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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)
20 Apr 2023
Olaparib (re-assessment: adult patients with advanced (FIGO stages III and IV) epithelial ovarian, fallopian tube or primary peritoneal cancer, homologous recombination deficiency (HRD) positive, maintenance treatment in combination with Bevacizumab)
20 Apr 2023
Tixagevimab / cilgavimab (obligation for benefit assessment for the first time: COVID-19; patients not requiring supplemental oxygen; patients aged ≥ 12 years)
6 Apr 2023
Lisocabtagene maraleucel (diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma (PMBCL) and follicular lymphoma grade 3b (FL3B); ≥ 2 prior therapies)
6 Apr 2023
Lonafarnib (Hutchinson-Gilford progeria syndrome or (processing-deficient) progeroid laminopathy)
6 Apr 2023
Relugolix (advanced hormone-sensitive prostate cancer)
6 Apr 2023
Vutrisiran (hereditary transthyretin-mediated amyloidosis with polyneuropathy (stage 1 or 2))
6 Apr 2023
Faricimab (diabetic macular edema (DME))
6 Apr 2023
Faricimab (neovascular age-related macular degeneration (nAMD))
6 Apr 2023
Remdesivir (new indication: COVID-19; patients requiring supplemental oxygen; patients aged ≥ 4 weeks to < 12 years)
6 Apr 2023
Remdesivir (new indication: COVID-19; patients not requiring supplemental oxygen; patients aged < 18 years and weighing ≥ 40 kg)
6 Apr 2023
Difelikefalin (pruritus in patients with chronic kidney disease who are on hemodialysis)
16 Mar 2023
Valoctocogene roxaparvovec (hemophilia A)
16 Mar 2023
Selinexor (multiple myeloma, ≥ 4 prior therapies, in combination with dexamethasone)
16 Mar 2023
Selinexor (multiple myeloma, ≥ 1 prior therapy, in combination with bortezomib and dexamethasone)
16 Mar 2023
Melphalan flufenamide (multiple myeloma, ≥ 3 prior therapies, in combination with dexamethasone)
16 Mar 2023
Asciminib (chronic myeloid leukemia, Ph+, ≥ 2 prior therapies)
16 Mar 2023
Brexucabtagene autoleucel (new indication: acute lymphoblastic leukemia, patients aged ≥ 26 years)
16 Mar 2023
Pertuzumab (re-assessment: early breast cancer, high risk of recurrence, adjuvant therapy, in combination with trastuzumab and chemotherapy)
16 Mar 2023
Pertuzumab / trastuzumab (re-assessment: early breast cancer, HER2-positive, high risk of recurrence, adjuvant therapy, in combination with chemotherapy)
16 Mar 2023
Selpercatinib (new indication: thyroid cancer, RET-mutation, monotherapy, patients aged ≥ 12 years)
16 Mar 2023
Olipudase alfa (acid sphingomyelinase deficiency (ASMD) type A/B or type B)
16 Feb 2023
Birch bark extract (wounds associated with dystrophic and junctional epidermolysis bullosa (EB), patients aged ≥ 6 months)
16 Feb 2023
Upadacitinib (new indication: non-radiographic axial spondyloarthritis)
16 Feb 2023
Upadacitinib (new indication: ulcerative colitis, pretreated patients)
16 Feb 2023
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)

 

Please contact

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