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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)
15 Sept 2022
Avapritinib (new indication: systemic mastocytosis, ≥ 1 prior therapies)
15 Sept 2022
Somatrogon (growth disturbance due to insufficient secretion of growth hormone; patients aged ≥ 3 - < 18 years)
15 Sept 2022
Dolutegravir (new scientific evidence (§13): HIV infection, patients aged 5 - < 18 years)
15 Sept 2022
Voretigene neparvovec (re-assessment: inherited renal dystrophy)
15 Sept 2022
Pegcetacoplan (paroxysmal nocturnal hemoglubinuria (PNH), pre-treated patients)
15 Sept 2022
Idebenone (re-assessment: Leber's hereditary optic neuropathy (LHON))
15 Sept 2022
Empagliflozin (new indication: chronic heart failure)
1 Sept 2022
Vedolizumab (new indication: antibiotic-resistant pouchitis, pre-treated patients)
1 Sept 2022
Tepotinib (non-small cell lung cancer (NSCLC), METex14-skipping mutation, pre-treated patients)
1 Sept 2022
Lorlatinib (new indication: non-small cell lung cancer (NSCLC), ALK+ mutation, 1st line)
1 Sept 2022
Brivaracetam (new indication: partial onset seizures in patients with epilepsy, adjunctive therapy, patients aged 2 –
4 Aug 2022
Ivacaftor (new indication: cystic fibrosis; F508del mutation, heterozygous, and other or unknown mutation; patients aged ≥ 6 - ≤ 11 years; in combination with ivacaftor / tezacaftor / elexacaftor)
4 Aug 2022
Ivacaftor (new indication: cystic fibrosis; F508del mutation, heterozygous, and RF mutation; patients aged ≥ 6 - ≤ 11 years; in combination with ivacaftor / tezacaftor / elexacaftor)
4 Aug 2022
Ivacaftor (new indication: cystic fibrosis; F508del mutation, heterozygous, and gating mutation; patients aged ≥ 6 - ≤ 11 years; in combination with ivacaftor / tezacaftor / elexacaftor)
4 Aug 2022
Ivacaftor (new indication: cystic fibrosis; in combination with ivacaftor / tezacaftor / elexacaftor, patients aged ≥ 6 - ≤ 11 years (homozygous for F508del mutation))
4 Aug 2022
Ivacaftor (new indication: cystic fibrosis; in combination with ivacaftor / tezacaftor / elexacaftor, patients aged ≥ 6 - ≤ 11 years (heterozygous for F508del and MF mutation))
4 Aug 2022
Sotorasib (non-small cell lung cancer (NSCLC); KRAS G12C mutation; ≥ 1 prior therapies)
4 Aug 2022
Avacopan (granulomatosis with polyangiitis or microscopic polyangiitis; in combination with rituximab or cyclophosphamide)
4 Aug 2022
Ivacaftor / tezacaftor / elexacaftor (new indication: cystic fibrosis; F508del mutation; heterozygous; and other or unknown mutation; patients aged ≥ 6 - ≤ 11 years (in combination with ivacaftor))
4 Aug 2022
Ivacaftor / tezacaftor / elexacaftor (new indication: cystic fibrosis; F508del mutation; heterozygous, and RF mutation; patients aged ≥ 6 - ≤ 11 years (in combination with ivacaftor))
4 Aug 2022
Ivacaftor / tezacaftor / elexacaftor (new indication: cystic fibrosis; F508del mutation; heterozygous, and gating mutation; patients aged ≥ 6 - ≤ 11 years (in combination with ivacaftor))
4 Aug 2022
Ivacaftor / tezacaftor / elexacaftor (new indication: cystic fibrosis; in combination with ivacaftor, patients aged ≥ 6 - ≤ 11 years (homozygous for F508del mutation))
4 Aug 2022
Ivacaftor / tezacaftor / elexacaftor (new indication: cystic fibrosis; in combination with ivacaftor; patients aged ≥ 6 - ≤ 11 years (heterozygous for F508del and MF mutation))
4 Aug 2022
Sofosbuvir / velpatasvir (new indication: chronic hepatitis C; patients aged ≥ 3 - 6 years)
21 Jul 2022
Duvelisib (chronic lymphatic leukemia (CLL), after ≥ 2 prior therapies)

 

Please contact

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