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Active substances for the treatment of:

Malignant breast cancer

Name of active substance (medicine) The European Society for Medical Oncology (ESMO). Published scientific research demonstrates that the observance of such scientific community guidelines has a positive impact on patient survival rates. Is it included in
the European standard  of treatment (according to ESMO)?
Access status (National Health Fund reimbursement) Additional information
Lapatinib The drug in this indication is reimbursed for a narrower group of patients than is apparent from the ESMO guidelines Reimbursement with restrictions Lapatinib is indicated for the treatment of adult patients with breast cancer, whose tumours overexpress HER2 (ErbB2); 1. combination with capecitabine for patients with advanced or metastatic disease with progression following prior therapy, which must have included anthracyclines and taxanes and therapy with trastuzumab in the metastatic setting. 2. in combination with trastuzumab for patients with hormone receptor-negative metastatic disease that has progressed on prior trastuzumab therapy(ies) in combination with chemotherapy. 3. in combination with an aromatase inhibitor for postmenopausal women with hormone receptor positive metastatic disease, not currently intended for chemotherapy. EPAR/SmPC Drug programme
Pertuzumab The drug in this indication is reimbursed for a narrower group of patients than is apparent from the ESMO guidelines Reimbursement with restrictions A. Early breast cancer: Pertuzumab is indicated for use in combination with trastuzumab and chemotherapy in: 1. the neoadjuvant treatment of adult patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer at high risk of recurrence 2. the adjuvant treatment of adult patients with HER2-positive early breast cancer at high risk of recurrence B. Metastatic breast cancer: Pertuzumab is indicated for use in combination with trastuzumab and docetaxel in adult patients with HER2-positive metastatic or locally recurrent unresectable breast cancer, who have not received previous anti-HER2 therapy or chemotherapy for their metastatic disease. EPAR/SmPC Drug programme
Bevacizumab The drug in this indication is not refunded No reimbursement Bevacizumab in combination with paclitaxel is indicated for first-line treatment of adult patients with metastatic breast cancer. For further information as to human epidermal growth factor receptor 2 (HER2) status, please refer to section 5.1. Bevacizumab in combination with capecitabine is indicated for first-line treatment of adult patients with metastatic breast cancer in whom treatment with other chemotherapy options including taxanes or anthracyclines is not considered appropriate. Patients who have received taxane and anthracyclinecontaining regimens in the adjuvant setting within the last 12 months should be excluded from treatment with Avastin in combination with capecitabine. For further information as to HER2 status, please refer to section 5.1. EPAR/SmPC
Everolimus The drug in this indication is not refunded No reimbursement Everolimus is indicated for the treatment of hormone receptor-positive, HER2/neu negative advanced breast cancer, in combination with exemestane, in postmenopausal women without symptomatic visceral disease after recurrence or progression following a non-steroidal aromatase inhibitor. EPAR/SmPC
Eribulin The drug in this indication is not refunded No reimbursement Eribulin is indicated for the treatment of adult patients with locally advanced or metastatic breast cancer who have progressed after at least one chemotherapeutic regimen for advanced disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting unless patients were not suitable for these treatments. EPAR/SmPC
Palbociclib The drug in this indication is not refunded No reimbursement Palbociclib is indicated for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer: - in combination with an aromatase inhibitor; - in combination with fulvestrant in women who have received prior endocrine therapy (see section 5.1). In pre- or perimenopausal women, the endocrine therapy should be combined with a luteinizing hormone-releasing hormone (LHRH) agonist. EPAR/SmPC
Ribociclib succinate The drug in this indication is not refunded No reimbursement Ribociclib in combination with an aromatase inhibitor is indicated for the treatment of postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer as initial endocrine-based therapy. EPAR/SmPC
Trastuzumab emtansine The drug in this indication is not refunded No reimbursement Trastuzumab emtansine as a single agent, is indicated for the treatment of adult patients with HER2-positive, unresectable locally advanced or metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination. Patients should have either: - Received prior therapy for locally advanced or metastatic disease, or - Developed disease recurrence during or within six months of completing adjuvant therapy EPAR/SmPC
Nab-paclitaxel The drug in this indication is not refunded No reimbursement Nab-paclitaxel monotherapy is indicated for the treatment of metastatic breast cancer in adult patients who have failed first-line treatment for metastatic disease and for whom standard, anthracycline containing therapy is not indicated. EPAR/SmPC
Neratinib The drug in this indication is not refunded No reimbursement Neratinib is indicated for the extended adjuvant treatment of adult patients with early-stage hormone receptor positive HER2-overexpressed/amplified breast cancer and who are less than one year from the completion of prior adjuvant trastuzumab based therapy. EPAR/SmPC
Abemaciclib The drug in this indication is not refunded No reimbursement Abemaciclib is indicated for the treatment of women with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor or fulvestrant as initial endocrine-based therapy, or in women who have received prior endocrine therapy. In pre- or perimenopausal women, the endocrine therapy should be combined with a luteinising hormone-releasing hormone (LHRH) agonist. EPAR/SmPC