TY - JOUR

T1 - Economic evaluation of adverse events of dabrafenib plus trametinib versus nivolumab in patients with advanced BRAF-mutant cutaneous melanoma for adjuvant therapy in Germany

AU - Wahler, S

AU - Müller, A

AU - Koll, C

AU - Seyed-Abbaszadeh, P

AU - Graf von der Schulenburg, Johann-Matthias

PY - 2021

Y1 - 2021

N2 - Background: Adjuvant treatment options have become the standard therapy for stage III and IV resectable cutaneous melanoma. Two recent studies led to the registration of dabrafenib and trametinib as targeted therapies for BRAF-mutated melanoma, and of immunotherapy with nivolumab irrespective of BRAF-mutation status. Both therapies have different spectrums of adverse events. Objective: To estimate the financial impact of side effects from the perspective of the German statutory sick funds to compare both therapeutic options and to relate the burden to the overall costs of the treatment.STUDY DESIGN AND SETTING: Thirty-six adverse event categories for the combination of dabrafenib and trametinib ('combi treatment') and for nivolumab were extracted from the original publications of the studies named COMBI-AD and CheckMate 238.PATIENTS AND INTERVENTION: For all event categories a diagnosis and therapy recommendation were determined according to current national or international guidelines or from leading German textbooks.MAIN OUTCOME MEASURE: The resulting diagnostic steps, treatments, and therapies were evaluated with unit costs based on the German fee schedule for ambulatory physicians, the German G-DRG scheme, and the German drug price list.RESULTS: The number of events with nivolumab per one hundred treatments amounted to 3.8 mandatory hospitalizations, 3.5 emergency care events and 0.8 life-threatening events. For the combi treatment, the respective number of events per one hundred treatments was 2.7, 1.8, and 0.5. The overall cost burden was calculated as €899 for nivolumab and €861 for combi-treatment.CONCLUSION: The treatment of adverse events resulting from adjuvant melanoma therapy showed comparable costs for both therapies.

AB - Background: Adjuvant treatment options have become the standard therapy for stage III and IV resectable cutaneous melanoma. Two recent studies led to the registration of dabrafenib and trametinib as targeted therapies for BRAF-mutated melanoma, and of immunotherapy with nivolumab irrespective of BRAF-mutation status. Both therapies have different spectrums of adverse events. Objective: To estimate the financial impact of side effects from the perspective of the German statutory sick funds to compare both therapeutic options and to relate the burden to the overall costs of the treatment.STUDY DESIGN AND SETTING: Thirty-six adverse event categories for the combination of dabrafenib and trametinib ('combi treatment') and for nivolumab were extracted from the original publications of the studies named COMBI-AD and CheckMate 238.PATIENTS AND INTERVENTION: For all event categories a diagnosis and therapy recommendation were determined according to current national or international guidelines or from leading German textbooks.MAIN OUTCOME MEASURE: The resulting diagnostic steps, treatments, and therapies were evaluated with unit costs based on the German fee schedule for ambulatory physicians, the German G-DRG scheme, and the German drug price list.RESULTS: The number of events with nivolumab per one hundred treatments amounted to 3.8 mandatory hospitalizations, 3.5 emergency care events and 0.8 life-threatening events. For the combi treatment, the respective number of events per one hundred treatments was 2.7, 1.8, and 0.5. The overall cost burden was calculated as €899 for nivolumab and €861 for combi-treatment.CONCLUSION: The treatment of adverse events resulting from adjuvant melanoma therapy showed comparable costs for both therapies.

KW - Combi-treatment

KW - cost burden

KW - dabrafenib

KW - nivolumab

KW - therapeutic strategy

KW - trametinib

UR - http://www.scopus.com/inward/record.url?scp=85114920850&partnerID=8YFLogxK

U2 - 10.1080/20016689.2020.1861804

DO - 10.1080/20016689.2020.1861804

M3 - Article

C2 - 33456727

VL - 9

JO - Journal of market access & health policy

JF - Journal of market access & health policy

SN - 2001-6689

IS - 1

M1 - 1861804

ER -