Beratung für Hersteller von Arzneimitteln,
Diagnostika und Medizinprodukten

 
 
 
 
 

English

Aktuelle Nutzenbewertungsverfahren

Hier finden Sie die aktuellen Verfahren der Frühen Nutzenbewertung. Für nähere Informationen klicken Sie auf die Wirkstoffe.

 

Ongoing (preliminary decision published)

› 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
  • Publication of assessment: 15.02.2021
  • End of public hearing: 09.03.2021
  • Final decision by G-BA: middle of May 2021

Comparative therapy:

  • For patients who are not indicated for a long-term/ continuous systemic therapy: A patient-individual optimized treatment regimen with topical and systemic therapy, depending on characteristics of the disease and under consideration of prior therapy, choosing from the following treatments:
    - topical glucocorticoids classes 2-4
    - tacrolimus (topical)
    - UV therapy (UVA/ NB-UVB/ balneotherapy
    - systemic glucocorticoids (short-term treatment only during therapy of relapse)
    - ciclosporin
  • For patients who are indicated for a long-term/ continuous systemic therapy: Dupilumab (if appropriate, in combination with TCS and/or TCI)

› 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
  • Publication of assessment: 01.03.2021
  • End of public hearing: 22.03.2021
  • Final decision by G-BA: middle of May 2021

Comparative therapy:

  • Patients who have responded insufficiently to or have not tolerated prior disease-modifying antirheumatic drug (DMARD) therapy: A TNF-α antagonist (adalimumab or certolizumab pegol or etanercept or golimumab or infliximab) or an IL17 inhibitor (ixekizumab) possibly in combination with methotrexate (MTX)
  • Patients who have responded insufficiently to or have not tolerated prior biological DMARD (bDMARD) therapy: Switch to another bDMARD (adalimumab or certolizumab pegol or etanercept or golimumab or infliximab or ixekizumab or secukinumab or ustekinumab) possibly in combination with MTX

› 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
  • Publication of assessment: 01.03.2021
  • End of public hearing: 22.03.2021
  • Final decision by G-BA: middle of May 2021

Comparative therapy:

  • Best supportive care (BSC)

› 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
  • Publication of assessment: 01.03.2021
  • End of public hearing: 22.03.2021
  • Final decision by G-BA: middle of May 2021

Comparative therapy:

  • Best supportive care (BSC)

› 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
  • Publication of assessment: 01.03.2021
  • End of public hearing: 22.03.2021
  • Final decision by G-BA: middle of May 2021

Comparative therapy:

  • Lumacaftor / ivacaftor

› 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
  • Publication of assessment: 01.03.2021
  • End of public hearing: 22.03.2021
  • Final decision by G-BA: middle of May 2021

Comparative therapy:

  • Best supportive care (BSC)

› 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
  • Publication of assessment: 01.03.2021
  • End of public hearing: 22.03.2021
  • Final decision by G-BA: middle of May 2021

Comparative therapy:

  • Patisiran

› 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
  • Publication of assessment: 01.03.2021
  • End of public hearing: 22.03.2021
  • Final decision by G-BA: middle of May 2021

Comparative therapy:

  • Therapy at the physician's discretion under consideration of
    - watchful waiting (after prior therapy with carboplatin in combination with paclitaxel)
    - bevacizumab (only after prior therapy with carboplatin in combination with paclitaxel and bevacizumab)

› 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
  • Publication of assessment: 01.03.2021
  • End of public hearing: 22.03.2021
  • Final decision by G-BA: middle of May 2021

Comparative therapy:

  • Best supportive care (BSC)

› 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
  • Publication of assessment: 01.03.2021
  • End of public hearing: 22.03.2021
  • Final decision by G-BA: middle of May 2021

Comparative therapy:

  • Lumacaftor / ivacaftor

› 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
  • Publication of assessment: 01.03.2021
  • End of public hearing: 22.03.2021
  • Final decision by G-BA: middle of May 2021

Comparative therapy:

  • Best supportive care (BSC)

› 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
  • Publication of assessment: 01.03.2021
  • End of public hearing: 22.03.2021
  • Final decision by G-BA: middle of May 2021

Comparative therapy:

  • Best supportive care (BSC)

› 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
  • Publication of assessment: 01.03.2021
  • End of public hearing: 22.03.2021
  • Final decision by G-BA: middle of May 2021

Comparative therapy:

  • An optimized standard therapy for treatment of symptomatic chronic heart failure and the underlying disease, such as hypertension, cardiac arrhythmias, coronary heart disease, diabetes mellitus, hypercholesterinaemia as well as accompanying symptoms

› 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
  • Publication of assessment: 01.03.2021
  • End of public hearing: 22.03.2021
  • Final decision by G-BA: middle of May 2021

Comparative therapy:

  • No comparative therapy due to orphan drug designation

› 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
  • Publication of assessment: 01.03.2021
  • End of public hearing: 22.03.2021
  • Final decision by G-BA: middle of May 2021

Comparative therapy:

  • Patients with HCC with Child-Pugh A or no liver cirrhosis without prior systemic therapy: Sorafenib or lenvatinib
  • Patients with HCC with Child-Pugh B without prior systemic therapy: Best supportive care (BSC)

› 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
  • Publication of assessment: 01.03.2021
  • End of public hearing: 22.03.2021
  • Final decision by G-BA: middle of May 2021

Comparative therapy:

  • No comparative therapy due to orphan drug designation

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

Comparative therapy:

  • Continuation of treatment with bevacizumab that has been started together with platinum-based 1st-line chemotherapy

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

Comparative therapy:

  • Patient-individual therapy choosing from abiraterone, enzalutamide, cabazitaxel, and docetaxel; under consideration of prior therapies and the marketing authorization of the respective medicinal products

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

Comparative therapy:

  • Watchful waiting

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

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 fludarabine in combination with cyclophosphamide and rituximab (FCR): FCR
  • b) Patients with neither 17p deletion nor TP53 mutation and who cannot be treated with FCR: bendamustine in combination with rituximab OR chlorambucil in combination with rituximab or obinutuzumab
  • c) Patients with 17p deletion or TP53 mutation or who cannot be treated with chemotherapy due to other reasons: ibrutinib

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

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 fludarabine in combination with cyclophosphamide and rituximab (FCR): FCR
  • b) Patients with neither 17p deletion nor TP53 mutation and who cannot be treated with FCR: bendamustine in combination with rituximab OR chlorambucil in combination with rituximab or obinutuzumab
  • c) Patients with 17p deletion or TP53 mutation or who cannot be treated with chemotherapy due to other reasons: ibrutinib

› 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

› 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
  • 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 therapy at the physician’s discretion (Note: guidelines recommend the use of phosphate binders containing calcium and sevelamer carbonate in children and adolescents with chronic kidney disease. Phosphate binders containing calcium are not approved in this indication. Sevelamer carbonate is approved for children aged 6 years or older with a body surface of > 0.75 m2. In clinical studies, the following comparators might be accepted: phosphate binders containing calcium and sevelamer carbonate)

› 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
  • 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 patient-individual anti-epileptic add-on therapy choosing from the following (only if indicated from a medical point of view and only without known pharmacoresistence (i.e. insufficient response), intolerance or contraindication): lamotrigine, topiramate, valproic acid (1), clobazam (2)
    (1) valproic acid is not first choice but can be a suitable option within a patient-individual therapy
    (2) for children aged 6 years or older

› 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
  • 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 patient-individual anti-epileptic add-on therapy choosing from the following (only if indicated from a medical point of view and only without known pharmacoresistance (i.e. insufficient response), intolerance or contraindication): eslicarbazepine acetate (1), gabapentin (2), lacosamide, lamotrigine, levetiracetam, oxcarbazepine (2), topiramate, valproic acid (3), zonisamide (2), brivaracetam
    (1) for children older than 6 years
    (2) for children aged 6 years or older
    (3) valproic acid is not first choice but can be a suitable option within a patient-individual therapy

› Nivolumab (new indication: non-small cell lung cancer (NSCLC), combination with ipilimumab and platinum-based chemotherapy, 1st 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
  • 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 a Tumor Proportion Score [TPS] ≥ 50% (PD-L1expression): pembrolizumab as monotherapy
  • b) Patients with a Tumor Proportion Score [TPS] < 50% (PD-L1expression):
    - Cisplatin in combination with a third generation cytostatic (vinorelbine or gemcitabine or docetaxel or paclitaxel or pemetrexed (except for mainly squamous epithelial histology)) OR
    - Carboplatin in combination with a third generation cytostatic (vinorelbine or gemcitabine or docetaxel or paclitaxel or pemetrexed (except for mainly squamous epithelial histology)) [see section K of appendix VI of Medicinal Products Directive] OR
    - Carboplatin in combination with nab-paclitaxel OR
    - Pembrolizumab in combination with pemetrexed and platinum-based chemotherapy (only for patients with non-squamous epithelial histology) OR
    - Pembrolizumab in combination with carboplatin and either paclitaxel or nab-paclitaxel (only for patients with squamous epithelial histology)

› Ipilimumab (new indication: non-small cell lung cancer (NSCLC), combination with nivolumab and platinum-based chemotherapy, 1st 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
  • 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 a Tumor Proportion Score [TPS] ≥ 50% (PD-L1expression): pembrolizumab as monotherapy
  • b) Patients with a Tumor Proportion Score [TPS] < 50% (PD-L1expression):
    - Cisplatin in combination with a third generation cytostatic (vinorelbine or gemcitabine or docetaxel or paclitaxel or pemetrexed (except for mainly squamous epithelial histology)) OR
    - Carboplatin in combination with a third generation cytostatic (vinorelbine or gemcitabine or docetaxel or paclitaxel or pemetrexed (except for mainly squamous epithelial histology)) [see section K of appendix VI of Medicinal Products Directive] OR
    - Carboplatin in combination with nab-paclitaxel OR
    - Pembrolizumab in combination with pemetrexed and platinum-based chemotherapy (only for patients with non-squamous epithelial histology) OR
    - Pembrolizumab in combination with carboplatin and either paclitaxel or nab-paclitaxel (only for patients with squamous epithelial histology)

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

Comparative therapy:

  • No comparative therapy due to orphan drug designation

› 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

 

Completed (final decision published)

› 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), 1st 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), 1st 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
  • This decision remains valid until: 01.10.2021

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, 1st 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); 1st 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:

  1. Narcolepsy without cataplexy: No additional benefit proved
  2. 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:

  1. Patients pretreated with a laxative: No additional benefit proved
  2. 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

› 15.10.2020: Givosiran (acute hepatic porphyria, patients aged ≥ 12 years)

Subject:

  • Active Substance: Givosiran
  • Name: Givlaari®
  • Therapeutic area: Acute hepatic porphyria
  • Pharmaceutical company: Alnylam Germany GmbH

Time table:

  • Start: 15.04.2020
  • Final decision by G-BA: 15.10.2020

Final decision:

  • Indication for a considerable additional benefit (orphan drug)

› 15.10.2020: Brigatinib (new indication: non-small cell lung cancer (NSCLC), ALK+, 1st line)

Subject:

  • Active Substance: Brigatinib
  • Name: Alunbrig®
  • Therapeutic area: Non-small cell lung cancer (NSCLC)
  • Pharmaceutical company: Takeda GmbH

Time table:

  • Start: 01.05.2020
  • Final decision by G-BA: 15.10.2020

Final decision:

  • a. Patients with brain metastasis: Hint for a considerable additional benefit
  • b. Patients without brain metastasis: Hint for minor additional benefit

› 15.10.2020: Darolutamide (prostate cancer, non-metastatic, high risk for metastasis)

Subject:

  • Active Substance: Darolutamide
  • Name: Nubeqa®
  • Therapeutic area: Prostate cancer
  • Pharmaceutical company: Bayer Vital GmbH

Time table:

  • Start: 01.05.2020
  • Final decision by G-BA: 15.10.2020

Final decision:

  • Indication for a considerable additional benefit

› 01.10.2020: Cobicistat (new indication: HIV infection, combination with atazanavir or darunavir, 12 - < 18 years)

Subject:

  • Active Substance: Cobicistat
  • Name: Tybost®
  • Therapeutic area: HIV infection
  • Pharmaceutical company: Gilead Sciences GmbH

Time table:

  • Start: 01.04.2020
  • Final decision by G-BA: 01.10.2020

Final decision:

  • No additional benefit proved

› 01.10.2020: Apalutamide (re-assessment: prostate cancer, non-metastatic, high risk of developing metastatic disease)

Subject:

  • Active Substance: Apalutamide
  • Name: Erleada®
  • Therapeutic area: Prostate cancer
  • Pharmaceutical company: Janssen-Cilag GmbH

Time table:

  • Start: 01.04.2020
  • Final decision by G-BA: 01.10.2020

Final decision:

  • Indication for a minor additional benefit

› 01.10.2020: Trifluridine / tipiracil (re-assessment: colorectal cancer (CRC), pretreated patients)

Subject:

  • Active Substance: Trifluridine / tipiracil
  • Name: Lonsurf®
  • Therapeutic area: Colorectal cancer
  • Pharmaceutical company: Servier Deutschland GmbH

Time table:

  • Start: 01.04.2020
  • Final decision by G-BA: 01.10.2020

Final decision:

  • Hint for a minor additional benefit

› 01.10.2020: Avelumab (assessment due to loss of orphan drug status: Merkel cell carcinoma (MCC))

Subject:

  • Active Substance: Avelumab
  • Name: Bavencio®
  • Therapeutic area: Merkel cell carcinoma
  • Pharmaceutical company: Merck Serono GmbH

Time table:

  • Start: 01.04.2020
  • Final decision by G-BA: 01.10.2020

Final decision:

  • No additional benefit proved

 

Ansprechpartner

Dr. Thomas Ecker
 
 
 
 
Dr. Thomas Ecker
Tel. +49 (40) 41 33 081-10
created by - sehstrand -