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Current benefit assessments

Ongoing (preliminary decision published)
Diroximel fumarate (relapsing-remitting multiple sclerosis)
Upadacitinib (new indication: Crohn's disease, pretreated patients)
Etranacogen Dezaparvovec (indication: Hemophilia B)
Cemiplimab (new indication: Non-Small Cell Lung Cancer (NSCLC), expressing PD-L1 (≥ 1%) for first-line treatment in combination with platinum‐based chemotherapy)
Cemiplimab (new indication: cervical cancer, pretreated patients)
Setmelanotide (new indication: obesity and the control of hunger associated with Bardet-Biedl syndrome (BBS), for patients aged ≥ 6 years)
Tixagevimab / cilgavimab (obligation for benefit assessment for the first time: COVID-19, pre-exposure prophylaxis for patients aged ≥ 12 years)
Luspatercept (re-assessment, 30 M € limit exceeded: myelodysplastic syndromes (MDS) with transfusion-dependent anemia, pretreated patients)
Luspatercept (re-assessment, 30 M € limit exceeded: beta-thalassemia with non-transfusion-dependent anemia)
Loncastuximab tesirine (indication: diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL), for patients with ≥ 2 prior therapies)
Lisocabtagene maraleucel (new indication: diffuse large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma (HGBCL), primary mediastinal large B-cell lymphoma (PMBCL) and follicular lymphoma grade 3B (FL3B), after 1 previous therapy for patients who relapsed within 12 months from completion of, or are refractory to previous therapy)
Ravulizumab (indication: neuromyelitis optica spectrum disorder (NMOSD), anti-aquaporin-4 (AQP4) IgG-sero-positive)
Secukinumab (new indication: hidradenitis suppurativa (HS) (acne inversa))
Sacubitril / valsartan (new indication: chronic heart failure with left ventricular systolic dysfunction for patients aged ≥ 1 year)
Riociguat (new indication: pulmonary arterial hypertension (PAH) for patients aged < 18 years)
Bimekizumab (new indication: psoriatic arthritis, as monotherapy or in combination with methotrexate)
Bimekizumab (new indication: ankylosing spondylitis)
Bimekizumab (new indication: axial spondyloarthritis, non-radiographic)
Axicabtagene-Ciloleucel (re-assessment, 30 M € limit exceeded: diffuse large B-cell lymphoma (DLBCL) and primary mediastinal large B-cell lymphoma (PMBCL), after ≥ 2 previous therapies)
Axicabtagene-Ciloleucel (new indication: follicular lymphoma (FL), after ≥ 3 previous therapies)
Axicabtagene-Ciloleucel (new indication: diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL), after 1 previous therapy and relapse within 12 months or refractory)
Nivolumab (new indication: melanoma, adolescents ≥ 12 to 18 years, monotherapy or in combination with ipilimumab)
Nivolumab (new indication: melanoma, adjuvant monotherapy, adolescents ≥ 12 to 18 years)
Selumetinib (re-assessment: neurofibromatosis, patients aged ≥ 3 to < 18 years, Type I)
Completed (final decision published)
16 Feb 2023
Eptinezumab (new indication: prophylaxis of migraine)
16 Feb 2023
Efgartigimod alfa (Myasthenia Gravis for AChR antibody positive patients)
16 Feb 2023
Burosumab (new indication, 50 M € limit exceeded: FGF23-related hypophosphatemia in tumor-induced osteomalacia)
2 Feb 2023
Trastuzumab Deruxtecan (indication: breast cancer, HER2+, ≥ 2 prior therapies)
2 Feb 2023
Trastuzumab Deruxtecan (indication: breast cancer, HER2+, 1 prior therapy)
2 Feb 2023
Pembrolizumab (new indication: cervical cancer with PD-L1 expression with a CPS ≥ 1, in combination with or without bevacizumab)
2 Feb 2023
Capmatinib (non-small cell lung cancer (NSCLC), pretreated patients with mesenchymal-epithelial transition factor gene exon 14 (METex14) skipping)
2 Feb 2023
Ceftolozane / tazobactam (new indication: bacterial infections; patients aged < 18 years (antibiotic of last resort))
2 Feb 2023
Eladocagene exuparvovec (aromatic L-amino acid decarboxylase (AADC) deficiency, patients aged ≥ 18 months)
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)

 

Please contact

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Dr. Thomas Ecker
Phone +49 (40) 41 33 081-10