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Ongoing (preliminary decision published)

› Acalabrutinib (chronic lymphocytic leukaemia (CLL); at least one prior therapy)

Subject:

Active Substance: Acalabrutinib
Name: Calquence^®
Therapeutic area: Chronic lymphocytic leukaemia (CLL)
Pharmaceutical company: AstraZeneca GmbH

Time table:

Start: 01.12.2020
Publication of assessment: 15.03.2021
End of public hearing: 06.04.2021
Final decision by G-BA: beginning of June 2021

Comparative therapy:

a) Patients with neither 17p deletion nor TP53 mutation and who can be treated with a chemo-immunotherapy: a patient-individual therapy choosing from fludarabine in combination with cyclophosphamide and rituximab (FCR), rituximab in combination with bendamustine (BR), venetoclax in combination with rituximab, rituximab in combination with chlorambucil (ClbR); under consideration of the molecular-cytogenic characteristics of the disease, the general health status, and success and tolerance of prior therapy
b) Patients with neither 17p deletion nor TP53 mutation and who cannot be treated with chemo-immunotherapy for other reasons: ibrutinib OR idelalisib + rituximab OR best supportive care (only for patients for whom prior therapy with ibrutinib or idelalisib + rituximab failed)
c) Patients with at least 2 prior therapies: a patient-individual therapy choosing from ibrutinib, idelalisib in combination with rituximab, venetoclax in combination with rituximab, FCR, BR, ClbR, ibrutinib in combination with BR and best supportive care; under consideration of the molecular-cytogenic characteristics of the disease, the general health status, and success and tolerance of prior therapy

› Lumasiran (hyperoxaluria)

Subject:

Active Substance: Lumasiran
Name: Oxlumo^®
Therapeutic area: Hyperoxaluria
Pharmaceutical company: Alnylam Germany GmbH

Time table:

Start: 01.01.2021
Publication of assessment: 01.04.2021
End of public hearing: 22.04.2021
Final decision by G-BA: beginning of July 2021

Comparative therapy:

No comparative therapy due to orphan drug designation

› Lenvatinib (re-assessment: renal cell carcinoma)

Subject:

Active Substance: Lenvatinib
Name: Kisplyx^®
Therapeutic area: Renal cell carcinoma
Pharmaceutical company: Eisai GmbH

Time table:

Start: 01.01.2021
Publication of assessment: 01.04.2021
End of public hearing: 22.04.2021
Final decision by G-BA: beginning of July 2021

Comparative therapy:

Nivolumab or cabozantinib

› Dupilumab (new indication: atopic dermatitis, children aged 6-11 years)

Subject:

Active Substance: Dupilumab
Name: Dupixent^®
Therapeutic area: Atopic dermatitis
Pharmaceutical company: Sanofi-Aventis Deutschland GmbH

Time table:

Start: 01.01.2021
Publication of assessment: 01.04.2021
End of public hearing: 22.04.2021
Final decision by G-BA: beginning of July 2021

Comparative therapy:

A patient-individual optimized treatment regimen in dependence of the severity of the disease and under consideration of prior treatment and the following therapies and their respective authorization status: topical glucocorticoids (classes 2-3), tacrolimus (topical)

› Afamelanotide (re-assessment: erythropoietic protoporphyria)

Subject:

Active Substance: Afamelanotide
Name: Scenesse^®
Therapeutic area: Erythropoietic protoporphyria (EPP)
Pharmaceutical company: Clinuvel UK Limited

Time table:

Start: 01.01.2021
Publication of assessment: 01.04.2021
End of public hearing: 22.04.2021
Final decision by G-BA: beginning of July 2021

Comparative therapy:

No comparative therapy due to orphan drug designation

› Nivolumab (new indication: squamous oesophageal cancer; pre-treated patients)

Subject:

Active Substance: Nivolumab
Name: Opdivo^®
Therapeutic area: Squamous oesophageal cancer
Pharmaceutical company: Bristol-Myers Squibb GmbH & Co. KGaA

Time table:

Start: 01.01.2021
Publication of assessment: 01.04.2021
End of public hearing: 22.04.2021
Final decision by G-BA: beginning of July 2021

Comparative therapy:

Best supportive care

› Carfilzomib (new indication: multiple myeloma; at least 1 prior treatment; combination with daratumumab and dexamethasone)

Subject:

Active Substance: Carfilzomib
Name: Kyprolis^®
Therapeutic area: Multiple myeloma
Pharmaceutical company: Amgen GmbH

Time table:

Start: 15.01.2021
Publication of assessment: 15.04.2021
End of public hearing: 06.05.2021
Final decision by G-BA: 15.07.2021

Comparative therapy:

Bortezomib in combination with pegylated liposomal doxorubicin OR
Bortezomib in combination with dexamethasone OR
Lenalidomide in combination with dexamethasone OR
Elotuzumab in combination with lenalidomide and dexamethasone OR
Carfilzomib in combination with lenalidomide and dexamethasone OR
Carfilzomib in combination with dexamethasone OR
Daratumumab in combination with lenalidomide and dexamethasone OR
Daratumumab in combination with bortezomib and dexamethasone

› Upadacitinib (new indication: ankylosing spondylitis)

Subject:

Active Substance: Upadacitinib
Name: Rinvoq^®
Therapeutic area: Ankylosing spondylitis
Pharmaceutical company: AbbVie Deutschland GmbH & Co. KG

Time table:

Start: 01.02.2021
Publication of assessment: 03.05.2021
End of public hearing: 25.05.2021
Final decision by G-BA: middle of July 2021

Comparative therapy:

a1) Patients who have responded inadequately to conventional therapy: a TNF-alpha inhibitor (etanercept or adalimumab or infliximab or golimumab or certolizumab pegol) or a IL-17 inhibitor (secukinumab)
a2) Patients who have responded inadequately or who are intolerant to biological disease-modifying antirheumatic drugs (bDMARDs): switch to another bDMARD, i.e. a TNF-alpha inhibitor (adalimumab or certolizumab pegol or etanercept or golimumab or infliximab) or a IL-17 inhibitor (secukinumab)

› Upadacitinib (new indication: psoriatic arthritis)

Subject:

Active Substance: Upadacitinib
Name: Rinvoq^®
Therapeutic area: Psoriatic arthritis
Pharmaceutical company: AbbVie Deutschland GmbH & Co. KG

Time table:

Start: 01.02.2021
Publication of assessment: 03.05.2021
End of public hearing: 25.05.2021
Final decision by G-BA: middle of July 2021

Comparative therapy:

a1) Patients who have responded inadequately to or did not tolerate conventional disease-modifying antirheumatic drugs (DMARDs): a TNF-alpha inhibitor (adalimumab or infliximab or golimumab or certolizumab pegol or etanercept) or a IL-17 inhibitor (ixekizumab), in combination with methotrexate if indicated
a2) Patients who have responded inadequately to or did not tolerate biological disease-modifying antirheumatic drugs (bDMARDs): switch to another bDMARD (adalimumab or certolizumab pegol or etanercept or golimumab or infliximab or ixekizumab or secukinumab or ustekinumab), in combination with methotrexate if indicated

› Inclisiran (primary hypercholesterolaemia or mixed dyslipidaemia)

Subject:

Active Substance: Inclisiran
Name: Leqvio^®
Therapeutic area: Primary hypercholesterolaemia or mixed dyslipidaemia
Pharmaceutical company: Novartis Pharma GmbH

Time table:

Start: 01.02.2021
Publication of assessment: 03.05.2021
End of public hearing: 25.05.2021
Final decision by G-BA: middle of July 2021

Comparative therapy:

Patients who have not already exhausted all available dietary and medicinal lipid-lowering options: maximum tolerated medicinal treatment at the physician’s discretion under consideration of statins, inhibitors of cholesterol absorption, and bile acid sequestrants
Patients who have already exhausted all available dietary and medicinal lipid-lowering options (except for evolocumab): evolocumab or LDL-apheresis (as “ultima ratio” in treatment refractory patients), if indicated in combination with medicinal lipid-lowering treatment

› Fenfluramine (Dravet syndrome; age ≥ 2 years)

Subject:

Active Substance: Fenfluramine
Name: Fintepla^®
Therapeutic area: Dravet syndrome
Pharmaceutical company: Zogenix GmbH

Time table:

Start: 01.02.2021
Publication of assessment: 03.05.2021
End of public hearing: 25.05.2021
Final decision by G-BA: middle of July 2021

Comparative therapy:

No comparative therapy due to orphan drug designation

› Niraparib (re-assessment: ovarian, fallopian tube, or primary peritoneal cancer)

Subject:

Active Substance: Niraparib
Name: Zejula^®
Therapeutic area: Ovarian, fallopian tube, or primary peritoneal cancer
Pharmaceutical company: GlaxoSmithKline GmbH & Co. KG

Time table:

Start: 01.02.2021
Publication of assessment: 03.05.2021
End of public hearing: 25.05.2021
Final decision by G-BA: middle of July 2021

Comparative therapy:

Olaparib or watchful waiting

› Dolutegravir (new indication: HIV infection, children at the age of ≥ 4 weeks up to < 6 years)

Subject:

Active Substance: Dolutegravir
Name: Tivicay^®
Therapeutic area: HIV-1 infection
Pharmaceutical company: ViiV Healthcare GmbH

Time table:

Start: 01.02.2021
Publication of assessment: 03.05.2021
End of public hearing: 25.05.2021
Final decision by G-BA: middle of July 2021

Comparative therapy:

Therapy-naïve children: abacavir plus lamivudine or abacavir plus emtricitabine, each in combination with either
- lopinavir / ritonavir or
- raltegravir or
- nevirapine
Pre-treated children: a patient-individual antiretroviral therapy considering all approved substances; under consideration of pre-treatment(s) and reason for therapy switch, especially failure of treatment due to virological failure and accompanying resistance or adverse events

› Levofloxacin / dexamethasone (infections and inflammation associated with cataract surgery)

Subject:

Active Substance: Levofloxacin / dexamethasone
Name: Ducressa^®
Therapeutic area: Infections and inflammation associated with cataract surgery
Pharmaceutical company: Santen GmbH

Time table:

Start: 01.02.2021
Publication of assessment: 03.05.2021
End of public hearing: 25.05.2021
Final decision by G-BA: middle of July 2021

Comparative therapy:

A combination of a local antibiotic therapy (cefuroxime, polymyxin-B/neomycin/gramicidin, tobramycin*, gentamicin*, neomycin*) together with an anti-inflammatory mono or combination therapy: glucocorticoid steroid, e.g. rimexolone, dexamethasone, fluorometholone, prednisolone, loteprednol etabonate and/or NSAID, e.g. diclofenac, nepafenac, indomethacin, ketorolac

* in fix-combination with dexamethasone only

› Pertuzumab / trastuzumab (breast cancer, HER2+, early with high risk of recurrence, adjuvant)

Subject:

Active Substance: Pertuzumab / trastuzumab
Name: Phesgo^®
Therapeutic area: Breast cancer
Pharmaceutical company: Roche Pharma AG

Time table:

Start: 01.02.2021
Publication of assessment: 03.05.2021
End of public hearing: 25.05.2021
Final decision by G-BA: middle of July 2021

Comparative therapy:

A therapy regimen consisting of trastuzumab, a taxane (paclitaxel or docetaxel) and, if appropriate, an anthracycline (doxorubicin or epirubicin)

› Pertuzumab / trastuzumab (breast cancer, HER2+, locally advanced or inflammatory or early with high risk of recurrence, neo-adjuvant)

Subject:

Active Substance: Pertuzumab / trastuzumab
Name: Phesgo^®
Therapeutic area: Breast cancer
Pharmaceutical company: Roche Pharma AG

Time table:

Start: 01.02.2021
Publication of assessment: 03.05.2021
End of public hearing: 25.05.2021
Final decision by G-BA: middle of July 2021

Comparative therapy:

A therapy regimen consisting of trastuzumab, a taxane (paclitaxel or docetaxel) and, if appropriate, an anthracycline (doxorubicin or epirubicin)

› Pertuzumab / trastuzumab (breast cancer, HER2+, metastasized or with local recurrence (inoperable), 1st line, combination with docetaxel)

Subject:

Active Substance: Pertuzumab / trastuzumab
Name: Phesgo^®
Therapeutic area: Breast cancer
Pharmaceutical company: Roche Pharma AG

Time table:

Start: 01.02.2021
Publication of assessment: 03.05.2021
End of public hearing: 25.05.2021
Final decision by G-BA: middle of July 2021

Comparative therapy:

Pertuzumab in combination with trastuzumab and docetaxel

› Blinatumomab (B-precursor acute lymphoblastic leukaemia (ALL), relapsed or refractory, Ph+ CD19+)

Subject:

Active Substance: Blinatumomab
Name: Blincyto^®
Therapeutic area: B-precursor acute lymphoblastic leukaemia (ALL)
Pharmaceutical company: Amgen GmbH

Time table:

Start: 01.02.2021
Publication of assessment: 03.05.2021
End of public hearing: 25.05.2021
Final decision by G-BA: middle of July 2021

Comparative therapy:

No comparative therapy due to orphan drug designation

› Autologous anti-CD19-transduced CD3+ cells (mantle cell lymphoma (MCL), pre-treated patients)

Subject:

Active Substance: Autologous anti-CD19-transduced CD3+ cells
Name: Tecartus^®
Therapeutic area: Mantle cell lymphoma (MCL)
Pharmaceutical company: Gilead Sciences GmbH

Time table:

Start: 15.02.2021
Publication of assessment: 17.05.2021
End of public hearing: 07.06.2021
Final decision by G-BA: beginning of August 2021

Comparative therapy:

No comparative therapy due to orphan drug designation

› Baloxavir marboxil (influenza, post-exposure prophylaxis, ≥ 12 years of age)

Subject:

Active Substance: Baloxavir marboxil
Name: Xofluza^®
Therapeutic area: Influenza
Pharmaceutical company: Roche Pharma AG

Time table:

Start: 15.02.2021
Publication of assessment: 17.05.2021
End of public hearing: 07.06.2021
Final decision by G-BA: beginning of August 2021

Comparative therapy:

Without risk for complications due to influenza: watchful waiting
With risk for complications due to influenza: an antiviral therapy (oseltamivir or zanamivir)

› Baloxavir marboxil (influenza, ≥ 12 years of age)

Subject:

Active Substance: Baloxavir marboxil
Name: Xofluza^®
Therapeutic area: Influenza
Pharmaceutical company: Roche Pharma AG

Time table:

Start: 15.02.2021
Publication of assessment: 17.05.2021
End of public hearing: 07.06.2021
Final decision by G-BA: beginning of August 2021

Comparative therapy:

Without risk for complications due to influenza: a symptomatic therapy (antipyretics, anti-inflammatory drugs, analgesics)
With increased risk for a severe course of the disease: an antiviral therapy (oseltamivir or zanamivir)

› Beclometasone / formoterol / glycopyrronium bromide (obligation for benefit assessment for the first time: asthma)

Subject:

Active Substance: Beclometasone / formoterol / glycopyrronium bromide
Name: Trimbow^®
Therapeutic area: Asthma
Pharmaceutical company: Chiesi GmbH

Time table:

Start: 15.02.2021
Publication of assessment: 17.05.2021
End of public hearing: 07.06.2021
Final decision by G-BA: beginning of August 2021

Comparative therapy:

Patients who are insufficiently treated with a medium-dosed ICS / LABA therapy: a patient-individual therapy escalation under consideration of prior therapy, severity of disease and symptoms, choosing from:
- Medium-dosed ICS and LABA and LAMA or
- High-dosed ICS and LABA
Patients who are insufficiently treated with a high-dosed ICS / LABA therapy: high-dosed ICS and LABA and LAMA

› Esketamine (depression, acute short-term treatment, conbination therapy)

Subject:

Active Substance: Esketamine
Name: Spravato^®
Therapeutic area: Depression
Pharmaceutical company: Janssen-Cilag GmbH

Time table:

Start: 01.03.2021
Publication of assessment: 01.06.2021
End of public hearing: 22.06.2021
Final decision by G-BA: middle of August 2021

Comparative therapy:

Therapy at the physician's discretion under consideration of:
- crisis intervention / psychotherapy,
- medicinal acute therapy of anxiety, insommnia, psychotic symptoms, agitation
- induction of an adequate anti-depressant medication or optimization of existing therapy,
- electroconvulsive therapy

› Esketamine (depression, treatment resistant, in combination with SSRI or SNRI)

Subject:

Active Substance: Esketamine
Name: Spravato^®
Therapeutic area: Depression
Pharmaceutical company: Janssen-Cilag GmbH

Time table:

Start: 01.03.2021
Publication of assessment: 01.06.2021
End of public hearing: 22.06.2021
Final decision by G-BA: middle of August 2021

Comparative therapy:

Augmentation with lithium (1) OR
augmentation with quetiapine retard (1) OR
combination with a second antidepressant OR
change of antidepressant monotherapy to another substance class
(1) as add-on to latest antidepressant monotherapy

› Avelumab (new indication: urothelial carcinoma, 1^st line)

Subject:

Active Substance: Avelumab
Name: Bavencio^®
Therapeutic area: Urothelial carcinoma
Pharmaceutical company: Merck Serono GmbH and Pfizer Pharma GmbH

Time table:

Start: 01.03.2021
Publication of assessment: 01.06.2021
End of public hearing: 22.06.2021
Final decision by G-BA: middle of August 2021

Comparative therapy:

Best supportive care

› Selpercatinib (thyroid cancer, RET fusion+, prior treatment with sorafenib and/or lenvatinib)

Subject:

Active Substance: Selpercatinib
Name: Retsevmo^®
Therapeutic area: Thyroid cancer
Pharmaceutical company: Lilly Deutschland GmbH

Time table:

Start: 15.03.2021
Publication of assessment: 15.06.2021
End of public hearing: 06.07.2021
Final decision by G-BA: beginning of September 2021

Comparative therapy:

a) Patients with an advanced, differentiated thyroid cancer (RET+, systemic therapy indicated, prior treatment with sorafenib and/or lenvatinib): Best supportive care
b) Patients with an advanced, anaplastic thyroid cancer (RET+, systemic therapy indicated, prior treatment with sorafenib and/or lenvatinib): Best supportive care

› Selpercatinib (medullary thyroid cancer, RET-mutated, prior treatment with cabozantinib and/or vandetanib, patients aged ≥ 12 years)

Subject:

Active Substance: Selpercatinib
Name: Retsevmo^®
Therapeutic area: Thyroid cancer
Pharmaceutical company: Lilly Deutschland GmbH

Time table:

Start: 15.03.2021
Publication of assessment: 15.06.2021
End of public hearing: 06.07.2021
Final decision by G-BA: beginning of September 2021

Comparative therapy:

Best supportive care

› Selpercatinib (NSCLC, RET fusion+, prior treatment with platinum-based chemo- and/or immunotherapy)

Subject:

Active Substance: Selpercatinib
Name: Retsevmo^®
Therapeutic area: NSCLC
Pharmaceutical company: Lilly Deutschland GmbH

Time table:

Start: 15.03.2021
Publication of assessment: 15.06.2021
End of public hearing: 06.07.2021
Final decision by G-BA: beginning of September 2021

Comparative therapy:

a) After first-line therapy with a PD-1/PD-L1 antibody as monotherapy:
- Cisplatin in combination with a third generation cytostatic drug (vinorelbine or gemcitabine or docetaxel or paclitaxel or pemetrexed (except for mostly squamous epithelial histology) OR
- Carboplatin in combination with a third generation cytostatic drug (vinorelbine or gemcitabine or docetaxel or paclitaxel or pemetrexed (except for mostly squamous epithelial histology) (see appendix VI, section K of AM-RL) OR
- Carboplatin in combination wit nab-paclitaxel OR
- Monotherapy with gemcitabine or vinorelbine (as alternative to platin-based combination therapy only for patients with ECOG performance status 2)
b) After first-line therapy with a cytotoxic chemotherapy:
- Docetaxel (only for patients with PD-L1 negative tumors) OR
- Pemetrexed (only for patients with PD-L1 negative tumors but except for mostly squamous epithelial histology) OR
- Nivolumab OR
- Pembrolizumab (only for patients with PD-L1 expressing tumors (TPS ≥ 1 %)) OR
- Atezolizumab OR
- Docetaxel in combination with nintedanib (only for patients with PD-L1 negative tumors and adenocarcinoma histology)
c) After first-line therapy with a PD-1/PD-L1 antibody in combination with a platin-based chemotherapy or after sequential therapy with a PD-1/PD-l1 antibody and a platin-based chemotherapy:
Patient-individual therapy under consideration of prior therapy and histology, choosing from: afatinib, pemetrexed, erlotinib, docetaxel, docetaxel in combination with ramucirumab, docetaxel in combination with nintedanib, and vinorelbine

› Tucatinib (breast cancer, HER2+, ≥ 2 prior therapies, combination with trastuzumab and capecitabine)

Subject:

Active Substance: Tucatinib
Name: Tukysa^®
Therapeutic area: Breast cancer
Pharmaceutical company: Seagen Germany GmbH

Time table:

Start: 15.03.2021
Publication of assessment: 15.06.2021
End of public hearing: 06.07.2021
Final decision by G-BA: beginning of September 2021

Comparative therapy:

Lapatinib in combination with capecitabine OR
Lapatinib in combination with trastuzumab (only for patients with hormone receptor negative breast cancer)

› Fedratinib (myelofibrosis)

Subject:

Active Substance: Fedratinib
Name: Inrebic^®
Therapeutic area: Chronic myeloproliferative diseases
Pharmaceutical company: Celgene GmbH

Time table:

Start: 15.03.2021
Publication of assessment: 15.06.2021
End of public hearing: 06.07.2021
Final decision by G-BA: beginning of September 2021

Comparative therapy:

No comparative therapy due to orphan drug designation

› Imlifidase (desensitization treatment of kidney transplant patients)

Subject:

Active Substance: Imlifidase
Name: Idefirix^®
Therapeutic area: Desensitization of kidney transplant
Pharmaceutical company: Hansa Biopharma AB

Time table:

Start: 15.03.2021
Publication of assessment: 15.06.2021
End of public hearing: 06.07.2021
Final decision by G-BA: beginning of September 2021

Comparative therapy:

No comparative therapy due to orphan drug designation

Completed (final decision published)

› 03.06.2021: Olaparib (new indication: ovarian, fallopian tube, or primary peritoneal cancer, FIGO stages III + IV, HRD-positive, maintenance therapy, combination with bevacizumab)

Subject:

Active Substance: Olaparib
Name: Lynparza^®
Therapeutic area: Ovarian cancer
Pharmaceutical company: AstraZeneca GmbH

Time table:

Start: 01.12.2020
Final decision by G-BA: 03.06.2021
This decision remains valid until: 01.10.2022

Final decision:

No additional benefit proved

› 03.06.2021: Olaparib (new indication: prostate cancer, BRCA 1/2 mutations, progress after hormonal treatment)

Subject:

Active Substance: Olaparib
Name: Lynparza^®
Therapeutic area: Prostate cancer
Pharmaceutical company: AstraZeneca GmbH

Time table:

Start: 01.12.2020
Final decision by G-BA: 03.06.2021

Final decision:

Hint for a considerable additional benefit

› 03.06.2021: Olaparib (new indication: pancreatic cancer, BRCA 1/2 mutations, maintenance therapy)

Subject:

Active Substance: Olaparib
Name: Lynparza^®
Therapeutic area: Pancreatic cancer
Pharmaceutical company: AstraZeneca GmbH

Time table:

Start: 01.12.2020
Final decision by G-BA: 03.06.2021

Final decision:

No additional benefit proved

› 03.06.2021: Acalabrutinib (chronic lymphocytic leukaemia (CLL); combination with obinutuzumab, 1^st line)

Subject:

Active Substance: Acalabrutinib
Name: Calquence^®
Therapeutic area: Chronic lymphocytic leukaemia (CLL)
Pharmaceutical company: AstraZeneca GmbH

Time table:

Start: 01.12.2020
Final decision by G-BA: 03.06.2021

Final decision:

a) Patients with neither 17p deletion nor TP53 mutation and who can be treated with fludarabine in combination with cyclophosphamide and rituximab (FCR): no additional benefit proved
b) Patients with neither 17p deletion nor TP53 mutation and who cannot be treated with FCR: hint for a minor additional benefit
c) Patients with 17p deletion or TP53 mutation or who cannot be treated with chemotherapy due to other reasons: no additional benefit proved

› 03.06.2021: Acalabrutinib (chronic lymphocytic leukaemia (CLL); monotherapy, 1^st line)

Subject:

Active Substance: Acalabrutinib
Name: Calquence^®
Therapeutic area: Chronic lymphocytic leukaemia (CLL)
Pharmaceutical company: AstraZeneca GmbH

Time table:

Start: 01.12.2020
Final decision by G-BA: 03.06.2021

Final decision:

a) Patients with neither 17p deletion nor TP53 mutation and who can be treated with fludarabine in combination with cyclophosphamide and rituximab (FCR): no additional benefit proved
b) Patients with neither 17p deletion nor TP53 mutation and who cannot be treated with FCR: hint for a minor additional benefit
c) Patients with 17p deletion or TP53 mutation or who cannot be treated with chemotherapy due to other reasons: no additional benefit proved

› 03.06.2021: Sucroferric oxyhydroxide (new indication: control of blood-phosphate levels in patients with chronic kidney disease, aged ≥ 2 – 18 years)

Subject:

Active Substance: Sucroferric oxyhydroxide
Name: Velphoro^®
Therapeutic area: To control blood-phosphate levels in patients with chronic kidney disease
Pharmaceutical company: Fresenius Medical Care Deutschland GmbH

Time table:

Start: 15.12.2020
Final decision by G-BA: 03.06.2021

Final decision:

No additional benefit proved

› 03.06.2021: Perampanel (new indication: epilepsy, primary generalised seizures, patients aged 7 – < 12 years)

Subject:

Active Substance: Perampanel
Name: Fycompa^®
Therapeutic area: Epilepsy
Pharmaceutical company: Eisai GmbH

Time table:

Start: 15.12.2020
Final decision by G-BA: 03.06.2021

Final decision:

No additional benefit proved

› 03.06.2021: Perampanel (new indication: epilepsy, partial seizures, patients aged 4 – < 12 years)

Subject:

Active Substance: Perampanel
Name: Fycompa^®
Therapeutic area: Epilepsy
Pharmaceutical company: Eisai GmbH

Time table:

Start: 15.12.2020
Final decision by G-BA: 03.06.2021

Final decision:

No additional benefit proved

› 03.06.2021: Nivolumab (new indication: non-small cell lung cancer (NSCLC), combination with ipilimumab and platinum-based chemotherapy, 1^st line)

Subject:

Active Substance: Nivolumab
Name: Opdivo^®
Therapeutic area: Non-small cell lung cancer (NSCLC)
Pharmaceutical company: Bristol-Myers Squibb Pharma EEIG

Time table:

Start: 15.12.2020
Final decision by G-BA: 03.06.2021

Final decision:

Patients with a Tumor Proportion Score [TPS] ≥ 50 % (PD-L1 expression): no additional benefit proved
Patients with a Tumor Proportion Score [TPS] < 50 % (PD-L1 expression): indication for a minor additional benefit

› 03.06.2021: Ipilimumab (new indication: non-small cell lung cancer (NSCLC), combination with nivolumab and platinum-based chemotherapy, 1^st line)

Subject:

Active Substance: Ipilimumab
Name: Yervoy^®
Therapeutic area: Non-small cell lung cancer (NSCLC)
Pharmaceutical company: Bristol-Myers Squibb Pharma EEIG

Time table:

Start: 15.12.2020
Final decision by G-BA: 03.06.2021

Final decision:

Patients with a Tumor Proportion Score [TPS] ≥ 50 % (PD-L1 expression): no additional benefit proved
Patients with a Tumor Proportion Score [TPS] < 50 % (PD-L1 expression): indication for a minor additional benefit proved

› 03.06.2021: Sebelipase alfa (re-assessment: lysosomal acid lipase deficiency)

Subject:

Active Substance: Sebelipase alfa
Name: Kanuma^®
Therapeutic area: Lysosomal acid lipase (LAL) deficiency
Pharmaceutical company: Alexion Pharma Germany GmbH

Time table:

Start: 01.12.2020
Final decision by G-BA: 03.06.2021

Final decision:

Patients with rapidly progressing LAL deficiency during infancy (≥ 6 months): hint for a non-quantifiable additional benefit (orphan drug designation)
Patients with LAL deficiency not already rapidly progressing during infancy (< 6 months): hint for a non-quantifiable additional benefit (orphan drug designation)

› 20.05.2021: Guselkumab (new indication: psoriatic arthritis)

Subject:

Active Substance: Guselkumab
Name: Tremfya^®
Therapeutic area: Psoriatic arthritis
Pharmaceutical company: Janssen-Cilag GmbH

Time table:

Start: 01.12.2020
Final decision by G-BA: 20.05.2021

Final decision:

Patients who have responded insufficiently to or have not tolerated prior disease-modifying antirheumatic drug (DMARD) therapy: no additional benefit proved
Patients who have responded insufficiently to or have not tolerated prior biological DMARD (bDMARD) therapy: no additional benefit proved

› 20.05.2021: Nusinersen (re-assessment, 50 Mio. € limit exceeded: spinal muscular atrophy)

Subject:

Active Substance: Nusinersen
Name: Spinraza^®
Therapeutic area: Spinal muscular atrophy (SMA)
Pharmaceutical company: Biogen GmbH

Time table:

Start: 01.12.2020
Final decision by G-BA: 20.05.2021

Final decision:

a) Type 1: indication for a major additional benefit
b) Type 2: hint for a considerable additional benefit
c) Type 3/4: no additional benefit proved
d1) Pre-symptomatic and 2 SMN2 gene copies: hint for a major addiitional benefit
d2) Pre-symptomatic and 3 SMN2 gene copies: hint for a non-quantifiable addiitional benefit
d3) Pre-symptomatic and more than 3 SMN2 gene copies: no additional benefit proved

› 20.05.2021: Tezacaftor / ivacaftor (new indication: cystic fibrosis, in combination with ivacaftor, patients aged 6 to < 12 years (heterozygous for F508del and CF mutation))

Subject:

Active Substance: Tezacaftor / ivacaftor
Name: Symkevi^®
Therapeutic area: Cystic fibrosis
Pharmaceutical company: Vertex Pharmaceuticals (Ireland) Limited

Time table:

Start: 01.12.2020
Final decision by G-BA: 20.05.2021

Final decision:

No additional benefit proved

› 20.05.2021: Tezacaftor / ivacaftor (new indication: cystic fibrosis, in combination with ivacaftor, patients aged 6 to < 12 years (homozygous for F508del and CF mutation))

Subject:

Active Substance: Tezacaftor / ivacaftor
Name: Symkevi^®
Therapeutic area: Cystic fibrosis
Pharmaceutical company: Vertex Pharmaceuticals (Ireland) Limited

Time table:

Start: 01.12.2020
Final decision by G-BA: 20.05.2021

Final decision:

No additional benefit proved

› 20.05.2021: Tafamidis (re-assessment, 50 Mio. € limit exceeded: amyloidosis with cardiomyopathy)

Subject:

Active Substance: Tafamidis
Name: Vyndaqel^®
Therapeutic area: Amyloidosis
Pharmaceutical company: Pfizer Pharma GmbH

Time table:

Start: 01.12.2020
Final decision by G-BA: 20.05.2021

Final decision:

Indication for a considerable additional benefit

› 20.05.2021: Tafamidis (re-assessment, 50 Mio. € limit exceeded: amyloidosis with polyneuropathy)

Subject:

Active Substance: Tafamidis
Name: Vyndaqel^®
Therapeutic area: Amyloidosis
Pharmaceutical company: Pfizer Pharma GmbH

Time table:

Start: 01.12.2020
Final decision by G-BA: 20.05.2021

Final decision:

No additional benefit proved

› 20.05.2021: Niraparib (new indication: ovarian, fallopian tube, or primary peritoneal cancer, FIGO stage III and IV, maintenance therapy)

Subject:

Active Substance: Niraparib
Name: Zejula^®
Therapeutic area: Ovarian, fallopian tube, or peritoneal cancer
Pharmaceutical company: GlaxoSmithKline GmbH & Co. KG

Time table:

Start: 01.12.2020
Final decision by G-BA: 20.05.2021

Final decision:

No additional benefit proved

› 20.05.2021: Ivacaftor (new indication: cystic fibrosis, in combination with tezacaftor/ ivacaftor, patients aged 6 to < 12 years (heterozygous for F508del and RF mutation))

Subject:

Active Substance: Ivacaftor
Name: Kalydeco^®
Therapeutic area: Cystic fibrosis
Pharmaceutical company: Vertex Pharmaceuticals (Ireland) Limited

Time table:

Start: 01.12.2020
Final decision by G-BA: 20.05.2021

Final decision:

No additional benefit proved

› 20.05.2021: Ivacaftor (new indication: cystic fibrosis, in combination with tezacaftor/ ivacaftor, patients aged 6 to < 12 years (homozygous for F508del and RF mutation))

Subject:

Active Substance: Ivacaftor
Name: Kalydeco^®
Therapeutic area: Cystic fibrosis
Pharmaceutical company: Vertex Pharmaceuticals (Ireland) Limited

Time table:

Start: 01.12.2020
Final decision by G-BA: 20.05.2021

Final decision:

No additional benefit proved

› 20.05.2021: Ivacaftor (new indication: cystic fibrosis, patients aged 4 to < 6 months, R117H mutation)

Subject:

Active Substance: Ivacaftor
Name: Kalydeco^®
Therapeutic area: Cystic fibrosis
Pharmaceutical company: Vertex Pharmaceuticals (Ireland) Limited

Time table:

Start: 01.12.2020
Final decision by G-BA: 20.05.2021

Final decision:

Hint for a non-quantifiable additional benefit

› 20.05.2021: Ivacaftor (new indication: cystic fibrosis, patients aged 4 to < 6 months, gating mutations)

Subject:

Active Substance: Ivacaftor
Name: Kalydeco^®
Therapeutic area: Cystic fibrosis
Pharmaceutical company: Vertex Pharmaceuticals (Ireland) Limited

Time table:

Start: 01.12.2020
Final decision by G-BA: 20.05.2021

Final decision:

Hint for a non-quantifiable additional benefit

› 20.05.2021: Dapagliflozin (new indication: chronic heart failure)

Subject:

Active Substance: Dapagliflozin
Name: Forxiga^®
Therapeutic area: Heart failure
Pharmaceutical company: AstraZeneca GmbH

Time table:

Start: 01.12.2020
Final decision by G-BA: 20.05.2021

Final decision:

Hint for a considerable additional benefit

› 20.05.2021: Crizanlizumab (prevention of recurrent vaso-occlusive crises in sickle cell disease, patients aged ≥ 16 years)

Subject:

Active Substance: Crizanlizumab
Name: Adakevo^®
Therapeutic area: Sickle cell disease
Pharmaceutical company: Novartis Pharma GmbH

Time table:

Start: 01.12.2020
Final decision by G-BA: 20.05.2021
This decision remains valid until: 01.12.2025

Final decision:

Hint for a minor additional benefit

› 20.05.2021: Atezolizumab (new indication: hepatocellular carcinoma, in combination with bevacizumab)

Subject:

Active Substance: Atezolizumab
Name: Tecentriq^®
Therapeutic area: Hepatocellular carcinoma (HCC)
Pharmaceutical company: Roche Pharma AG

Time table:

Start: 01.12.2020
Final decision by G-BA: 20.05.2021

Final decision:

a) Patients with HCC with Child-Pugh A or no liver cirrhosis without prior systemic therapy: indication for a considerable additional benefit
b) Patients with HCC with Child-Pugh B without prior systemic therapy: no additional benefit proved

› 20.05.2021: Amikacin sulfate (liposomal) (lung infection caused by Mycobacterium avium Complex (MAC))

Subject:

Active Substance: Amikacin sulfate
Name: Arikayce liposomal^®
Therapeutic area: MAC lung infection
Pharmaceutical company: Insmed Germany GmbH

Time table:

Start: 01.12.2020
Final decision by G-BA: 20.05.2021

Final decision:

Hint for a non-quantifiable additional benefit (orphan drug designation)

› 06.05.2021: Eszopiclone (insomnia)

Subject:

Active Substance: Eszopiclone
Name: Lunivia^®
Therapeutic area: Insomnia
Pharmaceutical company: Henning Arzneimittel GmbH & Co. KG

Time table:

Start: 15.02.2021
Final decision by G-BA: beginning of August 2021

Final decision:

No additional benefit proved since there has not been submitted any dossier. The drug is subject to reference pricing.

› 06.05.2021: Baricitinib (new indication: atopic dermatitis)

Subject:

Active Substance: Baricitinib
Name: Olumiant^®
Therapeutic area: Atopic dermatitis
Pharmaceutical company: Lilly Deutschland GmbH

Time table:

Start: 15.11.2020
Final decision by G-BA: 06.05.2021

Final decision:

No additional benefit proved

› 15.04.2021: Filgotinib (rheumatoid arthritis)

Subject:

Active Substance: Filgotinib
Name: Jyseleca^®
Therapeutic area: Rheumatoid arthritis
Pharmaceutical company: Gilead Sciences GmbH

Time table:

Start: 15.10.2020
Final decision by G-BA: 15.04.2021

Final decision:

a1) Patients without unfavourable prognostic factors and who have responded insufficiently or did not tolerate prior treatment with a disease-modifying agent (classical DMARDs, incl. methotrexate (MTX)): no additional benefit proved
a2) Patients without unfavourable prognostic factors and who have responded insufficiently or did not tolerate prior treatment with a disease-modifying agent (classical DMARDs, incl. MTX); filgotinib as in combination with MTX: no additional benefit proved
b1) Patients for whom treatment with biological DMARDs (bDMARDs) or targeted synthetic DMARDs (tsDMARDs) is indicated for the first time; filgotinib as monotherapy: no additional benefit proved
b2) Patients for whom treatment with bDMARDs or tsDMARDs is indicated for the first time; filgotinib in combination with MTX: hint for a minor additional benefit
c1) Patients who have responded insufficiently or did not tolerate prior treatment with one or several bDMARDs and/or tsDMARDs; filgotinib as monotherapy: no additional benefit proved
c2) Patients who have responded insufficiently or did not tolerate prior treatment with one or several bDMARDs and/or tsDMARDs; filgotinib in combination with MTX: no additional benefit proved

› 15.04.2021: Cannabidiol (reassessment: Dravet syndrome, patients ≥ 2 years of age, in combination with clobazam)

Subject:

Active Substance: Cannabidiol
Name: Epidyolex^®
Therapeutic area: Dravet syndrome
Pharmaceutical company: GW Pharmaceuticals plc

Time table:

Start: 15.10.2020
Final decision by G-BA: 15.04.2021

Final decision:

Hint for a considerable additional benefit (orphan drug designation)

› 15.04.2021: Cannabidiol (reassessment: Lennox-Gastaut syndrome, patients ≥ 2 years of age, in combination with clobazam)

Subject:

Active Substance: Cannabidiol
Name: Epidyolex^®
Therapeutic area: Lennox-Gastaut syndrome
Pharmaceutical company: GW Pharmaceuticals plc

Time table:

Start: 15.10.2020
Final decision by G-BA: 15.04.2021

Final decision:

Hint for a considerable additional benefit (orphan drug designation)

› 15.04.2021: Semaglutide (new scientific evidence (§13): diabetes mellitus type 2)

Subject:

Active Substance: Semaglutide
Name: Rybelsus^® / Ozempic^®
Therapeutic area: Diabetes mellitus type 2
Pharmaceutical company: Novo Nordisk Pharma GmbH

Time table:

Start: 01.11.2020
Final decision by G-BA: 15.04.2021

Final decision:

a) monotherapy:
- a1) patients with high CV risk: no additional benefit proved)
- a2) patients without high CV risk: no additional benefit proved
b) in combination with another antidiabetic (except for insulin, here: metformin):
- b1) patients with high CV risk: no additional benefit proved
- b2) patients without high CV risk: no additional benefit proved
c) in combination with two other antidiabetics (except for insulin):
- c1) patients with high cardiovascular risk: no additional benefit proved
- c2) patients without high CV risk: no additional benefit proved
d) in combination with insulin (with or w/o metformin or empagliflozin* or liraglutide*, if appropriate):
- d1) patients with high CV risk: no additional benefit proved
- d2) patients without high CV risk: no additional benefit proved

› 15.04.2021: Bempedoic acid / ezetimibe (primary hypercholersterolaemia and mixed dyslipidaemia)

Subject:

Active Substance: Bempedoic acid / ezetimibe
Name: Nustendi^®
Therapeutic area: Primary hypercholesterolaemia and mixed dyslipidaemia
Pharmaceutical company: Daiichi Sankyo Deutschland GmbH

Time table:

Start: 01.11.2020
Final decision by G-BA: 15.04.2021

Final decision:

a) Patients whose maximum tolerated lipid-lowering medicinal and dietary options have not been exhausted yet: no additional benefit proved
b) Patients whose maximum tolerated lipid-lowering medicinal (except of evolocumab) and dietary options have already been exhausted:
no additional benefit proved

› 15.04.2021: Bempedoic acid (primary hypercholersterolaemia and mixed dyslipidaemia)

Subject:

Active Substance: Bempedoic acid
Name: Nilemdo^®
Therapeutic area: Primary hypercholesterolaemia and mixed dyslipidaemia
Pharmaceutical company: Daiichi Sankyo Deutschland GmbH

Time table:

Start: 01.11.2020
Final decision by G-BA: 15.04.2021

Final decision:

a) Patients whose maximum tolerated lipid-lowering medicinal and dietary options have not been exhausted yet: no additional benefit proved
b) Patients whose maximum tolerated lipid-lowering medicinal (except of evolocumab) and dietary options have already been exhausted:
no additional benefit proved

› 15.04.2021: Burosumab (new indication: X-linked hypophosphataemia, ≥ 18 years of age)

Subject:

Active Substance: Burosumab
Name: Crysvita^®
Therapeutic area: Hypophosphataemia
Pharmaceutical company: Kyowa Kirin GmbH

Time table:

Start: 01.11.2020
Final decision by G-BA: 15.04.2021

Final decision:

Hint for a minor additional benefit (orphan drug designation)

› 15.04.2021: Avapritinib (gastrointestinal stromal tumors (GIST))

Subject:

Active Substance: Avapritinib
Name: Ayvakyt^®
Therapeutic area: Gastrointestinal stromal tumors (GIST)
Pharmaceutical company: Blueprint Medicines (Germany) GmbH

Time table:

Start: 01.11.2020
Final decision by G-BA: 15.04.2021

Final decision:

Hint for a non-quantifiable additional benefit (orphan drug designation)

› 01.04.2021: Ibrutinib (new indication: chronic lymphatic leukemia (CLL), 1^st line, combination with rituximab)

Subject:

Active Substance: Ibrutinib
Name: Imbruvica^®
Therapeutic area: Chronic lymphatic leukemia (CLL)
Pharmaceutical company: Janssen-Cilag GmbH

Time table:

Start: 01.10.2020
Final decision by G-BA: 01.04.2021
This decision remains valid until: 01.04.2024

Final decision:

a) Patients who can be treated with fludarabine in combination with cyclophosphamide and rituximab (FCR): hint for a considerable additional benefit
b) Patients who cannot be treated with FCR: no additional benefit proved
c) Patients with 17p-deletion and/or T53-mutation or for whom a chemoimmunotherapy is not indicated due to other reasons: no additional benefit proved

› 01.04.2021: Durvalumab (new indication: small-cell lung cancer (SCLC), 1^st line, combination with etoposide and either carboplatin or cisplatin

Subject:

Active Substance: Durvalumab
Name: Imfinzi^®
Therapeutic area: Small-cell lung cancer (SCLC)
Pharmaceutical company: AstraZeneca GmbH

Time table:

Start: 01.10.2020
Final decision by G-BA: 01.04.2021

Final decision:

Hint for a minor additional benefit

› 01.04.2021: Sofosbuvir / velpatasvir (new indication: chronic hepatitis C, patients aged ≥ 6 and < 18 years)

Subject:

Active Substance: Sofosbuvir / velpatasvir
Name: Epclusa^®
Therapeutic area: Chronic hepatitis C
Pharmaceutical company: Gilead Sciences GmbH

Time table:

Start: 01.10.2020
Final decision by G-BA: 01.04.2021

Final decision:

a) Patients aged 6 up to < 12 years (genotype 1, 4, 5, or 6): no additional benefit proved
b) Patients aged 6 up to < 12 years (genotype 2 or 3): no additional benefit proved
c) Patients aged 12 up to < 18 years (genotype 1, 4, 5, or 6): no additional benefit proved
d) Patients aged 12 up to < 18 years (genotype 2 or 3): no additional benefit proved

› 04.03.2021: Belantamab mafodotin (multiple myeloma, at least 4 prior therapies, monotherapy)

Subject:

Active Substance: Belantamap mafodotin
Name: Blenrep^®
Therapeutic area: Multiple myeloma
Pharmaceutical company: GlaxoSmithKline GmbH & Co. KG

Time table:

Start: 15.09.2020
Final decision by G-BA: 04.03.2021
This decision remains valid until: 01.09.2022

Final decision:

Hint for a non-quantifiable additional benefit (orphan drug)

› 18.02.2021: Alpelisib (breast cancer, PIK3CA-mutation, pre-treated patients, combination with fulvestrant)

Subject:

Active Substance: Alpelisib
Name: Piqray^®
Therapeutic area: Breast cancer
Pharmaceutical company: Novartis Pharma GmbH

Time table:

Start: 01.09.2020
Final decision by G-BA: 18.02.2021

Final decision:

A1) Postmenopausal women with progress after (neo)adjuvant endocrine monotherapy without lung or liver metastasis: Indication for less benefit
A2) Postmenopausal women with progress after (neo)adjuvant endocrine monotherapy without lung or liver metastasis: No additional benefit proved
A2) Men with progress after (neo)adjuvant endocrine monotherapy: No additional benefit proved
B1) Postmenopausal women with progress after endocrine monotherapy in locally advanced setting or metastasized stage: Indication for less benefit
B2) Men with progress after endocrine monotherapy in locally advanced setting or metastasized stage: No additional benefit proved

› 18.02.2021: Bulevirtide (chronic hepatitis delta virus (HDV) infection, HDV-RNA-positive)

Subject:

Active Substance: Bulevirtide
Name: Hepcludex^®
Therapeutic area: Chronic hepatitis D
Pharmaceutical company: MYR GmbH

Time table:

Start: 01.09.2020
Final decision by G-BA: 18.02.2021
The decision remains valid until: 01.06.2025

Final decision:

Hint for a non-quantifiable additional benefit (orphan drug)

› 18.02.2021: Ivacaftor / tezacaftor / elexacaftor (cystic fibrosis, combination with ivacaftor for patients aged ≥ 12 years (heterozygous for F508del and MF mutation)

Subject:

Active Substance: Ivacaftor / tezacaftor / elexacaftor
Name: Kaftrio^®
Therapeutic area: Cystic fibrosis
Pharmaceutical company: Vertex Pharmaceuticals

Time table:

Start: 01.09.2020
Final decision by G-BA: 18.02.2021

Final decision:

Hint for a major additional benefit

› 18.02.2021: Ivacaftor / tezacaftor / elexacaftor (cystic fibrosis, combination with ivacaftor for patients aged ≥ 12 years (homozygous for F508del and MF mutation)

Subject:

Active Substance: Ivacaftor / tezacaftor / elexacaftor
Name: Kaftrio^®
Therapeutic area: Cystic fibrosis
Pharmaceutical company: Vertex Pharmaceuticals

Time table:

Start: 01.09.2020
Final decision by G-BA: 18.02.2021

Final decision:

Indication for a major additional benefit

› 18.02.2021: Ivacaftor (cystic fibrosis, combination with ivacaftor / tezacaftor / elexacaftor for patients aged ≥ 12 years (heterozygous for F508del and MF mutation)

Subject:

Active Substance: Ivacaftor
Name: Kalydeco^®
Therapeutic area: Cystic fibrosis
Pharmaceutical company: Vertex Pharmaceuticals

Time table:

Start: 01.09.2020
Final decision by G-BA: 18.02.2021

Final decision:

Hint for a major additional benefit

› 18.02.2021: Ivacaftor (cystic fibrosis, combination with ivacaftor / tezacaftor / elexacaftor for patients aged ≥ 12 years (homozygous for F508del and MF mutation)

Subject:

Active Substance: Ivacaftor
Name: Kalydeco^®
Therapeutic area: Cystic fibrosis
Pharmaceutical company: Vertex Pharmaceuticals

Time table:

Start: 01.09.2020
Final decision by G-BA: 18.02.2021

Final decision:

Indication for a major additional benefit

› 18.02.2021: Entrectinib (NSCLC, ROS1-positive, advanced, 1^st line)

Subject:

Active Substance: Entrectinib
Name: Rozlytrek^®
Therapeutic area: Non-small cell lung cancer (NSCLC)
Pharmaceutical company: Roche Pharma AG

Time table:

Start: 01.09.2020
Final decision by G-BA: 18.02.2021
This decision remains valid until: 31.12.2027

Final decision:

No additional benefit proved

› 18.02.2021: Entrectinib (solid tumors, neurotrophin tyrosine receptor kinase (NTRK) gene fusion, histology-independent)

Subject:

Active Substance: Entrectinib
Name: Rozlytrek^®
Therapeutic area: Tumors with neurotrophin tyrosine receptor kinase (NTRK) gene fusion
Pharmaceutical company: Roche Pharma AG

Time table:

Start: 01.09.2020
Final decision by G-BA: 18.02.2021

Final decision:

No additional benefit proved

› 18.02.2021: Ibalizumab (multi-resistant HIV infection)

Subject:

Active Substance: Ibalizumab
Name: Trogarzo^®
Therapeutic area: HIV infection
Pharmaceutical company: Theratechnologies Europe limited

Time table:

Start: 01.09.2020
Final decision by G-BA: 18.02.2021

Final decision:

No additional benefit proved

› 18.02.2021: Secukinumab (new scientific evidence (§14): psoriatic arthritis)

Subject:

Active Substance: Secukinumab
Name: Cosentyx^®
Therapeutic area: Psoriatic arthritis
Pharmaceutical company: Novartis Pharma GmbH

Time table:

Start: 01.09.2020
Final decision by G-BA: 18.02.2021

Final decision:

A1) Patients who did not benefit sufficiently from or who did not tolerate a previous DMARD therapy with concurrent moderate to severe plaque psoriasis: Indication for a minor additional benefit
A2) Patients who did not benefit sufficiently from or who did not tolerate a previous DMARD therapy without concurrent moderate to severe plaque psoriasis: No additional benefit proved
B) Patients who did not benefit sufficiently from or who did not tolerate a previous bDMARD therapy: No additional benefit proved

› 18.02.2021: Secukinumab (new indication: Plaque psoriasis, patients aged > 6 years)

Subject:

Active Substance: Secukinumab
Name: Cosentyx^®
Therapeutic area: Plaque psoriasis
Pharmaceutical company: Novartis Pharma GmbH

Time table:

Start: 01.09.2020
Final decision by G-BA: 18.02.2021

Final decision:

Hint for a minor additional benefit

› 18.02.2021: Secukinumab (new indication: axial spondyloarthritis)

Subject:

Active Substance: Secukinumab
Name: Cosentyx^®
Therapeutic area: Axial spondyloarthritis
Pharmaceutical company: Novartis Pharma GmbH

Time table:

Start: 01.09.2020
Final decision by G-BA: 18.02.2021

Final decision:

No additional benefit proved

› 04.02.2021: Nintedanib (new indication: systemic sclerosis associated interstitial lung disease (SSc-ILD))

Subject:

Active Substance: Nintedanib
Name: Ofev^®
Therapeutic area: Systemic sclerosis associated interstitial lung disease (SSc-ILD)
Pharmaceutical company: Boehringer Ingelheim Pharma GmbH & Co. KG

Time table:

Start: 15.08.2020
Final decision by G-BA: 04.02.2021

Final decision:

No additional benefit proved (orphan drug, 50 M € sales exceeded)

› 04.02.2021: Nintedanib (new indication: chronic fibrosing interstitial lung disease (ILD) with progressive phenotype)

Subject:

Active Substance: Nintedanib
Name: Ofev^®
Therapeutic area: Chronic fibrosing interstitial lung disease (ILD) with progressive phenotype
Pharmaceutical company: Boehringer Ingelheim Pharma GmbH & Co. KG

Time table:

Start: 15.08.2020
Final decision by G-BA: 04.02.2021

Final decision:

Hint for a minor additional benefit (orphan drug, 50 M € sales exceeded)

› 04.02.2021: Trifarotene (acne vulgaris, ≥ 12 years of age)

Subject:

Active Substance: Trifarotene
Name: Selgamis^®
Therapeutic area: Acne vulgaris
Pharmaceutical company: Galderma Laboratorium GmbH

Time table:

Start: 15.08.2020
Final decision by G-BA: 04.02.2021

Final decision:

No additional benefit proved

› 04.02.2021: Indicaterol acetate / glycopyrronium bromide / mometasone furoate (asthma bronchiale)

Subject:

Active Substance: Indicaterol acetate
Name: Enerzair Breezhaler^®
Therapeutic area: Asthma bronchiale
Pharmaceutical company: Novartis Pharma GmbH

Time table:

Start: 15.08.2020
Final decision by G-BA: 04.02.2021

Final decision:

No additional benefit proved

› 21.01.2021: Luspatercept (beta thalassaemia)

Subject:

Active Substance: Luspatercept
Name: Reblozyl^®
Therapeutic area: Beta thalassaemia
Pharmaceutical company: Celgene GmbH

Time table:

Start: 01.08.2020
Final decision by G-BA: 21.01.2021

Final decision:

Hint for a non-quantifiable additional benefit (orphan drug)

› 21.01.2021: Luspatercept (anaemia due to myelodysplastic syndromes (MDS))

Subject:

Active Substance: Luspatercept
Name: Reblozyl^®
Therapeutic area: Anaemia due to myelodysplastic syndromes (MDS)
Pharmaceutical company: Celgene GmbH

Time table:

Start: 01.08.2020
Final decision by G-BA: 21.01.2021

Final decision:

Hint for a non-quantifiable additional benefit (orphan drug)

› 21.01.2021: Sofosbuvir (new indication: chronic hepatitis C, patients aged 3 to < 12 years)

Subject:

Active Substance: Sofosbuvir
Name: Sovaldi^®
Therapeutic area: Chronic hepatitis C
Pharmaceutical company: Gilead Sciences Ireland UC

Time table:

Start: 01.08.2020
Final decision by G-BA: 21.01.2021

Final decision:

HInt for non-quantifiable additional benefit

› 21.01.2021: Ledipasvir / sofosbuvir (new indication: chronic hepatitis C, patients aged 3 to < 12 years)

Subject:

Active Substance: Ledipasvir / sofosbuvir
Name: Harvoni^®
Therapeutic area: Chronic hepatitis C
Pharmaceutical company: Gilead Sciences Ireland UC

Time table:

Start: 01.08.2020
Final decision by G-BA: 21.01.2021

Final decision:

Genotype 1, 4, 5, or 6: hint for a non-quantifiable additional benefit
Genotype 3 (pre-treated patients or patients with cirrhosis): no additional benefit proved

› 21.01.2021: Ixekizumab (new indication: axial spondyloarthritis)

Subject:

Active Substance: Ixekizumab
Name: Taltz^®
Therapeutic area: Axial spondyloarthritis (AS)
Pharmaceutical company: Lilly Deutschland GmbH

Time table:

Start: 01.08.2020
Final decision by G-BA: 21.01.2021

Final decision:

a1) Patients who did not sufficiently respond to or who are intolerant to conventional therapy: no additional benefit proved
a2) Patients who did not sufficiently respond to a previous therapy with biological antirheumatic drugs (bDMARD) or who are intolerant to these: no additional benefit proved
b) Patients with severe disease without radiographic verification of a AS but with objective signs of inflammation who did not sufficiently respond to a previous therapy with non-steroidal antirheumatic drugs (NSAR) or who are intolerant to NSAR: no additional benefit proved

› 21.01.2021: Ixekizumab (new indication: plaque psoriasis in children and adolescents aged ≥ 6 to < 18 years, with body weight ≥ 25 kg)

Subject:

Active Substance: Ixekizumab
Name: Taltz^®
Therapeutic area: Plaque psoriasis
Pharmaceutical company: Lilly Deutschland GmbH

Time table:

Start: 01.08.2020
Final decision by G-BA: 21.01.2021

Final decision:

No additional benefit proved

› 21.01.2021: Ravulizumab (new indication: atypical haemolytic uremic syndrome (aHUS))

Subject:

Active Substance: Ravulizumab
Name: Ultomiris^®
Therapeutic area: Atypical haemolytic uremic syndrome (aHUS)
Pharmaceutical company: Alexion Pharma Germany GmbH

Time table:

Start: 01.08.2020
Final decision by G-BA: 21.01.2021

Final decision:

No additional benefit proved

› 07.01.2021: Osilodrostat (endogenous Cushing's syndrome)

Subject:

Active Substance: Osilodrostat
Name: Isturisa^®
Therapeutic area: Endogenous Cushing's syndrome
Pharmaceutical company: Recordati Rare Diseases Germany GmbH

Time table:

Start: 15.07.2020
Final decision by G-BA: 07.01.2021

Final decision:

Hint for a non-quantifiable additional benefit (orphan drug)

› 07.01.2021: Caplacizumab (new indication: thrombotic thrombocytopenic purpura (aTTP), 12 to < 18 years)

Subject:

Active Substance: Caplacizumab
Name: Cablivi^®
Therapeutic area: Acquired thrombotic thrombocytopenic purpura (aTTP)
Pharmaceutical company: Sanofi-Aventis Deutschland GmbH

Time table:

Start: 15.07.2020
Final decision by G-BA: 07.01.2021

Final decision:

Hint for a non-quantifiable additional benefit because the scientific data basis does not permit quantification (orphan drug)

› 07.01.2021: Ozanimod (relapsing remitting multiple sclerosis (RRMS))

Subject:

Active Substance: Ozanimod
Name: Zeposia^®
Therapeutic area: Multiple sclerosis (MS)
Pharmaceutical company: Celgene GmbH

Time table:

Start: 15.07.2020
Final decision by G-BA: 07.01.2021

Final decision:

a. Adult patients who have not yet received a disease-modifying treatment or whose disease is not highly active with a disease-modifying treatment: Indication for a minor additional benefit
b. Adult patients with highly active disease despite treatment with a disease-modifying therapy: No additional benefit proved

› 17.12.2020: Encorafenib (new indication: metastasized colorectal carcinoma (CRC) with BRAF-V600E mutation and previous systemic therapy)

Subject:

Active Substance: Encorafenib
Name: Braftovi^®
Therapeutic area: Colorectal carcinoma (CRC)
Pharmaceutical company: Pierre Fabre Pharma GmbH

Time table:

Start: 01.07.2020
Final decision by G-BA: 17.12.2020

Final decision:

Hint for a considerable additional benefit

› 17.12.2020: Fostamatinib (chronic immune thrombocytopenia (ITP))

Subject:

Active Substance: Fostamatinib
Name: Tavlesse^®
Therapeutic area: Chronic immune thrombocytopenia (ITP)
Pharmaceutical company: Grifols Deutschland GmbH

Time table:

Start: 01.07.2020
Final decision by G-BA: 17.12.2020

Final decision:

No additional benefit proved

› 17.12.2020: Ivacaftor (new indication: cystic fibrosis, patients aged ≥ 6 months - < 18 years (R117H))

Subject:

Active Substance: Ivacaftor
Name: Kalydeco^®
Therapeutic area: Cystic fibrosis
Pharmaceutical company: Vertex Pharmaceuticals

Time table:

Start: 01.07.2020
Final decision by G-BA: 17.12.2020

Final decision:

Patients aged 6 months up to < 6 years: Hint for a non-quantifiable additional benefit
Patients aged 6 years up to < 18 years: Hint for a non-quantifiable additional benefit

› 17.12.2020: Tezacaftor / ivacaftor (re-assessment, 50 Mio. € limit exceeded: cystic fibrosis, patients aged ≥ 12 years (homozygous for F508del))

Subject:

Active Substance: Tezacaftor / ivacaftor
Name: Symkevi^®
Therapeutic area: Cystic fibrosis
Pharmaceutical company: Vertex Pharmaceuticals

Time table:

Start: 01.07.2020
Final decision by G-BA: 17.12.2020

Final decision:

No additional benefit proved

› 17.12.2020: Tezacaftor / ivacaftor (re-assessment, 50 Mio. € limit exceeded: cystic fibrosis, patients aged ≥ 12 years (heterozygous for F508del))

Subject:

Active Substance: Tezacaftor / ivacaftor
Name: Symkevi^®
Therapeutic area: Cystic fibrosis
Pharmaceutical company: Vertex Pharmaceuticals

Time table:

Start: 01.07.2020
Final decision by G-BA: 17.12.2020

Final decision:

No additional benefit proved

› 03.12.2020: Brentuximab vedotin (new indication: systemic anaplastic large cell lymphoma (sALCL); 1^st line; combination with cyclophosphamide, doxorubicin and prednisone

Subject:

Active Substance: Brentuximab vedotin
Name: Adcetris^®
Therapeutic area: Non-Hodgkin lymphoma
Pharmaceutical company: Takeda GmbH

Time table:

Start: 15.06.2020
Final decision by G-BA: 03.12.2020
This decision remaims valid until: 01.07.2020

Final decision:

Hint for a minor additional benefit

› 03.12.2020: Mogamulizumab (Mycosis fungoides; Sézary syndrome)

Subject:

Active Substance: Mogamulizumab
Name: Poteligeo^®
Therapeutic area: Mycosis fungoides; Sézary syndrome
Pharmaceutical company: Kyowa Kirin GmbH

Time table:

Start: 15.06.2020
Final decision by G-BA: 03.12.2020

Final decision:

Hint for a non-quantifiable additional benefit (orphan drug)

› 03.12.2020: Onasemnogene abeparvovec (5q-associated spinal muscle atrophy)

Subject:

Active Substance: Onasemnogene abeparvovec
Name: Zolgensma^®
Therapeutic area: Spinal muscle atrophy
Pharmaceutical company: AveXis

Time table:

Start: 01.07.2020
Final decision by G-BA: 03.12.2020

Final decision:

Assessment is suspended due to expected full assessment after exceedance of 50 M € annual sales

› 20.11.2020: Ponatinib (re-assessment: acute lymphatic leukemia)

Subject:

Active Substance: Ponatinib
Name: Iclusig^®
Therapeutic area: Acute lymphatic leukemia (ALL)
Pharmaceutical company: Incyte Biosciences Germany GmbH

Time table:

Start: 01.06.2020
Final decision by G-BA: 20.11.2020

Final decision:

Hint for a non-quantifiable additional benefit (orphan drug)

› 20.11.2020: Ponatinib (re-assessment: chronic myeloid leukemia)

Subject:

Active Substance: Ponatinib
Name: Iclusig^®
Therapeutic area: Chronic myeloid leukemia (CML)
Pharmaceutical company: Incyte Biosciences Germany GmbH

Time table:

Start: 01.06.2020
Final decision by G-BA: 20.11.2020

Final decision:

Hint for a non-quantifiable additional benefit (orphan drug)

› 20.11.2020: Talazoparib (breast cancer, BRCA1/2 mutation, HER2-)

Subject:

Active Substance: Talazoparib
Name: Talzenna^®
Therapeutic area: Breast cancer
Pharmaceutical company: Pfizer Pharma GmbH

Time table:

Start: 01.06.2020
Final decision by G-BA: 20.11.2020

Final decision:

Hint for a considerable additional benefit

› 05.11.2020: Solriamfetol (narcolepsy)

Subject:

Active Substance: Solriamfetol
Name: Sunosi^®
Therapeutic area: Narcolepsy
Pharmaceutical company: Jazz Pharmaceuticals

Time table:

Start: 15.05.2020
Final decision by G-BA: 05.11.2020

Final decision:

Narcolepsy without cataplexy: No additional benefit proved
Narcolepsy with cataplexy: No additional benefit proved

› 05.11.2020: Enzalutamide (re-assessment: prostate cancer, non-metastatic, high risk)

Subject:

Active Substance: Enzalutamide
Name: Xtandi^®
Therapeutic area: Prostate cancer
Pharmaceutical company: Astellas Pharma GmbH

Time table:

Start: 15.05.2020
Final decision by G-BA: 05.11.2020

Final decision:

Indication for a minor additional benefit

› 05.11.2020: Apremilast (new indication: Behçet’s disease)

Subject:

Active Substance: Apremilast
Name: Otezla^®
Therapeutic area: Behçet’s disease
Pharmaceutical company: Amgen GmbH

Time table:

Start: 15.05.2020
Final decision by G-BA: 05.11.2020

Final decision:

No additional benefit proved

› 05.11.2020: Naldemedin (opioid-induced constipation)

Subject:

Active Substance: Naldemedin
Name: Rizmoic^®
Therapeutic area: Opioid-induced constipation
Pharmaceutical company: Hexal AG

Time table:

Start: 15.05.2020
Final decision by G-BA: 05.11.2020

Final decision by G-BA:

Patients pretreated with a laxative: No additional benefit proved
Patients not eligible anymore for a laxative not subject to prescription or for a reimbursable medicinal product for the treatment of constipation: No additional benefit proved

› 15.10.2020: Venetoclax (new indication: CLL, 1st line, in combination with obinutuzumab)

Subject:

Active Substance: Venetoclax
Name: Venclyxto^®
Therapeutic area: Chronic lymphatic leukaemia (CLL)
Pharmaceutical company: AbbVie Deutschland GmbH & Co. KG

Time table:

Start: 15.04.2020
Final decision by G-BA: 15.10.2020

Final decision:

a. Patients who are suited for a treatment with fludarabine in combination with cyclophosphamide and rituximab (FCR): No additional benefit proved
b. Patients who are not suited for a treatment with FCR: No additional benefit proved
c. Patients with 17p deletion or TP53 mutation, or who are not suited for chemoimmunotherapy due to other reasons: No additional benefit proved

› 15.10.2020: Insulin glargine / lixisenatide (new indication: type 2 diabetes mellitus, in combination with metformin and SGLT2-inhibitors)

Subject:

Active Substance: Insulin glargine / lixisenatide
Name: Suliqua^®
Therapeutic area: Diabetes mellitus, type 2
Pharmaceutical company: Sanofi-Aventis Deutschland GmbH

Time table:

Start: 15.04.2020
Final decision by G-BA: 15.10.2020

Final decision:

a. Patients who are not sufficiently treated with 2 antidiabetics (except of insulin): No additional benefit proved
b. Patients who are not sufficiently treated with insulin: No additional benefit proved