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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 Dec 2022
Selpercatinib (new indication: non-small cell lung cancer (NSCLC), RET fusion-positive, 1st line)
15 Dec 2022
Palbociclib (re-assessment: breast cancer, patient population a1)
15 Dec 2022
Nirmatrelvir / ritonavir (COVID-19, patients not requiring supplemental oxygen, with increased risk of progressing to severe COVID-19)
15 Dec 2022
Cerliponase alfa (re-assessment: neuronal ceroid lipofuscinosis type 2 (CLN2 disease))
1 Dec 2022
Tisagenlecleucel (new indication: follicular lymphoma (FL), pretreated patients)
1 Dec 2022
Polatuzumab vedotin (new indication: diffuse large-cell B-cell lymphoma (DLBCL), in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (R-CHP))
1 Dec 2022
Cabozantinib (new indication: thyroid carcinoma, pretreated patients, refractory to radioactive iodine)
1 Dec 2022
Setmelanotide (obesity and the control of hunger associated with deficiency in POMC, PCSK1 or LEPR, adults and children ≥ 6 years of age)
1 Dec 2022
Enfortumab vedotin (urothelial cancer (UC), pretreated with platinum-containing chemotherapy and PD-(L)-1 inhibitor)
3 Nov 2022
Sotrovimab (COVID-19 patients aged ≥ 12 years)
3 Nov 2022
Voxelotor (hemolytic anemia due to sickle cell disease, patients aged ≥ 12 years, monotherapy or combined with hydroxycarbamide)
3 Nov 2022
Axicabtagen-Ciloleucel (re-assessment: diffuse large B-cell lymphoma (DLBCL) and primary mediastinal large B-cell lymphoma (PMBCL), ≥ 2 prior therapies)
20 Oct 2022
Nivolumab (new indication: esophageal squamous cell carcinoma, PD-L1-expression ≥ 1%, 1st line in combination with ipilimumab)
20 Oct 2022
Nivolumab (new indication: esophageal squamous cell carcinoma, PD-L1-expression ≥ 1%, 1st line in combination with platinum- and fluoropyrimidine-based chemotherapy)
20 Oct 2022
Nivolumab (new indication: urothelial carcinoma, PD-L1-expression ≥ 1%, adjuvant therapy)
20 Oct 2022
Doravirine (new indication: HIV infection, patients aged 12 to < 18 years)
20 Oct 2022
Doravirine / lamivudine / tenofovir disoproxil (new indication: HIV infection, patients aged 12 to < 18 years)
20 Oct 2022
Abemaciclib (new indication: early breast cancer, HR+, HER2- patients at high risk of recurrence in combination with endocrine therapy)
20 Oct 2022
Brolucizumab (new indication: new indication: diabetic macular edema)
20 Oct 2022
Tebentafusp (new indication: uveal melanoma HLA-A*02:01-positive adult patients)
6 Oct 2022
Anifrolumab (systemic lupus erythematosus (SLE))
6 Oct 2022
Glucarpidase (reduce toxic plasma methotrexate concentration in adults and children aged ≥ 28 days)
6 Oct 2022
Dupilumab (new indication: asthma bronchiale, patients aged ≥ 6 bis ≤ 11)
6 Oct 2022
Casirivimab / imdevimab (COVID-19 infection, patients aged ≥ 12 years)
6 Oct 2022
Casirivimab / imdevimab (post-exposure prophylaxis of COVID-19 infection, patients aged ≥ 12 years)

 

Please contact

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