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Completed

Subject:

  • Active Substance: Abiraterone acetate
  • Name: Zytiga®
  • Therapeutic area: Prostatic Neoplasms
  • Pharmaceutical company: Janssen-Cilag GmbH

Time table:

  • Start: 01.10.2011
  • Final decision by G-BA: 29.03.2012

Final decision:

  • Considerable additional benefit (hint) for the best supportive care population
  • No additional benefit proved for Docetaxal-treated patients

Subject:

  • Active Substance: Abiraterone acetate (new therapeutic indication)
  • Name: Zytiga®
  • Therapeutic area: Prostatic Neoplasms (chemotherapy not yet indicated)
  • Company: Janssen-Cilag GmbH

Time table:

  • Start: 15.01.2013
  • Final decision by G-BA: 04.07.2013

Final decision:

  • considerable additional benefit (indication)

Subject:

  • Active Substance: Aclidinium bromidee
  • Name: Eklira® Genuair® / Bretaris® Genuair®
  • Therapeutic area: COPD
  • Pharmaceutical company: Almirall Hermal GmbH

Time table:

  • Start: 01.10.2012
  • Final decision by G-BA: 21.03.2013

Final decision:

  • No additional benefit proved

Subject:

  • Active Substance: Aclidinium bromide (re-assessment)
  • Name: Eklira® Genuair®/Bretaris® Genuair®
  • Therapeutic area: Pulmonary Disease, Chronic Obstructive (COPD)
  • Pharmaceutical company: AstraZeneca GmbH

Time table:

  • Start: 15.10.2015
  • Final decision by G-BA: 15.01.2016

Final decision:

  • 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.

Subject:

  • Active Substance: Aclidinium bromide/Formoterol
  • Name: Duaklir® Genuair®/Brimica® Genuair®
  • Therapeutic area: Pulmonary Disease, Chronic Obstructive (COPD)
  • Pharmaceutical company: AstraZeneca GmbH

Time table:

  • Start: 01.02.2015
  • Publication of assessment: 04.05.2015
  • End of public hearing: 26.05.2015
  • Final decision by G-BA: 16.07.2015

Final decision:

  • 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.

Subject:

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

Time table:

  • Start: 15.02.2016
  • Final decision by G-BA: 04.08.2016
  • The decision remains valid until: 21.01.2020

Final decision:

  • Non-quantifiable additional benefit (proved because of orphan drug status).

Subject:

  • Active Substance: Afatinib
  • Name: Giotrif®
  • Therapeutic area: non-small-cell lung cancer
  • Company: Boehringer Ingelheim Pharma GmbH & Co. KG

Time table:

  • Start: 15.11.2013
  • Final decision by G-BA: 08.05 2014

Final decision:

  • Minor additional benefit (hint) and considerable additional benefit (indication) for two mutations
  • Less benefit than the comparative therapy (indication) for all other mutations
  • The decision remains valid until 15.05.2015

Subject:

  • Active Substance: Afatinib (re-assessment)
  • Name: Giotrif®
  • Therapeutic area: Non-small-cell lung carcinoma
  • Pharmaceutical company: Boehringer Ingelheim Pharma GmbH & Co. KG

Time table:

  • Start: 15.05.2015
  • Final decision by G-BA: 05.11.2015

Final decision:

  • Patients without pre-treatment and with EGFR-mutation Del19 and ECOG performance status 0 or 1: Indication for a major additional benefit
  • All other patients (without pre-treatment and patients with pre-treatment (platin-based chemotherapy)): No additional benefit proved.

Subject:

  • Active Substance: Afatinib (new indication)
  • Name: Giotrif®
  • Therapeutic area: Non-small cell lung cancer (NSCLC)
  • Pharmaceutical company: Boehringer Ingelheim Pharma GmbH & Co. KG

Time table:

  • Start: 01.05.2016
  • Final decision by G-BA: 20.10.2016

Final decision:

  • No additional benefit proved for any patient subpopulation.

Subject:

  • Active Substance: Aflibercept
  • Name: Zaltrapi®
  • Therapeutic area: Metastatic colorectal cancer
  • Pharmaceutical company: Sanofi-Aventis Deutschland GmbH

Time table:

  • Start: 01.03.2013
  • Final decision by G-BA: 15.08.2013

Final decision:

  • Minor additional benefit (indication)

Subject:

  • Active Substance: Aflibercept
  • Name: Eylea®
  • Therapeutic area: neovascular age-related macular degeneration
  • Pharmaceutical company: Bayer Vital GmbH

Time table:

  • Start: 15.12.2012
  • Final decision by G-BA: 06.06.2013

Final decision:

  • No additional benefit proved

Subject:

  • Active Substance: Aflibercept (new indication)
  • Name: Eylea®
  • Therapeutic area: Macular oedema folowing a central-retinal-vein occlusion
  • Company: GlaxoSmithKline GmbH & Co. KG

Time table:

  • Start: 01.10.2013
  • Final decision by G-BA: 20.03.2014

Final decision:

  • No additional benefit proved

Subject:

  • Active Substance: Aflibercept
  • Name: Eylea®
  • Therapeutic area: Macular edema due to diabetes complications
  • Pharmaceutical company: Bayer Vital GmbH

Time table:

  • Start: 15.09.2014
  • Final decision by G-BA: 05.03.2015

Final decision:

  • No additional benefit proved.

Subject:

  • Active Substance: Aflibercept
  • Name: Eylea®
  • Therapeutic area: Macular edema due to branch retinal vein occlusion
  • Pharmaceutical company: Bayer Vital GmbH

Time table:

  • Start: 15.03.2015
  • Final decision by G-BA: 03.09.2015

Final decision:

  • No additional benefit proved.

Subject:

  • Active Substance: Aflibercept
  • Name: Eylea®
  • Therapeutic area: Impairment of sight due to myopic choroidal neovascularization
  • Pharmaceutical company: Bayer Vital GmbH

Time table:

  • Start: 01.12.2015
  • Final decision by G-BA: 19.05.2016

Final decision:

  • No additional benefit proved.

Subject:

  • Active Substance: Albiglutide
  • Name: Eperzan®
  • Therapeutic area: Diabetes Mellitus, Type 2
  • Pharmaceutical company: GlaxoSmithKline GmbH & Co.KG

Time table:

  • Start: 01.10.2014
  • Final decision by G-BA: 19.03.2015

Final decision:

  • In combination with metformin: Indication for a minor additional benefit.
  • For the other slices: No additional benefit proved.

Subject:

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

Time table:

  • Start: 01.06.2016
  • Final decision by G-BA: 01.12.2016

Final decision:

  • Non-quantifiable additional benefit (proved because of orphan drug designation)

Subject:

  • Active Substance: Alipogene tiparvovec
  • Name: Glybera®
  • Therapeutic area: Hyperlipoproteinemia Type I
  • Pharmaceutical company: Chiesi GmbH

Time table:

  • Start: 01.11.2014
  • Final decision by G-BA: 21.05.2015
  • The decision remains valid until: 31.12.2017

Final decision:

  • Non-quantifiable additional benefit (proved because of orphan drug status)

Subject:

  • Active Substance: Alirocumab
  • Name: Praluent®
  • Therapeutic area: Dyslipidemia
  • Pharmaceutical company: Sanofi-Aventis Deutschland GmbH

Time table:

  • Start: 15.11.2015
  • Final decision by G-BA: 04.05.2016

Final decision:

  • No additional benefit proved.

Subject:

  • Active Substance: Aliskiren/amlodipine
  • Name: Rasilamlo®
  • Therapeutic area: essential hypertonia
  • Pharmaceutical company: Novartis Pharma GmbH

Time table:

  • Start: 15.05.2011
  • Final decision by G-BA: 03.05.2012

Final decision:

  • No additional benefit proved
  • Novartis did not chose the comparative therapy, which was decided at the advisory meeting with the G-BA
  • Novartis is given the opportunity to resubmit the benefit dossier in one year

Subject:

  • Active Substance: Apremilast
  • Name: Otezla®
  • Therapeutic area: Psoriatic Arthritis and Psoriasis
  • Pharmaceutical company: Celgene GmbH

Time table:

  • Start: 15.02.2015
  • Final decision by G-BA: 06.08.2015

Final decision:

  • Psoriatic arthritis: No additional benefit proved
  • Psoriasis: No additional benefit proved

Subject:

  • Active Substance: Apixaban
  • Name: Eliquis®
  • Therapeutic area: Prophylaxis of thromboembolic events after total hip or knee replacement surgery
  • Pharmaceutical company: Bristol-Myers Squibb GmbH & Co. KGaA

Time table:

  • Start: 15.06.2011
  • Final decision by G-BA: 07.06.20112

Final decision:

  • No additional benefit proved in patients with knee replacement surgery because it is not clear, if risk-benefit-ratio is positive
  • Minor additional benefit (hint) in patients with hip replacement surgery

Subject:

  • Active Substance: Apixaban
  • Name: Eliquis®
  • Therapeutic area: Prophylaxis of strokes
  • Company: Bristol-Myers Squibb GmbH & Co. KGaA / Pfizer Deutschland GmbH

Time table:

  • Start: 01.01.2013
  • Final decision by G-BA: 20.06.2013

Final decision:

  • Minor aditional benefit (hint)

Subject:

  • Active Substance: Apixaban
  • Name: Eliquis®
  • Therapeutic area: Athroplasty Venous Thromboembolism
  • Pharmaceutical company: Bristol-Meyers Squibb GmbH & Co. KGaA / Pfizer Deutschland GmbH

Time table:

  • Start: 01.09.2014
  • Final decision by G-BA: 19.02.2015

Final decision:

  • Therapy: Indication for a minor additional benefit.
  • Prophylaxis: No additional benefit proved.

Subject:

  • Active Substance: Asfotase alfa
  • Name: Strensiq®
  • Therapeutic area: Hypophosphatasia
  • Pharmaceutical company: Alexion Europe SAS

Time table:

  • Start: 01.10.2016
  • Final decision by G-BA: 17.03.2016 (valid until 01.12.2018)

Final decision:

  • Patients age ≤ 5 years: non-quantifiable additional benefit (proved because of orphan drug designation)
  • Patients age > 5 years: non-quantifiable additional benefit (proved because of orphan drug designation)

Subject:

  • Active Substance: Ataluren
  • Name: TranslarnaTM
  • Therapeutic area: Muscular Dystrophy, Duchenne
  • Pharmaceutical company: PTC Therapeutics International Limited

Time table:

  • Start: 01.12.2014
  • Final decision by G-BA: 21.05.2015

Final decision:

  • Minor additional benefit (proved because of orphan drug status)
  • The resolution remains valid until 1 June 2016.

Subject:

  • Active Substance: Ataluren (re-assessment)
  • Name: TranslarnaTM
  • Therapeutic area: Duchenne Muscular Dystrophy
  • Pharmaceutical company: PTC Therapeutics International Limited

Time table:

  • Start: 01.06.2016
  • Final decision by G-BA: 01.12.2016

Final decision:

  • Minor additional benefit (proved because of orphan drug designation)

Subject:

  • Active Substance: Axitinib
  • Name: Inlyta®
  • Therapeutic area: Renal cell carcinoma
  • Pharmaceutical company: Pfizer GmbH

Time table:

  • Start: 01.10.2012
  • Final decision by G-BA: 21.03.2013

Final decision:

  • Minor aditional benefit (hint) in subgroup “after first-line therapy with cytokines“
  • No additional benefit proved in subgroup “after first-line therapy with sunitinib“
  • The decision remains valid until 21.03.2017

Subject:

  • Active Substance: Azilsartan medoxomil (as a calcium salt)
  • Name: Edarbi®
  • Therapeutic area: Hypertension
  • Pharmaceutical company: Takeda Pharma GmbH

Time table:

  • Start: 15.01.2012
  • Final decision by G-BA: 15.03.2012

Final decision:

  • No additional benefit proved
  • Takeda Pharma GmbH submitted no dossier
  • Edarbi® is allocated to the reference price group for angiotensin II receptor antagonists

Subject:

  • Active Substance: Belatacept
  • Name: Nulojix®
  • Therapeutic area: Kidney transplatation
  • Pharmaceutical company: Bristol-Myers Squibb GmbH & Co. KGaA

Time table:

  • Start: 15.07.2011
  • Final decision by G-BA: 05.07.2012

Final decision:

  • Minor additional benefit (indication) for the target patient population
  • The decision remains valid until 05.07.2015

Subject:

  • Active Substance: Belatacept
  • Name: Nulojix®
  • Therapeutic area: Kidney transplantation, graft rejection
  • Pharmaceutical company: Bristol-Myers Squibb GmbH & Co. KGaA

Time table:

  • Start: 15.07.2015
  • Final decision by G-BA: 07.01.2016

Final decision:

  • Indication for a considerable additional benefit.

Subject:

  • Active Substance: Belimumab
  • Name: Benlysta ®
  • Therapeutic area: Systemic lupus erythematosus (SLE)
  • Pharmaceutical company: GlaxoSmithKline GmbH & Co. KG

Time table:

  • Start: 27.07.2011
  • Final decision by G-BA: 02.08.2012

Final decision:

  • Considerable additional benefit (indication) for the target patient population

Subject:

  • Active Substance: Blinatumomab
  • Name: Blincyto®
  • Therapeutic area: Acute lymphatic leucaemia
  • Pharmaceutical company: Amgen GmbH

Time table:

  • Start: 15.12.2015
  • Final decision by G-BA: 02.06.2016

Final decision:

  • Non-quantifiable additional benefit (proved because of orphan drug designation).

Subject:

  • Active Substance: Boceprevir
  • Name: Victrelis®
  • Therapeutic area: Chronic hepatitis C
  • Pharmaceutical company: MSD SHARP & DOHME GmbH

Time table:

  • Start: 01.09.2011
  • Final decision by G-BA: 01.03.2012

Final decision:

  • Non-qantifiable additional benefit (indication) for patients without cirrhosis
  • No additional benefit proved for patients with cirrhosis

Subject:

  • Active Substance: Bosutinib
  • Name: Bosulif®
  • Therapeutic area: chronic myelogenous leukaemia
  • Company: Pfizer Pharma GmbH

Time table:

  • Start: 01.05.2013
  • Final decision by G-BA: 17.10.2013

Final decision:

  • Non-quantifiable additional benefit
  • The decision remains valid until 15.10.2018

Subject:

  • Active Substance: Brentuximab vedotin
  • Name: Adcetris®
  • Therapeutic area: Hodgkin-Lymphoma, anaplastic large cell lymphoma
  • Pharmaceutical company: Takeda Pharma Vertrieb GmbH & Co. KG

Time table:

  • Start: 01.12.2012
  • Final decision by G-BA: 16.05.2013

Final decision:

  • Non-quantifiable additional benefit

Subject:

  • Active Substance: Brivaracetam
  • Name: Briviact®
  • Therapeutic area: Epilepsy
  • Pharmaceutical company: UCB Pharma GmbH

Time table:

  • Start: 15.02.2016
  • Final decision by G-BA: 04.08.2016

Final decision:

  • No additional benefit proved.

Subject:

  • Active Substance: Bromfenac
  • Name: Yellox®
  • Therapeutic area: postoperative ocular inflammation following cataract extraction
  • Pharmaceutical company: Bausch & Lomb/Dr. Mann Pharma

Time table:

  • Start: 01.08.2011
  • Final decision by G-BA: 19.01.2012

Final decision:

  • No additional benefit proved
  • Bausch & Lomb/Dr. Mann Pharma submitted no dossier or an incomplete dossier

Subject:

  • Active Substance: Cabazitaxel
  • Name: Jevtana®
  • Therapeutic area: Prostate carcinoma
  • Pharmaceutical company: Sanofi-Aventis Deutschland GmbH

Time table:

  • Start: 15.04.2011
  • Final decision by G-BA: 29.03.2012

Final decision:

  • Minor additional benefit (indication) for the best supportive care population
  • No additional benefit proved for Docetaxal-treated patients

Subject:

  • Active Substance: Cabozantinib
  • Name: Cometriq®
  • Therapeutic area: Thyroid Neoplasms
  • Pharmaceutical company: Swedish Orphan Biovitrum GmbH

Time table:

  • Start: 01.08.2014
  • Final decision by G-BA: 22.01.2015

Final decision:

  • Minor additional benefit (proved because of orphan drug status).

Subject:

  • Active Substance: Canagliflozin
  • Name: Invokana®
  • Therapeutic area: Type 2 diabetes mellitus
  • Pharmaceutical company: Janssen-Cilag GmbH

Time table:

  • Start: 15.03.2014
  • Final decision by G-BA: 04.09.2014

Final decision:

  • No additional benefit proved

Subject:

  • Active Substance: Canagliflozin/Metformin
  • Name: Vokanamet®
  • Therapeutic area: Diabetes Mellitus, Type 2
  • Pharmaceutical company: Janssen-Cilag GmbH

Time table:

  • Start: 15.08.2014
  • Final decision by G-BA: 05.02.2015

Final decision:

  • No additional benefit proved.

Subject:

  • Active Substance: Carfilzomib
  • Name: Kyprolis®
  • Therapeutic area: Multiple Myeloma
  • Pharmaceutical company: Amgen GmbH

Time table:

  • Start: 15.12.2015
  • Final decision by G-BA: 02.06.2016

Final decision:

  • Non-quantifiable additional benefit (proved because of orphan drug designation).

Subject:

  • Active Substance: Ceftaroline fosamil
  • Name: Zinforo®
  • Therapeutic area: Other beta-lactam antibiotics
  • Company: AstraZeneca GmbH

Time table:

  • Start: Start: 14.05.2012
  • Final decision by G-BA: 03.05.2012

Final decision:

  • AstraZeneca GmbH is exempted from submitting a dossier as expected sales are below the legally defined threshold

Subject:

  • Active Substance: Ceritinib
  • Name: Zykadia®
  • Therapeutic area: Non-small-cell lung carcinoma
  • Pharmaceutical company: Novartis Pharma GmbH

Time table:

  • Start: 01.07.2015
  • Final decision by G-BA: 17.12.2015 (valid until 1.10.2016)

Final decision:

  • No additional benefit proved.

Subject:

  • Active Substance: Cholic Acid FGK
  • Name: Orphacol®
  • Therapeutic area: Inborn errors in primary bile acid synthesis
  • Pharmaceutical company: Laboratoires CTRS

Time table:

  • Start: 15.05.2014
  • Final decision by G-BA: 06.11.2014

Final decision:

  • Non-quantifiable additional benefit (proved because of orphan drug status)

Subject:

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

Time table:

  • Start: 01.04.2014
  • Final decision by G-BA: 18.09.2014

Final decision:

  • No additional benefit proved because of the submission of an incomplete dossier

Subject:

  • Active Substance: Cobimetinib
  • Name: Cotellic®
  • Therapeutic area: Melanoma
  • Pharmaceutical company: Roche Pharma AG

Time table:

  • Start: 15.12.2015
  • Final decision by G-BA: 02.06.2016

Final decision:

  • Indication for a considerable additional benefit.

Subject:

  • Active Substance: Crizotinib
  • Name: Xalkori®
  • Therapeutic area: Non-small cell lung carcinoma
  • Pharmaceutical company: Pfizer Pharma GmbH

Time table:

  • Start: 15.11.2012
  • Final decision by G-BA: 02.05.2013 (valid until 01.07.2016)

Final decision:

  • Considerable additional benefit (hint) for patients with non-small cell lung carcinoma and indication for chemotherapy
  • No additional benefit for patients without indication for chemotherapy

Subject:

  • Active Substance: Crizotinib (new indication)
  • Name: Xalkori®
  • Therapeutic area: Non-small-cell lung carcinoma
  • Pharmaceutical company: Pfizer Pharma GmbH

Time table:

  • Start: 01.01.2016
  • Final decision by G-BA: 16.06.2016

Final decision:

  • No additional benefit proved.

Subject:

  • Active Substance: Crizotinib (re-assessment)
  • Name: Xalkori®
  • Therapeutic area: Non-small-cell lung carcinoma
  • Pharmaceutical company: Pfizer Pharma GmbH

Time table:

  • Start: 15.06.2016
  • Final decision by G-BA: 15.12.2016

Final decision:

  • When chemotherapy is indicated (esp. patients with ECOG performance status 0, 1 or 2): Hint for a considerable additional benefit
  • When chemotherapy is not indicated (esp. patients with ECOG perfomance status 4, 3 or 2): No additional benefit proved

Subject:

  • Active Substance: Dabrafenib
  • Name: Tafinlar®
  • Therapeutic area: Melanoma
  • Pharmaceutical company: GlaxoSmithKline GmbH & Co. KG

Time table:

  • Start: 01.10.2013
  • Final decision by G-BA: 03.04.2014

Final decision:

  • No additional benefit proved
  • The decision remains valid until 01.10.2017

Subject:

  • Active Substance: Dabrafenib
  • Name: Tafinlar®
  • Therapeutic area: Melanoma
  • Pharmaceutical company: Novartis Pharma GmbH

Time table:

  • Start: 01.10.2016
  • Final decision by G-BA: 17.03.2016

Final decision:

  • Indication for a considerable additional benefit

Subject:

  • Active Substance: Daclatasvir
  • Name: Daklinza®
  • Therapeutic area: Hepatitis C, Chronic
  • Pharmaceutical company: Bristol-Meyers Squibb GmbH & Co. KGaA

Time table:

  • Start: 01.09.2014
  • Final decision by G-BA: 19.02.2015

Final decision:

  • Therapy-naïve patients without cirrhosis (Genotype 1): Hint for a minor additional benefit.
  • Therapy-naïve patients with 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-naïve): Hint for a considerable additional benefit.
  • Genotype 4 in combination with Peginterferon alfa and Ribavirin (pre-treated): No additional benefit proved.

Subject:

  • Active Substance: Dapagliflozin
  • Name: Forxiga®
  • Therapeutic area: Diabetes mellitus type 2
  • Pharmaceutical company: Bristol-Myers Squibb GmbH & Co. KGaA/ AstraZeneca GmbH

Time table:

  • Start: 15.12.2012
  • Final decision by G-BA: 06.06.2013

Final decision:

  • No additional benefit proved in four examined subgroups

Subject:

  • Active Substance: Dapagliflozin/Metformin
  • Name: Xigduo®
  • Therapeutic area: Diabetes Mellitus, Type 2
  • Company: Bristol-Myers Squibb GmbH & Co. KGaA/ AstraZeneca GmbH

Time table:

  • Start: 15.02.2014
  • Final decision: 07.08.2014

Final decision:

  • No additional benefit proved

Subject:

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

Time table:

  • Start: 01.06.2016
  • Final decision by G-BA: 01.12.2016

Final decision:

  • Non-quantifiable additional benefit (proved because of orphan drug designation)

Subject:

  • Active Substance: Dasabuvir
  • Name: Exviera®
  • Therapeutic area: Chronic Hepatitis C
  • Pharmaceutical company: AbbVie Deutschland GmbH & Co. KG

Time table:

  • Start: 01.02.2015
  • Final decision by G-BA: 16.07.2015

Final decision:

  • Therapy naive patients without cirrhosis, genotype 1a/1b: 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.

Subject:

  • Active Substance: Decitabine
  • Name: Dacogen®
  • Therapeutic area: Myeloid leukaemia
  • Pharmaceutical company: Janssen-Cilag GmbH

Time table:

  • Start: 01.11.2012
  • Final decision by G-BA: 02.05.2013

Final decision:

  • Minor additional benefit

Subject:

  • Active Substance: Dexmedetomidine hydrochloride
  • Name: Dexdor®
  • Therapeutic area: Conscious Sedation
  • Pharmaceutical company: Orion Corporation

Time table:

  • Start: 13.07.2011
  • Final decision by G-BA: 18.08.2011

Final decision:

  • Orion Corporation is exempted from submitting a dossier as expected sales are below the legally defined threshold

Subject:

  • Active Substance: Dimethyl fumarate
  • Name: Tecfidera®
  • Therapeutic area: Multiple Sclerosis
  • Pharmaceutical company: Biogen Idec GmbH

Time table:

  • Start: 01.05.2014
  • Final decision by G-BA: 16.10.2014

Final decision:

  • No additional benefit proved, because of inadequate statistical analysis

Subject:

  • Active Substance: Dolutegravir
  • Name: Tivicay®
  • Therapeutic area: HIV infection
  • Company: ViiV Healthcare GmbH

Time table:

  • Start: 15.02.2014
  • Final decision: 07.08.2014

Final decision:

  • Considerable additional benefit (proof) for therapy-naïve adult patients
  • Minor additional benefit (indication) for pretreated patients
  • No additional benefit proved for adolescent patients

Subject:

  • Active Substance: Dolutegravir/abacavir/lamivudine
  • Name: Triumeq®
  • Therapeutic area: HIV infections
  • Pharmaceutical company: ViiV Healthcare GmbH

Time table:

  • Start: 01.10.2014
  • Final decision by G-BA: 19.03.2015

Final decision:

  • Pre-treated patients: No additional benefit proved.
  • Therapy-naïve adults: Indication for a considerable additional benefit.

Subject:

  • Active Substance: Dulaglutid
  • Name: Trulicity®
  • Therapeutic area: Diabetes Mellitus Type 2
  • Pharmaceutical company: Lilly Deutschland GmbH

Time table:

  • Start: 01.02.2015
  • Final decision by G-BA: 16.07.2015

Final decision:

  • 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.

Subject:

  • 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

Time table:

  • Start: 01.08.2015
  • Final decision by G-BA: 21.01.2016

Final decision:

  • 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

Subject:

  • Active Substance: Efmoroctocog alfa
  • Name: Elocta®
  • Therapeutic area: Hemophilia A
  • Pharmaceutical company: Swedish Orphan Biovitrum GmbH

Time table:

  • Start: 01.01.2016
  • Final decision by G-BA: 16.06.2016

Final decision:

  • No additional benefit proved.

Subject:

  • Active Substance: Eftrenonacog alfa
  • Name: Alprolix®
  • Therapeutic area: Hemophilia B
  • Pharmaceutical company: Swedish Orphan Biovitrum GmbH

Time table:

  • Start: 15.06.2016
  • Final decision by G-BA: 15.12.2016

Final decision:

  • Non-quantifiable additional benefit (proved because of orphan drug designation)

Subject:

  • Active Substance: Eliglustat
  • Name: Cerdelga®
  • Therapeutic area: Morbus Gaucher, type 1
  • Pharmaceutical company: Genzyme GmbH

Time table:

  • Start: 01.04.2015
  • Final decision by G-BA: 01.10.2015

Final decision:

  • Non-quantifiable additional benefit (proved because of orphan drug designation).

Subject:

  • Active Substance: Elosulfase alfa
  • Name: Vimizim®
  • Therapeutic area: Mucopolysaccharidosis, type IVA (Morquio A Syndrome, MPS IVA)
  • Pharmaceutical company: BioMarin Deutschland

Time table:

  • Start: 01.06.2014
  • Final decision by G-BA: 20.11.2014

Final decision:

  • Minor additional benefit (proved because of orphan drug status)

Subject:

  • Active Substance: Elotuzumab
  • Name: Empliciti®
  • Therapeutic area: Multiple Myeloma
  • Pharmaceutical company: Bristol-Meyers Squibb GmbH & Co. KGaA

Time table:

  • Start: 01.06.2016
  • Final decision by G-BA: 01.12.2016

Final decision:

  • Hint for a minor additional benefit.

Subject:

  • Active Substance: Elvitegravir/cobicistat/emtricitabine/tenofovirr alafenamide
  • Name: Genvoya®
  • Therapeutic area: HIV infections
  • Pharmaceutical company: Gilead Sciences GmbH

Time table:

  • Start: 01.01.2016
  • Final decision by G-BA: 16.06.2016

Final decision:

  • 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.

Subject:

  • Active Substance: Elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate
  • Name: Stribild®
  • Therapeutic area: HIV-infection
  • Pharmaceutical company: Gilead Sciences GmbH

Time table:

  • Start: 15.06.2013
  • Final decision by G-BA: 05.12.2013

Final decision:

  • No additional benefit proved

Subject:

  • Active Substance: Empagliflozin
  • Name: Jardiance®
  • Therapeutic area: Diabetes Mellitus, Type 2
  • Pharmaceutical company: Boehringer Ingelheim Pharma GmbH & Co. KG

Time table:

  • Start: 15.08.2014
  • Final decision by G-BA: 05.02.2015

Final decision:

  • No additional benefit proved.

Subject:

  • Active Substance: Empagliflozin
  • Name: Jardiance®
  • Therapeutic area: Diabetes mellitus, type 2
  • Pharmaceutical company: Pharmaceutical company: Boehringer Ingelheim Pharma GmbH & Co. KG

Time table:

  • Start: 01.03.2016
  • Final decision by G-BA: 01.06.2016

Final decision:

  • 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

Subject:

  • Active Substance: Empagliflozin/Metformin
  • Name: Synjardy®
  • Therapeutic area: Diabetes mellitus, type 2
  • Pharmaceutical company: Boehringer Ingelheim Pharma GmbH & Co. KG

Time table:

  • Start: 01.03.2016
  • Final decision by G-BA: 01.06.2016

Final decision:

  • 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

Subject:

  • Active Substance: Emtricitabine/rilpivirine/tenofovir
  • Name: Eviplera®
  • Therapeutic area: HIV infection
  • Pharmaceutical company: Gilead Sciences GmbH

Time table:

  • Start: 15.01.2012
  • Final decision by G-BA: 05.07.2012

Final decision:

  • Minor additional benefit (proof) for the target patient population

Subject:

  • Active Substance: Emtricitabine/rilpivirine/tenofovir (new indication)
  • Name: Eviplera®
  • Therapeutic area: HIV infection
  • Pharmaceutical company: Gilead Sciences GmbH

Time table:

  • Start: 01.01.2014
  • Final decision by G-BA: 19.06.2014

Final decision:

  • No additional benefit proved

Subject:

  • Active Substance: Emtricitabine / tenofovir alafenamide
  • Name: Descovy®
  • Therapeutic area: HIV infections
  • Pharmaceutical company: Gilead Sciences GmbH

Time table:

  • Start: 15.05.2016
  • Final decision by G-BA: 03.11.2016

Final decision:

  • 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.

Subject:

  • Active Substance: Enzalutamide
  • Name: Xtandi®
  • Therapeutic area: Prostatic Neoplasms
  • Company: Astellas Pharma GmbH

Time table:

  • Start: 01.09.2013
  • Final decision by G-BA: 20.02.2014

Final decision:

  • Considerable additional benefit (indication)

Subject:

  • Active Substance: Enzalutamide
  • Name: XtandiTM
  • Therapeutic area: Prostatic Neoplasms
  • Pharmaceutical company: Astellas Pharma GmbH

Time table:

  • Start: 01.01.2015
  • Final decision by G-BA: 18.06.2015

Final decision:

  • Indication for a considerable additional benefit.

Subject:

  • Active Substance: Eribulin
  • Name: Halaven®
  • Therapeutic area: breast cancer
  • Pharmaceutical company: Eisai GmbH

Time table:

  • Start: 01.05.2011
  • Final decision by G-BA: 19.04.2012

Final decision:

  • Minor additional benefit (hint) in one subgroup (no possibilty of retreatment with taxanes or anthracyclines)
  • Less benefit than the comparative therapy (hint) in one subgroup (retreatment with taxanes or anthracyclines still possible)
  • The decision remains valid until 19.04.2014

Subject:

  • Active Substance: Eribulin
  • Name: Halaven®
  • Therapeutic area: Brest Neoplasms
  • Pharmaceutical company: Eisai GmbH

Time table:

  • Start: 01.08.2014
  • Final decision by G-BA: 22.01.2015

Final decision:

  • Re-assessment because of end of term and new indication
  • For patients that cannot be treated with taxane or anthracyclines: Hint for a considerable additional benefit
  • For the two other slices, no additional benefit is proved.

Subject:

  • Active Substance: Emtricitabine / tenofovir alafenamide
  • Name: Halaven®
  • Therapeutic area: Liposarcoma
  • Pharmaceutical company: Eisai GmbH

Time table:

  • Start: 01.06.2016
  • Final decision by G-BA: 01.12.2016

Final decision:

  • 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.

Subject:

  • Active Substance: Extract from Canabis Sativa
  • Name: Sativex®
  • Therapeutic area: Spasticity related to multiple sclerosis
  • Pharmaceutical company: Almirall Hermal GmbH

Time table:

  • Start: 01.07.2011
  • Final decision by G-BA: 21.06.2012

Final decision:

  • Minor additional benefit (hint) for the target patient population
  • The decision remains valid until 21.06.2015

Subject:

  • Active Substance: Evolocumab
  • Name: Repatha®
  • Therapeutic area: Hypercholesterolemia
  • Pharmaceutical company: Amgen GmbH

Time table:

  • Start: 15.09.2015
  • Final decision by G-BA: 09.03.2016

Final decision:

  • No additional benefit proved for any patient population.

Subject:

  • Active Substance: Frampridine
  • Name: Fampyra®
  • Therapeutic area: Multiple sclerosis
  • Pharmaceutical company: Biogen Idec GmbH

Time table:

  • Start: 29.07.2011
  • Final decision by G-BA: 02.08.2012

Final decision:

  • No additional benefit proved

Subject:

  • Active Substance: Fingolimod
  • Name: Gilenya®
  • Therapeutic area: multiple sclerosis
  • Pharmaceutical company: Novartis Pharma GmbH

Time table:

  • Start: 15.04.2011
  • Final decision by G-BA: 29.03.2012

Final decision:

  • Minor additional benefit (hint) for patients with highly reactive RRMS
  • No additional benefit proved for the second subgroup (ß-Interferon non-responder)
  • The decision remains valid until 29.03.2015

Subject:

  • Active Substance: Fingolimod (new indication)
  • Name: Gilenya®
  • Therapeutic area: Multiple Sclerosis
  • Pharmaceutical company: Novartis Pharma GmbH

Time table:

  • Start: 01.07.2014
  • Final decision by G-BA: 18.12.2014

Final decision:

  • No additional benefit proved.

Subject:

  • Active Substance: Fingolimod
  • Name: Gilenya®
  • Therapeutic area: Multiple Sclerosis
  • Pharmaceutical company: Novartis Pharma GmbH

Time table:

  • Start: 01.12.2015
  • Final decision by G-BA: 19.05.2016

Final decision:

  • No additional benefit proved.

Subject:

  • Active Substance: Fingolimod
  • Name: Gilenya®
  • Therapeutic area: Multiple Sclerosis
  • Pharmaceutical company: Novartis Pharma GmbH

Time table:

  • Start: 01.04.2015
  • Final decision by G-BA: 01.10.2015

Final decision:

  • Patients with highly active relapsing-remitting multiple sclerosis (RRMS), completely pre-treated (≥ 1 year) with IFN-β (comparator: Glatiramer acetate): No additional benefit proved.
  • Patients with highly active RRMS, not completely pre-treated with IFN-β (comparator: IFN-β): Indication for a considerable additional benefit.
  • Patients with rapidly progressing severe RRMS (comparator: glatiramer acetate or IFN-β (1a or 1b)): Indication for a minor additional benefit.

Subject:

  • Active Substance: Fluticasone/Vilanterol
  • Name: Relvar® Ellipta®
  • Therapeutic area: Asthma, COPD
  • Pharmaceutical company: GlaxoSmithKline GmbH & Co. KG

Time table:

  • Start: 01.01.2014
  • Final decision by G-BA: 20.03.2014

Final decision:

  • No additional benefit proved
  • Pharmaceutical company submitted no dossier
  • Relvar® Ellipta® is allocated to the reference price group
  • "combination of glucocorticoids and long-acting beta2-agonists"

Subject:

  • Active Substance: Gaxilose
  • LacTestTM
  • Therapeutic area: Diagnosis of hypolactasia
  • Pharmaceutical company: VENTER PHARMA S.L.

Time table:

  • Start: 15.08.2015
  • Final decision by G-BA: 04.02.2016

Final decision:

  • No additional benefit proved as there was no dossier submitted.

Subject:

  • Active Substance: Idebenone
  • Name: Raxone®
  • Therapeutic area: Leber hereditary optic atrophy
  • Pharmaceutical company: Santhera Pharmaceuticals

Time table:

  • Start: 01.10.2016
  • Final decision by G-BA: 17.03.2016 (valid until 01.04.2018)

Final decision:

  • Non-quantifiable additional benefit (proved because of orphan drug designation).

Subject:

  • Active Substance: Idelalisib
  • Name: Zydelig®
  • Therapeutic area: Non-Hodgkin Lymphoma, or Chronic Lymphocytic Leukemia, B-Cell (CLL)
  • Pharmaceutical company: Gilead Sciences GmbH

Time table:

  • Start: 01.10.2014
  • Final decision by G-BA: 19.03.2015

Final decision:

  • Patients with rezidivierender CLL (not indicated for chemotherapy): Hint for a non-quantifiable additional benefit.
  • All other patient groups: No additional benefit proved.

Subject:

  • Active Substance: Idelalisib (re-assessment)
  • Name: Zydelig®
  • Therapeutic area: Chronic Lymphocytic Leukemia (CLL)
  • Pharmaceutical company: Gilead Sciences GmbH

Time table:

  • Start: 01.04.2016
  • Final decision by G-BA: 15.09.2016

Final decicion:

  • Pre-treated patients with CLL:
    - If chemotherapy is appropriate: no additional benefit proved.
    - If chemotherapy is not appropriate: Hint for a non-quantifiable additional benefit.
  • Patients with 17p deletion or TP53 mutation, where chemoimmunotherapy is not appropriate and first-line therapy with ibrutinib has already been initiated: No additional benefit proved.

Subject:

  • Active Substance: Ibrutinib
  • Name: Imbruvica®
  • Therapeutic area: Chronic Lymphocytic Leukemia (CLL); Mantle-Cell Lymphoma (MCL)
  • Pharmaceutical company: Janssen-Cilag GmbH

Time table:

  • Start: 01.11.2014
  • Final decision by G-BA: 16.04.2015

Final decision:

  • Non-quantifiable additional benefit (proved because of orphan drug designation).

Subject:

  • Active Substance: Ibrutinib (new indication)
  • Name: Imbruvica®
  • Therapeutic area: Chronic lymphocytic leukemia
  • Pharmaceutical company: Janssen-Cilag GmbH

Time table:

  • Start: 01.07.2016
  • Final decision by G-BA: 15.12.2016

Comparative therapy:

  • For untreated patients: No additional benefit proved
  • When FCR is not indicated: No additional benefit proved
  • For patients who do not have a 17p deletion or TP-35 mutation and for whom chemoimmunotherapy is not appropriate: No additional benefit proved

Subject:

  • Active Substance: Ibrutinib (re-assessment)
  • Name: IMBRUVICA®
  • Therapeutic area: Chronic lymphocytic leukaemia (CLL), mantle cell lymphoma, Waldenström’s macroglobulinaemia
  • Pharmaceutical company: Janssen-Cilag GmbH

Time table:

  • Start: 01.02.2016
  • Final decision by G-BA: 21.07.2016

Final decision:

  • Patient population A: CLL
    -Patients with CLL for whom chemotherapy is appropriate: No additional benefit proved.
    -Patients with CLL for whom chemotherapy is not appropriate: Hint for a non-quantifiable additional benefit.
    -First-line therapy for patients with CLL and with a 17p-depletion or a TP53 mutation and for whom chemoimmunotherapy is not appropriate: Hint for a non-quantifiable additional benefit.
  • Patient population B: Patients with mantle cell lymphoma: patient-individual therapy
    -When temsirolimus is the appropriate patient individual therapy: Hint for a considerable additional benefit.
    -When temsirolimus is not the appropriate patient individual therapy: No additional benefit proved.
  • Patient population C: Patients with Waldenström‘s macroglobulinaemia: No additional benefit proved.

Subject:

  • Active Substance: Indacaterol/glycopyrronium bromide
  • Name: Ultibro® Breezhaler®, Xoterna® Breezhaler®
  • Therapeutic area: COPD
  • Pharmaceutical company: Novartis Pharma GmbH

Time table:

  • Start: 15.11.2013
  • Final decision by G-BA: 08.05.2014

Final decision:

  • Minor additional benefit (hint and indication) in two of four subgroups

Subject:

  • Active Substance: Ingenol mebutate
  • Name: Picato®
  • Therapeutic area: Actinic keratosis
  • Pharmaceutical company: LEO Pharma GmbH

Time table:

  • Start: 15.01.2013
  • Final decision by G-BA: 04.07.2013

Final decision:

  • No additional benefit proved

Subject:

  • Active Substance: Insulin degludec
  • Name: Tresiba®
  • Therapeutic area: Diabetes Mellitus
  • Pharmaceutical company: Novo Nordisk Pharma GmbH

Time table:

  • Start: 01.05.2014
  • Final decision by G-BA: 16.10.2014

Final decision:

  • No additional benefit proved because of missing access to relevant data concerning study methodology and results.

Subject:

  • Active Substance: Insulin degludec
  • Name: Tresiba®
  • Therapeutic area: Diabetes Mellitus
  • Pharmaceutical company: Novo Nordisk Pharma GmbH

Time table:

  • Start: 15.06.2014
  • Final decision by G-BA: 04.12.2014

Final decision:

  • No additional benefit proved.
  • There was no dossier submitted.

Subject:

  • Active Substance: Insulin degludec
  • Name: Tresiba®
  • Therapeutic area: Diabetes mellitus
  • Pharmaceutical company: Novo Nordisk Pharma GmbH

Time table:

  • Start: 01.03.2015
  • Final decision by G-BA: 20.08.2015

Final decision:

  • Diabetes mellitus type 1: No additional benefit proved.
  • Diabetes mellitus type 2: No additional benefit proved.

Subject:

  • Active Substance: Insulin degludec/Liraglutide
  • Name: Xultophy®
  • Therapeutic area: Diabetes mellitus, type 2
  • Pharmaceutical company: Novo Nordisk GmbH

Time table:

  • Start: 01.05.2015
  • Final decision by G-BA: 15.10.2015

Final decision:

  • No additional benefit proved for each of the three slices.

Subject:

  • Active Substance: Insulin degludec/Liraglutide (new indication)
  • Name: Xultophy®
  • Therapeutic area: Diabetes mellitus type 2
  • Pharmaceutical company: Novo Nordisk Pharma GmbH

Time table:

  • Start: 15.08.2015
  • Final decision by G-BA: 04.02.2016

Final decision:

  • No additional benefit proved.

Subject:

  • Active Substance: Ipilimumab
  • Name: Yervoy®
  • Therapeutic area: Melanoma
  • Pharmaceutical company: Bristol-Myers Squibb GmbH & Co. KGaA

Time table:

  • Start: 01.08.2011
  • Final decision by G-BA: 02.08.2012

Final decision:

  • Considerable additional benefit (indication) for the target patient population
  • The decision remains valid until 02.08.2017

Subject:

  • Active Substance: Ipilimumab
  • Name: Yervoy®
  • Therapeutic area: Advanced melanoma
  • Pharmaceutical company: Bristol-Myers Squibb GmbH & Co. KGaA

Time table:

  • Start: 15.12.2013
  • Final decision by G-BA: 05.06.2014

Final decision:

  • No additional benefit proved
  • The decision remains valid until 01.12.2017

Subject:

  • Active Substance: Isavuconazole
  • Name: Cresemba®
  • Therapeutic area: Aspergillosis and mucormycosis
  • Pharmaceutical company: Basilea Pharmaceutica International Ltd.

Time table:

  • Start: 15.11.2015
  • Final decision by G-BA: 04.05.2016

Final decision:

  • Non-quantifiable additional benefit, proved because of orphan drug designation

Subject:

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

Time table:

  • Start: 15.08.2012
  • Final decision by G-BA: 07.02.2013

Final decision:

  • Minor additional benefit (quality of evidence was not determined) for children (6-11 age group)
  • Considerable additional benefit (quality of evidence was not determined) for adolescents and adults

Subject:

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

Time table:

  • Start: 15.12.2015
  • Final decision by G-BA: 02.06.2016

Final decision:

  • Children ≤ 5 years with a gating mutation class III in CFTR-gene: Non-quantifiable additional benefit (proved because of orphan drug designation).
  • Adults (≥ 18 years) with R117H mutation in CFTR-gene: Minor additional benefit (proved because of orphan drug designation)

Subject:

  • Active Substance: Ivacaftor
  • Name: Kalydeco™
  • Therapeutic area: Cystic Fibrosis
  • Pharmaceutical company: Vertex Pharmaceuticals Limited

Time table:

  • Start: 01.09.2014
  • Final decision by G-BA: 19.02.2015

Final decision:

  • Minor additional benefit (proved because of orphan drug designation)

Subject:

  • Active Substance: Ivermectin
  • Name: Soolantra®
  • Therapeutic area: Rosacea
  • Pharmaceutical company: Galderma Laboratorium GmbH

Time table:

  • Start: 01.06.2015
  • Final decision by G-BA: 27.11.2015

Final decision:

  • No additional benefit proved because no dossier was submitted.

Subject:

  • Active Substance: Larvae of Lucilia sericata
  • Name: BioBag®/ BioMonde®
  • Therapeutic area: Wound debridement
  • Pharmaceutical company: BioMonde GmbH

Time table:

  • Start: 01.06.2014
  • Final decision by G-BA: 20.11.2014

Final decision:

  • No additional benefit proved because of no submission of a dossier.

Subject:

  • Active Substance: Ledipasvir/sofosbuvir
  • Name: Harvoni®
  • Therapeutic area: Hepatitis C, chronic
  • Pharmaceutical company: Gilead Sciences GmbH

Time table:

  • Start: 01.12.2014
  • Final decision by G-BA: 21.05.2015

Final decision:

  • For patients with…
  • Genotype 1, therapy-naïve: hint for a considerable additional benefit.
  • Genotype 1, pre-treated: hint for a considerable additional benefit.
  • Genotype 3, naïve pre-treated: no additional benefit proved.
  • Genotype 4, naïve and pre-treated: hint for a minor additional benefit.
  • Genotype 1, with HIV co-infection: hint for a non-quantifiable additional benefit.
  • Genotype 1, with de-compensated cirrhosis: hint for a non-quantifiable additional benefit.

Subject:

  • Active Substance: Lenvatinib
  • Name: Lenvima®
  • Therapeutic area: Thyroid neoplasms
  • Pharmaceutical company: Eisai GmbH

Time table:

  • Start: 01.07.2015
  • Final decision by G-BA: 17.12.2015

Final decision by G-BA:

  • Non-quantifiable additional benefit (proved because of orphan drug designation).

Subject:

  • Active Substance: Linaclotide
  • Name: Constella®
  • Therapeutic area: irritable bowel syndrome with constipation
  • Pharmaceutical company: Almirall Hermal GmbH

Time table:

  • Start: 01.05.2013
  • Publication of assessment: 01.08.2013
  • End of public hearing: 22.08.2013
  • Final decision by G-BA: expected for the middle of October 2013

Subject:

  • Active Substance: Linagliptin
  • Name: Trajenta®
  • Therapeutic area: Diabetes Mellitus, Type 2
  • Pharmaceutical company: Boehringer Ingelheim International GmbH

Time table:

  • Start: 01.10.2011
  • Publication of assessment: 02.01.2012
  • End of public hearing: 23.01.2012
  • Final decision by G-BA: 29.03.2012

Final decision:

  • No additional benefit proved

Subject:

  • Active Substance: Linagliptin
  • Name: Trajenta®
  • Therapeutic area: Diabetes Mellitus, Type 2
  • Pharmaceutical company: Boehringer Ingelheim International GmbH

Time table:

  • Start: 01.12.2012
  • Final decision by G-BA: 16.05.2013

Final decision:

  • No additional benefit proved
  • The pharmaceutical company submitted no dossier

Subject:

  • Active Substance: Linagliptin
  • Name: Trajenta®
  • Therapeutic area: Diabetes Mellitus, Type 2
  • Pharmaceutical company: Boehringer Ingelheim International GmbH

Time table:

  • Start: 01.09.2012
  • Publication of assessment: 03.12.2012
  • End of public hearing: 24.12.2012
  • Final decision by G-BA: 21.02.2013

Final decision:

  • No additional benefit proved

Subject:

  • Active Substance: Lisdexamfetamine
  • Name: Elvanse®
  • Therapeutic area: Attention Deficit Disorder with Hyperactivity (ADHD) for children 6-18 aged 6 and older
  • Pharmaceutical company: Shire Deutschland GmbH

Time table:

  • Start: 01.06.2013
  • Final decision by G-BA: 14.11.2013

Final decision:

  • No additional benefit proved

Subject:

  • Active Substance: Lixisenatide
  • Name: Lyxumia®
  • Therapeutic area: diabetes mellitus Type 2
  • Pharmaceutical company: Sanofi-Aventis Deutschland GmbH

Time table:

  • Start: 15.03.2013
  • Final decision by G-BA: 05.09.2013

Final decision:

  • no additional benefit proved

Subject:

  • Active Substance: Lomitapide
  • Name: Lojuxta®
  • Therapeutic area: Hypercholesterolaemia
  • Company: Aegerion Pharmaceuticals GmbH

Time table:

  • Start: 15.12.2013
  • Final decision by G-BA: 05.06.2014

Final decision:

  • No additional benefit proved
  • The decision remains valid until 15.06.2015

Subject:

  • Active Substance: Lomitapide
  • Name: Lojuxta®
  • Therapeutic area: Homozygous hypercholesterolemia
  • Pharmaceutical company: Aegerion Pharmaceuticals

Time table:

  • Start: 15.06.2015
  • Final decision by G-BA: 27.11.2015

Final decision:

  • 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.

Subject:

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

Time table:

  • Start: 15.12.2015
  • Final decision by G-BA: 02.06.2016

Final decision:

  • Indication for a considerable additional benefit.

Subject:

  • Active Substance: Lurasidon
  • Name: Latuda®
  • Therapeutic area: Schizophrenia
  • Pharmaceutical company: Takeda GmbH

Time table:

  • Start: 01.11.2014
  • Final decision by G-BA: 16.04.2015

Final decision:

  • Acute therapy: no additional benefit proved.
  • Relapse prophylaxis: no additional benefit proved.

Subject:

  • Active Substance: Macitentan
  • Name: Opsumit®
  • Therapeutic area: Pulmonary arterial hypertension
  • Pharmaceutical company: Actelion Pharmaceuticals Deutschland GmbH

Time table:

  • Start: 01.02.2014
  • Final decision by G-BA: 17.07.2014

Final decision:

  • Minor additional benefit

Subject:

  • Active Substance: Mepolizumab
  • Name: Nucala®
  • Therapeutic area: Refractory eosinophilic asthma
  • Pharmaceutical company: GlaxoSmithKline GmbH & Co. KG

Time table:

  • Start: 01.02.2016
  • Final decision by G-BA: 21.07.2016

Final decision:

  • 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.

Subject:

  • Active Substance: Active Substance: Microbial collagenase from Clostridium histolyticum
  • Name: Xiapex®
  • Therapeutic area: Dupuytren's contracture
  • Pharmaceutical company: Pfizer Pharma GmbH

Time table:

  • Start: 01.05.2011
  • Final decision by G-BA: 19.04.2012

Final decision:

  • No additional benefit proved
  • Pfizer deviated from the comparative therapies in three of four subgroups
  • For the fourth subgroup no additional benefit could be shown

Subject:

  • Active Substance: Migalastat
  • Name: GalafoldTM
  • Therapeutic area: Fabry Disease
  • Pharmaceutical company: Amicus Therapeutics GmbH

Time table:

  • Start: 01.06.2016
  • Final decision by G-BA: 01.12.2016

Final decision:

  • Non-quantifiable additional benefit (proved because of orphan drug designation)

Subject:

  • Active Substance: Mirabegron
  • Name: Betmiga™
  • Therapeutic area: Overactive bladder syndrome
  • Pharmaceutical company: Astellas Pharma GmbH

Time table:

  • Start: 01.06.2014
  • Final decision by G-BA: 20.11.2014

Final decision:

  • No additional benefit proved.

Subject:

  • Active Substance: Nalmefen
  • Name: Selincro®
  • Therapeutic area: Alcohol-related Disorders
  • Pharmaceutical company: Lundbeck GmbH

Time table:

  • Start: 01.09.2014
  • Final decision by G-BA: 19.02.2015

Final decision:

  • No additional benefit proved.

Subject:

  • Active Substance: Necitumumab
  • Name: Portrazza®
  • Therapeutic area: Non-small cell lung cancer (NSCLC)
  • Pharmaceutical company: Lilly Deutschland GmbH

Time table:

  • Start: 01.04.2016
  • Final decision by G-BA: 15.09.2016

Final decicion:

  • No additional benefit proved.

Subject:

  • Active Substance: Nepafenac
  • Name: Nevanac®
  • Therapeutic area: postoperative pain after cataract surgery
  • Pharmaceutical company: Alcon Pharma GmbH

Time table:

  • Start: 01.07.2013
  • Final decision by G-BA: 19.12.2013

Comparative therapy:

  • The additional benefit has not been proven, because Alcon Pharma GmbH submitted no dossier.

Subject:

  • Active Substance: Netupitant/palonosetron
  • Name: Akynzeo®
  • Therapeutic area: Nausea and vomiting during chemotherapy due to cancer
  • Pharmaceutical company: RIEMSER Pharma GmbH

Time table:

  • Start: 15.08.2015
  • Final decision by G-BA: 04.02.2016

Final decision:

  • Moderately emetogenic chemotherapy: No additional benefit proved.
  • Highly emetogenic chemotherapy: No additional benefit proved.

Subject:

  • Active Substance: Nintedanib
  • Name: Vargatef®
  • Therapeutic area: Non-small-cell Lung Carcinoma
  • Pharmaceutical company: Boehringer Ingelheim Pharma GmbH & Co. KG

Time table:

  • Start: 01.01.2015
  • Final decision by G-BA: 18.06.2015

Final decision:

  • Indication for a minor additional benefit

Subject:

  • Active Substance: Nintedanib
  • Name: Ofev®
  • Therapeutic area: Idiopathic Pulmonary Fibrosis
  • Pharmaceutical company: Boehringer Ingelheim Pharma GmbH & Co. KG

Time table:

  • Start: 15.03.2015
  • Final decision by G-BA: 03.09.2015

Final decision:

  • Minor additional benefit (proved because of orphan drug designation).

Subject:

  • Active Substance: Nivolumab
  • Name: Opdivo®
  • Therapeutic area: Melanoma
  • Pharmaceutical company: Bristol-Myers Squibb GmbH & Co. KGaA

Time table:

  • Start: 15.07.2015
  • Final decision by G-BA: 07.01.2016

Final decision:

  • 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.
  • Pre-treated patients: No additional benefit proved.

Subject:

  • Active Substance: Nivolumab (new indication)
  • Name: Nivolumab BMS
  • Therapeutic area: Non-small-cell lung carcinoma
  • Pharmaceutical company: Bristol-Myers Squibb GmbH & Co. KGaA

Time table:

  • Start: 15.08.2015
  • Final decision by G-BA: 04.02.2016

Final decision:

  • Docetaxel: Indication for a considerable additional benefit.
  • Best supportive care, if Docetaxel is not appropriate: No additional benefit proved.

Subject:

  • Active Substance: Nivolumab (new indication)
  • Name: Opdivo®
  • Therapeutic area: Non-small cell lung cancer (NSCLC))
  • Pharmaceutical company: Bristol-Myers Squibb GmbH & Co. KGaA

Time table:

  • Start: 01.05.2016
  • Final decision by G-BA: 20.10.2016

Final decision:

  • 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.

Subject:

  • Active Substance: Nivolumab (new indication)
  • Name: Opdivo®
  • Therapeutic area: Advanced renal cell carcinoma
  • Pharmaceutical company: Bristol-Myers Squibb GmbH & Co. KGaA

Time table:

  • Start: 01.05.2016
  • Final decision by G-BA: 20.10.2016

Final decision:

  • Patients who are pretreated with everolimus: Indication for a considerable additional benefit.
  • Patients who are pretreated with temsirolimus: No additional benefit proved.

Subject:

  • Active Substance: Nivolumab (new indication)
  • Name: Opdivo®
  • Therapeutic area: Melanoma
  • Pharmaceutical company: Bristol-Myers-Squibb GmbH & Co. KGaA

Time table:

  • Start: 15.06.2016
  • Final decision by G-BA: 15.12.2016

Final decision:

  • 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

Subject:

  • Active Substance: Obinutuzumab
  • Name: Gazyvaro™
  • Therapeutic area: Chronic lymphocytic leukaemia
  • Pharmaceutical company: Roche Pharma AG

Time table:

  • Start: 15.08.2014
  • Final decision by G-BA: 05.02.2015

Final decision:

  • Non-quantifiable additional benefit.
  • Benefit proved because of orphan drug status.

Subject:

  • Active Substance: Obinutuzumab (new indication)
  • Name: Gazyvaro®
  • Therapeutic area: Chronic lymphocytic leukemia
  • Pharmaceutical company: Roche Pharma AG

Time table:

  • Start: 01.07.2016
  • Final decision by G-BA: 15.12.2016

Final decision:

  • Non-quantifiable additional benefit (proved because of orphan drug designation)

Subject:

  • Active Substance: Ocriplasmin
  • Name: Jetrea®
  • Therapeutic area: Vitreomacular traction syndrome
  • Pharmaceutical company: ThromboGenics NV / Alcon Pharma GmbH

Time table:

  • Start: 01.05.2013
  • Final decision by G-BA: 17.10.2013

Final decision:

  • Considerable additional benefit (hint) for patients with mild symptoms
  • No additional benefit for patients with severe symptoms
  • The decision remains valid until 15.10.2018

Subject:

  • Active Substance: Olaparib
  • Name: LynparzaTM
  • Therapeutic area: Ovarian Neoplasms
  • Pharmaceutical company: AstraZeneca GmbH

Time table:

  • Start: 01.06.2015
  • Final decision by G-BA: 27.11.2015

Final decision:

  • Non-quantifiable additional benefit (proved because of orphan drug designation)

Subject:

  • Active Substance: Ombitasvir/paritaprevir/ritonavir
  • Name: Viekirax®
  • Therapeutic area: Chronic Hepatitis C
  • Pharmaceutical company: AbbVie Deutschland GmbH & Co. KG

Time table:

  • Start: 01.02.2015
  • Final decision by G-BA: 16.07.2015

Final decision:

  • Therapy naive patients without cirrhosis, genotype 1a/1b: 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 without cirrhosis, genotype 4: Hint for a minor additional benefit.
  • Therapy naive and pre-treated patients with cirrhosis, genotype 4: No additional benefit proved.
  • Therapy naive and pre-treated patients with HIV coinfection: Hint for a minor additional benefit.

Subject:

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

Time table:

  • Start: 15.03.2016
  • Publication of assessment: 15.06.2016
  • End of public hearing: 06.07.2016
  • Final decision by G-BA: expected for the middle of September 2016
  • The decision remains valid until: 30.04.2017

Comparative therapy:

  • Therapy-naive patients with de novo positive T790M mutation and activating EGFR mutation: Gefitinib or Erlotinib or Afatinib
  • Therapy-naive patients with de novo positive T790M mutation and ECOG perfomance status 0, 1 or 2: cisplatin or carboplatin, each in combination with a third generation cytostatic agent
  • Therapy-naive patients with de novo positive T790M mutation and ECOG perfomance status 2: Monotherapy with gemcitabine or vinorelbine
  • Pre-treated patients (with EGFR tyrosine kinase inhibitor): cytotoxic chemotherapy at the discretion of the physician or best supportive care, if appropriate

Subject:

  • Active Substance: Ospemifen
  • Name: Senshio®
  • Therapeutic area: Vulvovaginal atrophy post menopause
  • Pharmaceutical company: Shionogi GmbH

Time table:

  • Start: 01.05.2016
  • Final decision by G-BA: 20.10.2016

Final decision:

  • No additional benefit proved.

Subject:

  • Active Substance: Panobinostat
  • Name: Farydak®
  • Therapeutic area: Multiple Myeloma
  • Pharmaceutical company: Novartis Pharma GmbH

Time table:

  • Start: 01.10.2016
  • Final decision by G-BA: 17.03.2016

Final decision:

  • Non-quantifiable additional benefit (proved because of orphan drug designation).

Subject:

  • Active Substance: Pasireotide
  • Name: Signifor®
  • Therapeutic area: Hypophysis dysfunction
  • Pharmaceutical company: Novartis Pharma GmbH

Time table:

  • Start: 15.06.2012
  • Final decision by G-BA: 06.12.2012

Final decision:

  • Minor additional benefit (quality of evidence was not determined) for the target patient population

Subject:

  • Active Substance: Pasireotide
  • Name: Signifor®
  • Therapeutic area: Acromegaly
  • Pharmaceutical company: Novartis Pharma GmbH

Time table:

  • Start: 01.01.2015
  • Final decision by G-BA: 18.06.2015

Final decision:

  • Minor additional benefit (proved because of orphan drug designation)

Subject:

  • Active Substance: Pembrolizumab
  • Name: KEYTRUDA®
  • Therapeutic area: Melanoma
  • Pharmaceutical company: MSD Sharp & Dohme GmbH

Time table:

  • Start: 15.08.2015
  • Final decision by G-BA: 04.02.2016

Final decision:

  • 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.

Subject:

  • Active Substance: Perampanel
  • Name: Fycompa®
  • Therapeutic area: Partial epilepsies
  • Pharmaceutical company: Eisai GmbH

Time table:

  • Start: 15.05.2014
  • Final decision by G-BA: 06.11.2014

Final decision:

  • Re-assessment was applied by pharmaceutical company
  • No additional benefit proved

Subject:

  • Active Substance: Perampanel
  • Name: Fycompa®
  • Therapeutic area: Partial epilepsy
  • Pharmaceutical company: Eisai GmbH

Time table:

  • Start: 15.09.2012
  • Final decision by G-BA: 07.03.2013

Final decision:

  • No additional benefit proved

Subject:

  • Active Substance: Pertuzumab
  • Name: Perjeta®
  • Therapeutic area: Breast cancer
  • Pharmaceutical company: Roche Pharma AG

Time table:

  • Start: 01.04.2013
  • Final decision by G-BA: 01.10.2013

Final decision:

  • Considerable additional benefit (hint) for patient population with visceral metastasis
  • No additional benefit for two other patient populations
  • The decision remains valid until 01.10.2018

Subject:

  • Active Substance: Pertuzumab
  • Name: Perjeta®
  • Therapeutic area: Breast cancer
  • Pharmaceutical company: Roche Pharma AG

Time table:

  • Start: 01.09.2015
  • Final decision by G-BA: 18.02.2016

Final decision:

  • No additional benefit proved.

Subject:

  • Active Substance: Piperaquine tetraphosphate/dihydroartemisinin
  • Name: Eurartesim®
  • Therapeutic area: Malaria
  • Pharmaceutical company: Sigma-tau Arzneimittel GmbH

Time table:

  • Start: 21.03.2012
  • Final decision by G-BA: 03.05.2012

Final decision:

  • Sigma-tau Arzneimittel GmbH is exempted from submitting a dossier as expected sales are below the legally defined threshold

Subject:

  • Active Substance: Pirfenidone
  • Name: Esbriet®
  • Therapeutic area: Idiopathic Pulmonary Fibrosis (IPF)
  • Pharmaceutical company: InterMune Deutschland GmbH

Time table:

  • Start: 15.09.2011
  • Final decision by G-BA: 15.03.2012

Final decision:

  • Non-quantifiable additional benefit (quality of evidence was not determined)
  • The additional benefit is considered to be proven as a result of the market authorisation, because pirfenidon has orphan drug status in the EU

Subject:

  • Active Substance: Pitavastatin
  • Name: Livazo®
  • Therapeutic area: Primary hypercholesterolaemia and combined (mixed) dyslipidaemia
  • Pharmaceutical company: Merckle Recordati GmbH

Time table:

  • Start: 01.06.2011
  • Final decision by G-BA: 18.08.2011

Final decision:

  • No additional benefit proved
  • Merckle Recordati GmbH submitted no dossier
  • Livazo® is allocated to the reference price group for HMG CoA reductase inhibitors

Subject:

  • Active Substance: Pixantrone
  • Name: Pixuvri®
  • Therapeutic area: Lymphoma, Non-Hodgkin
  • Pharmaceutical company: CTI Life Sciences Ltd.

Time table:

  • Start: 01.12.2012
  • Final decision by G-BA: 16.05.2013

Final decision:

  • No additional benefit proved

Subject:

  • Active Substance: Pomalidomide
  • Name: Imnovid®
  • Therapeutic area: Multiple Myeloma
  • Pharmaceutical company: Celgene GmbH

Time table:

  • Start: 01.09.2013
  • Final decision by G-BA: 20.02.2014

Final decision:

  • Considerable additional benefit
  • The decision remains valid until 01.02.2015

Subject:

  • Active Substance: Pomalidomid
  • Name: Imnovid®
  • Therapeutic area: Multiple Myeloma
  • Pharmaceutical company: Celgene GmbH

Time table:

  • Start: 01.10.2016
  • Final decision by G-BA: 17.03.2016

Final decision:

  • 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.

Subject:

  • Active Substance: Ponatinib
  • Name: Iclusig®
  • Therapeutic area: Lymphoblastic or myeloid leukaemia
  • Pharmaceutical company: ARIAD Pharmaceuticals (Germany) GmbH

Time table:

  • Start: 01.08.2013
  • Final decision by G-BA: 23.01.2014
  • The decision remains valid until: 01.12.2019

Final decision:

  • Non-quantifiable additional benefit

Subject:

  • Active Substance: Propranolol
  • Name: Hemangiol®
  • Therapeutic area: Hemangioma
  • Pharmaceutical company: Pierre Fabre Dermatologie

Time table:

  • Start: 01.09.2014
  • Final decision by G-BA: 19.02.2015

Final decision:

  • Life-threatening or ulcerative hemangioma: Hint for a non-quantifiable additional benefit
  • Hemangioma with risk of permanent scars: Indication for a major additional benefit!

Subject:

  • Active Substance: Radium 223
  • Name: Xofigo®
  • Therapeutic area: Prostatic Neoplasms
  • Pharmaceutical company: Bayer Vital GmbH

Time table:

  • Start: 01.01.2014
  • Final decision by G-BA: 19.06.2014

Final decision:

  • Considerable additional benefit (indication)

Subject:

  • Active Substance: Ramucirumab
  • Name: Cyramza®
  • Therapeutic area: Stomach Neoplasms
  • Pharmaceutical company: Lilly Deutschland GmbH

Time table:

  • Start: 01.02.2015
  • Final decision by G-BA: 16.07.2015

Final decision:

  • Monotherapy: minor additional benefit
  • In combination with paclitaxel: minor additional benefit
  • Benefit proved because of orphan drug designation.

Subject:

  • Active Substance: Ramucirumab (new indication)
  • Name: Cyramza®
  • Therapeutic area: Colorectal cancer
  • Pharmaceutical company: Lilly Deutschland GmbH

Time table:

  • Start: 01.03.2016
  • Final decision by G-BA: 01.06.2016

Final decision:

  • No additional benefit proved.

Subject:

  • Active Substance: Ramucirumab (new indication)
  • Name: Cyramza®
  • Therapeutic area: Non-small cell lung cancer
  • Pharmaceutical company: Lilly Deutschland GmbH

Time table:

  • Start: 01.03.2016
  • Final decision by G-BA: 01.06.2016

Final decision:

  • No additional benefit proved.

Subject:

  • Active Substance: Ramucirumab (Withdrawal of orphan drug status)
  • Name: Cyramza®
  • Therapeutic area: Advanced gastric cancer
  • Pharmaceutical company: Lilly Deutschland GmbH

Time table:

  • Start: 01.05.2016
  • Final decision by G-BA: 20.10.2016

Final decision:

  • In combination with paclitaxel: Hint for a minor additional benefit.
  • Monotherapy: No additional benefit proved.

Subject:

  • Active Substance: Regadenoson
  • Name: Rapiscan®
  • Therapeutic area: Myocardial perfusion imaging
  • Pharmaceutical company: Rapidscan Pharma Solutions EU Ltd.

Time table:

  • Start: 15.04.2011
  • Final decision by G-BA: 29.03.2012

Final decision:

  • No additional benefit proved
  • Rapidscan Pharma Solutions EU Ltd. submitted an incomplete dossier
  • The pharmaceutical company is given the opportunity to resubmit the benefit dossier in one year

Subject:

  • Active Substance: Regorafenib
  • Name: Stivarga®
  • Therapeutic area: Colorectal cancer
  • Pharmaceutical company: Bayer Vital GmbH

Time table:

  • Start: 01.10.2013
  • Final decision by G-BA: 20.03.2014

Final decision:

  • Minor additional benefit (hint)
  • The decision remains valid until 01.10.2015

Subject:

  • Active Substance: Regorafenib
  • Name: Stivarga®
  • Therapeutic area: Colorectal Neoplasms
  • Pharmaceutical company: Bayer Vital GmbH

Time table:

  • Start: 01.09.2014
  • Final decision by G-BA: 19.02.2015

Final decision:

  • No additional benefit proved because of the submission of an incomplete dossier.

Subject:

  • Active Substance: Regorafenib
  • Name: Stivarga®
  • Therapeutic area: Colorectal Neoplasms
  • Pharmaceutical company: Bayer Vital GmbH

Time table:

  • Start: 01.10.2016
  • Final decision by G-BA: 17.03.2016

Final decision:

  • No additional benefit proved.

Subject:

  • Active Substance: Retigabine
  • Name: Trobalt®
  • Therapeutic area: additional therapie for focal seizures with or without secondary generalization in adults
  • Pharmaceutical company: GlaxoSmithKline GmbH & Co. KG

Time table:

  • Start: 15.05.2011
  • Final decision by G-BA: 03.05.2012

Final decision:

  • No additional benefit proved
  • 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

Subject:

  • Active Substance: Retigabine
  • Name: Trobalt®
  • Therapeutic area: drug-resistant partial-onset seizures (epileptic fits)
  • Pharmaceutical company: GlaxoSmithKline GmbH & Co. KG

Time table:

  • Start: 15.01.2014
  • Final decision by G-BA: 03.07.2014

Final decision:

  • No additional benefit proved

Subject:

  • Active Substance: Rilpivirine
  • Name: Edurant®
  • Therapeutic area: HIV infection
  • Pharmaceutical company: Janssen-Cilag GmbH

Time table:

  • Start: 15.01.2012
  • Final decision by G-BA: 05.07.2012

Final decision:

  • Minor additinonal benefit (proof) for the target patient population

Subject:

  • Active Substance: Rilpivirine (new indication)
  • Name: Edurant®
  • Therapeutic area: HIV infections
  • Pharmaceutical company: Janssen-Cilag GmbH

Time table:

  • Start: 01.01.2016
  • Final decision by G-BA: 16.06.2016

Final decision:

  • No additional benefit proved.

Subject:

  • Active Substance: Riociguat
  • Name: Adempas®
  • Therapeutic area: Pulmonary Hypertension
  • Pharmaceutical company: Bayer Vital GmbH

Time table:

  • Start: 01.05.2014
  • Final decision by G-BA: 16.10.2014

Final decision:

  • Minor additional benefit (proved because of orphan drug status)

Subject:

  • Active Substance: Ruxolitinib
  • Name: Jakavi®
  • Therapeutic area: Chronic myeloproliferative disorders
  • Pharmaceutical company: Novartis Pharma GmbH

Time table:

  • Start: 15.09.2012
  • Final decision by G-BA: 07.03.2013

Final decision:

  • Minor additional benefit (quality of evidence was not determined)

Subject:

  • Active Substance: Ruxolitinib
  • Name: Jakavi®
  • Therapeutic area: Myeloproliferative Disorders
  • Pharmaceutical company: Novartis Pharma GmbH

Time table:

  • Start: 15.05.2014
  • Final decision by G-BA: 06.11.2014

Final decision:

  • Re-assessement of orphan drug because turnover limit of 50 million euros was exceeded
  • Hint for an considerable additional benefit

Subject:

  • Active Substance: Ruxolitinib
  • Name: Jakavi®
  • Therapeutic area: Polycythaemia vera
  • Pharmaceutical company: Novartis Pharma GmbH

Time table:

  • Start: 15.04.2015
  • Final decision by G-BA: 15.10.2015

Final decision:

  • Hint for a considerable additional benefit.

Subject:

  • Active Substance: Sacubitril/valsartan
  • Name: Entresto®
  • Therapeutic area: Heart failure
  • Pharmaceutical company: Novartis Pharma GmbH

Time table:

  • Start: 01.01.2016
  • Final decision by G-BA: 16.06.2016

Final decision:

  • Patients who suffer from Diabetes mellitus: Hint for minor additional benefit.
  • Patients who don‘t suffer from Diabetes mellitus: Hint for a considerable additional benefit.

Subject:

  • Active Substance: Safinamide
  • Name: Xadago®
  • Therapeutic area: Parkinson Disease
  • Pharmaceutical company: Zambon S.p.A.

Time table:

  • Start: 15.05.2015
  • Final decision by G-BA: 05.11.2015

Final decision:

  • No additional benefit proved but the indirect comparison was accepted.

Subject:

  • Active Substance: Saxagliptin
  • Name: Onglyza®
  • Therapeutic area: Diabetes mellitus Type 2
  • Pharmaceutical company: Bristol-Myers Squibb GmbH & Co. KGaA / AstraZeneca GmbH

Time table:

  • Start: 01.04.2013
  • Final decision by G-BA: 01.10.2013

Final decision:

  • Minor additional benefit (hint)
  • The decision remains valid until 01.10.2015

Subject:

  • Active Substance: Saxagliptin
  • Name: Onglyza®
  • Therapeutic area: Diabetes Mellitus, Type 2
  • Pharmaceutical company: Bristol-Myers Squibb GmbH &Co. KGaA and AstraZeneca Gmb

Time table:

  • Start: 01.09.2013
  • Publication of assessment: 02.12.2013
  • End of public hearing: 23.12.2013
  • Final decision by G-BA: originally planned for the middle of February 2014

Final decision:

  • Process stopped due to withdrawal of „Bestandsmarkt“ (benefit assessment of selected pharmaceuticals in market)

Subject:

  • Active Substance: Saxagliptin (re-assessment)
  • Name: Onglyza®
  • Therapeutic area: Diabetes mellitus type 2
  • Pharmaceutical company: AstraZeneca GmbH

Time table:

  • Start: 01.07.2016
  • Final decision by G-BA: 15.12.2016

Final decision:

  • Monotherapy: No additional benefit proved
  • 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

Subject:

  • Active Substance: Saxagliptin/Metformin
  • Name: Komboglyze®
  • Therapeutic area: Diabetes mellitus Type 2
  • Pharmaceutical company: Astra Zeneca GmbH & Bristol-Myers Squibb GmbH & Co. KG

Time table:

  • Start: 15.11.2012
  • Final decision by G-BA: 02.05.2013

Final decision:

  • Minor additional benefit (hint) compared to sulfonyl urea + metformine
  • No additional benefit as add-on to insuline
  • The decision remains valid until 01.10.2015

Subject:

  • Active Substance: Saxagliptin/Metformin
  • Name: Komboglyze®
  • Therapeutic area: Diabetes mellitus Type 2
  • Pharmaceutical company: Bristol-Myers Squibb GmbH & Co. KGaA / AstraZeneca GmbH

Time table:

  • Start: 01.04.2013
  • Final decision by G-BA: 01.10.2013

Final decision:

  • No additional benefit proved

Subject:

  • Active Substance: Saxagliptin/metformin (re-assessment)
  • Name: Komboglyze®
  • Therapeutic area: Diabetes mellitus type 2
  • Pharmaceutical company: AstraZeneca GmbH

Time table:

  • Start: 01.07.2016
  • Final decision by G-BA: 15.12.2016

Final decision:

  • Monotherapy saxagliptin/metformin: No additional benefit proved
  • Combination with sulfonylurea: No additional benefit proved
  • Combination with insulin (± metformin): No additional benefit proved

Subject:

  • Active Substance: Sebelipase alfa
  • Name: Kanuma®
  • Therapeutic area: Lysosomal acid lipase (LAL) deficiency
  • Pharmaceutical company: Synageva BioPharma Limited

Time table:

  • Start: 01.10.2016
  • Final decision by G-BA: 17.03.2016

Final decision:

  • Infants rapidly progessive LAL deficiency: Non-quantifiable additional benefit (proved because of orphan drug designation).
  • Patients with LAL-deficiency: Non-quantifiable additional benefit (proved because of orphan drug designation)

Subject:

  • Active Substance: Secukinumab
  • Name: Cosentyx®
  • Therapeutic area: Psoriasis
  • Pharmaceutical company: Novartis Pharma GmbH

Time table:

  • Start: 01.06.2015
  • Final decision by G-BA: 27.11.2015

Final decision:

  • 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.

Subject:

  • Active Substance: Secukinumab
  • Name: Cosentyx®
  • Therapeutic area: Psoriatic arthritis and ankylosing spondylitis
  • Pharmaceutical company: Novartis Pharma GmbH

Time table:

  • Start: 15.12.2015
  • Final decision by G-BA: 02.06.2016

Final decision:

  • Psoriasis arthritis: No additional benefit proved.
  • Ankylosing spondylitis: No additional benefit proved.

Subject:

  • Active Substance: Selexipag
  • Name: Uptravi®
  • Therapeutic area: Pulmonary hypertension
  • Pharmaceutical company: Actelion Pharmaceuticals Deutschland GmbH

Time table:

  • Start: 15.06.2016
  • Final decision by G-BA: 15.12.2016

Final decision:

  • No additional benefit proved.

Subject:

  • Active Substance: Siltuximab
  • Name: Sylvant®
  • Therapeutic area: Multicentric Castleman‘s disease
  • Pharmaceutical company: Janssen-Cilag GmbH

Time table:

  • Start: 15.06.2014
  • Final decision by G-BA: 04.12.2014

Final decision:

  • Non quantifiable additional benefit (proved because of orphan drug indication).

Subject:

  • Active Substance: Simeprevir
  • Name: Olysio®
  • Therapeutic area: Chronic hepatitis C
  • Pharmaceutical company: Janssen-Cilag GmbH

Time table:

  • Start: 01.06.2014
  • Final decision by G-BA: 20.11.2014

Final decision:

  • Genotype 1: Indication for a considerable additional benefit
  • Genotype 4, therapy-naïve patients: Hint for a minor additional benefit
  • Genotype 4, pre-treated patients: No additional benefit proved
  • HIV co-infection (patients without cirrhosis): Hint for a minor additional benefit
  • HIV co-infection (patients with cirrhosis): No additional benefit proved

Subject:

  • Active Substance: Simoctocog alfa
  • Name: Nuwiq®
  • Therapeutic area: Hemophilia A
  • Pharmaceutical company: Octapharma GmbH

Time table:

  • Start: Start: 15.11.2014
  • Final decision by G-BA: 07.05.2015

Final decision:

  • No additional benefit proved.

Subject:

  • Active Substance: Sipuleucel-T
  • Name: Provenge®
  • Therapeutic area: Prostatic Neoplasms
  • Pharmaceutical company: Dendreon UK Limited

Time table:

  • Start: 01.10.2014
  • Final decision by G-BA: 19.03.2015

Final decision:

  • Hint for a non-quantifiable additional benefit.

Subject:

  • Active Substance: Sitagliptin
  • Name: Januvia®, Xelevia®
  • Therapeutic area: Diabetes mellitus Type 2
  • Pharmaceutical company: MSD SHARP & DOHME GmbH

Time table:

  • Start: 01.04.2013
  • Final decision by G-BA: 01.10.2013

Final decision:

  • Minor additional benefit (hint)
  • The decision remains valid until 01.10.2015

Subject:

  • Active Substance: Sitagliptin/Metformin
  • Name: Janumet®, Velmetia®
  • Therapeutic area: Diabetes mellitus Type 2
  • Pharmaceutical company: MSD SHARP & DOHME GmbH

Time table:

  • Start: 01.04.2013
  • Final decision by G-BA: 01.10.2013

Final decision:

  • Minor additional benefit (hint)
  • The decision remains valid until 01.10.2015

Subject:

  • Active Substance: Sitagliptin/metformin (re-assessment)
  • Name: Janumet®, Velmetia®
  • Therapeutic area: Diabetes mellitus type 2
  • Pharmaceutical company: MSD Sharp & Dohme GmbH

Time table:

  • Start: 01.07.2016
  • Final decision by G-BA: 15.12.2016

Final decision:

  • Monotherapy sitagliptin/metformin: No additional benefit proved
  • Combination with sulfonylurea: No additional benefit proved
  • Combination with insulin (± metformin): No additional benefit proved

Subject:

  • Active Substance: Sitagliptin (re-assessment)
  • Name: Januvia®, Xelevia®
  • Therapeutic area: Diabetes mellitus type 2
  • Pharmaceutical company: MSD Sharp & Dohme GmbH

Time table:

  • Start: 01.07.2016
  • Final decision by G-BA: 15.12.2016 (valid until 15.06.2018)

Final decision:

  • Monotherapy: No additional benefit proved
  • Combination with metformin: Hint for a minor additional benefit
  • Combination with sulfonylurea: No additional benefit proved
  • Combination with metformin + sulfonylurea: No additional benefit proved
  • Combination with insulin (± metformin): No additional benefit proved

Subject:

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

Time table:

  • Start: 01.02.2014
  • Final decision by G-BA: 17.07.2014

Final decision:

  • Minor additional benefit (hint) for two slices (Genotype 1 - 3)
  • Considerable benefit (indication) for one slice (Genotype 2)
  • No additional benefit proved for two slices (Genotype 1, 3 and 4 - 6)
  • Minor additional benefit (hint) for co-infection with HIV (Genotype 1)

Subject:

  • Active Substance: Sucroferric oxyhydroxide
  • Name: Velphoro®
  • Therapeutic area: Hyperphosphatemia, renal dialysis
  • Pharmaceutical company: Fresenius Medical Care Deutschland GmbH

Time table:

  • Start: 01.10.2014
  • Final decision by G-BA: 19.03.2015

Final decision:

  • No additional benefit proved.

Subject:

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

Time table:

  • Start: 15.12.2011
  • Final decision by G-BA: 07.06.2012

Final decision:

  • Minor additional benefit (quality of evidence was not determined)
  • The additional benefit is considered to be proven as a result of the market authorisation, because Tafamidis meglumine has orphan drug status in the EU

Subject:

  • Active Substance: Tafluprost/Timolol
  • Name: Taptiqom®
  • Therapeutic area: Open-angle glaucoma, ocular hypertension
  • Pharmaceutical company: Santen GmbH

Time table:

  • Start: 01.01.2015
  • Final decision by G-BA: 18.06.2015

Final decision:

  • No additional benefit proved.

Subject:

  • Active Substance: Talimogen laherparepvec
  • Name: Imlygic®
  • Therapeutic area: Melanoma
  • Pharmaceutical company: Amgen GmbH

Time table:

  • Start: 15.06.2016
  • Final decision by G-BA: 15.12.2016

Final decision:

  • 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.

Subject:

  • Active Substance: Teduglutide
  • Name: Revestive®
  • Therapeutic area: Malabsorption Syndromes
  • Pharmaceutical company: NPS Pharma Germany GmbH

Time table:

  • Start: 01.09.2014
  • Final decision by G-BA: 19.02.2015

Final decision:

  • Minor additional benefit (proved because of orphan drug designation)

Subject:

  • Active Substance: Tegafur/gimeracil/oteracil
  • Name: Teysuno®
  • Therapeutic area: Stomach cancer
  • Pharmaceutical company: Nordic Pharma GmbH

Time table:

  • Start: 01.07.2012
  • Final decision by G-BA: 20.12.2012

Final decision:

  • No additional benefit proved
  • Nordic Pharma GmbH submitted an incomplete dossier (only module 3)

Subject:

  • Active Substance: Telaprevir
  • Name: Incivo®
  • Therapeutic area: Hepatitis C
  • Pharmaceutical company: Janssen Cilag GmbH

Time table:

  • Start: 15.10.2011
  • Final decision by G-BA: 29.03.2012

Final decision:

  • Non-quantifiable additional benefit (quality of evidence was not determined)

Subject:

  • Active Substance: Teriflunomide
  • Name: Aubagio®
  • Therapeutic area: Multiple sclerosis
  • Pharmaceutical company: Sanofi-aventis groupe/Genzyme GmbH

Time table:

  • Start: 01.10.2013
  • Final decision by G-BA: 20.03.2014

Final decision:

  • No additional benefit proved

Subject:

  • Active Substance: Ticagrelor
  • Name: Brilique®
  • Therapeutic area: Acute coronary syndrome
  • Pharmaceutical company: AstraZeneca GmbH

Time table:

  • Start: 01.01.20111
  • Final decision by G-BA: 15.12.2011

Final decision:

  • Major additional (proof) for one patient subgroup
  • Non-quantifiable benefit (quality of evidence was not determined) (indication) for one patient subgroup
  • No additional benefit proved for three patient subgroups

Subject:

  • Active Substance: Ticagrelor (new indication)
  • Name: Brilique®
  • Therapeutic area: Prevention of atherothrombotic events in patients who have had a heart attack
  • Pharmaceutical company: AstraZeneca GmbH

Time table:

  • Start: 01.04.2016
  • Final decision by G-BA: 15.09.2016

Final decision:

  • Hint for a minor additional benefit.

Subject:

  • Active Substance: Tiotropium/olodaterol
  • Name: Spiolto® Respimat®
  • Therapeutic area: COPD
  • Pharmaceutical company: Boehringer Ingelheim Pharma GmbH & Co.KG

Time table:

  • Start: 15.08.2015
  • Final decision by G-BA: 04.02.2016

Final decision:

  • 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.

Subject:

  • Active Substance: Trametinib
  • Name: Mekinist®
  • Therapeutic area: Melanoma
  • Pharmaceutical company: Novartis Pharma GmbH

Time table:

  • Start: 01.10.2016
  • Final decision by G-BA: 17.03.2016

Final decision:

  • In combination with dabrafenib: Indication for a considerable additional benefit.
  • Monotherapy: No additional benefit proved.

Subject:

  • Active Substance: Trastuzumab emtansine
  • Name: Kadcyla®
  • Therapeutic area: Breast cancer
  • Pharmaceutical company: Roche Pharma AG

Time table:

  • Start: 01.01.2014
  • Final decision by G-BA: 19.06.2014

Final decision:

  • Considerable additional benefit (indication) for one slice
  • Comparative therapy: medicinal therapy with Lapatinib and Capecitabin

Subject:

  • Active Substance: Turoctocog alfa
  • Name: NovoEight®
  • Therapeutic area: Haemophilia A
  • Pharmaceutical company: Novo Nordisk Pharma GmbH

Time table:

  • Start: 15.01.2014
  • Final decision by G-BA: 03.07.2014

Final decision:

  • No additional benefit proved

Subject:

  • Active Substance: Umeclidinium
  • Name: Incruse®
  • Therapeutic area: COPD
  • Pharmaceutical company: GlaxoSmithKline GmbH & Co. KG

Time table:

  • Start: 01.02.2016
  • Final decision by G-BA: 21.07.2016

Final decision:

  • Patients with stage II: No additional benefit proved.
  • Patients with higher stages: No additional benefit proved.

Subject:

  • Active Substance: Umeclidinium/vilanterol
  • Name: Anoro®, Laventair®
  • Therapeutic area: Pulmonary Disease, Chronic Obstructive (COPD)
  • Pharmaceutical company: GlaxoSmithKline GmbH & Co. KG

Time table:

  • Start: 15.07.2014
  • Final decision by G-BA: 08.01.2015

Final decision:

  • No additional benefit proved.

Subject:

  • Active Substance: Vandetanib
  • Name: Caprelsa®
  • Therapeutic area: Medullary thyroid carcinoma (MTC)
  • Pharmaceutical company: AstraZeneca GmbH

Time table:

  • Start: 15.03.2012
  • Final decision by G-BA: 06.09.2012

Final decision:

  • No additional benefit proved
  • AstraZeneca GmbH submitted an incomplete dossier
  • The pharmaceutical company is given the opportunity to resubmit the benefit dossier in one year

Subject:

  • Active Substance: Vandetanib
  • Name: Caprelsa®
  • Therapeutic area: medullary thyroid cancer
  • Pharmaceutical company: AstraZeneca GmbH

Time table:

  • Start: 15.03.2013
  • Publication of assessment: 17.06.2013
  • End of public hearing: 08.07.2013
  • Final decision by G-BA: 05.09.2013
  • The decision remained valid until 05.09.2016
  • Prolongation of the limitation of G-BA‘s decision: 04.08.2016
  • The decision remains valid until: 01.10.2020

Final decision:

  • Hint for a minor additional benefit.

Subject:

  • Active Substance: Vedolizumab
  • Name: Entyvio®
  • Therapeutic area: Crohn Disease and Colitis, Ulcerative
  • Pharmaceutical company: Takeda Pharma A/S

Time table:

  • Start: 15.07.2014
  • Final decision by G-BA: 08.01.2015

Final decision:

  • No additional benefit proved.

Subject:

  • Active Substance: Vemurafenib
  • Name: Zelboraf®
  • Therapeutic area: Melanoma
  • Pharmaceutical company: Roche Pharma AG

Time table:

  • Start: 15.03.2012
  • Final decision by G-BA: 06.09.2012

Final decision:

  • Considerable additional benefit (indication)
  • The decision remains valid until 06.09.2013

Subject:

  • Active Substance: Vemurafenib
  • Name: Zelboraf®
  • Therapeutic area: Melanoma
  • Pharmaceutical company: Roche Pharma AG

Time table:

  • Start: 15.09.2012
  • Final decision by G-BA: 06.03.2014

Final decision:

  • Considerable additional benefit (indication)
  • The decision remains valid until 06.09.2013

Subject:

  • Active Substance: Vildagliptin
  • Name: Galvus®, Jalra®, Xiliarx®
  • Therapeutic area: Diabetes mellitus Type 2
  • Pharmaceutical company: Novartis Pharma GmbH

Time table:

  • Start: 01.04.2013
  • Final decision by G-BA: 01.10.2013

Final decision:

  • No additional benefit proved

Subject:

  • Active Substance: Vildagliptin
  • Name: Galvus®, Jalra®, Xiliarx®
  • Therapeutic area: Diabetes mellitus, type 2
  • Pharmaceutical company: Novartis Pharma GmbH

Time table:

  • Start: 01.12.2014
  • Publication of re-assessment: 02.03.2015
  • End of public hearing: 23.03.2015
  • Final decision by G-BA: expected for the end of May 2015

Comparative therapy:

  • Human insulin in combination with sulfonylurea for the new indication „combination with sulfonylurea“

Subject:

  • Active Substance: Vildagliptin/Metformin
  • Name: Eucreas®, Icandra®, Zomarist®
  • Therapeutic area: Diabetes mellitus Type 2
  • Pharmaceutical company: Novartis Pharma GmbH

Time table:

  • Start: 01.04.2013
  • Final decision by G-BA: 01.10.2013

Final decision:

  • No additional benefit proved

Subject:

  • Active Substance: Vismodegib
  • Name: Erivedge®
  • Therapeutic area: Basal-cell carcinoma
  • Pharmaceutical company: Roche Pharma AG

Time table:

  • Start: 15.08.2013
  • Final decision by G-BA: 06.02.2014

Final decision:

  • Minor additional benefit (hint) for one of two subgroups
  • The decision remains valid until 15.02.2016

Subject:

  • Active Substance: Vismodegib (re-assessment)
  • Name: Erivedge®
  • Therapeutic area: Basal cell carcinoma
  • Pharmaceutical company: Roche Pharma AG

Time table:

  • Start: 15.02.2016
  • Final decision by G-BA: 04.08.2016

Final decision:

  • Symptomatic metastasized basal cell carcinoma (smBCC): No additional benefit proved.
  • Locally advanced basal cell carcinoma (laBCC) where neither surgery nor radiotherapy are appropriate: Hint for a minor additional benefit.

Subject:

  • Active Substance: Vortioxetin
  • Name: Brintellix®
  • Therapeutic area: Major Depression
  • Pharmaceutical company: Lundbeck GmbH

Time table:

  • Start: 01.05.2015
  • Final decision by G-BA: 15.10.2015

Final decision:

  • No additional benefit proved for each of the three slices.

 

Ansprechpartner

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