Suspended procedures persuant to art. 35a SGB V

Onasemnogen-Abeparvovec (1) Zolgensma® AveXis Nervous system diseases Spinal muscular atrophy (SMA) suspended Orphan

Discontinued procedures persuant to art. 35a SGB V

Deutivacaftor / Tezacaftor / Vanzacaftor (1) Alyftrek® Vertex Pharmaceuticals (Germany) GmbH Metabolic diseases Cystic fibrosis, at least one non-Class I mutation, aged ≥ 6 years discontinued Orphan
Elosulfase alfa (3) Vimizim® BioMarin Deutschland Metabolic diseases Mucopolysaccharidoses (type IVA) discontinued Orphan
Iptacopan (2) Fabhalta® Novartis Pharma GmbH Genitourinary system diseases Complement-3 glomerulopathy discontinued Orphan
Bulevirtid (3) Hepcludex® Gilead Sciences GmbH Infectious diseases Hepatitis delta virus (HDV) infection, HDV RNA-positive discontinued Orphan
Bulevirtid (2) Hepcludex® Gilead Sciences GmbH Infectious diseases Hepatitis delta virus (HDV) infection, HDV RNA-positive, ≥ 3 to < 18 years, ≥ 10 kg bw discontinued Orphan
Melatonin (2) Slenyto® InfectoPharm Arzneimittel und Consilium GmbH Nervous system diseases Sleep disorders in neurogenetic diseases; ≥ 2 to ≤ 18 years of age discontinued
Brentuximab Vedotin (13) Adcetris® Takeda GmbH Oncological diseases Systemic anaplastic large cell lymphoma; first-line; combination with cyclophosphamide, doxorubicin and prednisone discontinued Orphan
Brentuximab Vedotin (8) Adcetris® Takeda GmbH Oncological diseases Hodgkin's lymphoma, CD30+, pre-treated discontinued Orphan
Brentuximab Vedotin (9) Adcetris® Takeda GmbH Oncological diseases Systemic anaplastic large cell lymphoma (sALCL) , relapsed, refractory discontinued Orphan
Brentuximab Vedotin (10) Adcetris® Takeda GmbH Oncological diseases Hodgkin's lymphoma, CD30+, increased risk of recurrence or progression after transplantation discontinued Orphan
Brentuximab Vedotin (11) Adcetris® Takeda GmbH Oncological diseases Cutaneous T-cell lymphoma, CD30+, pre-treated discontinued Orphan
Brentuximab Vedotin (12) Adcetris® Takeda GmbH Oncological diseases Hodgkin's lymphoma, CD30+, first-line, stage III + IV, in combination with doxorubicin, vinblastine and dacarbazine discontinued Orphan
Brentuximab Vedotin (7) Adcetris® Takeda GmbH Oncological diseases Hodgkin-Lymphoma (CD30+, first-line, stadium III, in combination with Doxorubicin, Vinblastin and Dacarbazin) discontinued Orphan
Idecabtagen vicleucel (2) Abecma® Bristol-Myers Squibb GmbH & Co. KGaA Oncological diseases Multiple myeloma, at least 3 previous therapies discontinued Orphan (turnover limit)
Melphalanflufenamid (2) Pepaxti® Oncopeptides AB Oncological diseases Multiple myeloma, refractory, after 2 prior therapies, combination with dexamethasone discontinued
Diroximelfumarat (1) Vumerity® Biogen GmbH Nervous system diseases Multiple Sclerosis (MS) discontinued
Belimumab (3) Benlysta® GlaxoSmithKline GmbH & Co. KG Musculoskeletal system diseases Lupus nephritis discontinued
Ceftolozan / Tazobactam (4) Zerbaxa® MSD SHARP & DOHME GMBH Infectious diseases Acute pyelonephritis discontinued
Ceftolozan / Tazobactam (3) Zerbaxa® MSD SHARP & DOHME GMBH Infectious diseases Complicated urinary tract infections discontinued
Ceftolozan / Tazobactam (2) Zerbaxa® MSD SHARP & DOHME GMBH Infectious diseases Complicated intra-abdominal infections discontinued
Ceftolozan / Tazobactam (1) Zerbaxa® MSD SHARP & DOHME GMBH Infectious diseases Ospital-acquired pneumonia, ventilator-associated pneumonia discontinued
Prasteron (1) Intrarosa® Endoceutics, Inc. Genitourinary system diseases Vulvovaginal atrophy discontinued
Ivacaftor (4) Kalydeco® Vertex Pharmaceuticals (Germany) GmbH Metabolic diseases Cystic fibrosis (CF), ≥ 12 years, combination with tezacaftor discontinued Orphan
Daratumumab (2) Darzalex® Janssen Cilag GmbH Oncological diseases Multiple myeloma (MM) discontinued Orphan
Ibrutinib (2) Imbruvica® Janssen-Cilag GmbH Oncological diseases Waldenström's disease discontinued Orphan
Bedaquilin (1) Sirturo® Janssen-Cilag GmbH Infectious diseases Multidrug-resistant pulmonary tuberculosis discontinued Orphan
Denosumab (1) Prolia, XGEVA® Amgen GmbH Musculoskeletal system diseases Osteoporosis (postmenopausal), bone loss (prostate cancer) discontinued
Dabigatranetexilat (1) Pradaxa® Boehringer Ingelheim Pharma GmbH & Co. KG Hematopoietic diseases Prevention of venous thromboembolic events after hip or knee replacement and prevention of stroke and systemic embolism discontinued
Rivaroxaban (1) Xarelto® Bayer Vital GmbH Hematopoietic diseases Prophylaxis / therapy of artherotrombotic / venothrombotic events discontinued
Saxagliptin (2) Onglyza® Bristol-Myers Squibb GmbH & Co. KGaA und AstraZeneca GmbH Metabolic diseases Diabetes mellitus type 2, monotherapy discontinued
Parathyroidhormon (1) Preotact® Takeda GmbH Musculoskeletal system diseases Osteoporosis (postmenopausal) discontinued
Retigabin (2) Trobalt® GlaxoSmithKline GmbH & Co. KG Nervous system diseases Epilepsy, focal seizures discontinued

Exempted procedures persuant to art. 35a SGB V

RdESAT-6 / rCFP-10 (1) Siiltibcy® Serum Life Science Europe GmbH Infectious diseases Other diagnostic agents exempted
Sargramostim (1) Imreplys® Partner Therapeutics Ltd n.d. Sargramostim (1) exempted
Macimorelinacetate (1) Gryvelin® Consilient Health Ltd. Other diseases Hypohysis function tests exempted
Indigocarmin (1) Indigokarmin Serb 40 mg/5 ml® SERB SA Genitourinary system diseases Other diagnostics exempted
Lutetium-(177Lu)-Oxodotreotid (1) Lutathera® Advanced Accelerator Applications Germany GmbH Oncological diseases Radiotherapy exempted Orphan
Landiololhydrochlorid (1) Rapibloc® Amomed Pharma GmbH Cardiovascular diseases Tachycardia, atrial fibrillation or atrial flutter exempted
Dinutuximab beta (1) Dinutuximab beta EUSA® EUSA Pharma (Germany) GmbH Oncological diseases Other antineoplastic agents exempted Orphan
Defibrotid (1) Defitelio® Gentium SpA Other diseases Severe hepatic veno-occlusive disease in haematopoietic stem cell transplantation exempted Orphan
Chloroprocain (1) Ampres® Meduna Arzneimittel GmbH Other diseases Spinal anaesthesia exempted
Piperaquintetraphosphat / Dihydroartemisinin (1) Eurartesim® Sigma-tau Arzneimittel GmbH Infectious diseases Antimalarial exempted
Ceftarolinfosamil (1) Zinforo® AstraZeneca GmbH Infectious diseases Beta-lactam antibiotic exempted
Dexmedetomidin (1) Dexdor® Firma Orion Corporation Other diseases Hypnotics and sedatives, parenteral exempted