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Current benefit assessments
Ongoing (preliminary decision published)
Diroximel fumarate (relapsing-remitting multiple sclerosis)
Cerliponase alfa (re-assessment: neuronal ceroid lipofuscinosis type 2 (CLN2 disease))
Pembrolizumab (new indication: cervical cancer with PD-L1 expression with a CPS ≥ 1, in combination with or without bevacizumab)
Trastuzumab Deruxtecan (indication: breast cancer, HER2+, ≥ 2 prior therapies)
Trastuzumab Deruxtecan (indication: breast cancer, HER2+, 1 prior therapy)
Eladocagene exuparvovec (aromatic L-amino acid decarboxylase (AADC) deficiency, patients aged ≥ 18 months)
Capmatinib (non-small cell lung cancer (NSCLC), pretreated patients with mesenchymal-epithelial transition factor gene exon 14 (METex14) skipping)
Ceftolozane / tazobactam (new indication: bacterial infections; patients aged < 18 years (antibiotic of last resort))
Birch bark extract (wounds associated with dystrophic and junctional epidermolysis bullosa (EB), patients aged ≥ 6 months)
Upadacitinib (new indication: non-radiographic axial spondyloarthritis)
Upadacitinib (new indication: ulcerative colitis, pretreated patients)
Olaparib (new indication: high risk early breast cancer with BRCA1/2-mutations and HER2-negative as monotherapy or in combination with endocrine therapy for the adjuvant treatment of previously treated patients)
Eptinezumab (new indication: prophylaxis of migraine)
Efgartigimod alfa (Myasthenia Gravis for AChR antibody positive patients)
Burosumab (new indication, 50 M € limit exceeded: FGF23-related hypophosphatemia in tumor-induced osteomalacia)
Valoctocogene roxaparvovec (hemophilia A)
Selpercatinib (new indication: thyroid cancer, RET-mutation, monotherapy, patients aged ≥ 12 years)
Pertuzumab / trastuzumab (re-assessment: early breast cancer, HER2-positive, high risk of recurrence, adjuvant therapy, in combination with chemotherapy)
Pertuzumab (re-assessment: early breast cancer, high risk of recurrence, adjuvant therapy, in combination with trastuzumab and chemotherapy)
Olipudase alfa (acid sphingomyelinase deficiency (ASMD) type A/B or type B)
Melphalan flufenamide (multiple myeloma, ≥ 3 prior therapies, in combination with dexamethasone)
Asciminib (chronic myeloid leukemia, Ph+, ≥ 2 prior therapies)
Selinexor (multiple myeloma, ≥ 4 prior therapies, in combination with dexamethasone)
Selinexor (multiple myeloma, ≥ 1 prior therapy, in combination with bortezomib and dexamethasone)
Difelikefalin (pruritus in patients with chronic kidney disease who are on hemodialysis)
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Completed (final decision published)
19 Jan 2023
Eravacyclin (antibiotic of last resort: complicated intra-abdominal infections (cIAI)
19 Jan 2023
Glycopyrronium (known active substance with new document protection (§16): severe primary axillary hyperhidrosis)
19 Jan 2023
Inebilizumab (indication: neuromyelitis optica spectrum disorders (NMOSD) anti-aquasporin-4 immunoglobulin G (AQP4-IgG) seropositive patients))
19 Jan 2023
Pembrolizumab (new indication: renal cell carcinoma, adjuvant therapy, pretreated patients)
19 Jan 2023
Pembrolizumab (new indication: colorectal cancer with MSI-H or dMMR tumors for patients treated with fluoropyrimidine-based combination therapy)
19 Jan 2023
Pembrolizumab (new indication: endometrial carcinoma with MSI-H or dMMR tumors, pretreated patients)
19 Jan 2023
Pembrolizumab (new indication: gastric cancer with MSI-H or dMMR tumors, pretreated patients)
19 Jan 2023
Pembrolizumab (new indication: small intestine cancer with MSI-H or dMMR tumors, pretreated patients)
19 Jan 2023
Pembrolizumab (new indication: biliary cancer with MSI-H or dMMR tumors, pretreated patients)
19 Jan 2023
Pembrolizumab (new indication: melanoma, patients aged ≥ 12 years, adjuvant therapy, monotherapy)
19 Jan 2023
Pembrolizumab (new indication: melanoma, patients aged ≥ 12 to < 18 years)
5 Jan 2023
Secukinumab (new indication: juvenile psoriatic arthritis, patients aged 6 ≥ years)
5 Jan 2023
Secukinumab (new indication: enthesitis-related arthritis, patients aged ≥ 6 years)
5 Jan 2023
Atezolizumab (new indication: non-small cell lung cancer (NSCLC), PD-L1 expression ≥ 50 %, EGFR/ALK negative, adjuvant therapy following resection and chemotherapy)
15 Dec 2022
Mosunetuzumab (follicular lymphoma (FL), ≥ 2 prior therapies)
15 Dec 2022
Pembrolizumab (new indication: breast cancer, triple negative, high risk of recurrence, neoadjuvant and adjuvant therapy, monotherapy or in combination with chemotherapy)
15 Dec 2022
Selpercatinib (new indication: non-small cell lung cancer (NSCLC), RET fusion-positive, 1st line)
15 Dec 2022
Palbociclib (re-assessment: breast cancer, patient population a1)
15 Dec 2022
Nirmatrelvir / ritonavir (COVID-19, patients not requiring supplemental oxygen, with increased risk of progressing to severe COVID-19)
15 Dec 2022
Cerliponase alfa (re-assessment: neuronal ceroid lipofuscinosis type 2 (CLN2 disease))
1 Dec 2022
Tisagenlecleucel (new indication: follicular lymphoma (FL), pretreated patients)
1 Dec 2022
Polatuzumab vedotin (new indication: diffuse large-cell B-cell lymphoma (DLBCL), in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (R-CHP))
1 Dec 2022
Cabozantinib (new indication: thyroid carcinoma, pretreated patients, refractory to radioactive iodine)
1 Dec 2022
Setmelanotide (obesity and the control of hunger associated with deficiency in POMC, PCSK1 or LEPR, adults and children ≥ 6 years of age)
1 Dec 2022
Enfortumab vedotin (urothelial cancer (UC), pretreated with platinum-containing chemotherapy and PD-(L)-1 inhibitor)
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Please contact
Dr. Thomas Ecker
Phone +49 (40) 41 33 081-10
Current Benefit Assessments
Current European Health Technology Assessment Procedures