Trastuzumab emtansine in locally advanced or metastatic HER2 positive breast cancer; GENESIS-SEFH drug evaluation report
Trastuzumab emtansina (T-DM1) is an antibody-drug conjugate directed against the HER2 for the treatment of HER2+ mestastatic breast cancer (MBC), who has previously received trastuzumab plus a taxane. According to the results of the EMILIA trial versus lapatinib plus capecitabine T-DM1 shows a...
Saved in:
| Main Authors: | , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Elsevier
2015-02-01
|
| Series: | Farmacia Hospitalaria |
| Subjects: | |
| Online Access: | http://www.aulamedica.es/fh/pdf/8912.pdf |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1846093621427699712 |
|---|---|
| author | Patricia Miranda Romero Roberto Marín Gil |
| author_facet | Patricia Miranda Romero Roberto Marín Gil |
| author_sort | Patricia Miranda Romero |
| collection | DOAJ |
| description | Trastuzumab emtansina (T-DM1) is an antibody-drug conjugate directed against the HER2 for the treatment of HER2+ mestastatic breast
cancer (MBC), who has previously received trastuzumab plus a taxane. According to the results of the EMILIA trial versus lapatinib plus
capecitabine T-DM1 shows an improvement in progression-free survival (PFS) and the overall survival (OS). It has a favorable profile
reducing the incidence of grade 3-4 adverse reactions such as hand-foot syndrome and diarrhea. On the contrary increases significantly
severe thrombocytopenia; bleeding risk and liver function should also be monitored. With the current import price T-DM1 has a cost per QALY of over 120,000 €. The price of the drug for the Spanish NHS has not yet been established. Drug cost would be the key factor in the sensitivity analysis and a 50% reduction in the price of the drug would place it close to the threshold of cost-effectiveness usually considered in our midst. According to the budget impact model used, a maximum of 1,218 patients / year and the budgetary impact throughout the Spanish state would be at € 70,490,850. In the initial analysis no advantage was found for T-DM1 in those patients without visceral involvement. Although a subsequent re-analysis of the results of PFS in which the definition of visceral involvement was specified a significant benefit was shown in this subgroup. We believe that this approach introduces a high degree of uncertainty, which does not guarantee the benefit achieved for this subgroup of patients |
| format | Article |
| id | doaj-art-199d959449ce428e8cc2efd7a04f29ef |
| institution | Kabale University |
| issn | 1130-6343 2171-8695 |
| language | English |
| publishDate | 2015-02-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Farmacia Hospitalaria |
| spelling | doaj-art-199d959449ce428e8cc2efd7a04f29ef2025-01-02T16:48:22ZengElsevierFarmacia Hospitalaria1130-63432171-86952015-02-0139317117510.7399/fh.2015.39.3.8912Trastuzumab emtansine in locally advanced or metastatic HER2 positive breast cancer; GENESIS-SEFH drug evaluation reportPatricia Miranda Romero0Roberto Marín Gil1Virgen del Rocío University Hospital. SevillaValme University Hospital. Sevilla. EspañaTrastuzumab emtansina (T-DM1) is an antibody-drug conjugate directed against the HER2 for the treatment of HER2+ mestastatic breast cancer (MBC), who has previously received trastuzumab plus a taxane. According to the results of the EMILIA trial versus lapatinib plus capecitabine T-DM1 shows an improvement in progression-free survival (PFS) and the overall survival (OS). It has a favorable profile reducing the incidence of grade 3-4 adverse reactions such as hand-foot syndrome and diarrhea. On the contrary increases significantly severe thrombocytopenia; bleeding risk and liver function should also be monitored. With the current import price T-DM1 has a cost per QALY of over 120,000 €. The price of the drug for the Spanish NHS has not yet been established. Drug cost would be the key factor in the sensitivity analysis and a 50% reduction in the price of the drug would place it close to the threshold of cost-effectiveness usually considered in our midst. According to the budget impact model used, a maximum of 1,218 patients / year and the budgetary impact throughout the Spanish state would be at € 70,490,850. In the initial analysis no advantage was found for T-DM1 in those patients without visceral involvement. Although a subsequent re-analysis of the results of PFS in which the definition of visceral involvement was specified a significant benefit was shown in this subgroup. We believe that this approach introduces a high degree of uncertainty, which does not guarantee the benefit achieved for this subgroup of patientshttp://www.aulamedica.es/fh/pdf/8912.pdfBreast CancerTrastuzumab emtansine; Cost-effectiveness; Lapatinib |
| spellingShingle | Patricia Miranda Romero Roberto Marín Gil Trastuzumab emtansine in locally advanced or metastatic HER2 positive breast cancer; GENESIS-SEFH drug evaluation report Farmacia Hospitalaria Breast Cancer Trastuzumab emtansine ; Cost-effectiveness ; Lapatinib |
| title | Trastuzumab emtansine in locally advanced or metastatic HER2 positive breast cancer; GENESIS-SEFH drug evaluation report |
| title_full | Trastuzumab emtansine in locally advanced or metastatic HER2 positive breast cancer; GENESIS-SEFH drug evaluation report |
| title_fullStr | Trastuzumab emtansine in locally advanced or metastatic HER2 positive breast cancer; GENESIS-SEFH drug evaluation report |
| title_full_unstemmed | Trastuzumab emtansine in locally advanced or metastatic HER2 positive breast cancer; GENESIS-SEFH drug evaluation report |
| title_short | Trastuzumab emtansine in locally advanced or metastatic HER2 positive breast cancer; GENESIS-SEFH drug evaluation report |
| title_sort | trastuzumab emtansine in locally advanced or metastatic her2 positive breast cancer genesis sefh drug evaluation report |
| topic | Breast Cancer Trastuzumab emtansine ; Cost-effectiveness ; Lapatinib |
| url | http://www.aulamedica.es/fh/pdf/8912.pdf |
| work_keys_str_mv | AT patriciamirandaromero trastuzumabemtansineinlocallyadvancedormetastaticher2positivebreastcancergenesissefhdrugevaluationreport AT robertomaringil trastuzumabemtansineinlocallyadvancedormetastaticher2positivebreastcancergenesissefhdrugevaluationreport |