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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)
21 Jul 2022
Duvelisib (follicular lymphoma, after ≥ 2 prior therapies)
21 Jul 2022
Burosumab (re-assessment, 50 M € limit exceeded: X-linked hypophosphatemia, patients aged ≥ 18 years)
21 Jul 2022
Burosumab (re-assessment, 50 M € limit exceeded: X-linked hypophosphatemia, patients aged ≥ 1 - < 18 years)
21 Jul 2022
Isoflurane (known active substance with new data exclusivity: sedation of mechanically ventilated patients during intensive care)
21 Jul 2022
Calcifediol (known active substance with new data exclusivity: secondary hyperparathyroidism in chronic renal failure)
7 Jul 2022
Remdesivir (new indication: COVID-19, patients not requiring supplemental oxygen, with increased risk of progressing to severe COVID-19)
7 Jul 2022
Amivantamab (non-small cell lung cancer (NSCLC), EGFR exon 20 insertion mutations, after platinum-based therapy)
7 Jul 2022
Abrocitinib (atopic dermatitis)
7 Jul 2022
Pembrolizumab (new indication: endometrial carcinoma, after platinum-based therapy, in combination with lenvatinib)
7 Jul 2022
Lenvatinib (new indication: endometrial carcinoma, after platinum-based therapy, in combination with pembrolizumab)
7 Jul 2022
Lenvatinib (new indication: advanced renal cell carcinoma, 1st line, in combination with pembrolizumab)
7 Jul 2022
Pembrolizumab (new indication: advanced renal cell carcinoma, 1st line, in combination with lenvatinib)
16 Jun 2022
Dapagliflozin (new indication: type 2 diabetes mellitus, patients ≥ 10 years)
16 Jun 2022
Ozanimod (new indication: ulcerative colitis, pre-treated patients)
16 Jun 2022
Zanubrutinib (Waldenström's macroglobulinemia (WM), first-line treatment for patients unsuitable for chemo-immunotherapy or patients ≥ 1 previous therapy)
16 Jun 2022
Tofacitinib (new indication: ankylosing spondylitis)
16 Jun 2022
Pralsetinib (non-small cell lung cancer (NSCLC), RET-fusion-positive advanced)
16 Jun 2022
Idecabtagen vicleucel (multiple myeloma. ≥ 3 previous therapies)
16 Jun 2022
Evolocumab (new indication: primary hypercholesterolemia, patients from ≥ 10 to < 18 years)
16 Jun 2022
Ripretinib (gastrointestinal stromal tumor (GIST), ≥ 3 previous therapies)
18 Mar 2022
Daratumumab (new scientific evidence (§ 14): newly diagnosed multiple myeloma, in combination with lenalidomide and dexamethasone for patients unsuitable for autologous stem cell transplantation)
17 Feb 2022
Nivolumab (new indication: oesophageal or gastro-oesophageal junction cancer, pretreated patients, adjuvant)
20 Jan 2022
Daratumumab (new indication: systemic light-chain amyloidosis, 1st line, in combination with cyclophosphamide, bortezomib and dexamethasone)

 

Please contact

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