Source: https://ecker-ecker.de/news-nutzenbewertung-archiv.html
Timestamp: 2019-02-19 15:18:25
Document Index: 617569810

Matched Legal Cases: ['art: 15', 'art: 15', 'art: 27', 'art: 15', 'art: 14', 'art: 15', 'art: 15', '§ 14', '§ 14', 'art: 13', 'art: 15', 'art: 15', '§ 14', '§ 14', 'art: 29', '§ 14', 'art: 15', 'art: 15', 'art: 15', 'art: 15', 'art: 01', 'art: 15']

Bestandsmarktaufruf, Bestandsmarkt, AMNOG, G-BA, Nutzenbewertung
Aktuell: ISPOR Europe – November 2018
Nutzenbewertungsverfahren
Hier finden Sie die Verfahren der Frühen Nutzenbewertung, die vor mindestens 9 Monaten abgeschlossen wurden. Für nähere Information, wählen Sie hier den gewünschten Wirkstoff alphabetisch aus.
› Abiraterone acetate
Name: Zytiga®
Final decision by G-BA: 29.03.2012
Best supportive care population: Hint for considerable additional benefit
Docetaxel-treated patients: No additional benefit proved
› Abiraterone acetate (new therapeutic indication: prostatic neoplasms, first-line treatment)
Active Substance: Abiraterone acetate (new therapeutic indication: prostatic neoplasms, first-line treatment)
Therapeutic area: Prostatic neoplasms (chemotherapy not yet indicated)
Company: Janssen-Cilag GmbH
Start: 15.01.2013
Final decision by G-BA: 04.07.2013
Indication for a considerable additional benefit
› Abiraterone acetate (new indication: metastastic hormone sensitive prostate cancer (mHSPC))
Name: Zytiga©
Final decision by G-BA: 07.06.2018
› Aclidinium bromide [repealed]
Active Substance: Aclidinium bromidee
Name: Eklira® Genuair® / Bretaris® Genuair®
Therapeutic area: Pulmonary disease, chronic obstructive (COPD)
Pharmaceutical company: Almirall Hermal GmbH
Final decision by G-BA: 21.03.2013
No additional benefit proved
› Aclidinium bromide (re-assessment)
Active Substance: Aclidinium bromide (re-assessment)
Name: Eklira® Genuair®/Bretaris® Genuair®
Pharmaceutical company: AstraZeneca GmbH
Final decision by G-BA: 15.01.2016
Adult patients with COPD with an intermediate (or higher) severity of disease:
-Patients with stage II: No additional benefit proved
-Patients with stage III and < 2 exacerbations per year: Indication for a considerable additional benefit
-Patients with stage IV and <; 2 exacerbations per year : No additional benefit proved
Patients with a higher severity of disease with ≥ 2 exacerbations per year: No additional benefit proved
› Aclidinium bromide/ formoterol
Active Substance: Aclidinium bromide/ formoterol
Name: Duaklir® Genuair®/Brimica® Genuair®
Final decision by G-BA: 16.07.2015
Stage II: Indication of a minor additional benefit
Stage III (with < 2 exacerbations per year): Indication of a considerable additional benefit
Stage IV: No additional benefit proved
Stage III/IV (with ≥ 2 exacerbations per year): No additional benefit proved
› Afamelanotide
Active Substance: Afamelanotide
Name: Scenesse®
Therapeutic area: Erythropoietic protoporphyria (EPP)
Pharmaceutical company: Clinuvel (UK) Limited
Final decision by G-BA: 04.08.2016
The decision remains valid until: 21.01.2020
Non-quantifiable additional benefit proved (because of orphan drug status)
› Afatinib [repealed]
Name: Giotrif®
Therapeutic area: Non-small cell lung carcinoma (NSCLC)
Company: Boehringer Ingelheim Pharma GmbH & Co. KG
Start: 15.11.2013
Final decision by G-BA: 08.05 2014
Patients without pre-treatment and ECOG performance status 0 or 1 and
EGFR mutation Del19: Indication of a considerable additional benefit
EGFR mutation L858R: Hint for a minor additional benefit
Other EGFR mutations: Indication of a lesser benefit than the comparative therapy
Patients without pre-treatment and ECOG performance status 2: No additional benefit proved
Pre-treated patients (one ore more chemotherapies): No additional benefit proved
› Afatinib (re-assessment)
Active Substance: Afatinib (re-assessment)
Therapeutic area: Non-small-cell lung carcinoma (NSCLC)
Pharmaceutical company: Boehringer Ingelheim Pharma GmbH & Co. KG
Final decision by G-BA: 05.11.2015
EGFR mutation Del19: Indication of a major additional benefit
EGFR mutation L858R: No additional benefit proved
Other EGFR mutations: No additional benefit proved
Pre-treated patients (platin-based chemotherapy): No additional benefit proved
› Afatinib (new indication: non-small cell lung carcinoma of squamous histology)
Active Substance: Afatinib (new indication: non-small cell lung carcinoma of squamous histology)
Therapeutic area: Non-small cell lung carcinoma (NSCLC) of squamous histology
Final decision by G-BA: 20.10.2016
No additional benefit proved for any patient subpopulation
› Aflibercept (new indication: colorectal cancer)
Name: Zaltrapi®
Therapeutic area: Metastatic colorectal cancer
Pharmaceutical company: Sanofi-Aventis Deutschland GmbH
Final decision by G-BA: 15.08.2013
Indication of a minor additional benefit
› Aflibercept
Name: Eylea®
Therapeutic area: Neovascular age-related macular degeneration (AMD)
Final decision by G-BA: 06.06.2013
› Aflibercept (new indication: macular oedema following central retinal vein occlusion)
Active Substance: Aflibercept (new indication)
Therapeutic area: Visual impairment due to macular oedema following central retinal vein occlusion (RVO)
Company: GlaxoSmithKline GmbH & Co. KG
Final decision by G-BA: 20.03.2014
› Aflibercept (new indication: diabetic macular oedema)
Therapeutic area: Visual impairment due to diabetic macular oedema (DMO)
Final decision by G-BA: 05.03.2015
› Aflibercept (new indication: macular oedema following branch retinal vein occlusion)
Therapeutic area: Visual impairment due to macular oedema following branch retinal vein occlusion (RVO)
Final decision by G-BA: 03.09.2015
› Aflibercept (new indication: myopic choroidal neovascularisation)
Therapeutic area: Visual impairment due to myopic choroidal neovascularisation (CNV)
Final decision by G-BA: 19.05.2016
› Albiglutide
Active Substance: Albiglutide
Name: Eperzan®
Therapeutic area: Type 2 diabetes mellitus
Pharmaceutical company: GlaxoSmithKline GmbH & Co.KG
Final decision by G-BA: 19.03.2015
In combination with metformin: Indication for a minor additional benefit
For the other slices: No additional benefit proved
› Albutrepenonacog alfa
Name: Idelvion®
Pharmaceutical company: CSL Behring GmbH
Final decision by G-BA: 01.12.2016
› Alecitinib
Active Substance: Active Substance: Alecitinib
Pharmaceutical company: Roche Pharma GmbH
Final decision by G-BA: 16.10.2017
Patients for whom therapy with docetaxel or pemetrexed or ceritinib is appropriate: hint for a minor additional benefit
Patients for whom therapy with docetaxel or pemetrexed or ceritinib is not appropriate: no additional benefit proved
› Alecitinib (new indication: first-line treatment NSCLC)
Final decision by G-BA: 21.06.2018
Hint for a non-quantifiable additional benefit
› Alipogene tiparvovec
Active Substance: Alipogene tiparvovec
Name: Glybera®
Therapeutic area: Hyperlipoproteinemia Type I
Pharmaceutical company: Chiesi GmbH
Final decision by G-BA: 21.05.2015
The decision remains valid until: 31.12.2017
› Alirocumab
Active Substance: Alirocumab
Name: Praluent®
Therapeutic area: Dyslipidaemia
Final decision by G-BA: 04.05.2016
› Aliskiren/ amlodipine
Active Substance: Aliskiren/ amlodipine
Name: Rasilamlo®
Therapeutic area: Essential hypertension
Final decision by G-BA: 03.05.2012
› Allogeneic, genetically modified T cells
Active Substance: Allogeneic, genetically modified T cells
Name: Zalmoxis©
Therapeutic area: Haematopoietic stem cell transplantation (HSCT), graft-versus-host disease (GvHD)
Pharmaceutical company: Dompé farmaceutici S.p.A.
Final decision by G-BA: 05.07.2018
The decision remains valid until: 01.04.2021
Non-quantifiable additional benefit (proved because of orphan drug designation)
› Apremilast
Active Substance: Apremilast
Name: Otezla®
Therapeutic area: Psoriatic arthritis and psoriasis
Final decision by G-BA: 06.08.2015
Psoriatic arthritis: No additional benefit proved
Psoriasis: No additional benefit proved
Name: Eliquis®
Therapeutic area: Prophylaxis of thromboembolic events after total hip or knee replacement surgery
Pharmaceutical company: Bristol-Myers Squibb GmbH & Co. KGaA
Final decision by G-BA: 07.06.2012
Patients who have undergone elective knee replacement surgery: No additional benefit proved
Patients who have undergone elective hip replacement surgery: Hint for minor additional benefit
› Apixaban (new indication: prevention of stroke and systemic embolism)
Therapeutic area: Prevention of stroke and systemic embolism
Company: Bristol-Myers Squibb GmbH & Co. KGaA / Pfizer Deutschland GmbH
Final decision by G-BA: 20.06.2013
Therapeutic area: Treatment and prevention of recurrent vein thrombosis and pulmonary embolism
Pharmaceutical company: Bristol-Meyers Squibb GmbH & Co. KGaA / Pfizer Deutschland GmbH
Final decision by G-BA: 19.02.2015
Treatment: Indication of a minor additional benefit
Prophylaxis: No additional benefit proved
› Asfotase alfa
Name: Strensiq®
Pharmaceutical company: Alexion Europe SAS
Final decision by G-BA: 17.03.2016
The decision remains valid until: 01.12.2019
Patients aged ≤ 5 years: Non-quantifiable additional benefit proved (because of orphan drug status)
Patients aged > 5 years: Non-quantifiable additional benefit proved (because of orphan drug status)
› Ataluren [repealed]
Active Substance: Ataluren
Name: TranslarnaTM
Therapeutic area: Muscular Dystrophy, Duchenne
Pharmaceutical company: PTC Therapeutics International Limited
Minor additional benefit proved (because of orphan drug status)
› Ataluren (re-assessment)
Active Substance: Ataluren (re-assessment)
› Atezolizumab (indication: urothelial carcinoma)
Active Substance: Atezolizumab
Name: Tecentriq©
Therapeutic area: Urothelial carcinoma (UC)
Final decision by G-BA: 16.03.2018
Patients for whom a cisplatin-based chemotherapy is inappropriate (first-line): no additional benefit proved
Patients with prior platin-based therapy: hint for a minor additional benefit
› Atezolizumab (indication: non-small cell lung carcinoma)
Pre-treated patients for whom a therapy with docetaxel, pemetrexed, nivolumab or pembrolizumab is indicated: indication for a considerable additional benefit
Pre-treated patients for whom a therapy with docetaxel, pemetrexed, nivolumab or pembrolizumab is not indicated: no additional benefit proved
› Avelumab
Active Substance: Avelumab
Name: Bavencio©
Therapeutic area: Merkel cell carcinoma (MCC)
Pharmaceutical company: Merck Serono GmbH/ Pfizer Pharma GmbH
› Axitinib [repealed]
Active Substance: Axitinib
Name: Inlyta®
Therapeutic area: Renal cell carcinoma
Pharmaceutical company: Pfizer GmbH
The decision remains valid until: 21.03.2017
Patients pre-treated with cytokines: Hint for a minor additional benefit
Patients pre-treated with sunitinib: No additional benefit proved
› Axitinib (re-assessment)
Name: Inlyta©
Therapeutic area: Renal cell carcinoma (RCC)
Final decision by G-BA: 21.09.2017
After first-line therapy with sunitinib: additional benefit not proved
After first-line therapy with a cytokine: hint for a minor additional benefit
› Azilsartan medoxomil (as a calcium salt)
Active Substance: Azilsartan medoxomil (as a calcium salt)
Name: Edarbi®
Pharmaceutical company: Takeda Pharma GmbH
Final decision by G-BA: 15.03.2012
Takeda Pharma GmbH submitted no dossier
Edarbi® is allocated to the reference price group for angiotensin II receptor antagonists
› Baricitinib
Active Substance: Active Substance: Baricitinib
Name: Olumiant©
Therapeutic area: Rheumatoid arthritis
Patients without unfavourable prognostic factors who have responded insufficiently to prior treatment with one DMARD (incl. MTX): no additional benefit proved
bDMARD-naive patients for whom a bDMARD therapy is indicated: no additional benefit proved
Patients who have responded insufficiently to or who have not tolerated prior bDMARD therapy: additional benefit not proved
› Belatacept [repealed]
Name: Nulojix®
Therapeutic area: Kidney transplatation
Final decision by G-BA: 05.07.2012
The decision remains valid until: 05.07.2015
Indication for a minor additional benefit
› Belatacept (re-assessment)
Therapeutic area: Kidney transplantation, graft rejection
Final decision by G-BA: 07.01.2016
Indication for a considerable additional benefit.
Active Substance: Belimumab
Name: Benlysta ®
Therapeutic area: Systemic lupus erythematosus (SLE)
Pharmaceutical company: GlaxoSmithKline GmbH & Co. KG
Start: 27.07.2011
Final decision by G-BA: 02.08.2012
› Benralizumab
Active Substance: Benralizumab
Name: Fasenra©
Final decision by G-BA: 02.08.2018
a) Pre-treated patients who have not exhausted further therapy options: No additional benefit proved
b) Pre-treated patients who have exhausted all therapy options: Hint for a minor additional benefit
› Bezlotoxumab
Active Substance: Bezlotoxumab
Name: Zinplava©
Therapeutic area: Clostridium difficile infection
Final decision by G-BA: 20.09.2018
› Bictegravir/ emtricitabine/ tenofovir alafenamide
Active Substance: Bictegravir/ emtricitabine/ tenofovir alafenamide
Name: Biktarvy©
Pharmaceutical company: Gilead Sciences GmbH
Final decision by G-BA: 10.12.2018
Therapy-naive patients: no additional benefit proved.
Pre-treated patients: no additional benefit proved.
› Blinatumomab [repealed]
Active Substance: Blinatumomab
Name: Blincyto®
Therapeutic area: Acute lymphatic leucaemia (ALL)
Pharmaceutical company: Amgen GmbH
Final decision by G-BA: 02.06.2016
› Blinatumumab (re-assessment)
Active Substance: Blinatumumab
Name: Blincyto©
Therapeutic area: B-precursor acute lymphoblastic leukaemia (ALL)
Final decision by G-BA: 07.12.2017
Considerable additional benefit proven (because of orphan drug status)
› Boceprevir
Name: Victrelis®
Therapeutic area: Chronic hepatitis C
Final decision by G-BA: 01.03.2012
Indication for a non-quantifiable additional benefit
› Bosutinib
Active Substance: Bosutinib
Name: Bosulif®
Therapeutic area: Chronic myelogenous leukaemia
Final decision by G-BA: 17.10.2013
The decision remains valid until: 15.10.2018
› Bosutinib (new indication: newly diagnosed chronic myeloid leukemia)
Therapeutic area: Chronic myeloid leukemia (CML)
Final decision by G-BA: 22.11.2018
› Brentuximab vedotin
Active Substance: Brentuximab vedotin
Name: Adcetris®
Therapeutic area: Hodgkin lymphoma (HL), systemic anaplastic large cell lymphoma (sALCL)
Pharmaceutical company: Takeda Pharma Vertrieb GmbH & Co. KG
Final decision by G-BA: 16.05.2013
› Brentuximab vedotin (new indication: patients with CD30+ Hodgkin lymphoma at increased risk of relapse or progression following ASCT)
Therapeutic area: Hodgkin lymphoma (HL)
Pharmaceutical company: Takeda GmbH
Final decision by G-BA: 19.01.2017
› Brentuximab vedotin (new indication: CD30+ CTCL)
Name: Adcetris©
Therapeutic area: Non-Hodgkin lymphoma, CD30+ cutaneous T-cell lymphoma (CTCL)
Minor additional benefit (proven because of orphan drug designation)
› Brivaracetam
Name: Briviact®
Pharmaceutical company: UCB Pharma GmbH
No additional benefit proved.
› Brodalumab
Name: Kyntheum©
Therapeutic area: Plaque psoriasis
Pharmaceutical company: Leo Pharma GmbH
Final decision by G-BA: 01.03.2018
Patients who are candidates for systemic therapy: additional benefit not proven
Patients whose response to other systemic therapies, including ciclosporin, methotrexate or PUVA (psoralen and ultraviolet A-light) has been inadequate or who have a contraindication or intolerance for these therapies: indication for a non-quantifiable additional benefit
› Bromfenac
Active Substance: Bromfenac
Name: Yellox®
Therapeutic area: Postoperative ocular inflammation following cataract extraction
Pharmaceutical company: Bausch & Lomb/Dr. Mann Pharma
Final decision by G-BA: 19.01.2012
Bausch & Lomb/Dr. Mann Pharma submitted no dossier or an incomplete dossier
› Burosumab
Active Substance: Burosumab
Name: Crysvita©
Therapeutic area: Hypophosphataemia
Pharmaceutical company: Kyowa Kirin GmbH
Final decision by G-BA: 04.10.2018
The decision remains valid until: 01.10.2019
› Cabazitaxel
Name: Jevtana®
Therapeutic area: Prostate carcinoma
Patients that have been previously treated with a docetaxel-containing regimen and for whom an additional treatment with docetaxel is not suitable: indication for a minor additional benefit
Patients that have been previously treated with a docetaxel-containing regimen and for whom an additional treatment with a docetaxel-containing regimen is suitable: no additional benefit proved
› Cabozantinib
Active Substance: Cabozantinib
Name: Cometriq®
Therapeutic area: Thyroid neoplasms
Pharmaceutical company: Swedish Orphan Biovitrum GmbH
Final decision by G-BA: 22.01.2015
The decision remains valid until: 01.01.2020
› Cabozantinib (new indication: renal cell carcinoma) [repealed]
Name: Cabometyx®
Pharmaceutical company: Ipsen Pharma GmbH
Final decision by G-BA: 20.04.2017
The decision remains valid until: 15.10.2017
› Cabozantinib (new indication: 1st line treatment)
Active Substance: Cabozantinib (new indication: 1st line treatment)
Final decision by G-BA: 06.12.2018
This decision remains valid until: 06.06.2019
› Cabozantinib (re-assessment)
Name: Cabometyx©
Final decision by G-BA: 05.04.2018
Start: 15.03.2014
Final decision by G-BA: 04.09.2014
› Canagliflozin/Metformin
Active Substance: Canagliflozin/Metformin
Name: Vokanamet®
Final decision by G-BA: 05.02.2015
› Carfilzomib [repealed]
Active Substance: Carfilzomib
Name: Kyprolis®
› Carfilzomib (new indication: multiple myeloma in combination with dexamethasone) [repealed]
› Carfilzomib (re-assessment)
Name: Kyprolis©
Final decision by G-BA: 15.02.2018
In combination with lenalidomide and dexamethasone for patients who have received at least one prior therapy: hint for a considerable additional benefit
In combination with dexamethasone for patients who have received at least one prior therapy: hint for a considerable additional benefit
› Cariprazine
Active Substance: Cariprazine
Name: Reagila©
Pharmaceutical company: Recordati Pharma GmbH
Acute treatment of schizophrenia: No additional benefit proved
Schizophrenia with predominantly negative symptoms in long term treatment: Hint for a minor additional benefit
Schizophrenia without predominantly negative symptoms in long term treatment: No additional benefit proved
› Ceftaroline fosamil
Name: Zinforo®
Therapeutic area: Other beta-lactam antibiotics
Company: AstraZeneca GmbH
Start: Start: 14.05.2012
AstraZeneca GmbH is exempted from submitting a dossier as expected sales are below the legally defined threshold
› Cenegermin
Active Substance: Cenegermin
Name: Oxervate©
Therapeutic area: Keratitis
Final decision by G-BA: 02.05.2018
› Ceritinib [repealed]
Active Substance: Ceritinib
Name: Zykadia®
Final decision by G-BA: 17.12.2015
The decision remains valid until: 01.10.2016
› Ceritinib (re-assessment)
Pharmaceutical company: Novartis Pharma Gm
Final decision by G-BA: 16.03.2017
Patients eligible for a therapy with docetaxel or pemetrexed: hint for a considerable additional benefit
Patients not eligible for a therapy with docetaxel or pemetrexed: no additional benefit proved
› Ceritinib (new indication: first-line)
Active Substance: Certinib
Name: Zykadia©
Final decision by G-BA: 01.02.2018
Additional benefit not proven
› Cerliponase alfa
Name: Brineura©
Therapeutic area: Neuronal ceroid lipofuscinosis type 2 (CLN2 disease)
Pharmaceutical company: BioMarin Deutschland GmbH
Final decision by G-BA: 21.12.2017
The decision remains valid until: 01.06.2021
Non-quantifiable additional benefit proven (because of orphan drug designation)
› Cholsäure
Name: Orphacol®
Therapeutic area: Inborn errors in primary bile acid synthesis
Pharmaceutical company: Laboratoires CTRS
Final decision by G-BA: 06.11.2014
› Cladribine
Name: Mavenclad©
Pharmaceutical company: Merck Serono GmbH
Final decision by G-BA: 17.05.2018
Patients who have not had a disease-modifying therapy yet: additional benefit not proved
Patients with highly active disease despite a disease-modifying therapy: additional benefit not proved
› Cobicistat
Active Substance: Cobicistat
Name: Tybost®
Therapeutic area: HIV infection
Final decision by G-BA: 18.09.2014
No additional benefit proved because of the submission of an incomplete dossier
› Cobimetinib
Active Substance: Cobimetinib
Name: Cotellic®
› Crizotinib [repealed]
Active Substance: Crizotinib
Name: Xalkori®
Final decision by G-BA: 02.05.2013
The decision remains valid until: 01.07.2016
Patients for whom chemotherapy is indicated: hint for a considerable additional benefit
Patients for whom chemotherapy is not indicated: no additional benefit proved
› Crizotinib (new indication: non-small cell lung carcinoma (NSCLC)
Active Substance: Crizotinib (new indication)
Final decision by G-BA: 16.06.2016
› Crizotinib (re-assessment)
Active Substance: Crizotinib (re-assessment)
Start: 15.06.2016
Final decision by G-BA: 15.12.2016
› Crizotinib (new indication: non-small cell lung carcinoma, ROS1 positive)
Therapy-naive patients with ROS1 positive advanced NSCLC: no additional benefit proved
Pre-treated patients with ROS1 positive advanced NSCLC: no additional benefit proved
› Dabrafenib
Name: Tafinlar®
Final decision by G-BA: 03.04.2014
The decision remains valid until: 01.10.2017
› Dabrafenib (new indication: melanoma in combination with trametinib)
› Dabrafenib (new indication: non-small cell lung carcinoma)
Name: Tafinlar©
› Daclatasvir
Name: Daklinza®
Therapeutic area: Chronic hepatitis C virus (HCV) infection
Therapy-naive patients without cirrhosis (genotype 1): hint for a minor additional benefit
Therapy-naive patients with compensated cirrhosis (genotype 1): no additional benefit proved
Pre-treated patients (genotype 1): no additional benefit proved
Genotype 3: no additional benefit proved
Genotype 4 in combination with sofosbuvir: no additional benefit proved
Genotype 4 in combination with peginterferon alfa and ribavirin (therapy-naive): hint for a considerable additional benefit
Genotype 4 in combination with peginterferon alfa and ribavirin (pre-treated): no additional benefit proved
› Dapagliflozin
Active Substance: Dapagliflozin
Name: Forxiga®
Pharmaceutical company: Bristol-Myers Squibb GmbH & Co. KGaA/ AstraZeneca GmbH
No additional benefit proved in four examined subgroups
› Dapagliflozin/ metformin
Active Substance: Dapagliflozin/ metformin
Name: Xigduo®
Company: Bristol-Myers Squibb GmbH & Co. KGaA/ AstraZeneca GmbH
Start: 15.02.2014
Final decision: 07.08.2014
› Dapagliflozin (re-assessment accord. to § 14)
Name: Forxiga©
› Dapagliflozin/ metformin (re-assessment accord. to § 14)
Name: Xigduo©
› Daratumumab [repealed]
Active Substance: Daratumumab
Name: Darzalex®
› Daratumumab (re-assessment)
Name: Darzalex©
In combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for patients who have received at least one prior therapy: hint for a considerable additional benefit
As monotherapy for patients with relapsed and refractory multiple myeloma, whose prior therapy included a proteasome inhibitor and an immunomodulatory agent and who have demonstrated disease progression on the last therapy: additional benefit not proven
› Darunavir/ cobicistat/ emtricitabine/ tenofovir alafenamide
Active Substance: Darunavir/ cobicistat/ emtricitabine/ tenofovir alafenamide
Name: Symtuza©
› Darvadstrocel
Active Substance: Darvadstrocel
Name: Alofisel®
Therapeutic area: Rectal fistulas in adults with Morbus Crohn’s disease
› Dasabuvir
Active Substance: Dasabuvir
Name: Exviera®
Pharmaceutical company: AbbVie Deutschland GmbH & Co. KG
Therapy-naive patients without cirrhosis (genotype 1): indication for a considerable additional benefit
Therapy-naive patients with cirrhosis (genotype 1a/1b): hint for a minor additional benefit
Pre-treated patients without cirrhosis (genotype 1a/1b): hint for a considerable additional benefit
Pre-treated patients with cirrhosis (genotype 1a/1b): hint for a minor additional benefit
Therapy-naive and pre-treated patients with HIV coinfection (genotype 1a/1b): hint for a minor additional benefit
› Decitabine
Name: Dacogen®
Therapeutic area: Myeloid leukaemia
› Dexmedetomidine hydrochloride
Active Substance: Dexmedetomidine hydrochloride
Name: Dexdor®
Therapeutic area: Conscious sedation
Pharmaceutical company: Orion Corporation
Start: 13.07.2011
Final decision by G-BA: 18.08.2011
Orion Corporation is exempted from submitting a dossier as expected sales are below the legally defined threshold
› Dimethyl fumarate
Name: Tecfidera®
Pharmaceutical company: Biogen Idec GmbH
Final decision by G-BA: 16.10.2014
No additional benefit proved, because of inadequate statistical analysis
› Dimethyl fumarate (new indication: psoriasis)
Name: Skilarence©
› Dolutegravir
Active Substance: Dolutegravir
Name: Tivicay®
Company: ViiV Healthcare GmbH
Therapy-naive adult patients: proof of a considerable additional benefit
Pre-treated patients: indication for a minor additional benefit
Adolescent patients: no additional benefit proved
› Dolutegravir (new indication: HIV, age 6 and older)
Name: Tivicay©
Pharmaceutical company: ViiV Healthcare GmbH
Treatment-naive patients, from 6 to 12 years: no additional benefit proved
Pre-treated patients, from 6 to 12 years: no additional benefit proved
› Dolutegravir/ abacavir/ lamivudine
Active Substance: Dolutegravir/ abacavir/ lamivudine
Name: Triumeq®
Pre-treated patients: no additional benefit proved
Therapy-naive adult patients: indication for a considerable additional benefit
› Dolutegravir/ rilpivirin
Active Substance: Dolutegravir/ rilpivirin
Name: Juluca®
› Dulaglutide
Active Substance: Dulaglutid
Name: Trulicity®
Monotherapy: no additional benefit proved
Dual therapy (+ oral antidiabetic drug): no additional benefit proved
Triple therapy (+ 2 oral antidiabetic drugs): no additional benefit proved
Combination with Insulin (with or without oral antidiabetic drug): hint for a minor additional benefit
› Dupilumab
Active Substance: Dupilumab
Name: Dupixent©
Therapeutic area: Atopic dermatitis
› Edoxaban
Active Substance: Edoxaban
Name: Lixiana®
Therapeutic area: Prophylaxis of stroke and treatment and prophylaxis of venous thrombosis and pulmonary embolism
Pharmaceutical company: Daiichi Sankyo Deutschland GmbH
Final decision by G-BA: 21.01.2016
Prophylaxis of stroke and systemic embolism of adult patients with non-valvular atrial fibrillation (NVAF) and one or more risk factors: indication for a minor additional benefit
Treatment of deep venous thrombosis (TVT) and pulmonary embolism (LE) as well as prophylaxis of recurrent TVT and LE: no additional benefit proved
› Efmoroctocog alfa
Active Substance: Efmoroctocog alfa
Name: Elocta®
› Eftrenonacog alfa
Active Substance: Eftrenonacog alfa
Name: Alprolix®
› Elbasvir/ grazoprevir
Active Substance: Elbasvir/ grazoprevir
Name: Zepatier®
Therapeutic area: Chronic hepatitis C virus (HCV) infections
Final decision by G-BA: 15.06.2014
Genotype 1, Patients without cirrhosis or with compensated cirrhosis: no additional benefit proved
Genotype 4, Patients without cirrhosis or with compensated cirrhosis: no additional benefit proved
› Eliglustat
Name: Cerdelga®
Therapeutic area: Gaucher disaese type 1 (GD1)
Pharmaceutical company: Genzyme GmbH
Final decision by G-BA: 01.10.2015
› Elosulfase alfa [repealed]
Active Substance: Elosulfase alfa
Name: Vimizim®
Therapeutic area: Mucopolysaccharidosis, type IVA (Morquio A Syndrome, MPS IVA)
Pharmaceutical company: BioMarin Deutschland
Final decision by G-BA: 20.11.2014
› Elosulfase alfa (re-assessment)
Active Substance: Elosulfase alfa (re-assessment)
Name: Vimizim©
Therapeutic area: Mucopolysaccharidosis type IVA (Morquio A syndrome, MPS IVA)
Minor additional benefit proven (because of orphan drug status)
› Elotuzumab
Active Substance: Elotuzumab
Name: Empliciti®
Pharmaceutical company: Bristol-Meyers Squibb GmbH & Co. KGaA
Hint for a minor additional benefit
› Elvitegravir/ cobicistat/ emtricitabine/ tenofovir alafenamide
Active Substance: Elvitegravir/ cobicistat/ emtricitabine/ tenofovir alafenamide
Name: Genvoya®
Therapy-naïve adults: no additional benefit proved
Therapy-naïve patients older than 12 years: no additional benefit proved
Pre-treated adults: no additional benefit proved
Pre-treated patients older than 12 years: no additional benefit proved
› Elvitegravir/ cobicistat/ emtricitabine/ tenofovir alafenamide (new indication: patients of 6 years and older)
Active Substance: Elvitegravir/ cobicistate/ emtricitabine/ tenofovir alafenamide
Name: Genvoya©
Treatment-naïve patients (age ≥ 6 years < 12 years): No additional benefit proved
Pre-treated patients (age ≥ 6 years < 12 years): No additional benefit proved
› Elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil
Active Substance: Elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil
Name: Stribild©
Additional benefit not proved
› Elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil fumarate
Active Substance: Elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil fumarate
Name: Stribild®
Final decision by G-BA: 05.12.2013
› Emicizumab
Active Substance: Emicizumab
Name: Hemlibra©
Patients for whom exclusive on-demand treatment with bypassing products equals a patient-individual therapy: hint for a non-quantifiable additional benefit
Patients for whom another therapy equals a patient-individual therapy: no additional benefit proved.
› Empagliflozin [repealed]
Name: Jardiance®
› Empagliflozin (re-assessment)
Pharmaceutical company: Pharmaceutical company: Boehringer Ingelheim Pharma GmbH & Co. KG
Final decision by G-BA: 01.06.2016
Monotherapy (without cardiovascular disease): no additional benefit proved
Monotherapy (with cardiovascular disease): no additional benefit proved
Combination with metformin (without cardiovascular disease): hint for a minor additional benefit
Combination with metformin (with cardiovascular disease): hint for a considerable additional benefit
Combination with 1 other anti-diabetic medicinal product (except of metformin and insulin) (without cardiovascular disease): no additional benefit proved
Combination with 1 other anti-diabetic medicinal product (except of metformin and insulin) (with cardiovascular disease): hint for a considerable additional benefit
Combination with at least 2 other anti-diabetic medicinal products (without cardiovascular disease): no additional benefit proved
Combination with at least 2 other anti-diabetic medicinal products (with cardiovascular disease): hint for a considerable additional benefit
Combination with insulin (with or without oral anti-diabetic drug) (without cardiovascular disease): no additional benefit proved
Combination with insulin (with or without oral anti-diabetic drug) (with cardiovascular disease): hint for a considerable additional benefit
› Empagliflozin/ metformin
Active Substance: Empagliflozin/ metformin
Name: Synjardy®
Monotherapy empagliflozin/metformin (with or without cardiovascular disease): no additional benefit proved
Combination with other anti-diabetic medicinal products (except of insulin) (with or without cardiovascular disease): no additional benefit proved
Combination with insulin (with or without cardiovascular disease): no additional benefit proved
› Emtricitabine/ rilpivirine hydrochloride/ tenofovir disoproxil fumarate
Active Substance: Emtricitabine/ rilpivirine hydrochloride/ tenofovir disoproxil fumarate
Name: Eviplera®
Proof of a minor additional benefit
› Emtricitabine/ rilpivirine hydrochloride/ tenofovir disoproxil fumarate (new indication: pre-treated patients infected with HIV-1 without mutations associated with resistance)
Therapeutic area: HIV-1 infection with viral load ≤ 100,000 HIV-1 RNA copies/mL without mutations associated with resistance
Final decision by G-BA: 19.06.2014
› Emtricitabine/ rilpivirine/ tenofovir alafenamide
Active Substance: Emtricitabine/ rilpivirine/ tenofovir alafenamide
Name: Odefsey®
Final decision by G-BA: 05.01.2017
Therapy-naive patients, 12 years or older: no additional benefit proved
Pre-treated patients, 12 years or older: no additional benefit proved
› Emtricitabine / tenofovir alafenamide
Active Substance: Emtricitabine / tenofovir alafenamide
Name: Descovy®
Start: 15.05.2016
Final decision by G-BA: 03.11.2016
Therapy-naïve adults: no additional benefit proved.
Therapy-naïve teenagers (12 – 18 years): no additional benefit proved.
Pre-treated patients (≥ 12 years): no additional benefit proved.
› Enzalutamide
Name: Xtandi®
Therapeutic area: Prostate cancer
Company: Astellas Pharma GmbH
Final decision by G-BA: 20.02.2014
› Enzalutamide (new indication: prostate cancer after failure of androgen deprivation therapy and prior to chemotherapy
Name: XtandiTM
Pharmaceutical company: Astellas Pharma GmbH
Final decision by G-BA: 18.06.2015
› Eribulin [repealed]
Name: Halaven®
Pharmaceutical company: Eisai GmbH
Final decision by G-BA: 19.04.2012
The decision remains valid until: 19.04.2014
Patients for whom retreatment with taxanes or anthracyclines is not indicated: hint for a minor additional benefit
Patients for whom retreatment with taxanes or anthracyclines is indicated: hint for a less benefit than the comparative therapy
› Eribulin (re-assessment and new indication: breast cancer progression after chemotherapy)
Patients for whom retreatment with taxanes or anthracyclines is not indicated: hint for a considerable additional benefit
Patients for whom retreatment with taxanes or anthracyclines is indicated: no additional benefit proved
Patients with HER2-positive breast cancer for whom an anti-HER2-therapy is indicated: no additional benefit proved
› Eribulin (new indication: liposarcoma)
Therapeutic area: Liposarcoma
Patients for whom dacarbazine is an appropriate option: hint for a considerable additional benefit
Patients for whom dacarbazine is not an appropriate option: no additional benefit proved
› Ertugliflozin/ sitagliptin
Active Substance: Ertugliflozin/ sitagliptin
Name: Steglujan®
Therapeutic area: Diabetes mellitus type 2
Final decision by G-BA: 01.11.2018
› Etelcalcetid
Active Substance: Etelcalcetid
Name: Parsabiv©
Therapeutic area: Secondary hyperparathyroidism
Final decision by G-BA: 17.11.2017
› Extract from Canabis Sativa
Active Substance: Extract from Canabis Sativa
Name: Sativex®
Therapeutic area: Spasticity related to multiple sclerosis
Final decision by G-BA: 21.06.2012
The decision remains valid until: 21.06.2015
› Extract of Cannabis sativa (re-assessment)
Active Substance: Extract of Cannabis sativa
› Evolocumab
Active Substance: Evolocumab
Name: Repatha®
Start: 15.09.2015
Final decision by G-BA: 09.03.2016
No additional benefit proved for any patient population
› Evolocumab (re-assessment accord. to § 14)
Active Substance: Evolocumab (re-assessment accord. to § 14)
Final decision by G-BA: 06.09.2018
Evolocumab in combination with a statin or a statin and other lipid lowering therapies:
Patients without known atherosclerotic cardiovascular disease: no additional benefit proved
Patients with known atherosclerotic cardiovascular disease: no additional benefit proved
Patients whose medicinal and dietetic therapy options to lower lipids have been exhausted: no additional benefit proved
› Frampridine
Active Substance: Frampridine
Name: Fampyra®
Start: 29.07.2011
› Fingolimod [repealed]
Name: Gilenya®
The decision remains valid until: 20.03.2015
Patients with highly active RRMS: hint for a minor additional benefit
Patients that have not been treated sufficiently with INF-β: no additional benefit proved
Patients with rapidly evolving severe RRMS: hint for a minor additional benefit
› Fingolimod (new indication: multiple sclerosis after prior therapy) [repealed]
Final decision by G-BA: 18.12.2014
› Fingolimod (new indication: multiple sclerosis, modified prerequisites for pre-treatment)
› Fingolimod (re-assessment)
Patients with highly active relapsing-remitting multiple sclerosis (RRMS), completely pre-treated (≥ 1 year) with IFN-β: no additional benefit proved
Patients with highly active RRMS, not completely pre-treated with IFN-β: indication for a considerable additional benefit
Patients with rapidly progressing severe RRMS: indication for a minor additional benefit
› Fluticasone/ vilanterol
Active Substance: Fluticasone/ vilanterol
Name: Relvar® Ellipta®
Therapeutic area: Asthma, COPD
Pharmaceutical company submitted no dossier
› Fluticasone furoate/ vilanterol (re-assessment accord. to § 14)
Active Substance: Fluticasone furoate/ vilanterol
Therapeutic area: Asthma, bronchial
Proof for therapeutic improvements not provided (no comparative therapy as Relvar Ellipta® is part of the reference price group “combination of glucocorticoids and long-acting beta2-agonists”)
› Fluticasone furoate/ umeclidinium bromide/ vilanterol
Active Substance: Fluticasone furoate/ umeclidinium bromide/ vilanterol
Name: Trelegy Ellipta©
Therapeutic area: Chronic obstructive pulmonary disease (COPD)
Final decision by G-BA: 16.08.2018
› Gaxilose
Name: LacTestTM
Therapeutic area: Diagnosis of hypolactasia
Pharmaceutical company: VENTER PHARMA S.L.
Final decision by G-BA: 04.02.2016
› Glecaprevir/ pibrentasvir
Active Substance: Glecaprevir/ pibrentasvir
Name: Maviret©
Additional benefit not proven for any patient population:
Patients without cirrhosis or with compensated cirrhosis genotype 1
Patients without cirrhosis genotype 2
Patients with compensated cirrhosis genotype 2
Patients without cirrhosis or with compensated cirrhosis genotype 3
Patients without cirrhosis or with compensated cirrhosis genotype 4
Patients without or with compensated cirrhosis with genotypes 5, 6
Patients pre-treated with sofosbuvir + ribavirin
› Glycerol phenylbutyrate
Active Substance: Glycerol phenylbutyrate
Name: Ravicti©
Therapeutic area: Urea cycle disorders (UCD)
› Glycopyrroniumbromid
Active Substance: Glycopyrroniumbromid
Name: Sialanar©
Therapeutic area: Sialorrhea
Pharmaceutical company: Proveca Limited
› Guselkumab
Active Substance: Guselkumab
Name: Tremfya©
Patients for whom systemic therapy is appropriate: indication for a considerable additional benefit
Patients whose response to other systemic therapies, including ciclosporin, methotrexate or oral PUVA (psoralen and ultraviolet A-light) has been inadequate or who have a contraindication or intolerance for these therapies: proof for a considerable additional benefit
Name: Alkindi®
Therapeutic area: Adrenal insufficiency of patients › 18 years
Pharmaceutical company: Diurnal Ltd.
› Ibrutinib [repealed]
Name: Imbruvica®
Therapeutic area: Chronic lymphocytic leukaemia (CLL), mantle cell lymphoma (MCL)
Final decision by G-BA: 16.04.2015
› Ibrutinib (new indication: chronic lymphocytic leukaemia, first-line)
Therapeutic area: Chronic lymphocytic leukaemia (CLL)
Comparative therapy:
Patients with previously untreated CLL who are eligible for a FCR therapy: no additional benefit proved
Patients with previously untreated CLL who are not eligible for FCR therapy: no additional benefit proved
Patients with previously untreated CLL without a 17p deletion or TP53 mutation who are not eligible for chemoimmunotherapy: no additional benefit proved
› Ibrutinib (re-assessment)
Therapeutic area: Chronic lymphocytic leukaemia (CLL), mantle cell lymphoma (MCL), Waldenström‘s macroglobulinaemia (WM)
Final decision by G-BA: 21.07.2016
Patient population A: CLL
- Patients with recurrent or refractory CLL for whom chemotherapy is indicated: no additional benefit proved
- Patients with recurrent or refractory CLL for whom chemotherapy is not indicated: hint for a non-quantifiable additional benefit
- Patients with 17p deletion or TP53 mutation who are not eligible for chemoimmunotherapy (first-line): hint for a non-quantifiable additional benefit
Patient population B: recurrent or refractory MCL
- Patients for whom temsirolimus is the appropriate therapy: indication for a considerable additional benefit
- Patients for whom temsirolimus is not the appropriate therapy: no additional benefit proved
Patient population C: WM
› Ibrutinib (chronic lymphocytic leukaemia, in combination with bendamustine and rituximab)
Patients with at least 2 prior therapies for whom Bendamustin in combination with Rituximab is the patient individual optimized therapy: hint for a considerable additional benefit
Patients with a prior treatment for whom Bendamustin in combination with Rituximab is not the patient individual optimized therapy: no additional benefit proved
› Idebenone
Name: Raxone®
Therapeutic area: Leber‘s Hereditary Optic Neuropathy (LHON)
Pharmaceutical company: Santhera Pharmaceuticals
The decision remains valid until: 01.09.2020
› Idelalisib
Active Substance: Idelalisib
Name: Zydelig®
Therapeutic area: Chronic lymphocytic leukaemia (CLL), follicular lymphoma (FL)
The decision remains valid until: 01.04.2016
Patients with recurrent CLL for whom chemotherapy is indicated: no additional benefit proved
Patients with recurrent CLL for whom chemotherapy is not indicated: hint for a non-quantifiable additional benefit
Patients with refractory CLL for whom chemotherapy or ofatumumab therapy is indicated: no additional benefit proved
Patients with refractory CLL for whom chemotherapy or ofatumumab therapy is not indicated: no additional benefit proved
Patients with 17p deletion or TP53 mutation who are not eligible for any other therapies (first-line treatment): hint for a non-quantifiable additional benefit
› Idelalisib (re-assessment)
Final decision by G-BA: 15.09.2016
Final decicion:
Patients with recurrent or refractory CLL for whom chemotherapy is indicated: no additional benefit proved
Patients with recurrent or refractory CLL for whom chemotherapy is not indicated: hint for a non-quantifiable additional benefit
Patients with 17p deletion or TP53 mutation who are not eligible for chemoimmunotherapy and where idelalisib treatment has already been initiated: no additional benefit proved
› Idelalisib (new indication: chronic lymphocytic leukaemia in combination with ofatumumab or rituximab)
In combination with rituximab:
Treatment-naive patients with 17p deletion or TP53 mutation for whom no other therapy is appropriate: hint for a non-quantifiable additional benefit
In combination with ofatumumab:
Pre-treated patients with relapsing or refractory CLL: no additional benefit proved
Treatment-naive patients with 17p deletion or TP53 mutation for whom no other therapy is appropriate: no additional benefit proved
› Indacaterol/ glycopyrronium bromide
Active Substance: Indacaterol/ glycopyrronium bromide
Name: Ultibro® Breezhaler®, Xoterna® Breezhaler®
Final decision by G-BA: 08.05.2014
Patients with COPD stage II: hint for a minor additional benefit
Patients with COPD stage III and ≤ 1 exacerbation/year: indication for a minor additional benefit
Patients with COPD stage IV and ≤ 1 exacerbation/year: no additional benefit proved
Patients with COPD stage III and IV and ≥ 2 exacerbations/year: no additional benefit proved
› Ingenol mebutate
Active Substance: Ingenol mebutate
Name: Picato®
Therapeutic area: Actinic keratosis
› Inotuzumab Ozogamicin
Name: Besponsa©
Therapeutic area: B cell precursor acute lymphoblastic leukaemia (ALL)
Final decision by G-BA: 18.01.2018
Minor additional benefit proven (because of orphan drug designation)
› Insulin degludec
Name: Tresiba®
Pharmaceutical company: Novo Nordisk Pharma GmbH
No additional benefit proved because of missing access to relevant data concerning study methodology and results
› Insulin degludec (new indication: diabetes mellitus, type 2, in combination with GLP-1 receptor agonists)
Final decision by G-BA: 04.12.2014
› Insulin degludec (new indication: diabetes mellitus, children from the age of 1 year)
Final decision by G-BA: 20.08.2015
Diabetes mellitus type 1: no additional benefit proved
Diabetes mellitus type 2: no additional benefit proved
› Insulin degludec/ liraglutide
Active Substance: Insulin degludec/ liraglutide
Name: Xultophy®
Pharmaceutical company: Novo Nordisk GmbH
Final decision by G-BA: 15.10.2015
No additional benefit proved for each of the three slices
› Insulin degludec/ liraglutide (new indication: diabetes mellitus, type 2, in combination with oral antidiabetic medicinal products)
› Insulin glargine/ lixisenatide
Active Substance: Insulin glargine/ lixisenatide
Name: Suliqua®
Patients for whom the treatment with at least two blood glucose lowering medicines (only oral drugs including metformin) is inadequate: no additional benefit proved
Patients who are inadequately treated by insulin (in combination with another blood glucose lowering medicine, here metformin): no additional benefit proved
› Ipilimumab
Active Substance: Ipilimumab
Name: Yervoy®
› Ipilimumab (new indication: melanoma, first-line)
Start: 15.12.2013
Final decision by G-BA: 05.06.2014
› Ipilimumab (new indication: melanoma patients from 12 years and older)
› Ipilimumab (new indication: melanoma; in combination with nivolumab)
Name: Yervoy©
Treatment-naive BRAFwt patients: indication for less benefit
Treatment-naive BRAFmut patients: no additional benefit proved
› Isavuconazole
Name: Cresemba®
Therapeutic area: Aspergillosis and mucormycosis
Pharmaceutical company: Basilea Pharmaceutica International Ltd.
Non quantifiable additional benefit proved (because of orphan drug status)
› Ivacaftor
Active Substance: Ivacaftor
Name: Kalydeco®
Pharmaceutical company: Vertex Pharmaceuticals GmbH
Final decision by G-BA: 07.02.2013
Children aged 6-11 years: minor additional benefit
Adolescents and adults aged 12 years and older: considerable additional benefit
› Ivacaftor (new indication: cystic fibrosis in patients aged 2-5 years and in patients aged 18 years and older who have an R117H mutation in the CFTR gene)
Pharmaceutical company: Vertex Pharmaceuticals (Europe) Limited
Children aged 2-5 years with a gating mutation class III in the CFTR gene: non-quantifiable additional benefit proved (because of orphan drug status)
Patients aged 18 years and older who have an R117H mutation in the CFTR gene: minor additional benefit proved (because of orphan drug status)
› Ivacaftor (new indication: cystic fibrosis, extension to various gating mutations)
Name: Kalydeco™
Pharmaceutical company: Vertex Pharmaceuticals Limited
› Ivermectin
Name: Soolantra®
Therapeutic area: Rosacea
Pharmaceutical company: Galderma Laboratorium GmbH
Final decision by G-BA: 27.11.2015
› Ixazomib
Active Substance: Ixazomib
Name: Ninlaro®
Final decision by G-BA: 06.07.2014
The decision remains valid until: 01.07.2020
› Ixekizumab
Active Substance: Ixekizumab
Name: Taltz®
Final decision by G-BA: 17.08.2017
Patients for whom systemic therapy is appropriate: hint for a considerable additional benefit
Patients whose response to other systemic therapies, including ciclosporin, methotrexate or PUVA (psoralen and ultraviolet A-light) has been inadequate or who have contraindication or intolerance for these therapies: hint for a minor additional benefit
› Ixekizumab (new indication: psoriatic arthritis)
Name: Taltz©
Therapeutic area: Psoriatic arthritis
Patients for whom another classical disease-modifying anti-rheumatic drug (DMARD) therapy except MTX is indicated: no additional benefit proved
bDMARD-naïve patients for whom a therapy with bDMARDs is indicated for the first time: hint for a minor additional benefit
Patients who have responded inadequately or who are intolerant to one prior therapy with bDMARDs: no additional benefit proved
› Larvae of Lucilia sericata
Active Substance: Larvae of Lucilia sericata
Name: BioBag®/ BioMonde®
Therapeutic area: Wound debridement
Pharmaceutical company: BioMonde GmbH
› Ledipasvir/ sofosbuvir
Active Substance: Ledipasvir/ sofosbuvir
Name: Harvoni®
Therapy-naive patients without cirrhosis (genotype 1): hint for a considerable additional benefit
Therapy-naive patients with compensated cirrhosis (genotype 1): hint for a considerable additional benefit
Pre-treated patients without cirrhosis or with compensated cirrhosis (genotype 1): hint for a considerable additional benefit
Therapy-naive patients with compensated cirrhosis and pre-treated patients (genotype 3): no additional benefit proved
Therapy-naive patients and pre-treated patients (genotype 4): hint for a minor additional benefit
Therapy-naive patients and pre-treated patients with a HIV coinfection (genotype 1): hint for a non-quantifiable additional benefit
Patients with decompensated cirrhosis (genotype 1): hint for a non-quantifiable additional benefit
› Ledipasvir/ sofosbuvir (new indication: juvenile patients (12-17 years))
Name: Harvoni©
Treatment-naïve patients, genotypes 1, 4, 5 or 6: hint for a non quantifiable additional benefit
Treatment-naïve patients with compensated cirrhosis, genotype 3: additional benefit not proven
vPretreated patients, genotypes 1, 4, 5 or 6: hint for a non quantifiable additional benefit
Pretreated patients, genotype 3: additional benefit not proven
› Lenvatinib
Active Substance: Lenvatinib
Name: Lenvima®
Final decision by G-BA:
› Lenvatinib (new indication: renal cell carcinoma)
Name: Kisplyx®
Pharmaceutical company: Eisei GmbH
The decision remains valid until: 31.12.2020
› Letermovir
Active Substance: Letermovir
Name: Prevymis©
Therapeutic area: Cytomegalovirus infections
› Linaclotide
Active Substance: Linaclotide
Name: Constella®
Therapeutic area: Irritable bowel syndrome (IBS) with constipation
› Linagliptin [repealed]
Active Substance: Linagliptin
Name: Trajenta®
Pharmaceutical company: Boehringer Ingelheim International GmbH
› Linagliptin (new indication: diabetes mellitus, type 2, in combination with insulin with or without metformin)
› Linagliptin (re-assessment)
Final decision by G-BA: 21.02.2013
› Lisdexamfetamine
Name: Elvanse®
Therapeutic area: Attention deficit hyperactivity disorder (ADHD)
Pharmaceutical company: Shire Deutschland GmbH
Final decision by G-BA: 14.11.2013
› Lixisenatide
Active Substance: Lixisenatide
Name: Lyxumia®
Final decision by G-BA: 05.09.2013
› Lomitapide [repealed]
Name: Lojuxta®
Therapeutic area: Hypercholesterolaemia
Company: Aegerion Pharmaceuticals GmbH
The decision remains valid until: 15.06.2015
› Lomitapide (re-assessment)
Therapeutic area: Homozygous hypercholesterolemia
Pharmaceutical company: Aegerion Pharmaceuticals
Patients whose lipid lowering therapy is exhausted (with LDL apheresis): no additional benefit proved
Patients whose lipid lowering therapy is exhausted (without LDL apheresis): no additional benefit proved
Patients whose lipid lowering therapy is not exhausted: no additional benefit proved
› Lonoctocog alfa
Active Substance: Lonoctocog alfa
Name: Afstyla®
Final decision by G-BA: 20.07.2017
No additional benefit benefit proved
› Lumacaftor/ ivacaftor
Active Substance: Lumacaftor/ ivacaftor
Name: Orkambi®
› Lumacaftor/ ivacaftor (new indication: patients of 6 years and older)
Name: Orkambi©
› Lurasidone
Active Substance: Lurasidon
Name: Latuda®
Acute therapy: no additional benefit proved
Relapse prophylaxis: no additional benefit proved
› Macitentan [repealed]
Name: Opsumit®
Therapeutic area: Pulmonary arterial hypertension (PAH)
Pharmaceutical company: Actelion Pharmaceuticals Deutschland GmbH
Final decision by G-BA: 17.07.2014
› Macitentan (re-assessment, 50 Mio. € limit exceeded)
Final decision by G-BA: 06.04.2017
› Mepolizumab
Active Substance: Mepolizumab
Name: Nucala®
Therapeutic area: Refractory eosinophilic asthma
Patients who are not (or only during acute exacerbations) treated with oral corticosteroids: no additional benefit proved
Patients who are treated with oral corticosteroids on a regular basis: hint for a minor additional benefit
› Microbial collagenase from Clostridium histolyticum
Active Substance: Active Substance: Microbial collagenase from Clostridium histolyticum
Name: Xiapex®
Therapeutic area: Dupuytren's contracture
› Midostaurin (Acute myeloid leukaemia (AML))
Name: Rydapt©
Considerable additional benefit (proved because of orphan drug status)
› Midostaurin (Advanced systemic mastocytosis (advSM))
Therapeutic area: Advanced systemic mastocytosis (advSM)
Pharmaceutical company: : Novartis Pharma GmbH
Non-quantifiable additional benefit (proved because of orphan drug status)
› Migalastat
Active Substance: Migalastat
Name: GalafoldTM
Therapeutic area: Fabry Disease
Pharmaceutical company: Amicus Therapeutics GmbH
› Mirabegron
Active Substance: Mirabegron
Name: Betmiga™
Therapeutic area: Overactive bladder syndrome
› Nalmefene
Active Substance: Nalmefene
Name: Selincro®
Therapeutic area: Reduction of alcohol consumption in patients with alcohol dependence
Pharmaceutical company: Lundbeck GmbH
› Necitumumab
Active Substance: Necitumumab
Name: Portrazza®
› Nepafenac
Name: Nevanac®
Therapeutic area: Postoperative pain after cataract surgery
Pharmaceutical company: Alcon Pharma GmbH
Final decision by G-BA: 19.12.2013
› Netupitant/ palonosetron
Active Substance: Netupitant/ palonosetron
Name: Akynzeo®
Therapeutic area: Nausea and vomiting during chemotherapy due to cancer
Pharmaceutical company: RIEMSER Pharma GmbH
Moderately emetogenic chemotherapy: no additional benefit proved
Highly emetogenic chemotherapy: no additional benefit proved
› Nintedanib
Name: Vargatef®
› Nintedanib (new indication: Idiopathic Pulmonary Fibrosis)
Name: Ofev®
› Niraparib
Active Substance: Niraparib
Name: Zejula©
Therapeutic area: Ovarian, fallopian tube, or primary peritoneal cancer
Pharmaceutical company: TESARO Bio Germany GmbH
The decision remains valid until: 01.10.2020
› Nivolumab
Name: Opdivo®
Therapy-naive patients with BRAF-V600-mutated tumor: no additional benefit proved
Therapy-naive patients with BRAF-V600-wildtype tumor: indication for a considerable additional benefit
› Nivolumab (new indication: non-small cell lung carcinoma)
Name: Nivolumab BMS
Patients for whom docetaxel is indicated: indication for a considerable additional benefit
Patients for whom docetaxel is not indicated: no additional benefit proved
› Nivolumab (new indication: non-small cell lung carcinoma, after prior chemotherapy)
Patients for whom a therapy with docetaxel, pemetrexed, gefitinib, erlotinib or crizotinib is appropriate: hint for considerable additional benefit
Patients for whom such a therapy is not appropriate: no additional benefit proved
› Nivolumab (new indication: renal cell carcinoma)
Patients who are pretreated with everolimus: indication for a considerable additional benefit.
Patients who are pretreated with temsirolimus: no additional benefit proved.
› Nivolumab (new indication: melanoma, in combination with ipilimumab)
Pharmaceutical company: Bristol-Myers-Squibb GmbH & Co. KGaA
Therapy-naive patients with BRAF-V600 mutation: no additional benefit proved.
Therapy-naive patients with BRAF-V600 wildtype tumor: no additional benefit proved.
Pre-treated patients: Patient-individual therapy: no additional benefit proved
› Nivolumab (new indication: Hodgkin lymphoma)
› Nivolumab (new indication: squamous cell cancer of the head and neck)
Name: Opdivo©
Therapeutic area: Squamous cell cancer of the head and neck (SCCHN)
Patients with early progression during or after a platin-based therapy: hint for a considerable additional benefit
Patients with late progression after a platin-based therapy and for whom another platin-based therapy is appropriate: no additional benefit proved
› Nivolumab (re-assessment: melanoma, in combination with ipilimumab)
The decision remains valid until: 15.06.2018
› Nivolumab (new indication: urothelial carcinoma)
Therapeutic area: Urothel carcinoma
› Nivolumab (re-assessment: melanoma; in combination with ipilimumab)
Active Substance: Nivolumab (combi with Ipilimumab, melanoma, re-assessment)
Final decision by G-BA: 20.12.2018
Indication for less benefit (treatment-naive BRAFwt patients)
› Nonacog beta pegol
Active Substance: Nonacog beta pegol
Name: Refixia©
Therapeutic area: Haemophilia B
Final decision by G-BA: 19.04.2018
› Nusinersen
Active Substance: Nusinersen
Name: Spinraza©
Therapeutic area: Spinal muscular atrophy (5q-SMA)
Pharmaceutical company: Biogen GmbH
Type 1: major additional benefit proven (because of orphan drug designation)
Type 2: considerable additional benefit proven (because of orphan drug designation)
Type 3: Non-quantifiable additional benefit proven (because of orphan drug designation)
Type 4: Non-quantifiable additional benefit proven (because of orphan drug designation)
› Obeticholic acid
Active Substance: Obeticholic acid
Name: Ocaliva®
Therapeutic area: Biliary liver cirrhosis
Pharmaceutical company: Intercept Pharma Deutschland GmbH
The decision remains valid until: 31.10.2023
› Obinutuzumab
Name: Gazyvaro™
› Obinutuzumab (new indication: follicular lymphoma)
Name: Gazyvaro®
Therapeutic area: Follicular lymphoma (FL)
› Obinutuzumab (new indication: follicular lymphoma, 1st line)
Name: Gazyvaro©
› Ocrelizumab
Active Substance: Ocrelizumab
Name: Ocrevus©
Patients with RMS and active disease who either have not been pretreated with a disease-modifying therapy or have been pretreated but do not have highly active disease: Proof for a minor additional benefit
Patients with RMS and highly active disease despite treatment with a disease-modifying therapy: No additional benefit proved
Patients with primary progredient MS (PPMS): Hint for a minor additional benefit
› Ocriplasmin
Active Substance: Ocriplasmin
Name: Jetrea®
Therapeutic area: Vitreomacular traction syndrome
Pharmaceutical company: ThromboGenics NV / Alcon Pharma GmbH
Patients with mild symptoms: hint for a considerable additional benefit
Patients with severe symptoms: no additional benefit proved
› Olaparib
Active Substance: Olaparib
Name: LynparzaTM
Therapeutic area: Ovarial neoplasms
› Olaparib (new indication: high-grade cancer of the ovary, fallopian tube or peritoneum, including re-assessment after revocation of orphan drug designation)
Active Substance: Olaparib (new indication: high-grade cancer of the ovary, fallopian tube or peritoneum)
Name: Lynparza®
Therapeutic area: Ovarian neoplasms
› Olaratumab
Name: LartruvoTM
Final decision by G-BA: 18.05.2017
The decision remains valid until: 01.05.2020
Considerable additional benefit proved (because of orphan drug status)
› Ombitasvir/ paritaprevir/ ritonavir
Active Substance: Ombitasvir/ paritaprevir/ ritonavir
Name: Viekirax®
Therapy-naive patients without cirrhosis (genotype 1a/1b): indication for a considerable additional benefit
Therapy-naive patients with compensated cirrhosis (genotype 1a/1b): hint for a minor additional benefit
Pre-treated patients with compensated cirrhosis (genotype 1a/1b): hint for a minor additional benefit
Therapy-naive patients and pre-treated patients without cirrhosis (genotype 4): hint for a minor additional benefit
Therapy-naive patients and pre-treated patients with a HIV coinfection (genotype 1a/1b): hint for a minor additional benefit
› Opicapone
Name: Ongentys®
Therapeutic area: Parkinson’s disease
Pharmaceutical company: Bial Portela
› Osimertinib
Active Substance: Osimertinib
Name: TAGRISSO®
Start: 15.03.2016
The decision remains valid until: 30.04.2017
Patients with prior treatment with an EGFR tyrosine kinase inhibitor: no additional benefit proved
Therapy-naive patients with de novo positive T790M mutation: no additional benefit proved
Patients with prior platin-based chemotherapy and de novo positive T790M mutation: no additional benefit proved
› Osimertinib (re-assessment)
Name: Tagrisso©
With EGFR tyrosine kinase inhibitor pre-treated patients: hint for a major additional benefit
› Ospemifen
Active Substance: Ospemifen
Name: Senshio®
Therapeutic area: Vulvar and vaginal atrophy (VVA) in post-menopausal women
› Palbociclib
Active Substance: Palbociclib
Name: Ibrance®
The decision remains valid until: 02.01.2021 (first-line)/01.10.2018 (second-line)
Treatment-naive patients: no additional benefit proved
› Panobinostat
Active Substance: Panobinostat
Name: Farydak®
› Pasireotide
Name: Signifor®
Therapeutic area: Hypophysis dysfunction
Start: 15.06.2012
Final decision by G-BA: 06.12.2012
› Pasireotide (new indication: acromegaly)
Therapeutic area: Acromegaly
› Patiromer
Active Substance: Patiromer
Name: Veltassa©
Pharmaceutical company: Fresenius Medical Care Nephrologica Deutschland GmbH
› Pembrolizumab
Name: KEYTRUDA®
Therapy-naive patients with BRAF-V600 mutation: No additional benefit proved
Therapy-naive patients without BRAF-V600 mutation: hint for a considerable additional benefit
Pre-treated patients: indication for a considerable additional benefit
› Pembrolizumab (new indication: non-small cell lung carcinoma after prior chemotherapy)
Final decision by G-BA: 02.02.2017
Patients for whom a therapy with docetaxel, pemetrexed or nivolumab is appropriate: indication for a considerable additional benefit
Patients for whom the above therapy is not appropriate: no additional benefit proved
› Pembrolizumab (new indication: non-small cell lung carcinoma, first-line)
Final decision by G-BA: 03.08.2017
› Pembrolizumab (new indication: Hodgkin lymphoma)
Name: Keytruda©
› Pembrolizumab (new indication: urothelial carcinoma)
Active Substance: Pembrolizumab (new indication: urothelial carcinoma)
Therapeutic area: Urothelial carcinoma
Patients for whom cisplatin-based chemotherapy based is inappropriate: no additional benefit proved
Patients who are pretreated with cisplatin-based chemotherapy: indication for a considerable additional benefit
› Perampanel (re-assessement)
Active Substance: Perampanel
Name: Fycompa®
Therapeutic area: Partial epilepsies
Re-assessment was applied by pharmaceutical company
› Perampanel [repealed]
Therapeutic area: Partial epilepsy
Final decision by G-BA: 07.03.2013
› Perampanel (new indication: adjunctive treatment of primary generalised tonic-clonic seizures in adult and adolescent patients from 12 years of age)
Name: Fycompa©
› Pertuzumab
Active Substance: Pertuzumab
Name: Perjeta®
Final decision by G-BA: 01.10.2013
Patients with HER2-positive metastatic breast cancer with visceral metastases: hint for a considerable additional benefit
Patients with HER2-positive metastatic breast cancer with non-visceral metastases: no additional benefit proved
Patients with HER2-positive locally recurrent, not resectable breast cancer: no additional benefit proved
› Pertuzumab (new indication)
Final decision by G-BA: 18.02.2016
› Pertuzumab (new indication: breast cancer; adjuvant treatment)
Name: Perjeta©
This decision remains valid until: 02.01.2022
› Piperaquine tetraphosphate/ dihydroartemisinin
Active Substance: Piperaquine tetraphosphate/ dihydroartemisinin
Name: Eurartesim®
Therapeutic area: Malaria
Pharmaceutical company: Sigma-tau Arzneimittel GmbH
Sigma-tau Arzneimittel GmbH is exempted from submitting a dossier as expected sales are below the legally defined threshold
› Pirfenidone
Name: Esbriet®
Pharmaceutical company: InterMune Deutschland GmbH
› Pitavastatin
Name: Livazo®
Therapeutic area: Primary hypercholesterolaemia and combined (mixed) dyslipidaemia
Pharmaceutical company: Merckle Recordati GmbH
› Pitolisant
Active Substance: Pitolisant
Name: Wakix®
Therapeutic area: Narcolepsy
Pharmaceutical company: Bioprojet Pharma SARL
› Pixantrone
Active Substance: Pixantrone
Name: Pixuvri®
Therapeutic area: Non-Hodgkin B-cell lymphoma (NHL)
Pharmaceutical company: CTI Life Sciences Ltd.
› Pomalidomide [repealed]
Active Substance: Pomalidomide
Name: Imnovid®
› Pomalidomide (re-assessment, 50 Mio. € limit exceeded)
Active Substance: Pomalidomid
High dose dexamethasone as patient-individual target-oriented therapy is appropriate: hint for a considerable additional benefit
High dose dexamethasone is not appropriate as patient-individual target-oriented therapy: no additional benefit proved
› Ponatinib
Active Substance: Ponatinib
Name: Iclusig®
Therapeutic area: Lymphoblastic or myeloid leukaemia
Pharmaceutical company: ARIAD Pharmaceuticals (Germany) GmbH
Final decision by G-BA: 23.01.2014
› Propranolol
Name: Hemangiol®
Therapeutic area: Hemangioma
Pharmaceutical company: Pierre Fabre Dermatologie
Life-threatening or ulcerative hemangioma: hint for a non-quantifiable additional benefit
Hemangioma with risk of permanent scars: indication for a major additional benefit
› Radium 223
Active Substance: Radium 223
Name: Xofigo®
› Ramucirumab [repealed]
Therapeutic area: Gastric cancer
Monotherapy: minor additional benefit proved (because of orphan drug status)
In combination with paclitaxel: minor additional benefit proved (because of orphan drug status)
› Ramucirumab (new indication: colorectal cancer)
Therapeutic area: Colorectal cancer (CRC
› Ramucirumab (new indication: non-small cell lung carcinoma)
› Ramucirumab (withdrawal of orphan drug status)
In combination with paclitaxel: hint for a minor additional benefit
› Regadenoson
Name: Rapiscan®
Therapeutic area: Myocardial perfusion imaging
Pharmaceutical company: Rapidscan Pharma Solutions EU Ltd.
Rapidscan Pharma Solutions EU Ltd. submitted an incomplete dossier
The pharmaceutical company is given the opportunity to resubmit the benefit dossier in one year
› Regorafenib [repealed]
Name: Stivarga®
Therapeutic area: Colorectal cancer (CRC)
The decision remains valid until: 01.10.2015
› Regorafenib (new indication)
Therapeutic area: Gastrointestinal stromal tumours (GIST)
Bayer Vital GmbH submitted an incomplete dossier
› Regorafenib (re-assessment)
› Reslizumab
Active Substance: Reslizumab
Name: Cinqaero®
Pharmaceutical company: Teva GmbH
The decision remains valid until: 31.07.2020
Patients who are treated with inhaled corticosteroids in case of exacerbations: no additional benefit proved
Patients who are regularly treated with inhaled corticosteroids: minor additional benefit
› Retigabine [repealed]
Name: Trobalt®
GlaxoSmithKline did not chose the comparative therapy, which was decided at the advisory meeting with the G-BA
GlaxoSmithKline is given the opportunity to resubmit the benefit dossier in one year
› Retigabine (re-assessment)
Final decision by G-BA: 03.07.2014
› Ribociclib
Active Substance: Ribociclib
Name: Kisqali©
› Rilpivirine
Name: Edurant®
› Rilpivirine (new indication: HIV infections, patients aged 12-17 years)
› Riociguat
Name: Adempas®
Therapeutic area: Pulmonary hypertension
Adult patients with chronic thromboembolic pulmonary hypertension (CTEPH): minor additional benefit proved (because of orphan drug status)
Adult patients with pulmonary arterial hypertension (PAH): minor additional benefit proved (because of orphan drug status)
› Rolapitant
Active Substance: Rolapitant
Name: Varuby©
Therapeutic area: Nausea and vomiting due to chemotherapy
Patients with highly emetogenic chemotherapy: no additional benefit proved
Patients with moderately emetogenic chemotherapy: no additional benefit proved
› Rurioctocog alfa pegol)
Active Substance: Rurioctocog alfa pegol
Name: Adynovi®
› Ruxolitinib [repealed]
Active Substance: Ruxolitinib
Name: Jakavi®
Therapeutic area: Chronic myeloproliferative disorders
Minor additional benefit proved proved (because of orphan drug status)
› Ruxolitinib (re-assessment, 50 Mio. € limit exceeded)
Hint for a considerable additional benefit
› Ruxolitinib (new indication: polycythaemia vera)
Therapeutic area: Polycythaemia vera
› Sacubitril/ valsartan
Active Substance: Sacubitril/ valsartan
Name: Entresto®
Therapeutic area: Chronic heart failure with reduced ejection fraction
Patients who suffer from diabetes mellitus: hint for a minor additional benefit
Patients who do not suffer from diabetes mellitus: hint for a considerable additional benefit
› Safinamide
Active Substance: Safinamide
Name: Xadago®
Therapeutic area: Parkinson‘s disease (PD)
Pharmaceutical company: Zambon S.p.A.
The indirect comparison was accepted for benefit assessment
› Sarilumab
Name: Kevzara©
As monotherapy or in combination with methotrexate (MTX) for patients who have responded inadequately to, or who are intolerant to one disease modifying anti rheumatic drug (DMARD), and who do not have unfavourable prognostic factors: additional benefit not proven
As monotherapy for bDMARD naïve patients for whom a bDMARD therapy is indicated for the first time and who are intolerant to MTX or for whom MTX treatment is inappropriate: hint for a considerable additional benefit
In combination with MTX for bDMARD naïve patients for whom a bDMARD therapy is indicated for the first time: additional benefit not proven
As monotherapy or in combination with MTX for patients who have responded inadequately to, or who are intolerant to one or more bDMARDs: additional benefit not proven
› Saxagliptin [repealed]
Name: Onglyza®
Pharmaceutical company: Bristol-Myers Squibb GmbH & Co. KGaA / AstraZeneca GmbH
› Saxagliptin (new indication: diabetes mellitus, type 2, monotherapy)
Pharmaceutical company: Bristol-Myers Squibb GmbH &Co. KGaA and AstraZeneca Gmb
Process stopped due to withdrawal of „Bestandsmarkt“ (benefit assessment of selected pharmaceuticals in market)
› Saxagliptin (re-assessment)
Combination with metformin: no additional benefit proved
Combination with sulfonylurea: no additional benefit proved
Combination with metformin + sulfonylurea: no additional benefit proved
Combination with insulin (± metformin): no additional benefit proved
› Saxagliptin/ metformin [repealed]
Active Substance: Saxagliptin/ metformin
Name: Komboglyze®
Pharmaceutical company: Astra Zeneca GmbH & Bristol-Myers Squibb GmbH & Co. KG
Dual combination therapy saxagliptin + metformin: hint for a minor additional benefit
Triple combination therapy saxagliptin + metformin + insulin: no additional benefit proved
› Saxagliptin/ metformin (new indication: diabetes mellitus, type 2, in combination with sulfonylurea)
› Saxagliptin/ metformin (new indication: combination with other antidiabetic drugs)
Name: Komboglyze©
› Saxagliptin/ metformin (re-assessment)
Dual combination therapy saxagliptin + metformin: no additional benefit proved
› Sebelipase alfa
Active Substance: Sebelipase alfa
Name: Kanuma®
Therapeutic area: Lysosomal acid lipase (LAL) deficiency
Pharmaceutical company: Synageva BioPharma Limited
The decision remains valid until: 01.12.2020
Infants (< 6 months) with rapidly progressive LAL deficiency: non-quantifiable additional benefit proved (because of orphan drug status)
Patients with LAL deficiency: non-quantifiable additional benefit proved (because of orphan drug status)
› Secukinumab
Active Substance: Secukinumab
Name: Cosentyx®
Adult patients with moderate to severe psoriasis that are suitable for a systemic and/or phototherapy: no additional benefit proved
Adult patients with moderate to severe psoriasis if other systemic therapies (incl. ciclosporin, methotrexate or phototherapy) were not sufficiently effective or if there are contraindications or intolerances (previous therapy with biologica): indication for a considerable additional benefit.
Adult patients with moderate to severe psoriasis if other systemic therapies (incl. ciclosporin, methotrexate or phototherapy) were notsufficiently effective or if there are contraindications or intolerances (no previous therapy with biologica): indication for a minor additional benefit.
› Secukinumab (new indication: psoriatric arthritis, ankylosing spondylitis)
Therapeutic area: Psoriatic arthritis and ankylosing spondylitis
Psoriasis arthritis: no additional benefit proved
Ankylosing spondylitis: no additional benefit proved
› Secukinumab (re-assessment)
› Selexipag
Active Substance: Selexipag
Name: Uptravi®
› Siltuximab
Active Substance: Siltuximab
Name: Sylvant®
Therapeutic area: Multicentric Castleman‘s disease (MCD)
› Simeprevir
Active Substance: Simeprevir
Name: Olysio®
Therapy-naive patients with and without cirrhosis (genotype 1): indication for a considerable additional benefit
Pre-treated patients (genotype 1): indication for a considerable additional benefit
Pre-treated patients who were non-responders (genotype 1): indication for a considerable additional benefit
Pre-treated patients who were non-responders (genotype 4): no additional benefit proved
Therapy-naive patients and pre-treated patients without cirrhosis and a HIV coinfection (genotype 1, 4): hint for a minor additional benefit
Therapy-naive patients with cirrhosis and pre-treated patients who were non-responders with/without cirrhosis and a HIV coinfection: no additional benefit proved
› Simoctocog alfa
Active Substance: Simoctocog alfa
Name: Nuwiq®
Pharmaceutical company: Octapharma GmbH
Start: Start: 15.11.2014
Final decision by G-BA: 07.05.2015
› Sipuleucel-T
Active Substance: Sipuleucel-T
Name: Provenge®
Pharmaceutical company: Dendreon UK Limited
› Sitagliptin [repealed]
Name: Januvia®, Xelevia®
› Sitagliptin/ metformin [repealed]
Active Substance: Sitagliptin/ metformin
Name: Janumet®, Velmetia®
› Sitagliptin/ metformin (re-assessment)
Monotherapy sitagliptin/metformin: no additional benefit proved
› Sitagliptin (re-assessment)
Active Substance: Sitagliptin (re-assessment)
Combination with metformin: hint for a minor additional benefit
› Sofosbuvir
Name: Sovaldi®
Therapy-naive patients with cirrhosis (genotype 1): hint for a minor additional benefit
Therapy-naive patients (genotype 2): indication for a considerable additional benefit
Pre-treated patients (genotype 2): hint for a minor additional benefit
Therapy-naive patients and pre-treated patients in combination with ribavirin (genotype 3): hint for a minor additional benefit
Therapy-naive and pre-treated patients in combination with ribavirin and peginterferon alfa (genotype 3): no additional benefit proved
Therapy-naive patients and pre-treated patients (genotype 4, 5, 6): no additional benefit proved
Therapy-naive patients and pre-treated patients in combination with ribavirin and peginterferon alfa: hint for a minor additional benefit
› Sofosbuvir (new indication: chronic hepatitis C in juvenile patients (12-18 years))
Name: Sovaldi©
Treatment-naïve patients: hint for a non-quantifiable additional benefit
Pre-treated patients: hint for a non-quantifiable additional benefit
› Sofosbuvir/ velpatasvir
Active Substance: Sofosbuvir/ velpatasvir
Name: Epclusa®
Patients without cirrhosis, genotype 1: no additional benefit proved
Patients with compensated cirrhosis, genotype 1: no additional benefit proved
Patients without cirrhosis or with compensated cirrhosis, genotype 2: hint for a minor additional benefit
Patients without cirrhosis or with compensated cirrhosis, genotype 3: hint for a considerable additional benefit
Patients without cirrhosis, genotype 4: no additional benefit proved
Patients with compensated cirrhosis, genotype 4: no additional benefit proved
Patients without cirrhosis or with compensated cirrhosis, genotype 5 or 6: no additional benefit proved
Patients with decompensated cirrhosis, genotype 1: no additional benefit proved
Patients with decompensated cirrhosis, genotype 2, 3, 4, 5 or 6: hint for a non-quantifiable additional benefit
› Sofosbuvir/ velpatasvir/ voxilaprevir
Active Substance: Sofosbuvir/ velpatasvir/ voxilarprevir
Name: Vosevi©
DAA naïve patients without cirrhosis or with compensated cirrhosis, genotype 1: additional benefit not proven
DAA naïve patients without cirrhosis or with compensated cirrhosis, genotype 2: additional benefit not proven
DAA naïve patients without cirrhosis or with compensated cirrhosis, genotype 3: additional benefit not proven
DAA naïve patients without cirrhosis or with compensated cirrhosis, genotype 4: additional benefit not proven
DAA naïve patients without cirrhosis or with compensated cirrhosis, genotypes 5 or 6: additional benefit not proven
DAA experienced patients without cirrhosis or with compensated cirrhosis: additional benefit not proven
› Sonidegib
Active Substance: Sonidegib
Name: Odomzo©
Therapeutic area: Basal cell carcinoma
Pharmaceutical company: Sun Pharmaceuticals Germany GmbH
› Sucroferric oxyhydroxide
Active Substance: Sucroferric oxyhydroxide
Name: Velphoro®
Therapeutic area: Hyperphosphatemia, renal dialysis
Pharmaceutical company: Fresenius Medical Care Deutschland GmbH
› Tafamidis meglumine
Active Substance: Tafamidis meglumine
Name: Vyndaqel®
Therapeutic area: Amyloidosis
› Tafluprost/ timolol
Active Substance: Tafluprost/ timolol
Name: Taptiqom®
Therapeutic area: Open-angle glaucoma, ocular hypertension
Pharmaceutical company: Santen GmbH
› Talimogen laherparepvec
Active Substance: Talimogen laherparepvec
Name: Imlygic®
Therapy-naive patients with BRAF-V600 wildtype tumor: no additional benefit proved
› Tasimelteon
Name: Hetlioz®
Therapeutic area: Non-24-Hour Sleep-Wake Disorder (Non-24)
Pharmaceutical company: Vanda Pharmaceuticals Inc.
› Teduglutide
Active Substance: Teduglutide
Name: Revestive®
Therapeutic area: Short Bowel Syndrome (SBS)
Pharmaceutical company: NPS Pharma Germany GmbH
› Teduglutide (new indication: Short Bowel Syndrome in patients aged 1 year and above)
Active Substance: Teduglutide (new indication)
Therapeutic area: Short Bowel Syndrome in patients aged 1 year and above
› Tegafur/ gimeracil/ oteracil
Active Substance: Tegafur/ gimeracil/ oteracil
Name: Teysuno®
Therapeutic area: Gastric cancer (GC)
Pharmaceutical company: Nordic Pharma GmbH
Final decision by G-BA: 20.12.2012
Nordic Pharma GmbH submitted an incomplete dossier (only module 3)
› Telaprevir
Active Substance: Telaprevir
Name: Incivo®
Pharmaceutical company: Janssen Cilag GmbH
› Telotristat ethyl
Active Substance: Telotristat ethyl
Name: Xermelo©
Therapeutic area: Carcinoid syndrome diarrhoea
› Tenofovir alafenamide
Active Substance: Tenofovir alafenamide
Name: Vemlidy©
Therapeutic area: Chronic hepatitis B virus (HBV) infections
The decision remains valid until: 01.10.2018
Treatment-naive adult patients: additional benefit not proved
Pre-treated adult patients: additional benefit not proved
Treatment-naive adolescent patients (≥ 12 years): additional benefit not proved
Pre-treated adolescent patients (≥ 12 years): additional benefit not proved
› Teriflunomide
Name: Aubagio®
Pharmaceutical company: Sanofi-aventis groupe/Genzyme GmbH
› Ticagrelor
Name: Brilique®
Therapeutic area: Acute coronary syndromes (ACS)
Start: 01.01.20111
Final decision by G-BA: 15.12.2011
Instable angina pectoris (IA)/non-ST-segment elevation myocardial infarction (NSTEMI): proof of a considerable additional benefit
ST-segment elevation myocardial infarction (STEMI), pharmaceutically treated: no additional benefit proved
ST-segment elevation myocardial infarction (STEMI), percutaneous coronary intervention (PCI): no additional benefit proved (except for patients ≥ 75 years for whom treatment with prasugrel is not appropriate and patients with a history of transient ischemic attack or ischemic stroke: hint for a non-quantifiable additonal benefit)
ST-segment elevation myocardial infarction (STEMI), coronary artery bypass surgery: no additional benefit proved
› Ticagrelor (new indication: prevention of artherothrombotic events in patients with a history of myocardial infarction and a hig risk of developing an atherothrombotic event)
Active Substance: Ticagrelor (new indication: prevention of artherothrombotic events in patients with a history of myocardial infarction and a hig risk of developing an atherothrombotic event)
Therapeutic area: Prevention of artherothrombotic events in patients with a history of myocardial infarction (MI) and a hig risk of developing an atherothrombotic event
› Tiotropium/ olodaterol
Active Substance: Tiotropium/ olodaterol
Name: Spiolto® Respimat®
Pharmaceutical company: Boehringer Ingelheim Pharma GmbH & Co.KG
COPD stage II and higher: indication for a minor additional benefit
COPD stage II/IV or respiratory insufficiency and 2 or more exacerbations per year: hint for less benefit than the comparative therapy
› Tivozanib
Active Substance: Tivozanib
Name: Fotivda©
Pharmaceutical company: EUSA Pharma GmbH
1. with favorable or intermediate prognosis (MSKCC score 0-2): additional benefit not proved
2. with non-favorable prognosis (MSKCC score ≥ 3): additional benefit not proved
With progression following cytokine therapy but only if treatment-naïve regarding VEGFR or TOR pathway inhibitors: additional benefit not proved
› Tofacitinib
Name: Xeljanz©
Final decision by G-BA: 19.10.2017
› Tofacitinib (re-assessment of patient population b2)
Name: Xeljanz®
b2) insufficiently pre-treated patients who are bDMARD-naïve: no additional benefit proved
› Trametinib
Active Substance: Trametinib
Name: Mekinist®
In combination with dabrafenib: indication for a considerable additional benefit
› Trametinib (new indication: non-small cell lung carcinoma)
Name: Mekinist©
› Trastuzumab emtansine
Name: Kadcyla®
Patients with HER2 positive, locally advanced, unresectable breast cancer: no additional benefit proved
Patients with HER2 positive, metastatic breast cancer after prior therapy containing anthracyclines, taxanes, trastuzumab: indication for a considerable additional benefit
Patients with HER2 positive, metastatic breast cancer after prior therapy containing taxanes and trastuzumab: no additional benefit proved
› Trifludine/ tipiracil
Active Substance: Trifludine/ tipiracil
Name: Lonsurf®
Pharmaceutical company: Servier Deutschland GmbH
The decision remains valid until: 31.01.2019
› Turoctocog alfa
Name: NovoEight®
Therapeutic area: Haemophilia A
› Umeclidinium
Active Substance: Umeclidinium
Name: Incruse®
Patients with stage II: no additional benefit proved
Patients with higher stages: no additional benefit proved
› Umeclidinium/ vilanterol
Active Substance: Umeclidinium/ vilanterol
Name: Anoro®, Laventair®
Start: 15.07.2014
Final decision by G-BA: 08.01.2015
› Vantedanib [repealed]
Active Substance: Vandetanib
Name: Caprelsa®
Therapeutic area: Medullary thyroid carcinoma (MTC)
Final decision by G-BA: 06.09.2012
AstraZeneca GmbH submitted an incomplete dossier
› Vandetanib (re-assessment)
Therapeutic area: Medullary thryoid cancer (MTC)
› Vandetanib (new indication: thyroid neoplasms, age 5 and older)
Therapeutic area: Thyroid neoplasms (age 5 and older)
Non-quantifiable additional benefit (because of evidence transfer to pediatric population)
› Vedolizumab
Name: Entyvio®
Therapeutic area: Crohn‘s disease, ulcerative colitis
Pharmaceutical company: Takeda Pharma A/S
› Velmanase alfa
Active Substance: Velmanase alfa
Name: Lamzede©
Therapeutic area: Alpha-mannosidosis
› Vemurafenib [repealed]
Active Substance: Vemurafenib
Name: Zelboraf®
The decision remains valid until: 06.09.2013
› Vemurafenib (re-assessment)
Final decision by G-BA: 06.03.2014
› Venetoclax
Name: Venclyxto®
Pharmaceutical company: AbbVie Deutschland GmbH
The decision remains valid until: 15.06.2022
Adult patients with CLL with 17p depletion or TP53 mutation who are not suited for treatment with a B cell pathway inhibitor or whose therapy failed: non-quantifiable additional benefit proved (because of orphan drug status)
Adult patients with CLL without 17p depletion or TP53 mutation who failed chemoimmunotherapy as well as treatment with a B cell pathway inhibitor: non-quantifiable additional benefit proved (because of orphan drug status)
› Vildagliptin
Name: Galvus®, Jalra®, Xiliarx®
› Vildagliptin (new assessment)
› Vildagliptin/ metformin
Active Substance: Vildagliptin/ metformin
Name: Eucreas®, Icandra®, Zomarist®
› Vismodegib [repealed]
Active Substance: Vismodegib
Name: Erivedge®
Final decision by G-BA: 06.02.2014
The decision remains valid until: 15.02.2016
Patients with symptomatic metastatic basal cell carcinoma: no additional benefit proved
Patients with lokally advanced basal cell carcinoma inappropriate for surgery or radiotherapy: hint for a minor additional benefit
› Vismodegib (re-assessment)
Active Substance: Vismodegib (re-assessment)
› Vortioxetine
Active Substance: Vortioxetin
Name: Brintellix®