ArticleAnnals of gastroenterology2025
Darvadstrocel: real-world clinical outcomes and economic impact in the Spanish national health system.
Article in Annals of gastroenterology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
1 citing paper in PubMed.
- Perianal Crohn's Disease in Inflammatory Bowel Disease: Diagnosis, Assessment and Treatment.Life (Basel, Switzerland) · 2026Review
Corrections and comments
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Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Background: Complex perianal fistulas in Crohn's disease (CD) represent a therapeutic challenge. Darvadstrocel has demonstrated efficacy in clinical trials, but evidence from real-life clinical practice is limited. This study evaluated the effectiveness and safety of darvadstrocel in real-life clinical practice, and assessed the economic impact associated with the outcome-based payment model (OBPM) linked to its funding within the Spanish National Health System. Methods: An observational, descriptive, retrospective study was conducted on patients treated with darvadstrocel in the Servizo Galego de Saúde (SERGAS) between December 2019 and December 2024. Data were collected from the Therapeutic Value of Medicines Information System (VALTERMED), including demographic, clinical, safety and effectiveness variables at 6 and 12 months post-treatment. Descriptive statistics and Fisher's exact test were used for subgroup analyses. Results: A total of 26 patients were included (50.0% female; median age: 38.4 years). Combined remission was achieved in 69.2% (n=18) at 6 months and 57.7% (n=15) at 12 months. No significant differences were observed among subgroups. No treatment-related adverse events were reported. Regarding sustainability, the OBPM resulted in SERGAS covering 81.5% of the total treatment costs, as the second payment installment was not made for non-responders. Conclusions: Darvadstrocel demonstrated high effectiveness and safety in real-world clinical practice for patients with CD and complex perianal fistulas, with remission rates consistent with previous studies. The implementation of the OBPM linked to health outcomes proved to be a valuable tool for funding innovative therapies.
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