TY - JOUR
T1 - Treatment with Tumor-infiltrating Lymphocytes in Advanced Melanoma Evaluation of Early Clinical Implementation of an Advanced Therapy Medicinal Product
AU - Lindenberg, Melanie A.
AU - Retl, Valesca P.
AU - van den Berg, Joost H.
AU - Geukes Foppen, Marnix H.
AU - Haanen, John B.
AU - Van Harten, Wim H.
N1 - Lippincott WW deal
PY - 2018/11/1
Y1 - 2018/11/1
N2 - Tumor-infiltrating lymphocytes (TIL)-therapy in advanced melanoma is an advanced therapy medicinal product (ATMP) which, despite promising results, has not been implemented widely. In a European setting, TIL-therapy has been in use since 2011 and is currently being evaluated in a randomized controlled trial. As clinical implementation of ATMPs is challenging, this study aims to evaluate early application of TIL-therapy, through the application of a constructive technology assessment (CTA). First the literature on ATMP barriers and facilitators in clinical translation was summarized. Subsequently, application of TILtherapy was evaluated through semistructured interviews with 26 stakeholders according to 6 CTA domains: clinical, economic, patient-related, organizational, technical, and future. In addition, treatment costs were estimated. A number of barriers to clinical translation were identified in the literature, including: inadequate financial support, lack of regulatory knowledge, risks in using live tissues, and the complex path to market approval. Innovative reimbursement procedures could particularly facilitate translation. The CTA survey of TIL-therapy acknowledged these barriers, and revealed the following facilitators: the expected effectiveness resulting in institutional support for an internal pilot, the results of which led to the inclusion of TIL-therapy in a national coverage
AB - Tumor-infiltrating lymphocytes (TIL)-therapy in advanced melanoma is an advanced therapy medicinal product (ATMP) which, despite promising results, has not been implemented widely. In a European setting, TIL-therapy has been in use since 2011 and is currently being evaluated in a randomized controlled trial. As clinical implementation of ATMPs is challenging, this study aims to evaluate early application of TIL-therapy, through the application of a constructive technology assessment (CTA). First the literature on ATMP barriers and facilitators in clinical translation was summarized. Subsequently, application of TILtherapy was evaluated through semistructured interviews with 26 stakeholders according to 6 CTA domains: clinical, economic, patient-related, organizational, technical, and future. In addition, treatment costs were estimated. A number of barriers to clinical translation were identified in the literature, including: inadequate financial support, lack of regulatory knowledge, risks in using live tissues, and the complex path to market approval. Innovative reimbursement procedures could particularly facilitate translation. The CTA survey of TIL-therapy acknowledged these barriers, and revealed the following facilitators: the expected effectiveness resulting in institutional support for an internal pilot, the results of which led to the inclusion of TIL-therapy in a national coverage
KW - UT-Hybrid-D
KW - Advanced therapy medicinal product
KW - Malignant melanoma
KW - Translational medical research
KW - Tumor-infiltrating lymphocytes
KW - Adoptive immunotherapy
UR - http://www.scopus.com/inward/record.url?scp=85054772740&partnerID=8YFLogxK
U2 - 10.1097/CJI.0000000000000245
DO - 10.1097/CJI.0000000000000245
M3 - Article
C2 - 30300260
AN - SCOPUS:85054772740
VL - 41
SP - 413
EP - 425
JO - Journal of immunotherapy with emphasis on tumor immunology : official journal of the Society for Biological Therapy
JF - Journal of immunotherapy with emphasis on tumor immunology : official journal of the Society for Biological Therapy
SN - 1524-9557
IS - 9
ER -