Publications
2024
Scholarly publications
Madrid Paredes, J.
, Versteeg, J.-W., Vreman, R. A., & Bloem, L. T. (2024).
Agreement about Availability of Alternative Treatments for Innovative Drugs Assessed by the EMA and HTA Organizations.
Clinical Pharmacology and Therapeutics. Advance online publication.
https://doi.org/10.1002/cpt.3252Brinkhuis, F., Goettsch, W. G., Mantel - Teeuwisse, A., & Bloem, L. T. (2024).
High cost oncology drugs without proof of added benefit are burdening health systems.
The BMJ,
384, q511.
https://doi.org/10.1136/bmj.q511 Verweij, S., Haverhoek, V., Bergman, E., Westman, G.
, & Bloem, L. T. (2024).
A Natural Language Processing Approach towards Harmonized Communication of Uncertainties Identified during the European Medicine Authorization Process.
Clinical Pharmacology and Therapeutics. Advance online publication.
https://doi.org/10.1002/cpt.31952023
Scholarly publications
Verschueren, M. V., Peters, B. J., Bloem, L. T., Kruik, V. R., Uitvlugt, E. B., Bijsmans, A. R.
, Egberts, A. C., & van de Garde, E. M. (2023).
Pembrolizumab Plus Chemotherapy Per PD-L1 Stratum In Patients With Metastatic Non-Small Cell Lung Cancer: Real-World Effectiveness Versus Trial Efficacy.
Clinical Lung Cancer. Advance online publication.
https://doi.org/10.1016/j.cllc.2023.12.011 van den Berg, R. B., Laarman, A. R. C.
, Bloem, L. T., Dijkstra, J. A., Veldkamp, A. I., Allegaert, K., Swart, E. L., & van Weissenbruch, M. M. (2023).
Neonatal pain score after use of paracetamol: Is there a relationship with serum trough concentration at steady state in preterm and term neonates? International Journal of Clinical Pharmacology and Therapeutics,
61(8), 354 - 362.
https://doi.org/10.5414/CP204431Verschueren, M. V., Dijs, T., Gulikers, J. L.
, Veelen, A. V., Croes, S., Hendriks, L. E., Smit, A. A.
, Bloem, L. T., Egberts, A. C., van de Garde, E. M., & Peters, B. J. (2023).
Durvalumab after chemoradiotherapy in patients with stage III non-small-cell lung cancer: real-world outcomes versus clinical trial results.
Immunotherapy,
15(11), 839-851.
https://doi.org/10.2217/imt-2023-0002 Bloem, L. T., Schelhaas, J., López-Anglada, L., Herberts, C., van Hennik, P. B., & Tenhunen, O. (2023).
European Conditional Marketing Authorization in a Rapidly Evolving Treatment Landscape: A Comprehensive Study of Anticancer Medicinal Products in 2006-2020.
Clinical Pharmacology and Therapeutics,
114(1), 148-160.
https://doi.org/10.1002/cpt.2906 Professional publications
Gort, J.
, van Hattem, C. C., Bloem, L. T., & ten Ham, R. M. T. (2023).
Geneesmiddelen voor Geavanceerde Therapie (ATMP’s) in Nederland: Veldverkenning, Knelpuntanalyse en Activiteitenkaart. Utrecht University.
https://doi.org/10.33540/1874/433501European Commission, Directorate-General for Health and Food Safety
, Mantel - Teeuwisse, A., Bloem, L. T., Boon, W., De Bruin, M. L., Hoekman, J., Klein, K., Stolk, P.
, & Vreman, R. (2023).
Study in support of the evaluation and impact assessment of the EU general pharmaceuticals legislation: Analytical Report. Publications Office of the European Union.
https://doi.org/10.2875/780874https://dspace.library.uu.nl/bitstream/handle/1874/436130/study_in_support_of_the_evaluation_and_impact_assessment_EW0423300ENN.pdf?sequence=1European Commission, Directorate-General for Health and Food Safety
, Mantel - Teeuwisse, A., Bloem, L. T., Boon, W., De Bruin, M. L., Hoekman, J., Klein, K., Stolk, P.
, & Vreman, R. (2023).
Study in support of the evaluation and impact assessment of the EU general pharmaceuticals legislation: Evaluation Report. Publications Office of the European Union.
https://doi.org/10.2875/62709https://dspace.library.uu.nl/bitstream/handle/1874/436129/study_in_support_of_the_evaluation_and_impact_assessment_EW0423299ENN.pdf?sequence=1Other output
Hoogendoorn, M., Fabriek, B., & Bloem, L. T. (2023). Regulatory and health technology assessment of cell and gene therapies in Europe: Convergence or divergence? Pharmacoepidemiology and Drug Safety, 32, 16-16.
Eskola, S. M., Jokinen, S., Bloem, L. T., Brouwer, E., Brown, D. A., Camarero, J., De Bruin, M. L. L., Gardarsdottir, H., & Hakkarainen, K. M. (2023). Systematic review of externally controlled (EC) trials, data used in them, and their role in regulatory decision-making. Pharmacoepidemiology and Drug Safety, 32(supplement 1), 260-261. Article 260.
van Hattem, C. C., de Jong, A., de Groot, J. S., & Bloem, L. T. (2023). Feasibility of post-authorization randomized controlled trials for conditionally authorized anticancer medicines-A multistakeholder perspective. Pharmacoepidemiology and Drug Safety, 32, 623-623.
Verschueren, M., Kruik, V., Peters, B., Bloem, L., Bijsmans, A. R., Egberts, T., & van de Garde, E. (2023). Real-world versus clinical trial outcomes of pembrolizumab plus chemotherapy in patients with stage IV non-squamous non-small cell lung cancer. Journal of Thoracic Oncology, 18(4), S72-S72.
2022
Scholarly publications
Ebbelaar, C. F., Schrader, A. M. R., van Dijk, M., Meijers, R. W. J., de Leng, W. W. J.
, Bloem, L. T., Jansen, A. M. L., Blokx, W. A. M., & on behalf of the MOLecular Evaluation of Melanocytic Ambiguous Tumors (MOLEMAT) investigators (2022).
Towards diagnostic criteria for malignant deep penetrating melanocytic tumors using single nucleotide polymorphism array and next-generation sequencing.
Modern Pathology,
35(8), 1110-1120.
https://doi.org/10.1038/s41379-022-01026-6 Bloem, L. T., Bot, R. E.
, Mantel-Teeuwisse, A. K., van der Elst, M. E., Sonke, G. S.
, Klungel, O. H., Leufkens, H. G. M., & Hoekman, J. (2022).
Pre-approval and post-approval availability of evidence and clinical benefit of conditionally approved cancer drugs in Europe: a comparison with standard approved cancer drugs.
British Journal of Clinical Pharmacology,
88(5), 2169-2179.
https://doi.org/10.1111/bcp.15141 Vreman, R. A., Bloem, L. T., van Oirschot, S.
, Hoekman, J., van der Elst, M. E.
, Leufkens, H. G., Klungel, O. H., Goettsch, W. G., & Mantel-Teeuwisse, A. K. (2022).
The Role of Regulator-Imposed Post-Approval Studies in Health Technology Assessments for Conditionally Approved Drugs.
International Journal of Health Policy and Management,
11(5), 642-650.
https://doi.org/10.34172/ijhpm.2020.198 Other output
Hogervorst, M., Goettsch, W., Mantel-Teeuwisse, A. K., Bloem, L., & Vreman, R. A. (2022). Uncertainties Around Tumour Agnostic Therapies in Europe: Barriers and Facilitators of Patient Access. Value in Health, 25(12), S266-S266.
2021
Scholarly publications
Ebbelaar, C. F., Jansen, A. M. L.
, Bloem, L. T., & Blokx, W. A. M. (2021).
Genome-wide copy number variations as molecular diagnostic tool for cutaneous intermediate melanocytic lesions: a systematic review and individual patient data meta-analysis.
Virchows Archiv,
479(4), 773-783.
https://doi.org/10.1007/s00428-021-03095-5 Bloem, L. T. (2021).
Evidence generation on benefits and risks of medicines and its impact on regulatory and downstream decision-making. [Doctoral thesis 1 (Research UU / Graduation UU), Universiteit Utrecht]. Utrecht University.
https://doi.org/10.33540/888 Bloem, L. T., Karomi, M.
, Hoekman, J., van der Elst, M. E.
, Leufkens, H. G. M., Klungel, O. H., & Mantel-Teeuwisse, A. K. (2021).
Comprehensive evaluation of post-approval regulatory actions during the drug lifecycle–a focus on benefits and risks.
Expert Opinion on Drug Safety,
20(11), 1433-1442.
https://doi.org/10.1080/14740338.2021.1952981 Bloem, L. T., Vreman, R. A., Peeters, N. W. L.
, Hoekman, J., van der Elst, M. E.
, Leufkens, H. G. M., Klungel, O. H., Goettsch, W. G., & Mantel-Teeuwisse, A. K. (2021).
Associations between uncertainties identified by the European Medicines Agency and national decision making on reimbursement by HTA agencies.
Clinical and Translational Science,
14(4), 1566-1577.
https://doi.org/10.1111/cts.13027 2019
Scholarly publications
Vreman, R. A., Bouvy, J. C., Bloem, L. T., Hövels, A. M., Mantel-Teeuwisse, A. K., Leufkens, H. G. M., & Goettsch, W. G. (2019).
Weighing of Evidence by Health Technology Assessment Bodies: Retrospective Study of Reimbursement Recommendations for Conditionally Approved Drugs.
Clinical Pharmacology and Therapeutics,
105(3), 684-691.
https://doi.org/10.1002/cpt.1251 Bloem, L. T., Mantel-Teeuwisse, A. K., Leufkens, H. G. M., De Bruin, M. L., Klungel, O. H., & Hoekman, J. (2019).
Postauthorization Changes to Specific Obligations of Conditionally Authorized Medicines in the European Union: A Retrospective Cohort Study.
Clinical Pharmacology and Therapeutics,
105(2), 426-435.
https://doi.org/10.1002/cpt.1169 2017
Other output
Bloem, L. T., Mantel-Teeuwisse, A. K., Leufkens, H. G. M., De Bruin, M. L., Klungel, O. H., & Hoekman, J. (2017).
Risk factors associated with post-marketing changes in specific obligations of conditionally authorised products in the EU.
Pharmacoepidemiology and Drug Safety,
26, 605.
https://doi.org/10.1002/pds.4275 2016
Scholarly publications
Bloem, L. T., De Abreu Lourenco, R., Chin, M., Ly, B., & Haas, M. (2016).
Factors impacting treatment choice in the first-line treatment of colorectal cancer.
Oncology and Therapy,
4(1), 103–116.
https://doi.org/10.1007/s40487-016-0020-4