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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)
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)

 

Please contact

Dr. Thomas Ecker

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