimbursement

Journal

International journal of cancer
ISSN: 1097-0215
Titre abrégé: Int J Cancer
Pays: United States
ID NLM: 0042124

Informations de publication

Date de publication:
20 Oct 2023
Historique:
revised: 01 09 2023
received: 14 07 2023
accepted: 19 09 2023
medline: 21 10 2023
pubmed: 21 10 2023
entrez: 21 10 2023
Statut: aheadofprint

Résumé

Patients across Europe face inequity regarding access to anticancer medicines. While access is typically evaluated through reimbursement status or sales data, patients can receive first access through early access programs (EAPs) or off-label use. This study aims to assess the time to patient access at the hospital level, considering different indications and countries. (Pre-)registered access to six innovative medicines (Olaparib, Niraparib, Ipilimumab, Osimeritinib, Nivolumab and Ibritunib) was measured using a cross-sectional survey. First patient access to medicines and indications were collected using the hospital databases. Nineteen hospitals from Hungary, Italy, the Netherlands, Belgium, Switzerland and France participated. Analysis showed that some hospitals achieved patient access before national reimbursement, primarily through EAPs. The average time from EMA-approval to patient access for these medicines was 2.1 years (Range: -0.9-7.1 years). Hospitals in Italy and France had faster access compared to Hungary and Belgium. Variation was also found within countries, with specialized hospitals (x̄: -0.9 years; SD: 2.0) more likely to provide patient access prior to national reimbursement than general hospitals (x̄: 0.4 years; SD: 2.9). Contextual differences were observed, with EAPs or off-label use being more prevalent in Switzerland than Hungary. Recent EMA-approved indications and drug combinations reached patients at a later stage. Substantial variation in patient access time was observed between and within countries. Improving pricing and reimbursement timelines, fostering collaboration between national health authorities and market authorization holders, and implementing nationally harmonized, data-generating EAPs can enhance timely and equitable patient access to innovative cancer treatments in Europe.

Identifiants

pubmed: 37864395
doi: 10.1002/ijc.34753
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Subventions

Organisme : European Fair Pricing Network

Informations de copyright

© 2023 The Authors. International Journal of Cancer published by John Wiley & Sons Ltd on behalf of UICC.

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Auteurs

Julie M Vancoppenolle (JM)

Department of Psychosocial Research and Epidemiology, Netherlands Cancer Institute-Antoni van Leeuwenhoek, Amsterdam, The Netherlands.
Department Health Technology and Services Research Technical Medical Centre, University of Twente, Enschede, The Netherlands.
The European Fair Pricing Network, Amsterdam, The Netherlands.

Nora Franzen (N)

Department of Psychosocial Research and Epidemiology, Netherlands Cancer Institute-Antoni van Leeuwenhoek, Amsterdam, The Netherlands.
Department Health Technology and Services Research Technical Medical Centre, University of Twente, Enschede, The Netherlands.
The European Fair Pricing Network, Amsterdam, The Netherlands.

Simone N Koole (SN)

Department of Psychosocial Research and Epidemiology, Netherlands Cancer Institute-Antoni van Leeuwenhoek, Amsterdam, The Netherlands.

Valesca P Retèl (VP)

Department of Psychosocial Research and Epidemiology, Netherlands Cancer Institute-Antoni van Leeuwenhoek, Amsterdam, The Netherlands.
Erasmus School of Health Policy & Management Health Technology Assessment (HTA), Erasmus University Rotterdam, The Netherlands.

Wim H van Harten (WH)

Department of Psychosocial Research and Epidemiology, Netherlands Cancer Institute-Antoni van Leeuwenhoek, Amsterdam, The Netherlands.
Department Health Technology and Services Research Technical Medical Centre, University of Twente, Enschede, The Netherlands.
The European Fair Pricing Network, Amsterdam, The Netherlands.
Organization of European Cancer Institutes (OECI), Brussels, Belgium.

Classifications MeSH