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Current benefit assessments

Ongoing (preliminary decision published)
Diroximel fumarate (relapsing-remitting multiple sclerosis)
Dupilimab (new indication: prurigo nodularis)
Tremelimumab (hepatocellular carcinoma, first-line therapy, in combination with durvalumab)
Tremelimumab (non-small cell lung cancer (NSCLC) EGFR / ALK negative mutations, first line, in combination with durvalumab and platinum-based chemotherapy)
Durvalumab (hepatocellular carcinoma, first-line therapy, in combination with tremelimumab)
Durvalumab (non-small cell lung cancer (NSCLC), EGFR / ALK negative mutations, first line, in combination with tremelimumab and platinum-based chemotherapy)
Durvalumab (new indication: biliary tract cancer, first-line therapy in combination with gemcitabine and cisplatin)
Belantamab-Mafodotin (re-assessment: multiple myeloma, as monotherapy for patients with ≥ 4 therapies)
Lasmiditan (indication: acute treatment of migraine attacks)
Deucravacitinib (indication: moderate to severe plaque psoriasis)
Tabelecleucel (indication: relapsed or refractory Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV + PTLD), pretreated, ≥ 2 years of age)
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)
Completed (final decision published)
21 Sept 2023
Pitolisant (new indication: narcolepsy with our without cataplexy for patients 6 to 17 years of age)
21 Sept 2023
Dupilumab (new indication: eosinophilic esophagitis for patients ≥ 40 kg and ≥ 12 years of age)
21 Sept 2023
Dupilumab (new indication: atopic dermatitis for patients 6 months to 5 years of age)
21 Sept 2023
Luspatercept (new indication: beta-thalassemia, treatment of non-transfusion-dependent anemia)
21 Sept 2023
Dulaglutide (new indication: type 2 diabetes mellitus for patients ≥ 10 years of age)
21 Sept 2023
Olaparib (re-assessment: ovarian, fallopian tube or primary peritoneal cancer, BRCA-mutated, FIGO stages III and IV, maintenance therapy)
21 Sept 2023
Darolutamide (new indication: prostate cancer, metastatic and hormone-sensitive, in combination with docetaxel and androgen deprivation therapy)
21 Sept 2023
Esketamine (re-assessment: depression, treatment-resistant, in combination with a SSRI or SNRI)
21 Sept 2023
Rucaparib (re-assessment: ovarian, fallopian tube or primary peritoneal cancer, maintenance therapy)
17 Aug 2023
Ciltacabtagene autoleucel (multiple myeloma, patients with at least three prior therapies)
17 Aug 2023
Dapagliflozin (new indication: chronic heart failure with left ventricular ejection fraction (LVEF) > 40 %)
17 Aug 2023
Dolutegravir / abacavir / lamivudine (new indication: HIV infection; ≥ 14 kg and < 12 years of age)
17 Aug 2023
Finerenone (chronic kidney disease associated with type 2 diabetes; stage 1 and 2 with albuminuria)
17 Aug 2023
Finerenone (chronic kidney disease associated with type 2 diabetes; stage 3 and 4 with albuminuria)
17 Aug 2023
Emicizumab (new indication: moderate hemophilia A; without factor VIII inhibitors; severe bleeding phenotype)
17 Aug 2023
Voclosporin (lupus nephritis)
3 Aug 2023
Fenfluramine (new indication: Lennox-Gastaut syndrome as an add-on therapy for patients aged ≥ 2 years)
3 Aug 2023
Sotorasib (re-assessment: non-small cell lung cancer (NSCLC); KRAS G12C mutation; ≥ 1 previous therapy)
20 Jul 2023
Trastuzumab deruxtecan (new indication: breast cancer; HER2-low; pre-treated patients)
20 Jul 2023
Trastuzumab deruxtecan (new indication: gastric or gastroesophageal junction (GEJ) adenocarcinoma; HER2-positive; after a trastuzumab-based regimen)
20 Jul 2023
Ibrutinib (new indication: chronic lymphocytic leukemia (CLL); first line; in combination with venetoclax)
20 Jul 2023
Spesolimab (generalized pustular psoriasis (GPP); acute treatment)
6 Jul 2023
Olaparib (new indication: metastatic castration-resistant prostate cancer (mCRPC) in combination with abiraterone and/or prednisone for patients in whom chemotherapy is not clinically indicated)
6 Jul 2023
Maralixibat (Alagille syndrome (ALGS) patients aged ≥ 2 months)
6 Jul 2023
Lutetium (177Lu) vipivotide tetraxetan (progressive prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) for patients who have progressed after treatment with AR pathway inhibition and taxane-based chemotherapy, in combination with androgen deprivation therapy (ADT))

 

Please contact

Dr. Thomas Ecker

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