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Ongoing (preliminary decision published)

› Dapagliflozin (new indication: type 2 diabetes mellitus, patients ≥ 10 years)

Subject:

Active Substance: Dapagliflozin
Name: Forxiga^®
Therapeutic area: Type 2 diabetes mellitus
Pharmaceutical company: AstraZeneca GmbH

Time table:

Start: 15.12.2021
Publication of assessment: 15.03.2022
End of public hearing: 05.04.2022
Final decision by G-BA: middle of June 2022

Comparative therapy:

Insulin-naive children aged 10 to 17 years with type 2 diabetes mellitus who have not achieved adequate glycemic control with their current drug therapy consisting of at least one blood glucose-lowering drug in addition to diet and exercise:
- human insulin + metformin
Insulin-experienced children aged 10 to 17 years with type 2 diabetes mellitus who have not achieved adequate glycemic control with their previous insulin regimen in addition to diet and exercise:
- escalation of insulin therapy (conventional therapy (CT) if necessary + metformin OR
- intensified insulin therapy (ICT))

› Ozanimod (new indication: ulcerative colitis, pre-treated patients)

Subject:

Active Substance: Ozanimod
Name: Zeposia^®
Therapeutic area: Ulcerative colitis
Pharmaceutical company: Bristol-Myers Squibb GmbH & Co. KGaA

Time table:

Start: 15.12.2021
Publication of assessment: 15.03.2022
End of public hearing: 05.04.2022
Final decision by G-BA: middle of June 2022

Comparative therapy:

Adult patients who have an intolerance or contraindication to conventional therapy:
- TNF-α antagonist (adalimumab or infliximab or golimumab) OR
- vedolizumab OR
- tofacitinib OR
- ustekinumab
Adult patients who are intolerant or have an inadequate or no response to a biologic (TNF-α antagonist or integrin inhibitor or interleukin inhibitor):
- vedolizumab OR
- tofacitinib OR
- TNF-α antagonist (adalimumab or infliximab or golimumab) OR
- ustekinumab

› Zanubrutinib (Waldenström's macroglobulinemia (WM), first-line treatment for patients unsuitable for chemo-immunotherapy or patients ≥ 1 previous therapy)

Subject:

Active Substance: Zanubrutinib
Name: Brukinsa^®
Therapeutic area: Waldenström's macroglobulinemia
Pharmaceutical company: BeiGene Germany GmbH

Time table:

Start: 15.12.2021
Publication of assessment: 15.03.2022
End of public hearing: 05.04.2022
Final decision by G-BA: middle of June 2022

Comparative therapy:

A patient-individual therapy depending on the general condition and, if applicable, previous therapies and the duration of remission after initial therapy

› Tofacitinib (new indication: ankylosing spondylitis)

Subject:

Active Substance: Tofacitinib
Name: Xeljanz^®
Therapeutic area: Ankylosing spondylitis
Pharmaceutical company: Pfizer Pharma GmbH

Time table:

Start: 15.12.2021
Publication of assessment: 15.03.2022
End of public hearing: 05.04.2022
Final decision by G-BA: middle of June 2022

Comparative therapy:

a1) Adult patients who have had an inadequate response to conventional therapy:
- TNF-α inhibitor (adalimumab or certolizumab pegol or etanercept or golimumab or infliximab) OR
- IL-17 inhibitor (secukinumab)
a1) Adult patients who have had an inadequate response to, or intolerance to, prior biologic antirheumatic drug (bDMARD) therapy: switch to another disease-modifying antirheumatic drug:
- TNF-α inhibitor (adalimumab or certolizumab pegol or etanercept or golimumab or infliximab) OR
- IL-17 inhibitor (secukinumab)

› Pralsetinib (non-small cell lung cancer (NSCLC), RET-fusion-positive advanced)

Subject:

Active Substance: Pralsetinib
Name: Gavreto^®
Therapeutic area: Non-small cell lung cancer (NSCLC)
Pharmaceutical company: Roche Registration GmbH

Time table:

Start: 15.12.2021
Publication of assessment: 15.03.2022
End of public hearing: 05.04.2022
Final decision by G-BA: middle of June 2022

Comparative therapy:

Adult patients with PD-L1 expression ≥ 50% of tumor cells; first-line therapy:
- pembrolizumab as monotherapy
Adult patients with PD-L1 expression ≤ 50% of tumor cells; first-line therapy:
- cisplatin in combination with a third-generation cytostatic (vinorelbine or gemcitabine or docetaxel or paclitaxel or pemetrexed (except in cases of predominantly squamous histology)) OR
- carboplatin in combination with a third-generation cytostatic (vinorelbine or gemcitabine or docetaxel or paclitaxel or pemetrexed (except in the case of predominantly squamous histology)) cf. Annex VI to Section K of the Pharmaceutical Guideline OR
- carboplatin in combination with nab-paclitaxel OR
- pembrolizumab in combination with pemetrexed and platinum-containing chemotherapy (only for patients without EGFR- or ALK-positive tumor mutations and with non-squamous histology) OR
- pembrolizumab in combination with carboplatin and either paclitaxel or nab-paclitaxel (for squamous histology only) OR
- monotherapy with gemcitabine or vinorelbine (only for patients with ECOG performance status 2 as an alternative to platinum-based combination treatment)
Adult patients after first-line therapy with a PD-1/PD-L1 antibody as monotherapy:
- cisplatin in combination with a third-generation cytostatic (vinorelbine or gemcitabine or docetaxel or paclitaxel or pemetrexed (except in cases of predominantly squamous histology)) OR
- carboplatin in combination with a third-generation cytostatic (vinorelbine or gemcitabine or docetaxel or paclitaxel or pemetrexed (except in the case of predominantly squamous histology)) cf. Annex VI to Section K of the Pharmaceutical Guideline OR
- carboplatin in combination with nab-paclitaxel OR
- monotherapy with gemcitabine or vinorelbine (only for patients with ECOG performance status 2 as an alternative to platinum-based combination treatment)
Adult patients after first-line therapy with cytotoxic chemotherapy:
- docetaxel (only for patients with PD-L1 negative tumors) OR
- pemetrexed (only for patients with PD-L1 negative tumors and except in cases of predominantly squamous histology) OR
- nivolumab OR
- pembrolizumab (only for patients with PD-L1 expressing tumors and PD-L1 expression ≥ 1% of tumor cells) OR
- atezolizumab OR
- docetaxel in combination with nintedanib (only for patients with PD-L1 negative tumors and adenocarcinoma histology)
Adult patients after first-line therapy with a PD-1/PD-L1 antibody in combination with platinum-containing chemotherapy or after sequential therapy with a PD-1/PD-L1 antibody and platinum-containing chemotherapy:
- A patient-individual therapy depending on prior therapy and histology choosing from afatinib, pemetrexed, erlotinib, docetaxel, docetaxel in combination with ramucirumab, docetaxel in combination with nintedanib and vinorelbine

› Idecabtagen vicleucel (multiple myeloma. ≥ 3 previous therapies)

Subject:

Active Substance: Idecabtagen vicleucel
Name: Abecma^®
Therapeutic area: Multiple myeloma
Pharmaceutical company: Bristol-Myers Squibb GmbH & Co. KGaA

Time table:

Start: 01.01.2022
Publication of assessment: 01.04.2022
End of public hearing: 22.04.2022
Final decision by G-BA: middle of June 2022

Comparative therapy:

No comparative therapy due to orphan drug designation

› Evolocumab (new indication: primary hypercholesterolemia, patients from ≥ 10 to < 18 years)

Subject:

Active Substance: Evolocumab
Name: Repatha^®
Therapeutic area: Primary hypercholesterolemia or mixed dislipidemia
Pharmaceutical company: Amgen GmbH

Time table:

Start: 01.01.2022
Publication of assessment: 01.04.2022
End of public hearing: 22.04.2022
Final decision by G-BA: middle of June 2022

Comparative therapy:

Patients with heterozygous familial hypercholesterolemia (HeFH)
a1) Patients aged 10 to 17 years for whom dietary and medical options for lipid lowering have not been exhausted:
- Maximum tolerated drug therapy at the physician's discretion, taking into account statins, cholesterol resorption inhibitors and anion exchangers
a2) Patients aged 10 to 17 years for whom dietary and medical options for lipid lowering have been exhausted:
- LDL apheresis (as the "ultima ratio" in therapy-refractory courses), if necessary with accompanying drug-based lipid-lowering therapy
Patients with homozygous familial hypercholesterolemia (HoFH)
b1) Patients aged 10 or 11 years for whom dietary and medical options for lipid lowering have not been exhausted:
- Maximum tolerated drug therapy at the physician's discretion, taking into account statins, cholesterol resorption inhibitors and anion exchangers
b2) Patients aged 10 or 11 years for whom dietary and medical options for lipid lowering have been exhausted:
- LDL apheresis (as the "ultima ratio" in therapy-refractory courses), if necessary with accompanying drug-based lipid-lowering therapy

› Diroximel fumarate (relapsing-remitting multiple sclerosis)

Subject:

Active Substance: Diroximel fumarate
Name: Vumerity^®
Therapeutic area: Multiple sclerosis
Pharmaceutical company: Biogen GmbH

Time table:

Start: 01.01.2022
Publication of assessment: 01.04.2022
End of public hearing: 22.04.2022
Final decision by G-BA: middle of June 2022

Comparative therapy:

Interferon β-1a or interferon β-1b or glatiramer acetate or dimethyl fumarate or teriflunomide or ocrelizumab, taking into account the drugs' approval

› Ripretinib (gastrointestinal stromal tumor (GIST), ≥ 3 previous therapies)

Subject:

Active Substance: Ripretinib
Name: Qinlock^®
Therapeutic area: Gastrointestinal stromal tumor (GIST)
Pharmaceutical company: Deciphera Pharmaceuticals (Netherlands) B.V.

Time table:

Start: 01.01.2022
Publication of assessment: 01.04.2022
End of public hearing: 22.04.2022
Final decision by G-BA: middle of June 2022

Comparative therapy:

No comparative therapy due to orphan drug designation

› Remdesivir (new indication: COVID-19, patients not requiring supplemental oxygen, with increased risk of progressing to severe COVID-19)

Subject:

Active Substance: Remdesivir
Name: Veklury^®
Therapeutic area: Coronavirus disease 2019 (COVID-19)
Pharmaceutical company: Gilead Sciences GmbH

Time table:

Start: 15.01.2022
Publication of assessment: 19.04.2022
End of public hearing: 10.05.2022
Final decision by G-BA: beginning of July 2022

Comparative therapy:

Therapy at the physician’s discretion

› Amivantamab (non-small cell lung cancer (NSCLC), EGFR exon 20 insertion mutations, after platinum-based therapy)

Subject:

Active Substance: Amivantamab
Name: Rybrevant^®
Therapeutic area: Non-small cell lung cancer (NSCLC)
Pharmaceutical company: Janssen-Cilag GmbH

Time table:

Start: 15.01.2022
Publication of assessment: 19.04.2022
End of public hearing: 10.05.2022
Final decision by G-BA: beginning of July 2022

Comparative therapy:

Patients who are eligible for another chemotherapy:
- docetaxel OR
- docetaxel + nintedanib OR
- pemetrexed
Patients who are not eligible for another chemotherapy:
- Best supportive care

› Abrocitinib (atopic dermatitis)

Subject:

Active Substance: Abrocitinib
Name: Cibinqo^®
Therapeutic area: Atopic dermatitis
Pharmaceutical company: Pfizer Pharma GmbH

Time table:

Start: 15.01.2022
Publication of assessment: 19.04.2022
End of public hearing: 10.05.2022
Final decision by G-BA: beginning of July 2022

Comparative therapy:

Dupilumab (in combination with TCS and/or TCI, if necessary)

› Pembrolizumab (new indication: endometrial carcinoma, after platinum-based therapy, in combination with lenvatinib)

Subject:

Active Substance: Pembrolizumab
Name: Keytruda^®
Therapeutic area: Endometrial carcinoma
Pharmaceutical company: MSD Sharp & Dohme GmbH

Time table:

Start: 15.01.2022
Publication of assessment: 19.04.2022
End of public hearing: 10.05.2022
Final decision by G-BA: beginning of July 2022

Comparative therapy:

Therapy at the physician's discretion (appropriate therapies include:)

endocrine therapy:
- medroxyprogesterone acetate, - megestrol acetate;
systemic chemotherapy, which can also be a platinum-based re-therapy:
- cisplatin (monotherapy or in combination with doxorubicin), - doxorubicin (monotherapy or in combination with cisplatin), - carboplatin in combination with paclitaxel), - paclitaxel (monotherapy);
as well as a best supportive care only.)

› Lenvatinib (new indication: endometrial carcinoma, after platinum-based therapy, in combination with pembrolizumab)

Subject:

Active Substance: Lenvatinib
Name: Lenvima^®
Therapeutic area: Endometrial carcinoma
Pharmaceutical company: Eisai GmbH

Time table:

Start: 15.01.2022
Publication of assessment: 19.04.2022
End of public hearing: 10.05.2022
Final decision by G-BA: beginning of July 2022

Comparative therapy:

Therapy at the physician's discretion (appropriate therapies include:

endocrine therapy:
- medroxyprogesterone acetate,
- megestrol acetate;
systemic chemotherapy, which can also be a platinum-based re-therapy:
- cisplatin (monotherapy or in combination with doxorubicin),
- doxorubicin (monotherapy or in combination with cisplatin),
- carboplatin in combination with paclitaxel),
- paclitaxel (monotherapy);
as well as a best supportive care only.)

› Lenvatinib (new indication: advanced renal cell carcinoma, 1^st line, in combination with pembrolizumab)

Subject:

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

Time table:

Start: 15.01.2022
Publication of assessment: 19.04.2022
End of public hearing: 10.05.2022
Final decision by G-BA: beginning of July 2022

Comparative therapy:

Patients with a favorable risk profile (IMDC Score 0):
- pembrolizumab in combination with axitinib
Patients with an intermediary (IMDC Risk Score 1-2) favorable risk profile (IMDC Score ≥ 3)
- avelumab in combination with axitinib (only for patients with unfavorable risk profile) OR
- nivolumab in combination with ipilimumab OR
- pembrolizumab in combination with axitinib

› Pembrolizumab (new indication: advanced renal cell carcinoma, 1^st line, in combination with lenvatinib)

Subject:

Active Substance: Pembrolizumab
Name: Keytruda^®
Therapeutic area: Renal cell carcinoma
Pharmaceutical company: MSD Sharp & Dohme GmbH

Time table:

Start: 15.01.2022
Publication of assessment: 19.04.2022
End of public hearing: 10.05.2022
Final decision by G-BA: beginning of July 2022

Comparative therapy:

Patients with a favorable risk profile (IMDC Score 0):
- pembrolizumab in combination with axitinib
Patients with an intermediary (IMDC Risk Score 1-2) favorable risk profile (IMDC Score ≥ 3)
- avelumab in combination with axitinib (only for patients with unfavorable risk profile) OR
- nivolumab in combination with ipilimumab OR
- pembrolizumab in combination with axitinib

› Duvelisib (chronic lymphatic leukemia (CLL), after ≥ 2 prior therapies)

Subject:

Active Substance: Duvelisib
Name: Copiktra^®
Therapeutic area: Chronic lymphatic leukemia
Pharmaceutical company: Secura Bio Limited

Time table:

Start: 01.02.2022
Publication of assessment: 02.05.2022
End of public hearing: 23.05.2022
Final decision by G-BA: end of July 2022

Comparative therapy:

Patients who have not yet received a BTK inhibitor and/or BCL2 inhibitor:
- ibrutinib OR venetoclax + rituximab OR a chemoimmunotherapy with FCR or BR or ClbR (only in the case of a long relapse-free interval and absence of genetic risk factors)
After prior therapy with at least one BTK inhibitor:
- venetoclax + rituximab
After prior therapy with at least one BCL2 inhibitor:
- ibrutinib
After prior therapy with at least one BTK inhibitor and one BCL2 inhibitor:
- A patient-individual therapy choosing from: idelalisib in combination with rituximab OR bendamustine in combination with rituximab OR chlorambucil in combination with rituximab OR best supportive care (taking into account comorbidities, general condition of health, genetic risk factors, and success and tolerability of prior therapy(ies)

› Duvelisib (follicular lymphoma, after ≥ 2 prior therapies)

Subject:

Active Substance: Duvelisib
Name: Copiktra^®
Therapeutic area: Follicular lymphoma
Pharmaceutical company: Secura Bio Limited

Time table:

Start: 01.02.2022
Publication of assessment: 02.05.2022
End of public hearing: 23.05.2022
Final decision by G-BA: end of July 2022

Comparative therapy:

Patient-individual therapy taking into account prior therapies, course of disease and general condition
(appropriate therapies include:
- Bendamustine + rituximab / obinutuzumab
- CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone) + rituximab / obinutuzumab
- CVP + rituximab / obinutuzumab
- FCM (fludarabine, cyclophosphamide, mitoxantrone) + rituximab / obinutuzumab
- chlorambucil + rituximab
- cyclophosphamide + rituximab
- FM (fludarabine + mitoxantrone) + rituximab / obinutuzumab
- ICE (ifosamide, carboplatin, etoposide) + rituximab / obinutuzumab
- MCP (mitoxantrone, chlorambucil, prednisone) + rituximab / obinutuzumab
- DHAP (dexamethasone, Ara-C / cytarabine, cisplatin) + rituximab / obinutuzumab
- lenalidomide + rituximab
- rituximab monotherapy
- [90Y]-radio labelled ibritumomab tiuxetan
- idelalisib)

› Burosumab (re-assessment, 50 M € limit exceeded: X-linked hypophosphatemia, patients aged ≥ 18 years)

Subject:

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

Time table:

Start: 01.02.2022
Publication of assessment: 02.05.2022
End of public hearing: 23.05.2022
Final decision by G-BA: end of July 2022

Comparative therapy:

Phosphate replacement
(under the assumption that:
- vitamin D replacement (calcitriol or alfacalcidol) is continued
- patients in the present indication are symptomatic and thus in need of treatment)

› Burosumab (re-assessment, 50 M € limit exceeded: X-linked hypophosphatemia, patients aged ≥ 1 - < 18 years)

Subject:

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

Time table:

Start: 01.02.2022
Publication of assessment: 02.05.2022
End of public hearing: 23.05.2022
Final decision by G-BA: end of July 2022

Comparative therapy:

Phosphate replacement
(under the assumption that:
- vitamin D replacement (calcitriol or alfacalcidol) is continued)

› Isoflurane (known active substance with new data exclusivity: sedation of mechanically ventilated patients during intensive care)

Subject:

Active Substance: Isoflurane
Name: Sedaconda^®
Therapeutic area: Sedation of mechanically ventilated patients during intensive care
Pharmaceutical company: Sedana Medical AB

Time table:

Start: 01.02.2022
Publication of assessment: 02.05.2022
End of public hearing: 23.05.2022
Final decision by G-BA: end of July 2022

Comparative therapy:

Therapy at the physician's discretion choosing from: propofol, midazolam and dexmedetomidine

› Calcifediol (known active substance with new data exclusivity: secondary hyperparathyroidism in chronic renal failure)

Subject:

Active Substance: Calcifediol
Name: Rayaldee^®
Therapeutic area: Secondary hyperparathyreoidism in chronic renal failure
Pharmaceutical company: Fresenius Medical Care Nephrologica Deutschland GmbH

Time table:

Start: 01.02.2022
Publication of assessment: 02.05.2022
End of public hearing: 23.05.2022
Final decision by G-BA: end of July 2022

Comparative therapy:

Paricalcitol

› Ivacaftor (new indication: cystic fibrosis; F508del mutation, heterozygous, and other or unknown mutation; patients aged ≥ 6 - ≤ 11 years; in combination with ivacaftor / tezacaftor / elexacaftor)

Subject:

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

Time table:

Start: 15.02.2022
Publication of assessment: 16.05.2022
End of public hearing: 07.06.2022
Final decision by G-BA: beginning of August 2022

Comparative therapy:

Best supportive care

› Ivacaftor (new indication: cystic fibrosis; F508del mutation, heterozygous, and RF mutation; patients aged ≥ 6 - ≤ 11 years; in combination with ivacaftor / tezacaftor / elexacaftor)

Subject:

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

Time table:

Start: 15.02.2022
Publication of assessment: 16.05.2022
End of public hearing: 07.06.2022
Final decision by G-BA: beginning of August 2022

Comparative therapy:

Tezacaftor / ivacaftor in combination with ivacaftor

› Ivacaftor (new indication: cystic fibrosis; F508del mutation, heterozygous, and gating mutation; patients aged ≥ 6 - ≤ 11 years; in combination with ivacaftor / tezacaftor / elexacaftor)

Subject:

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

Time table:

Start: 15.02.2022
Publication of assessment: 16.05.2022
End of public hearing: 07.06.2022
Final decision by G-BA: beginning of August 2022

Comparative therapy:

Patients who are heterozygous for F508 mutation in CFTR gene and have a mutation with minimal activity on the second allele: best supportive care
Patients who are homozygous for F508 mutation in CFTR gene: lumacaftor / ivacaftor OR tezacaftor / elexacaftor
Patients who are heterozygous for F508 mutation in CFTR gene and have a gating mutation (incl. R117H) on the second allele: ivacaftor
Patients who are heterozygous for F508 mutation in CFTR gene and have a mutation with remaining activity on the second allele: tezacaftor / ivacaftor in combination with ivacaftor
Patients who are heterozygous for F508 mutation in CFTR gene and neither have a mutation on the second allele with minimal activity nor with remaining activity nor a gating mutation or who have an unknown mutation on the second allele (other mutation): best supportive care

› Ivacaftor (new indication: cystic fibrosis; in combination with ivacaftor / tezacaftor / elexacaftor, patients aged ≥ 6 - ≤ 11 years (homozygous for F508del mutation))

Subject:

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

Time table:

Start: 15.02.2022
Publication of assessment: 16.05.2022
End of public hearing: 07.06.2022
Final decision by G-BA: beginning of August 2022

Comparative therapy:

Lumacaftor / ivacaftor
Tezacaftor / ivacaftor in combination with ivacaftor

› Ivacaftor (new indication: cystic fibrosis; in combination with ivacaftor / tezacaftor / elexacaftor, patients aged ≥ 6 - ≤ 11 years (heterozygous for F508del and MF mutation))

Subject:

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

Time table:

Start: 15.02.2022
Publication of assessment: 16.05.2022
End of public hearing: 07.06.2022
Final decision by G-BA: beginning of August 2022

Comparative therapy:

Best supportive care

› Sotorasib (non-small cell lung cancer (NSCLC); KRAS G12C mutation; ≥ 1 prior therapies)

Subject:

Active Substance: Sotorasib
Name: Lumykras^®
Therapeutic area: Non-small cell lung cancer (NSCLC)
Pharmaceutical company: Amgen Europe B.V.

Time table:

Start: 15.02.2022
Publication of assessment: 16.05.2022
End of public hearing: 07.06.2022
Final decision by G-BA: beginning of August 2022

Comparative therapy:

Patients with PD-1/PD-L1 antibody monotherapy as first line therapy:
- cisplatin in combination with 3^rd generation cytostatic (vinorelbine or gemcitabine or docetaxel or paclitaxel or pemetrexed (except for predominantly squamous cell histology)
- carboplatin in combination with a 3^rd generation cytostatic (vinorelbine or gemcitabine or docetaxel or paclitaxel or pemetrexed (except for predominantly squamous cell histology), see attachment VI for chapter K of pharmaceutical guideline (AM-RL)
- carboplatin in combination with nab-paclitaxel
- monotherapy with gemcitabine or vinorelbine (only for patients with ECOG performance status 2 as an alternative for platinum-based combination therapy)
Patients with a cytotoxic chemotherapy as first line therapy:
- docetaxel (only for patients with PD-L1 negative tumours)
- pemetrexed (only for patients with PD-L1 negative tumours, except for patients with predominantly squamous cell histology)
- nivolumab
- pembrolizumab (only for patients with PD-L1 expressing tumours (PD-L1 expression ≥ 1 % of tumour cells))
- atezolizumab
- docetaxel in combination with nintedanib (only for patients with (PD-L1 negative tumours and adenocarcinoma histology))
Patients with either a PD-1/PD-L1 antibody in combination with a platinum-based chemotherapy or a sequential therapy with a PD-1/PD-L1 antibody and a platinum-based chemotherapy as first line therapy:
- A patient-individual therapy depending on the previous therapy and histology choosing from afatinib, pemetrexed, erlotinib, docetaxel, docetaxel in combination with ramucirumab, docetaxel in combination with nintedanib and vinorelbine.

› Avacopan (granulomatosis with polyangiitis or microscopic polyangiitis; in combination with rituximab or cyclophosphamide)

Subject:

Active Substance: Avacopan
Name: Tavneos^®
Therapeutic area: Granulomatosis with polyangiitis or microscopic polyangiitis
Pharmaceutical company: Vifor Pharma Deutschland GmbH

Time table:

Start: 15.01.2022
Publication of assessment: 19.04.2022
End of public hearing: 10.05.2022
Final decision by G-BA: beginning of July 2022

Comparative therapy:

No comparative therapy due to orphan drug designation

› Ivacaftor / tezacaftor / elexacaftor (new indication: cystic fibrosis; F508del mutation; heterozygous; and other or unknown mutation; patients aged ≥ 6 - ≤ 11 years (in combination with ivacaftor))

Subject:

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

Time table:

Start: 15.02.2022
Publication of assessment: 16.05.2022
End of public hearing: 07.06.2022
Final decision by G-BA: beginning of August 2022

Comparative therapy:

Best supportive care

› Ivacaftor / tezacaftor / elexacaftor (new indication: cystic fibrosis; F508del mutation; heterozygous, and RF mutation; patients aged ≥ 6 - ≤ 11 years (in combination with ivacaftor))

Subject:

Active Substance: Ivacaftor / texacaftor / elexacaftor
Name: Kaftrio^®
Therapeutic area: Cystic fibrosis
Pharmaceutical company: Vertex Pharmaceuticals (Germany) GmbH

Time table:

Start: 15.02.2022
Publication of assessment: 16.05.2022
End of public hearing: 07.06.2022
Final decision by G-BA: beginning of August 2022

Comparative therapy:

Tezacaftor / ivacaftor in combination with ivacaftor

› Ivacaftor / tezacaftor / elexacaftor (new indication: cystic fibrosis; F508del mutation; heterozygous, and gating mutation; patients aged ≥ 6 - ≤ 11 years (in combination with ivacaftor))

Subject:

Active Substance: Ivacaftor / texacaftor / elexacaftor
Name: Kaftrio^®
Therapeutic area: Cystic fibrosis
Pharmaceutical company: Vertex Pharmaceuticals (Germany) GmbH

Time table:

Start: 15.02.2022
Publication of assessment: 16.05.2022
End of public hearing: 07.06.2022
Final decision by G-BA: beginning of August 2022

Comparative therapy:

Ivacaftor

› Ivacaftor / tezacaftor / elexacaftor (new indication: cystic fibrosis; in combination with ivacaftor, patients aged ≥ 6 - ≤ 11 years (homozygous for F508del mutation))

Subject:

Active Substance: Ivacaftor / texacaftor / elexacaftor
Name: Kaftrio^®
Therapeutic area: Cystic fibrosis
Pharmaceutical company: Vertex Pharmaceuticals (Germany) GmbH

Time table:

Start: 15.02.2022
Publication of assessment: 16.05.2022
End of public hearing: 07.06.2022
Final decision by G-BA: beginning of August 2022

Comparative therapy:

Lumacaftor / ivacaftor OR
Tezacaftor / ivacaftor in combination with ivacaftor

› Ivacaftor / tezacaftor / elexacaftor (new indication: cystic fibrosis; in combination with ivacaftor; patients aged ≥ 6 - ≤ 11 years (heterozygous for F508del and MF mutation))

Subject:

Active Substance: Ivacaftor / texacaftor / elexacaftor
Name: Kaftrio^®
Therapeutic area: Cystic fibrosis
Pharmaceutical company: Vertex Pharmaceuticals (Germany) GmbH

Time table:

Start: 15.02.2022
Publication of assessment: 16.05.2022
End of public hearing: 07.06.2022
Final decision by G-BA: beginning of August 2022

Comparative therapy:

Best supportive care

› Sofosbuvir / velpatasvir (new indication: chronic hepatitis C; patients aged ≥ 3 - 6 years)

Subject:

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

Time table:

Start: 15.02.2022
Publication of assessment: 16.05.2022
End of public hearing: 07.06.2022
Final decision by G-BA: beginning of August 2022

Comparative therapy:

Patients with genotype 1, 4, 5 or 6: ledipasvir / sofosbuvir
Patients with genotype 2 or 3: sofobusvir plus ribavirin

Completed (final decision published)

› 19.05.2022: Abemaciclib (re-assessment: breast cancer, HR+, HER2^- in combination with fulvestrant)

Subject:

Active Substance: Abemaciclib
Name: Verzenios^®
Therapeutic area: Breast cancer
Pharmaceutical company: Lilly Deutschland GmbH

Time table:

Start: 01.12.2021
Final decision by G-BA: 19.05.2022

Final decision:

Patients who have not yet received initial endocrine therapy: No additional benefit proved
Patients who have received initial endocrine therapy: Indication for a minor additional benefit

› 19.05.2022: Filgotinib (new indication: ulcerative colitis, pretreated patients)

Subject:

Active Substance: Filgotinib
Name: Jyseleca^®
Therapeutic area: Ulcerative colitis
Pharmaceutical company: Galapagos Biopharma Germany GmbH

Time table:

Start: 01.12.2021
Final decision by G-BA: 19.05.2022

Final decision:

Patients who have responded inadequately to conventional therapy, no longer respond to it, or have an intolerance or contraindication:
No additional benefit proved
Patients who have responded inadequately to a biologic (TNF-α antagonist or integrin inhibitor or interleukin inhibitor), no longer respond to it, or have an intolerance to a corresponding treatment:
No additional benefit proved

› 19.05.2022: Mepolizumab (new indication: eosinophilic granulomatosis with polyangiitis (EGPA))

Subject:

Active Substance: Mepolizumab
Name: Nucala^®
Therapeutic area: Eosinophilic granulomatosis with polyangiitis (EGPA)
Pharmaceutical company: GlaxoSmithKline GmbH & Co. KG

Time table:

Start: 01.12.2021
Final decision by G-BA: 19.05.2022

Final decision:

No additional benefit proved

› 19.05.2022: Mepolizumab (new indication: chronic rhinosinusitis with nasal polyps)

Subject:

Active Substance: Mepolizumab
Name: Nucala^®
Therapeutic area: Rhinosinusitis
Pharmaceutical company: GlaxoSmithKline GmbH & Co. KG

Time table:

Start: 01.12.2021
Final decision by G-BA: 19.05.2022

Final decision:

No addtional benefit proved

› 19.05.2022: Mepolizumab (new indication: hypereosinophilic syndrome)

Subject:

Active Substance: Mepolizumab
Name: Nucala^®
Therapeutic area: Hypereosinophilic syndrome
Pharmaceutical company: GlaxoSmithKline GmbH & Co. KG

Time table:

Start: 01.12.2021
Final decision by G-BA: 19.05.2022

Final decision:

Hint for a considerable additional benefi

› 19.05.2022: Lusutrombopag (thrombocytopenia with chronic liver disease)

Subject:

Active Substance: Lusutrombopag
Name: Mulpleo^®
Therapeutic area: Thrombocytopenia
Pharmaceutical company: Shionogi GmbH

Time table:

Start: 01.12.2021
Final decision by G-BA: 19.05.2022

Final decision:

No additional benefit proved

› 19.05.2022: Sacituzumab Govitecan (triple-negative breast cancer, ≥ 2 previous therapies)

Subject:

Active Substance: Sacituzumab Govitecan
Name: Trodelvy^®
Therapeutic area: Breast cancer
Pharmaceutical company: Gilead Sciences GmbH

Time table:

Start: 01.12.2021
Final decision by G-BA: 19.05.2022

Final decision:

Indication for a major additional benefit

› 19.05.2022: Risankizumab (new indication: psoriatic arthritis, monotherapy or in combination with methotrexate)

Subject:

Active Substance: Risankizumab
Name: Skyrizi^®
Therapeutic area: Psoriatic arthritis
Pharmaceutical company: AbbVie Deutschland GmbH

Time table:

Start: 01.12.2021
Final decision by G-BA: 19.05.2022

Final decision:

Patients who have had an inadequate response to or have been intolerant of prior disease-modifying antirheumatic (DMARD) therapy: No additional benefit proved
Patients who have had an inadequate response to or have not tolerated, prior therapy with disease-modifying biologic antirheumatic drugs (bDMARDs): No additional benefit proved

› 19.05.2022: Nivolumab (new indication: gastric, gastro-esophageal junction (GEJ) or esophageal adenocarcinoma, CPS ≥ 5 HER2^-, first-line therapy in combination with fluoropyrimidine-and platinum-based combination chemotherapy)

Subject:

Active Substance: Nivolumab
Name: Opdivo^®
Therapeutic area: Gastric, gastro-esophageal junction (GEJ) or esophageal adenocarcinoma
Pharmaceutical company: Bristol-Myers Squibb GmbH & Co. KGaA

Time table:

Start: 01.12.2021
Final decision by G-BA: 19.05.2022

Final decision:

Hint for a considerable additional benefit

› 19.05.2022: Ertugliflozin (type 2 diabetes mellitus)

Subject:

Active Substance: Ertugliflozin
Name: Steglatro^®
Therapeutic area: Type 2 diabetes mellitus
Pharmaceutical company: MSD Sharp & Dohme GmbH

Time table:

Start: 01.12.2021
Final decision by G-BA: 19.05.2022

Final decision:

a1) Insulin-naive patients without manifested cardiovascular disease who have not achieved adequate glycemic control with their current drug therapy consisting of 1 blood glucose-lowering drug:

a2) Insulin-naive patients with manifested cardiovascular disease who have not achieved adequate glycemic control with their current drug therapy consisting of 1 blood glucose-lowering drug:

b1) Insulin-naive patients without manifested cardiovascular disease who have not achieved adequate glycemic control with their current drug therapy consisting of 2 blood glucose-lowering drugs, for whom there is no indication for insulin therapy:

b2) Insulin-naive patients with manifested cardiovascular disease who have not achieved adequate glycemic control with their current drug therapy consisting of 2 blood glucose-lowering drugs, for whom there is no indication for insulin therapy:

c1) Insulin-naive patients without manifested cardiovascular disease who have not achieved adequate glycemic control with their current drug therapy consisting of ≥ 2 blood glucose-lowering drugs, who are indicated for an insulin therapy:

c2) Insulin-naive patients with manifested cardiovascular disease who have not achieved adequate glycemic control with their current drug therapy consisting of ≥ 2 blood glucose-lowering drugs, who are indicated for an insulin therapy:

d1) Insulin-experienced patients without manifested cardiovascular disease who have not achieved adequate glycemic control with their existing insulin regimen:

d2) Insulin-experienced patients with manifested cardiovascular disease who have not achieved adequate glycemic control with their existing insulin regimen:

› 19.05.2022: Ponesimod (relapsing forms of multiple sclerosis (RMS))

Subject:

Active Substance: Ponesimod
Name: Ponvory^®
Therapeutic area: Multiple sclerosis
Pharmaceutical company: Janssen-Cilag GmbH

Time table:

Start: 01.12.2021
Final decision by G-BA: 19.05.2022

Final decision:

a1) Patients with EDSS-Score ≤ 3,5:

a2) Patients with EDSS-Score > 3,5:

› 05.05.2022: Pembrolizumab (new indication: breast cancer, triple-negative, PD-L1 expression ≥ 10 (CPS), in combination with chemotherapy)

Subject:

Active Substance: Pembrolizumab
Name: Keytruda^®
Therapeutic area: Breast cancer
Pharmaceutical company: MSD Sharp & Dohme GmbH

Time table:

Start: 15.11.2021
Final decision by G-BA: 05.05.2022

Final decision:

Pembrolizumab in combination with nab-paclitaxel or paclitaxel in comparison to nab-paclitaxel or paclitaxel: Hint for a considerable additional benefit
Pembrolizumab in combination with a chemotherapy except for nab-paclitaxel or paclitaxel: No additional benefit proved

› 05.05.2022: Pembrolizumab (new indication: carcinoma of the esophagus or gastroesophageal junction, PD-L1 expression ≥ (CPS), 1^st line, in combination with platinum- and fluoropyrimidine-based chemotherapy)

Subject:

Active Substance: Pembrolizumab
Name: Keytruda^®
Therapeutic area: Carcinoma of the esophagus
Pharmaceutical company: MSD Sharp & Dohme GmbH

Time table:

Start: 15.11.2021
Final decision by G-BA: 05.05.2022

Final decision:

a) Squamous cell carcinoma of the esophagus which is not amenable to curative treatment: Indication for a considerable additional benefit
b1) HER2-negative adenocarcinoma of the esophagus which is not amenable to curative treatment: No additional benefit proved
b2) HER2-positive adenocarcinoma of the esophagus or gastrointestinal junction which is not amenable to curative treatment: No additional benefit proved

› 05.05.2022: Elbasvir / grazoprevir (new indication: chronic hepatitis C; adolescents from 12 to < 18 years)

Subject:

Active Substance: Elbasvir / grazoprevir
Name: Zepatier^®
Therapeutic area: Chronic hepatitis C
Pharmaceutical company: Merck Sharp & Dohme B.V.

Time table:

Start: 15.11.2021
Final decision by G-BA: 05.05.2022

Final decision:

No additional benefit proved

› 05.05.2022: Delamanid (revocation of exemption: pulmonary multi-drug resistant tuberculosis, patients ≥ 10 kg)

Subject:

Active Substance: Delamanid
Name: Deltyba^®
Therapeutic area: Tuberculosis
Pharmaceutical company: Otsuka Novel Products GmbH

Time table:

Start: 15.11.2021
Final decision by G-BA: 05.05.2022

Final decision:

Pediatric patients weighing 10 kg or more: Hint for a non-quantifiable additional benefit (orphan drug)
Adult patients: Hint for a non-quantifiable additional benefit (orphan drug)

› 05.05.2022: Cefiderocol (antibiotic of last resort: infections caused by aerobic gram-negative pathogens)

Subject:

Active Substance: Cefiderocol
Name: Fetcroja^®
Therapeutic area: Infections caused by aerobic gram-negative pathogens
Pharmaceutical company: Shionogi GmbH

Time table:

Start: 15.11.2021
Final decision by G-BA: 05.05.2022

Final decision:

Additional benefit proved (reserve antibiotic)

› 21.04.2022: Ixazomib (re-assessment: multiple myeloma, ≥ 1 prior therapy(ies), in combination with lenalidomide and dexamethasone)

Subject:

Active Substance: Ixazomib
Name: Ninlaro^®
Therapeutic area: Multiple myeloma
Pharmaceutical company: Takeda GmbH

Time table:

Start: 01.11.2021
Final decision by G-BA: 21.04.2022

Final decision:

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

› 21.04.2022: Pitolisant (excessive daytime sleepiness (EDS) with obstructive sleep apnoea (OSA) after previous therapy)

Subject:

Active Substance: Pitolisant
Name: Ozawade^®
Therapeutic area: Obstructive sleep apnoea
Pharmaceutical company: Bioprojet Deutschland GmbH

Time table:

Start: 01.11.2021
Final decision by G-BA: 21.04.2022

Final decision:

No additional benefit proved

› 07.04.2022: Sofosbuvir / velpatasvir / voxilaprevir (new indication: chronic hepatitis C; adolescents from 12 to < 18 years)

Subject:

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

Time table:

Start: 15.10.2021
Final decision by G-BA: 07.04.2022

Final decision:

No additional benefit proved

› 07.04.2022: Albutrepenonacog alfa (re-assessment, 50 M € limit exceeded: hemophilia B; congenital factor IX deficiency)

Subject:

Active Substance: Albutrepenonacog alfa
Name: Idelvion^®
Therapeutic area: Hemophilia B
Pharmaceutical company: CSL Behring GmbH

Time table:

Start: 15.10.2021
Final decision by G-BA: 07.04.2022

Final decision:

No additional benefit proved

› 07.04.2022: Peanut protein as defatted powder of Arachis hypogaea L., semen (peanuts) (peanut allergy; patients aged ≥ 4 years)

Subject:

Active Substance: Peanut protein as defatted powder of Arachis hypogaea L., semen (peanuts)
Name: Palforzia^®
Therapeutic area: Peanut allergy
Pharmaceutical company: Aimmune Therapeutics Germany GmbH

Time table:

Start: 15.10.2021
Final decision by G-BA: 07.04.2022

Final decision:

No additional benefit proved

› 18.03.2022: Ravulizumab (new indication: paroxysmal nocturnal haemoglobinuria (PNH); pediatric patients)

Subject:

Active Substance: Ravulizumab
Name: Ultomiris^®
Therapeutic area: Paroxysmal nocturnal haemoglobinuria (PNH)
Pharmaceutical company: Alexion Pharma Germany GmbH

Time table:

Start: 01.10.2021
Final decision by G-BA: 18.03.2022

Final decision:

1) Pediatric patients weighing 10 kg or more with paroxysmal nocturnal hemoglobinuria (PNH) with high disease activity characterized by clinical symptoms of hemolysis: No additional benefit proved
2) Pediatric patients weighing 10 kg or more with paroxysmal nocturnal hemoglobinuria (PNH) who have been receiving eculizumab for ≥ 6 months and are clinically stable: No additional benefit proved

› 18.03.2022: Lumacaftor / ivacaftor (re-assessment: cystic fibrosis; homozygous F508del mutation in CFTR gene; aged ≥ 2 - ≤ 5 years)

Subject:

Active Substance: Lumacaftor / ivacaftor
Name: Orkambi^®
Therapeutic area: Cystic fibrosis
Pharmaceutical company: Vertex Pharmaceuticals (Europe) Limited

Time table:

Start: 01.10.2021
Final decision by G-BA: 18.03.2022

Final decision:

Hint for a non-quantifiable additional benefit

› 18.03.2022: Daratumumab (new scientific evidence (§ 14): newly diagnosed multiple myeloma, in combination with lenalidomide and dexamethasone for patients unsuitable for autologous stem cell transplantation)

Subject:

Active Substance: Daratumumab
Name: Darzalex^®
Therapeutic area: Multiple myeloma
Pharmaceutical company: Janssen-Cilag GmbH

Time table:

Start: 01.10.2021
Final decision by G-BA: 18.03.2022

Final decision:

Hint for a considerable additional benefit

› 18.03.2022: Vosoritide (achondroplasia, patients aged ≥ 2 years)

Subject:

Active Substance: Vosoritide
Name: Voxzogo^®
Therapeutic area: Achondroplasia
Pharmaceutical company: BioMarin International Limited

Time table:

Start: 01.10.2021
Final decision by G-BA: 18.03.2022

Final decision:

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

› 18.03.2022: Vandetanib (re-assessment: medullary thyroid cancer (MTC))

Subject:

Active Substance: Vandetanib
Name: Caprelsa^®
Therapeutic area: Medullary thyroid cancer
Pharmaceutical company: Sanofi Aventis Deutschland GmbH

Time table:

Start: 01.10.2021
Final decision by G-BA: 18.03.2022

Final decision:

No additional benefit proved

› 18.03.2022: Solriamfetol (obligation for benefit assessment for the first time: excessive daytime sleepiness (EDS) with obstructive sleep apnoea (OSA) after previous therapy)

Subject:

Active Substance: Solriamfetol
Name: Sunosi^®
Therapeutic area: Obstructive sleep apnoea (OSA)
Pharmaceutical company: Jazz Pharmaceuticals Ireland Ltd.

Time table:

Start: 01.10.2021
Final decision by G-BA: 18.03.2022

Final decision:

No additional benefit proved

› 03.03.2022: Roxadustat (symptomatic anaemia associated with chronic kidney disease (CKD))

Subject:

Active Substance: Roxadustat
Name: Evrenzo^®
Therapeutic area: Anaemia
Pharmaceutical company: Astellas Pharma GmbH

Time table:

Start: 15.09.2021
Final decision by G-BA: 03.03.2022

Final decision:

No additional benefit proved

› 03.03.2022: Bimekizumab (moderate to severe plaque psoriasis)

Subject:

Active Substance: Bimekizumab
Name: Bimzelx^®
Therapeutic area: Plaque psoriasis
Pharmaceutical company: UCB Pharma GmbH

Time table:

Start: 15.09.2021
Final decision by G-BA: 03.03.2022

Final decision:

Patients with moderate to severe plaque psoriasis who are not eligible for conventional therapy in the setting of initial systemic therapy: Indication for a minor additional benefit
Patients with moderate to severe plaque psoriasis who have had an inadequate response to or have not tolerated systemic therapy: Indication for a minor additional benefit

› 03.03.2022: Vericiguat (chronic heart failure)

Subject:

Active Substance: Vericiguat
Name: Verquvo^®
Therapeutic area: Chronic heart failure
Pharmaceutical company: Bayer Vital GmbH

Time table:

Start: 15.09.2021
Final decision by G-BA: 03.03.2022

Final decision:

Hint for a minor additional benefit

› 03.03.2022: Odevixibat (progressive familial intrahepatic cholestasis (PFIC) in patients aged ≥ 6 months)

Subject:

Active Substance: Odevixibat
Name: Bylvay^®
Therapeutic area: Cholestasis
Pharmaceutical company: Albireo Pharma AB

Time table:

Start: 15.09.2021
Final decision by G-BA: beginning of March 2022
This decision remains valid until: 01.06.2027

Final decision:

Hint for a minor additional benefit (orphan drug)

› 03.03.2022: Tafasitamab (diffuse large B-cell lymphoma (DLBCL) in combination with lenalidomide)

Subject:

Active Substance: Tafasitamab
Name: Minjuvi^®
Therapeutic area: Diffuse large B-cell lymphoma
Pharmaceutical company: Incyte Biosciences Germany GmbH

Time table:

Start: 15.09.2021
Final decision by G-BA: 03.03.2022

Final decision:

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

› 03.03.2022: Tofacitinib (new indication: polyarticular juvenile idiopathic arthritis (pJIA), rheumatoid factor positive [RF+] or negative [RF-] polyarthritis and extended oligoarthritis, and juvenile psoriatic arthritis (PsA) in patients aged ≥ 2 years)

Subject:

Active Substance: Tofacitinib
Name: Xeljanz^®
Therapeutic area: Polyarticular juvenile idiopathic arthritis and juvenile psoriatic arthritis
Pharmaceutical company: Pfizer Pharma GmbH

Time table:

Start: 15.09.2021
Final decision by G-BA: 03.03.2022

Final decision:

a1) Patients with active PJIA for whom previous treatment with disease-modifying antirheumatic drugs (DMARDs) proved inadequate or was not tolerated (classical DMARDs, inclusive methotrexate (MTX)) and treatment with tofacitinib as monotherapy is indicated:
No additional benefit proved
a2) Patients with active PJIA for whom previous treatment with DMARDs proved inadequate or was not tolerated (classical DMARDs, inclusive methotrexate (MTX)) and treatment with tofacitinib in combination with MTX is indicated:
No additional benefit proved
b1) Patients with active PJIA for whom previous treatment with one or more bDMARDs proved inadequate or was not tolerated and treatment with tofacitinib as monotherapy is indicated:
No additional benefit proved
b2) Patients with active PJIA for whom previous treatment with one or more bDMARDs proved inadequate or was not tolerated and treatment with tofacitinib in combination with MTX is indicated:
No additional benefit proved
c1) Patients with juvenile psoriatic arthritis for whom previous treatment with DMARDs proved inadequate:
No additional benefit proved

› 17.02.2022: Upadacitinib (new indication: atopic dermatitis, patients aged ≥ 12 years)

Subject:

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

Time table:

Start: 01.09.2021
Final decision by G-BA: 17.02.2022

Final decision:

Adult patients for which 30 mg upadacitinib is the appropriate dosage:
- Indication for a considerable additional benefit
Adult patients for which 15 mg upadacitinib is the appropriate dosage:
- No additional benefit proved
Adolescents of 12 - < 18 years of age:
- No additional benefit proved

› 17.02.2022: Dapagliflozin (new indication: chronic kidney disease)

Subject:

Active Substance: Dapagliflozin
Name: Forxiga^®
Therapeutic area: Chronic kidney diaease
Pharmaceutical company: AstraZeneca GmbH

Time table:

Start: 01.09.2021
Final decision by G-BA: 17.02.2022

Final decision:

Patients without symptomatic chronic heart failure as a comorbidity:
- Hint for a considerable additional benefit
Patients with symptomatic heart failure as a comorbidity:
- Hint for a minor additional benefit

› 17.02.2022: Relugolix / estradiol / norethisterone acetate (uterine fibroids)

Subject:

Active Substance: Relugolix / estradiol / norethisterone acetate
Name: Ryeqo^®
Therapeutic area: Uterine fibroids
Pharmaceutical company: Gedeon Richter Pharma GmbH

Time table:

Start: 01.09.2021
Final decision by G-BA: 17.02.2022

Final decision:

Patients for whom watchful waiting is the best suited patient-individual therapy:
- Hint for a considerable additional benefit
Patients for whom watchful waiting is not the best suited patient-individual therapy:
- No additional benefit proved

› 17.02.2022: Tirbanibulin (actinic keratosis (Olsen grade 1))

Subject:

Active Substance: Tirbanibulin
Name: Klisyri^®
Therapeutic area: Actinic keratosis
Pharmaceutical company: Almirall Hermal GmbH

Time table:

Start: 01.09.2021
Final decision by G-BA: 17.02.2022

Final decision:

No additional benefit proved

› 17.02.2022: Tofacitinib (new scientific evidence (§ 13): rheumatoid arthritis, pretreated patients, monotherapy or in combination with methotrexate)

Subject:

Active Substance: Tofacitinib
Name: Xeljanz^®
Therapeutic area: Rheumatoid arthritis
Pharmaceutical company: Pfizer Pharma GmbH

Time table:

Start: 01.09.2021
Final decision by G-BA: 17.02.2022

Final decision:

a1) Patients who do not have unfavorable prognostic factors and for whom previous treatment with disease-modifying antirheumatic drugs (DMARDs) proved inadequate or was not tolerated (classical DMARDs, inclusive methotrexate (MTX)) and treatment with tofacitinib as monotherapy is indicated:
- No additional benefit proved
a2) Patients who do not have unfavorable prognostic factors and for whom previous treatment with DMARDs proved inadequate or was not tolerated (classical DMARDs, inclusive methotrexate (MTX)) and treatment with tofacitinib in combination with MTX is indicated:
- No additional benefit proved
b1) Patients for whom a therapy with biotechnologically manufactured DMARDs (bDMARDs) or target-oriented synthetic DMARDs (tsDMARDs) is indicated for the first time and for whom and treatment with tofacitinib as monotherapy is indicated:
- No additional benefit proved
b2) Patients for whom a therapy with bDMARDs or tsDMARDs is indicated for the first time and for whom treatment with tofacitinib in combination with MTX is indicated:
- No additional benefit proved
c1) Patients for whom previous treatment with one or more bDMARDs and/or tsDMARDs proved inadequate or was not tolerated and treatment with tofacitinib as monotherapy is indicated:
- No additional benefit proved
c2) Patients for whom previous treatment with one or more bDMARDs and/or tsDMARDs proved inadequate or was not tolerated and treatment with tofacitinib in combination with MTX is indicated:
- No additional benefit proved

› 17.02.2022: Icosapent ethyl (dislipidemia, pre-treated patients)

Subject:

Active Substance: Icosapent ethyl
Name: Vazkepa^®
Therapeutic area: Dyslipidemia
Pharmaceutical company: Amarin Pharmaceuticals Ireland Limited

Time table:

Start: 01.09.2021
Final decision by G-BA: 17.02.2022

Final decision:

No additional benefit proved

› 17.02.2022: Migalastat (new indication: Fabry disease, patients aged 12 - < 16 years)

Subject:

Active Substance: Migalastat
Name: Galafold^®
Therapeutic area: Fabry disease
Pharmaceutical company: Amicus Therapeutics GmbH

Time table:

Start: 01.09.2021
Final decision by G-BA: 17.02.2022

Final decision:

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

› 17.02.2022: Nivolumab (new indication: oesophageal or gastro-oesophageal junction cancer, pretreated patients, adjuvant)

Subject:

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

Time table:

Start: 01.09.2021
Final decision by G-BA: 17.02.2022
This decision remains valid until: 01.10.2024

Final decision:

Indication for a non-quantifiable additional benefit

› 17.02.2022: Misoprostol (known substance with new data exclusivity: labour induction)

Subject:

Active Substance: Misoprostol
Name: Angusta^®
Therapeutic area: Labour induction
Pharmaceutical company: Norgine GmbH

Time table:

Start: 01.09.2021
Final decision by G-BA: 17.02.2022

Final decision:

No additional benefit proved

› 03.02.2022: Selumetinib (neurofibromatosis type 1, patients aged ≥ 3 - < 18 years)

Subject:

Active Substance: Selumetinib
Name: Koselugo^®
Therapeutic area: Neurofibromatosis
Pharmaceutical company: AstraZeneca GmbH

Time table:

Start: 15.08.2021
Final decision by G-BA: 03.2022
This decision remains valid until: 01.07.2023

Final decision:

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

› 03.02.2022: Daratumumab (new indication: multiple myeloma, ≥ previous therapy(ies), in combination with pomalidomide and dexamethasone)

Subject:

Active Substance: Daratumumab
Name: Darzalex^®
Therapeutic area: Multiple myeloma
Pharmaceutical company: Janssen-Cilag GmbH

Time table:

Start: 01.08.2021
Final decision by G-BA: 03.02.2022

Final decision:

a) Patients with one previous therapy containing a proteasome inhibitor and lenalidomide who became refractory towards lenalidomide: No additional benefit proved
b1) Patients with ≥ two previous therapies containing a proteasome inhibitor and lenalidomide who showed disease progression during the last therapy: Hint for a minor additional benefit
b2) Patients with ≥ two previous therapies containing a proteasome inhibitor and lenalidomide who showed disease progression after the last therapy: No additional benefit proved

› 20.01.2022: Nivolumab (new indication: colorectal cancer (CRC) with microsatellite-instability-high (MSI-H) or mismatch repair-deficient (dMMR), pre-treated patients, in combination with ipilimumab)

Subject:

Active Substance: Nivolumab
Name: Opdivo^®
Therapeutic area: Colorectal cancer (CRC)
Pharmaceutical company: Bristol-Myers Squibb GmbH & Co. KGaA

Time table:

Start: 01.08.2021
Final decision by G-BA: 20.01.2022

Final decision:

No additional benefit proved

› 20.01.2022: Daratumumab (new indication: systemic light-chain amyloidosis, 1^st line, in combination with cyclophosphamide, bortezomib and dexamethasone)

Subject:

Active Substance: Daratumumab
Name: Darzalex^®
Therapeutic area: Systemic light-chain amyloidosis
Pharmaceutical company: Janssen-Cilag GmbH

Time table:

Start: 01.08.2021
Final decision by G-BA: 20.01.2022
This decision remains valid until: 01.03.2025

Final decision:

Patients for whom bortezomib in combination with cyclophosphamide and dexamethasone is the patient-individual therapy: Hint for a minor additional benefit
Patients for whom another therapy is the patient-individual therapy: No additional benefit proved

› 20.01.2022: Cemiplimab (new indication: basal cell carcinoma, metastatic or locally advanced)

Subject:

Active Substance: Cemiplimab
Name: Libtayo^®
Therapeutic area: Basal cell carcinoma
Pharmaceutical company: Sanofi-Aventis Deutschland GmbH

Time table:

Start: 01.08.2021
Final decision by G-BA: 20.01.2022

Final decision:

Locally advanced basal cell carcinoma (laBCC): Hint for a minor additional benefit
Metastatic basal cell carcinoma (mBCC): No additional benefit proved

› 20.01.2022: Cemiplimab (new indication: non-small cell lung cancer (NSCLC), 1^st line)

Subject:

Active Substance: Cemiplimab
Name: Libtayo^®
Therapeutic area: Non-small cell lung cancer (NSCLC)
Pharmaceutical company: Sanofi-Aventis Deutschland GmbH

Time table:

Start: 01.08.2021
Final decision by G-BA: 20.01.2022

Final decision:

No additional benefit proved

› 20.01.2022: Blinatumomab (new indication: B-precursor acute lymphoblastic leukaemia (ALL), high-risk first relapsed, Ph^-, CD19⁺, patients aged ≥ 1 - < 18 years)

Subject:

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

Time table:

Start: 01.08.2021
Final decision by G-BA: 20.01.2022

Final decision:

Indication for a major additional benefit (orphan drug)

› 20.01.2022: Teriflunomide (new indication: relapsing remitting multiple sclerosis (RRMS) in patients aged 10-17 years)

Subject:

Active Substance: Teriflunomide
Name: Aubagio^®
Therapeutic area: Multiple sclerosis
Pharmaceutical company: Sanofi-Aventis Deutschland GmbH

Time table:

Start: 01.08.2021
Final decision by G-BA: 20.01.2022

Final decision:

No additional benefit proved

› 06.01.2022: Angiotensin II acetate (hypotension)

Subject:

Active Substance: Angiotensin II acetate
Name: Giapreza^®
Therapeutic area: Hypotension
Pharmaceutical company: PAION Deutschland GmbH

Time table:

Start: 15.07.2021
Final decision by G-BA: 06.01.2022

Final decision:

No additional benefit proved

› 06.01.2022: Tralokinumab (atopic dermatitis)

Subject:

Active Substance: Tralokinumab
Name: Adtralza^®
Therapeutic area: Atopic dermatitis
Pharmaceutical company: Leo Pharma A/S

Time table:

Start: 15.07.2021
Final decision by G-BA: 06.01.2022

Final decision:

No additional benefit proved

› 06.01.2022: Empagliflozin (new indication: chronic heart failure)

Subject:

Active Substance: Empagliflozin
Name: Jardiance^®
Therapeutic area: Chronic heart failure
Pharmaceutical company: Boehringer Ingelheim Pharma GmbH & Co. KG

Time table:

Start: 15.07.2021
Final decision by G-BA: 06.01.2022

Final decision:

Hint for a minor additional benefit

› 06.01.2022: Satralizumab (neuromyelitis optica spectrum disorders in anti-aquaporin-4 IgG (AQP4-IgG) seropositive patients ≥ 12 years of age)

Subject:

Active Substance: Satralizumab
Name: Enspryng^®
Therapeutic area: Neuromyelitis optica spectrum disorders
Pharmaceutical company: Roche Pharma AG

Time table:

Start: 15.07.2021
Final decision by G-BA: 06.01.2022

Final decision:

Hint for a minor additional benefit (orphan drug)

› 16.12.2021: Elotuzumab (re-assessment: multiple myeloma, ≥ 2 prior therapies, combination with pomalidomide and dexamethasone)

Subject:

Active Substance: Elotuzumab
Name: Empliciti^®
Therapeutic area: Multiple myeloma
Pharmaceutical company: Bristol Myers-Squibb GmbH & Co. KGaA

Time table:

Start: 01.07.2021
Final decision by G-BA: 16.12.2021

Final decision:

Hint for a considerable additional benefit

› 16.12.2021: Osimertinib (new indication: non-small cell lung cancer (NSCLC), EGFR mutations, adjuvant therapy)

Subject:

Active Substance: Osimertinib
Name: Tagrisso^®
Therapeutic area: Non-small cell lung cancer (NSCLC)
Pharmaceutical company: AstraZeneca GmbH

Time table:

Start: 01.07.2021
Final decision by G-BA: 16.12.2021
This resolution remains valid until: 01.07.2024

Final decision:

Patients without prior adjuvant platin-based chemotherapy: No additional benefit proved
Patients with or who are not eligible for prior adjuvant platin-based chemotherapy: Indication for a non-quantifiable additional benefit

› 16.12.2021: Nivolumab (new indication: malignant pleural mesothelioma (MPM), 1^st line, combination with ipilimumab)

Subject:

Active Substance: Nivolumab
Name: Opdivo^®
Therapeutic area: Malignant pleural mesothelioma (MPM)
Pharmaceutical company: Bristol-Myers Squibb GmbH & Co. KGaA

Time table:

Start: 01.07.2021
Final decision by G-BA: 16.12.2021

Final decision:

Patients with epithelioid tumor histology: No additional benefit proved
Patients without epithelioid tumor histology: Indication for a considerable additional benefit

› 16.12.2021: Glecaprevir / pibrentasvir (new indication: chronic hepatitis C, patients aged 3 – < 12 years)

Subject:

Active Substance: Glecaprevir / pibrentasvir
Name: Maviret^®
Therapeutic area: Chronic hepatitis C
Pharmaceutical company: AbbVie Deutschland GmbH & Co. KG

Time table:

Start: 01.07.2021
Final decision by G-BA: 16.12.2021

Final decision:

Patients with genotype 1, 4, 5 or 6: No additional benefit proved
Patients with genotype 2 or 3: No additional benefit proved

› 16.12.2021: Cabozantinib (re-assessment: thyroid carcinoma)

Subject:

Active Substance: Cabozantinib
Name: Cometriq^®
Therapeutic area: Thyroid carcinoma
Pharmaceutical company: Ipsen Pharma GmbH

Time table:

Start: 01.07.2021
Final decision by G-BA: 16.12.2021

Final decision:

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

› 16.12.2021: Brentuximab vedotin (re-assessment: systemic anaplastic large cell lymphoma (sALCL), 1^st line, in combination with cyclophosphamide, doxorubicin and prednisone (CHP))

Subject:

Active Substance: Brentuximab
Name: Adcetris^®
Therapeutic area: Anaplastic large cell lymphoma
Pharmaceutical company: Takeda GmbH

Time table:

Start: 01.07.2021
Final decision by G-BA: 16.12.2021

Final decision:

Hint for a minor additional benefit (orphan drug)

› 02.12.2021: Dostarlimab (endometrial cancer (EC), following prior treatment with a platinum-containing regimen)

Subject:

Active Substance: Dostarlimab
Name: Jemperli^®
Therapeutic area: Endometrial cancer (EC)
Pharmaceutical company: GlaxoSmithKline GmbH & Co. KG

Time table:

Start: 15.06.2021
Final decision by G-BA: 02.12.2021

Final decision:

No additional benefit proved

› 02.12.2021: Tagraxofusp (blastic plasmacytoid dendritic cell neoplasm (BPDCN), 1^st line)

Subject:

Active Substance: Tagraxofusp
Name: Elzonris^®
Therapeutic area: Blastic plasmacytoid dendritic cell neoplasm (BPDCN)
Pharmaceutical company: Stemline Therapeutics B.V.

Time table:

Start: 15.06.2021
Final decision by G-BA: 02.12.2021

Final decision:

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

› 02.12.2021: Ponesimod (relapsing forms of multiple sclerosis (RMS))

Subject:

Active Substance: Ponesimod
Name: Ponvory^®
Therapeutic area: Multiple sclerosis
Pharmaceutical company: Janssen-Cilag GmbH

Time table:

Start: 15.06.2021
Final decision by G-BA: 02.12.2021

Final decision:

Patients who did not yet receive disease modifying therapeutics or who did receive disease modifying therapeutics but have not a highly active disease:
- No decision on additional benefit yet. G-BA updated the comparative therapy and assigned IQWiG to assess the now relevant study. The final decision on additional benefit is due in 6 months.
Patients who received disease modifying therapeutics but still have a highly active disease: No additional benefit proved

› 02.12.2021: Berotralstat (prevention of recurrent attacks of hereditary angioedema (HAE), patients aged ≥ 12 years)

Subject:

Active Substance: Berotralstat
Name: Orladeyo^®
Therapeutic area: Hereditary angioedema (HAE)
Pharmaceutical company: BioCryst Pharma Deutschland GmbH

Time table:

Start: 15.06.2021
Final decision by G-BA: 02.12.2021

Final decision:

No additional benefit proved

› 02.12.2021: Venetoclax (new indication: acute myeloid leukaemia (AML), combination therapy, 1^st line)

Subject:

Active Substance: Venetoclax
Name: Venclyxto^®
Therapeutic area: Acute myeloid leukaemia (AML)
Pharmaceutical company: AbbVie Deutschland GmbH & Co. KG

Time table:

Start: 15.06.2021
Final decision by G-BA: 02.12.2021

Final decision:

Hint for a considerable additional benefit

› 19.11.2021: Bosutinib (re-assessment: chronic myelogenous leukemia (CML), Ph+, 1^st line)

Subject:

Active Substance: Bosutinib
Name: Bosulif^®
Therapeutic area: Chronic myelogenous leukemia (CML)
Pharmaceutical company: Pfizer Pharma GmbH

Time table:

Start: 01.06.2021
Final decision by G-BA: 19.11. 2021

Final decision:

No additional benefit proved

› 19.11.2021: Ivacaftor / tezacaftor / elexacaftor (new indication, 50 M € limit exceeded: cystic fibrosis, in combination with ivacaftor, patients aged ≥ 12 years (heterozygous for F508del and other or unknown mutation))

Subject:

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

Time table:

Start: 01.06.2021
Final decision by G-BA: 19.11. 2021

Final decision:

No additional benefit proved

› 19.11.2021: Ivacaftor / tezacaftor / elexacaftor (new indication, 50 M € limit exceeded: cystic fibrosis, in combination with ivacaftor, patients aged ≥ 12 years (heterozygous for F508del and RF mutation))

Subject:

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

Time table:

Start: 01.06.2021
Final decision by G-BA: 19.11. 2021

Final decision:

No additional benefit proved

› 19.11.2021: Ivacaftor / tezacaftor / elexacaftor (new indication, 50 M € limit exceeded: cystic fibrosis, in combination with ivacaftor, patients aged ≥ 12 years (heterozygous for F508del and gating mutation (including R117H))

Subject:

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

Time table:

Start: 01.06.2021
Final decision by G-BA: 19.11. 2021

Final decision:

No additional benefit proved

› 19.11.2021: Ivacaftor (new indication, 50 M € limit exceeded: cystic fibrosis, in combination with ivacaftor / tezacaftor / elexacaftor, patients aged ≥ 12 years (heterozygous for F508del and other or unknown mutation))

Subject:

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

Time table:

Start: 01.06.2021
Final decision by G-BA: 19.11. 2021

Final decision:

No additional benefit proved

› 19.11.2021: Ivacaftor (new indication, 50 M € limit exceeded: cystic fibrosis, in combination with ivacaftor / tezacaftor / elexacaftor, patients aged ≥ 12 years (heterozygous for F508del and RF mutation))

Subject:

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

Time table:

Start: 01.06.2021
Final decision by G-BA: 19.11. 2021

Final decision:

No additional benefit proved

› 19.11.2021: Ivacaftor (new indication, 50 M € limit exceeded: cystic fibrosis, in combination with ivacaftor / tezacaftor / elexacaftor, patients aged ≥ 12 years (heterozygous for F508del and gating mutation (including R117H))

Subject:

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

Time table:

Start: 01.06.2021
Final decision by G-BA: 19.11. 2021

Final decision:

No additional benefit proved

› 19.11.2021: Enzalutamide (new indication: prostate cancer, metastatic, hormone-sensitive, combination with androgen deprivation therapy)

Subject:

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

Time table:

Start: 01.06.2021
Final decision by G-BA: 19.11. 2021

Final decision:

No additional benefit proved

› 19.11.2021: Cenobamate (epilepsy, focal seizures, ≥ 2 prior therapies)

Subject:

Active Substance: Cenobamate
Name: Ontozry^®
Therapeutic area: Epilepsy
Pharmaceutical company: Angelini Pharma Deutschland GmbH

Time table:

Start: 01.06.2021
Final decision by G-BA: 19.11. 2021

Final decision:

No additional benefit proved

› 19.11.2021: Atezolizumab (new indication: non-small cell lung cancer (NSCLC), PD-L1 expression ≥ 50% on tumour cells (TC) or ≥ 10% on immune cells (IC), EGFR/ALK-negative, 1^st line)

Subject:

Active Substance: Atezolizumab
Name: Tecentriq^®
Therapeutic area: Lung cancer, non-small cell
Pharmaceutical company: Roche Pharma AG

Time table:

Start: 01.06.2021
Final decision by G-BA: 19.11. 2021

Final decision:

Patients with PD-L1 expression ≥ 50% on tumour cells (TC) or ≥10% on immune cells (IC), EGFR/ALK-negative: No additional benefit proved
Patients with PD-L1 expression < 50% on tumour cells (TC) or ≥10% on immune cells (IC), EGFR/ALK-negative: No additional benefit proved

› 04.11.2021: Atidarsagene autotemcel OTL-200 (metachromatic leukodystrophy with biallelic mutation in ARSA gene)

Subject:

Active Substance: Atidarsagene autotemcel OTL-200
Name: Libmeldy^®
Therapeutic area: Metachromatic leukodystrophy
Pharmaceutical company: Orchard Therapeutics GmbH

Time table:

Start: 01.05.2021
Final decision by G-BA: 04.11.2021
The decision remains valid until: 01.07.2024

Final decsion:

Children with late infantile or early juvenile stage of MLD without clinical manifestation of the disease:: Hint for a major additional benefit
Children with early juvenile stage of MLD with untimely clinical manifestation of the disease, who are able to walk independently, before cognitive deterioration:: Hint for a non-quantifiable additional benefit

› 04.11.2021: Cannabidiol (new indication: seizures associated with tuberous sclerosis complex (TSC); ≥ 2 years of age)

Subject:

Active Substance: Cannabidiol
Name: Epidyolex^®
Therapeutic area: Seizures associated with tuberous sclerosis complex (TSC)
Pharmaceutical company: GW Pharmaceuticals plc

Time table:

Start: 15.05.2021
Final decision by G-BA: 04.11.2021

Final decision:

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

› 04.11.2021: Obinutuzumab (re-assessment, 50 M € limit exceeded: follicular lymphoma (FL))

Subject:

Active Substance: Obinutuzumab
Name: Gazyvaro^®
Therapeutic area: Follicular lymphoma
Pharmaceutical company: Roche Pharma AG

Time table:

Start: 15.05.2021
Final decision by G-BA: 04.11.2021

Final decision:

No additional benefit proved

› 04.11.2021: Obinutuzumab (re-assessment, 50 M € limit exceeded: chronic lymphocytic leukemia (CLL))

Subject:

Active Substance: Obinutuzumab
Name: Gazyvaro^®
Therapeutic area: Chronic lymphocytic leukemia (CLL)
Pharmaceutical company: Roche Pharma AG

Time table:

Start: 15.05.2021
Final decision by G-BA: 04.11.2021

Final decision:

No additional benefit proved

› 04.11.2021: Obinutuzumab (re-assessment, 50 M € limit exceeded: follicular lymphoma, 1^st line)

Subject:

Active Substance: Obinutuzumab
Name: Gazyvaro^®
Therapeutic area: Follicular lymphoma (FL)
Pharmaceutical company: Roche Pharma AG

Time table:

Start: 15.05.2021
Final decision by G-BA: 04.11.2021

Final decision:

No additional benefit proved

› 04.11.2021: Onasemnogene abeparvovec (re-assessment, 50 M € limit exceeded: 5q-associated spinal muscular atrophy (SMA))

Subject:

Active Substance: Onasemnogene abeparvovec
Name: Zolgensma^®
Therapeutic area: Spinal muscular atrophy (SMA)
Pharmaceutical company: Novartis Gene Therapies EU Limited

Time table:

Start: 15.05.2021
Final decision by G-BA: 04.11.2021

Final decision:

Symptomatic patients with 5q-associated SMA type I: No additional benefit proved
Symptomatic patients with 5q-associated SMA type II (up to 3 copies of SMN2 gene: No additional benefit proved
Symptomatic patients with 5q-associated SMA type III (up to 3 copies of SMN2 gene: No additional benefit proved
Pre-symptomatic patients with 5q-associated SMA (up to 3 copies of SMN2 gene: No additional benefit proved