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6. What does cell therapy manufacturing cost? A framework and methodology to facilitate academic and other small-scale cell therapy manufacturing costings

Author

ten Ham, Renske M.T., Hövels, Anke M., Hoekman, Jarno, Frederix, Geert W.J., Leufkens, Hubert G.M., Klungel, Olaf H., Jedema, Inge, Veld, Sabrina A.J., Nikolic, Tatjana, Van Pel, Melissa, Zwaginga, Jaap J., Lin, Fong, de Goede, Anna L., Schreibelt, Gerty, Budde, Sandy, de Vries, I. Jolanda M., Wilkie, Gwen M., Dolstra, Harry, Ovelgönne, Hans, Meij, Pauline, Mountford, Joanne C., Turner, Marc L., and Hoefnagel, Marcel H.N.

Published
2020
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9. Cost-effectiveness of treating advanced melanoma with tumor-infiltrating lymphocytes based on an international randomized phase 3 clinical trial

Author

Ten Ham, Renske M.T., Rohaan, Maartje W., Jedema, Inge, Kessels, Rob, Stegeman, Wim, Scheepmaker, Walter, Nuijen, Bastiaan, Nijenhuis, Cynthia, Lindenberg, Melanie, Borch, Troels Holz, Monberg, Tine, Donia, Marco, Marie Svane, Inge, van Harten, Wim, Haanen, John, Retel, Valesca P., Ten Ham, Renske M.T., Rohaan, Maartje W., Jedema, Inge, Kessels, Rob, Stegeman, Wim, Scheepmaker, Walter, Nuijen, Bastiaan, Nijenhuis, Cynthia, Lindenberg, Melanie, Borch, Troels Holz, Monberg, Tine, Donia, Marco, Marie Svane, Inge, van Harten, Wim, Haanen, John, and Retel, Valesca P.

Abstract

INTRODUCTION: In a multicenter, open-label randomized phase 3 clinical trial conducted in the Netherlands and Denmark, treatment with ex vivo-expanded tumor-infiltrating lymphocytes (TIL-NKI/CCIT) from autologous melanoma tumor compared with ipilimumab improved progression-free survival in patients with unresectable stage IIIC-IV melanoma after failure of first-line or second-line treatment. Based on this trial, we conducted a cost-utility analysis. METHODS: A Markov decision model was constructed to estimate expected costs (expressed in 2021€) and outcomes (quality-adjusted life years (QALYs)) of TIL-NKI/CCIT versus ipilimumab in the Netherlands. The Danish setting was assessed in a scenario analysis. A modified societal perspective was applied over a lifetime horizon. TIL-NKI/CCIT production costs were estimated via activity-based costing. Through sensitivity analyses, uncertainties and their impact on the incremental cost-effectiveness ratio (ICER) were assessed. RESULTS: Mean total undiscounted lifetime benefits were 4.47 life years (LYs) and 3.52 QALYs for TIL-NKI/CCIT and 3.33 LYs and 2.46 QALYs for ipilimumab. Total lifetime undiscounted costs in the Netherlands were €347,168 for TIL-NKI/CCIT (including €67,547 for production costs) compared with €433,634 for ipilimumab. Undiscounted lifetime cost in the Danish scenario were €337,309 and €436,135, respectively. This resulted in a dominant situation for TIL-NKI/CCIT compared with ipilimumab in both countries, meaning incremental QALYs were gained at lower costs. Survival probabilities, and utility in progressive disease affected the ICER most. CONCLUSION: Based on the data of a randomized phase 3 trial, treatment with TIL-NKI/CCIT in patients with unresectable stage IIIC-IV melanoma is cost-effective and cost-saving, both in the current Dutch and Danish setting. These findings led to inclusion of TIL-NKI/CCIT as insured care and treatment guidelines. Publicly funded development of the TIL-NKI/CCIT cell ther

Published
2024

12. Toward Transplantation of Liver Organoids: From Biology and Ethics to Cost-effective Therapy

Author

Healthcare Innovation & Evaluation, HEE, Child Health, JC onderzoeksprogramma Methodologie, MDL onderzoek 2, Ten Dam, Marjolein J.M., Frederix, Geert W.J., Ten Ham, Renske M.T., Van Der Laan, Luc J.W., Schneeberger, Kerstin, Healthcare Innovation & Evaluation, HEE, Child Health, JC onderzoeksprogramma Methodologie, MDL onderzoek 2, Ten Dam, Marjolein J.M., Frederix, Geert W.J., Ten Ham, Renske M.T., Van Der Laan, Luc J.W., and Schneeberger, Kerstin

Published
2023

13. Tumor-Infiltrating Lymphocyte Therapy or Ipilimumab in Advanced Melanoma

Author

Rohaan, Maartje W., primary, Borch, Troels H., additional, van den Berg, Joost H., additional, Met, Özcan, additional, Kessels, Rob, additional, Geukes Foppen, Marnix H., additional, Stoltenborg Granhøj, Joachim, additional, Nuijen, Bastiaan, additional, Nijenhuis, Cynthia, additional, Jedema, Inge, additional, van Zon, Maaike, additional, Scheij, Saskia, additional, Beijnen, Jos H., additional, Hansen, Marten, additional, Voermans, Carlijn, additional, Noringriis, Inge M., additional, Monberg, Tine J., additional, Holmstroem, Rikke B., additional, Wever, Lidwina D.V., additional, van Dijk, Marloes, additional, Grijpink-Ongering, Lindsay G., additional, Valkenet, Ludy H.M., additional, Torres Acosta, Alejandro, additional, Karger, Matthias, additional, Borgers, Jessica S.W., additional, ten Ham, Renske M.T., additional, Retèl, Valesca P., additional, van Harten, Wim H., additional, Lalezari, Ferry, additional, van Tinteren, Harm, additional, van der Veldt, Astrid A.M., additional, Hospers, Geke A.P., additional, Stevense-den Boer, Marion A.M., additional, Suijkerbuijk, Karijn P.M., additional, Aarts, Maureen J.B., additional, Piersma, Djura, additional, van den Eertwegh, Alfons J.M., additional, de Groot, Jan-Willem B., additional, Vreugdenhil, Gerard, additional, Kapiteijn, Ellen, additional, Boers-Sonderen, Marye J., additional, Fiets, W. Edward, additional, van den Berkmortel, Franchette W.P.J., additional, Ellebaek, Eva, additional, Hölmich, Lisbet R., additional, van Akkooi, Alexander C.J., additional, van Houdt, Winan J., additional, Wouters, Michel W.J.M., additional, van Thienen, Johannes V., additional, Blank, Christian U., additional, Meerveld-Eggink, Aafke, additional, Klobuch, Sebastian, additional, Wilgenhof, Sofie, additional, Schumacher, Ton N., additional, Donia, Marco, additional, Svane, Inge Marie, additional, and Haanen, John B.A.G., additional

Published
2022
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14. Key Considerations in the Health Technology Assessment of Advanced Therapy Medicinal Products in Scotland, The Netherlands, and England

Author

Afd Pharmacoepi & Clinical Pharmacology, Innovation and Sustainability, Pharmacoepidemiology and Clinical Pharmacology, ten Ham, Renske M.T., Frederix, Geert W.J., Wu, Olivia, Goettsch, Wim, Leufkens, Hubert G.M., Klungel, Olaf H., Hoekman, Jarno, Afd Pharmacoepi & Clinical Pharmacology, Innovation and Sustainability, Pharmacoepidemiology and Clinical Pharmacology, ten Ham, Renske M.T., Frederix, Geert W.J., Wu, Olivia, Goettsch, Wim, Leufkens, Hubert G.M., Klungel, Olaf H., and Hoekman, Jarno

Published
2022

15. Tumor-Infiltrating Lymphocyte Therapy or Ipilimumab in Advanced Melanoma.

Author

Rohaan, Maartje W., Borch, Troels H., Van Den Berg, Joost H., Met, Özcan, Kessels, Rob, Geukes Foppen, Marnix H., Stoltenborg Granhøj, Joachim, Nuijen, Bastiaan, Nijenhuis, Cynthia, Jedema, Inge, Van Zon, Maaike, Scheij, Saskia, Beijnen, Jos H., Hansen, Marten, Voermans, Carlijn, Noringriis, Inge M., Monberg, Tine J., Holmstroem, Rikke B., Wever, Lidwina D.V., Van Dijk, Marloes, Grijpink-Ongering, Lindsay G., Valkenet, Ludy H.M., Torres Acosta, Alejandro, Karger, Matthias, Borgers, Jessica S.W., Ten Ham, Renske M.T., Retèl, Valesca P., Van Harten, Wim H., Lalezari, Ferry, Van Tinteren, Harm, Van Der Veldt, Astrid A.M., Hospers, Geke A.P., Stevense-Den Boer, Marion A.M., Suijkerbuijk, Karijn P.M., Aarts, Maureen J.B., Piersma, Djura, Van Den Eertwegh, Alfons J.M., De Groot, Jan Willem B., Vreugdenhil, Gerard, Kapiteijn, Ellen, Boers-Sonderen, Marye J., Fiets, W. Edward, Van Den Berkmortel, Franchette W.P.J., Ellebaek, Eva, Hölmich, Lisbet R., Van Akkooi, Alexander C.J., Van Houdt, Winan J., Wouters, Michel W.J.M., Van Thienen, Johannes V., Blank, Christian U., Meerveld-Eggink, Aafke, Klobuch, Sebastian, Wilgenhof, Sofie, Schumacher, Ton N., Donia, Marco, Svane, Inge Marie, Haanen, John B.A.G., Rohaan, Maartje W., Borch, Troels H., Van Den Berg, Joost H., Met, Özcan, Kessels, Rob, Geukes Foppen, Marnix H., Stoltenborg Granhøj, Joachim, Nuijen, Bastiaan, Nijenhuis, Cynthia, Jedema, Inge, Van Zon, Maaike, Scheij, Saskia, Beijnen, Jos H., Hansen, Marten, Voermans, Carlijn, Noringriis, Inge M., Monberg, Tine J., Holmstroem, Rikke B., Wever, Lidwina D.V., Van Dijk, Marloes, Grijpink-Ongering, Lindsay G., Valkenet, Ludy H.M., Torres Acosta, Alejandro, Karger, Matthias, Borgers, Jessica S.W., Ten Ham, Renske M.T., Retèl, Valesca P., Van Harten, Wim H., Lalezari, Ferry, Van Tinteren, Harm, Van Der Veldt, Astrid A.M., Hospers, Geke A.P., Stevense-Den Boer, Marion A.M., Suijkerbuijk, Karijn P.M., Aarts, Maureen J.B., Piersma, Djura, Van Den Eertwegh, Alfons J.M., De Groot, Jan Willem B., Vreugdenhil, Gerard, Kapiteijn, Ellen, Boers-Sonderen, Marye J., Fiets, W. Edward, Van Den Berkmortel, Franchette W.P.J., Ellebaek, Eva, Hölmich, Lisbet R., Van Akkooi, Alexander C.J., Van Houdt, Winan J., Wouters, Michel W.J.M., Van Thienen, Johannes V., Blank, Christian U., Meerveld-Eggink, Aafke, Klobuch, Sebastian, Wilgenhof, Sofie, Schumacher, Ton N., Donia, Marco, Svane, Inge Marie, and Haanen, John B.A.G.

Abstract

Background Immune checkpoint inhibitors and targeted therapies have dramatically improved outcomes in patients with advanced melanoma, but approximately half these patients will not have a durable benefit. Phase 1-2 trials of adoptive cell therapy with tumor-infiltrating lymphocytes (TILs) have shown promising responses, but data from phase 3 trials are lacking to determine the role of TILs in treating advanced melanoma. Methods In this phase 3, multicenter, open-label trial, we randomly assigned patients with unresectable stage IIIC or IV melanoma in a 1:1 ratio to receive TIL or anti-cytotoxic T-lymphocyte antigen 4 therapy (ipilimumab at 3 mg per kilogram of body weight). Infusion of at least 5×109 TILs was preceded by nonmyeloablative, lymphodepleting chemotherapy (cyclophosphamide plus fludarabine) and followed by high-dose interleukin-2. The primary end point was progression-free survival. Results A total of 168 patients (86% with disease refractory to anti-programmed death 1 treatment) were assigned to receive TILs (84 patients) or ipilimumab (84 patients). In the intention-to-treat population, median progression-free survival was 7.2 months (95% confidence interval [CI], 4.2 to 13.1) in the TIL group and 3.1 months (95% CI, 3.0 to 4.3) in the ipilimumab group (hazard ratio for progression or death, 0.50; 95% CI, 0.35 to 0.72; P<0.001); 49% (95% CI, 38 to 60) and 21% (95% CI, 13 to 32) of the patients, respectively, had an objective response. Median overall survival was 25.8 months (95% CI, 18.2 to not reached) in the TIL group and 18.9 months (95% CI, 13.8 to 32.6) in the ipilimumab group. Treatment-related adverse events of grade 3 or higher occurred in all patients who received TILs and in 57% of those who received ipilimumab; in the TIL group, these events were mainly chemotherapy-related myelosuppression. Conclusions In patients with advanced melanoma, progression-free survival was significantly longer among those who received TIL therapy than amon

Published
2022

17. Estimation of manufacturing development costs of cell-based therapies: a feasibility study

Author

HEE, Child Health, JC onderzoeksprogramma Methodologie, ten Ham, Renske M.T., Nievaart, Julianne C., Hoekman, Jarno, Cooper, Rachel S., Frederix, Geert W.J., Leufkens, Hubert G.M., Klungel, Olaf H., Ovelgönne, Hans, Hoefnagel, Marcel H.N., Turner, Marc L., Mountford, Joanne C., HEE, Child Health, JC onderzoeksprogramma Methodologie, ten Ham, Renske M.T., Nievaart, Julianne C., Hoekman, Jarno, Cooper, Rachel S., Frederix, Geert W.J., Leufkens, Hubert G.M., Klungel, Olaf H., Ovelgönne, Hans, Hoefnagel, Marcel H.N., Turner, Marc L., and Mountford, Joanne C.

Published
2021

18. Estimation of manufacturing development costs of cell-based therapies: a feasibility study

Author

Innovation Studies, Pharmacoepidemiology and Clinical Pharmacology, Afd Pharmacoepi & Clinical Pharmacology, Innovation and Sustainability, ten Ham, Renske M.T., Nievaart, Julianne C., Hoekman, Jarno, Cooper, Rachel S., Frederix, Geert W.J., Leufkens, Hubert G.M., Klungel, Olaf H., Ovelgönne, Hans, Hoefnagel, Marcel H.N., Turner, Marc L., Mountford, Joanne C., Innovation Studies, Pharmacoepidemiology and Clinical Pharmacology, Afd Pharmacoepi & Clinical Pharmacology, Innovation and Sustainability, ten Ham, Renske M.T., Nievaart, Julianne C., Hoekman, Jarno, Cooper, Rachel S., Frederix, Geert W.J., Leufkens, Hubert G.M., Klungel, Olaf H., Ovelgönne, Hans, Hoefnagel, Marcel H.N., Turner, Marc L., and Mountford, Joanne C.

Published
2021

19. Cost-Effectiveness Assessment of Monitoring Abiraterone Levels in Metastatic Castration-Resistant Prostate Cancer Patients

Author

Apotheek Opleiding, Apotheek O&O&O, Cancer, ten Ham, Renske M.T., van Nuland, Merel, Vreman, Rick A., de Graaf, Laurens G., Rosing, Hilde, Bergman, André M., Huitema, Alwin D.R., Beijnen, Jos H., Hövels, Anke M., Apotheek Opleiding, Apotheek O&O&O, Cancer, ten Ham, Renske M.T., van Nuland, Merel, Vreman, Rick A., de Graaf, Laurens G., Rosing, Hilde, Bergman, André M., Huitema, Alwin D.R., Beijnen, Jos H., and Hövels, Anke M.

Published
2021

20. Understanding the major factors affecting response shift effects on health-related quality of life: what the then-test measures in a longitudinal prostate cancer registry

Author

Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, ten Ham, Renske M.T., Broering, Jeanette M., Cooperberg, Matthew, Carroll, Peter, Wilson, Leslie S., Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, ten Ham, Renske M.T., Broering, Jeanette M., Cooperberg, Matthew, Carroll, Peter, and Wilson, Leslie S.

Published
2020

21. Robust Health Utility Assessment Among Long-term Survivors of Prostate Cancer: Results from the Cancer of the Prostate Strategic Urologic Research Endeavor Registry

Author

Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, Jeong, Chang Wook, Cowan, Janet E., Broering, Jeanette M., ten Ham, Renske M.T., Wilson, Leslie S., Carroll, Peter R., Cooperberg, Matthew R., Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, Jeong, Chang Wook, Cowan, Janet E., Broering, Jeanette M., ten Ham, Renske M.T., Wilson, Leslie S., Carroll, Peter R., and Cooperberg, Matthew R.

Published
2019

22. Use of social media in the assessment of relative effectiveness: Explorative review with examples from oncology

Author

Kalf, Rachel R.J., Makady, Amr, ten Ham, Renske M.T., Meijboom, Kim, Goettsch, Wim G., Kalf, Rachel R.J., Makady, Amr, ten Ham, Renske M.T., Meijboom, Kim, and Goettsch, Wim G.

Abstract

Background: An element of health technology assessment constitutes assessing the clinical effectiveness of drugs, generally called relative effectiveness assessment. Little real-world evidence is available directly after market access, therefore randomized controlled trials are used to obtain information for relative effectiveness assessment. However, there is growing interest in using real-world data for relative effectiveness assessment. Social media may provide a source of real-world data. Objective: We assessed the extent to which social media-generated health data has provided insights for relative effectiveness assessment. Methods: An explorative literature review was conducted following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines to identify examples in oncology where health data were collected using social media. Scientific and grey literature published between January 2010 and June 2016 was identified by four reviewers, who independently screened studies for eligibility and extracted data. A descriptive qualitative analysis was performed. Results: Of 1032 articles identified, eight were included: Four articles identified adverse events in response to cancer treatment, three articles disseminated quality of life surveys, and one study assessed the occurrence of disease-specific symptoms. Several strengths of social media-generated health data were highlighted in the articles, such as efficient collection of patient experiences and recruiting patients with rare diseases. Conversely, limitations included validation of authenticity and presence of information and selection bias. Conclusions: Social media may provide a potential source of real-world data for relative effectiveness assessment, particularly on aspects such as adverse events, symptom occurrence, quality of life, and adherence behavior. This potential has not yet been fully realized and the degree of usefulness for relative effectiveness assessment should be

Published
2018

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