Aktuelle europäische Nutzenbewertungsverfahren

Hier finden Sie die aktuellen Verfahren der europäischen Nutzenbewertung (Pilotverfahren der EUnetHTA). Für nähere Informationen klicken Sie auf die Wirkstoffe.

 

Ongoing

Subject:

  • Active Substance: Brolucizumab
  • Name: N.N.
  • Therapeutic area: Neovascular age-related macular degeneration
  • Pharmaceutical company: Novartis Pharma GmbH

Time table:

  • Application for centralized marketing authorization: March 2019

Assessment information:

  • Title: Brolucizumab for the treatment of adults with neovascular (wet) age-related macular degeneration (AMD)
  • Author/Co-Author: FIMEA (Finland), AEMPS/ AETSA (Spain)
  • Dedicated Reviewers: HAS (France), AOTMiT (Poland), HVB (Austria), RER (Italy)
  • Observer: HTA department/EC Ukraine

Subject:

  • Active Substance: Cefiderocol
  • Name: N.N.
  • Therapeutic area: Infectious diseases
  • Pharmaceutical company: Shionogi GmbH

Time table:

  • Application for centralized marketing authorization: April 2019

Assessment information:

  • Title: Cefiderocol for the treatment of infections due to aerobic Gram-negative bacteria in adult patients with limited treatment options
  • Author/Co-Author: AIFA (Italy), NOMA (Norway)
  • Dedicated Reviewers: AEMPS (Spain), HAS (France), IQWIG (Germany)

Subject:

  • Active Substance: Crizanlizumab
  • Name: N.N.
  • Therapeutic area: Haematology - Hemostaseology
  • Pharmaceutical company: Novartis Pharma GmbH

Time table:

  • Application for centralized marketing authorization: July 2019

Assessment information:

  • Title: Crizanlizumab for the prevention of vaso-occlusive crises in sickle cell disease patients aged 16 years and over
  • Author/Co-Author: HVB (Austria), NCPE (Ireland)
  • Dedicated Reviewers: INFARMED (Portugal), SNHTA (Switzerland), HAS (France)

Subject:

  • Active Substance: Enasidenib
  • Name: N.N.
  • Therapeutic area: Acute myeloid leukaemia (AML)
  • Pharmaceutical company: Celgene GmbH

Time table:

  • Application for centralized marketing authorization: July 2018

Assessment information:

  • Title: Enasidenib for the treatment of adult patients with relapsed or refractory acute myeloid leukaemia (AML) with an isocitrate dehydrogenase 2 (IDH2) mutation
  • Author/Co-Author: NOMA (Norway), AEMPS/AETSA (Spain)
  • Dedicated Reviewers: HAS (France), AIFA (Italy), SNHTA (Switzerland), HIS (UK), DPA/MoH Malta (Malta)

Subject:

  • Active Substance: Glasdegib
  • Name: N.N.
  • Therapeutic area: Acute myeloid leukaemia (AML)
  • Pharmaceutical company: Pfizer Pharma GmbH

Time table:

  • Application for centralized marketing authorization: June 2019

Assessment information:

  • Title: Glasdegib indicated for the treatment of newly diagnosed de novo or secondary acute myeloid leukaemia (AML)
  • Author/Co-Author: HVB (Austria), NCPE (Ireland)
  • Dedicated Reviewers: INFARMED (Portugal), SNHTA (Switzerland), HAS (France)

Subject:

  • Active Substance: Polatuzumab vedotin
  • Name: Polivy
  • Therapeutic area: Diffuse large B-cell lymphoma (DLBCL)
  • Pharmaceutical company: Roche Pharma AG

Time table:

  • Publication of project plan: 22.11.2019
  • Publication of final assessment expected: 13.02.2019

Assessment information:

  • Title: Polatuzumab vedotin in combination with bendamustine and rituximab for the treatment of relapsed/refractory diffuse large B-cell lymphoma (DLBCL)
  • Author/Co-Author: IQWiG (Germany), HAS (France)
  • Dedicated Reviewers: FIMEA (Finland), SUKL (Czech Republic), TLV (Sweden), INFARMED (Portugal)
  • Observer: GBA (Germany)

Subject:

  • Active Substance: Satralizumab
  • Name: N.N.
  • Therapeutic area: Neuromyelitis optica spectrum disorders (NMOSD)
  • Pharmaceutical company: Roche Pharma AG

Time table:

  • Application for centralized marketing authorization: October 2019

Assessment information:

  • Title: Satralizumab indicated for the treatment of adult and adolescent patients (≥12 yrs) with neuromyelitis optica spectrum disorders (NMOSD)
  • Author/Co-Author: INFARMED (Portugal), EUR (Netherlands), ZIN (Netherlands)
  • Dedicated Reviewers: AEMPS (Spain), JAZMP (Slovenia), HIS (UK)

Subject:

  • Active Substance: Siponimod
  • Name: N.N.
  • Therapeutic area: Secondary Progressive Multiple Sclerosis (SPMS)
  • Pharmaceutical company: Novartis Pharma GmbH

Time table:

  • Publication of project plan: 20.11.2019
  • Publication of final assessment expected: 13.02.2020

Assessment information:

  • Title: Siponimod for the treatment of adult patients with secondary progressive multiple sclerosis (SPMS)
  • Author/Co-Author: INFARMED (Portugal), NCPE (Ireland)
  • Dedicated Reviewers: AIFA (Italy), ZIN (Netherlands), SESCS/FUNCANIS (Spain), RER (Italy)

 

Completed

Subject:

  • Active Substance: Sofosbuvir, Ledipasvir/Sofosbuvir, Simeprevir, Daclatasvir, Ombitasvir/Paritaprevir/Ritonavir, Dasabuvir
  • Name: SOVALDI®, HARVONI®, OLYSIO, DAKLINZA, VIEKIRAX®, EXVIERA®
  • Therapeutic area: Hepatitis C
  • Pharmaceutical company: Bristol-Myers Squibb GmbH & Co. KGaA, AbbVie Deutschland GmbH & Co. KG, Janssen-Cilag GmbH, Gilead Sciences GmbH

Time table:

  • Publication of final assessment: 17.12.2015

Assessment information:

  • Title: Rapid relative effectiveness assessment of new pharmaceuticals for the treatment of chronic Hepatitis C
  • Author/Co-Author: KCE (Belgium), AAZ (Croatia), UCSC Gemelli (Italy), HVB (Austria)
  • Dedicated Reviewers: SNHTA (Switzerland), SAGEM HTA (Turkey), ZIN (Netherlands), AETSA (Spain), AIFA (Italy), MoH Slovak Republic (Slovakia), NIPHNO (Norway), HAS (France), MoH Malta (Malta), NVD (Latvia), FIMEA (Finland), SMC (Scotland), IQWiG (Germany), INFARMED (Portugal)

G-BA assessment available for › Sofosbuvir (D-091), › Ledipasvir/Sofosbuvir (D-143), › Simeprevir (D-113), › Daclatasvir (D-129), › Ombitasvir/Paritaprevir/Ritonavir (D-153), › Dasabuvir (D-152)

Subject:

  • Active Substance: Alecitinib
  • Name: Alecensa©
  • Therapeutic area: Non-small cell lung cancer (NSCLC)
  • Pharmaceutical company: Roche Pharma AG

Time table:

  • Publication of project plan: 20.10.2018
  • Publication of final assessment: 23.01.2018

Assessment information:

  • Title: Alecitinib as monotherapy for the first-line treatment of adult patients with ALK-positive advanced non-small cell lung cancer
  • Author/Co-Author: TLV (Sweden), HVB (Austria), AAZ (Croatia)
  • Dedicated Reviewers: NICE (UK), Regione Veneto (Italy), AETSA (Spain), NIPN (Hungary)
  • Information retrieval: IQWiG (Germany)
  • Observer: MoH (Malta)

› G-BA assessment available (D-326)

Subject:

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

Time table:

  • Publication of final assessment: 26.02.2014

Assessment information:

  • Title: Canagliflozin for the treatment of type 2 diabetes mellitus
  • Author/Co-Author: AAZ (Croatia), FIMEA (Finland), PRIHTA (Italy)
  • Dedicated Reviewers: CAHIAQ (Spain), HAS (France), HVB (Austria), MU Sofia (Bulgaria), MoH Czech (Czech Republic)

› G-BA assessment available (D-101)

Subject:

  • Active Substance: Midostaurin
  • Name: Rydapt®
  • Therapeutic area: Acute myeloid leukaemia (AML)
  • Pharmaceutical company: Novartis Pharma GmbH

Time table:

  • Publication of project plan: 20.06.2017
  • Publication of final assessment: 08.11.2017

Assessment information:

  • Title: Midostaurin for the indication of Acute Myeloid Leukaemia
  • Author/Co-Author: FIMEA (Finnland), NOMA (Norway)
  • Dedicated Reviewers: TLV (Sweden), ZIN (Netherlands), HAS (France), AEMPS (Spain)
  • Information retrieval: IQWIG (Germany)
  • Observer: SUKL (Czech Republic), EOPYY (Greece), SESCS (Spain)

› G-BA assessment available (D-319)

Subject:

  • Active Substance: Pazopanib
  • Name: Votrient®
  • Therapeutic area: Treatment of advanced renal cell carcinoma
  • Pharmaceutical company: Novartis Pharma GmbH

Time table:

  • Publication of final assessment: September 2012

Assessment information:

  • Title: Treatment-naïve patients (first-line treatment) and cytokine pre-treated patients (second-line treatment) with advanced or metastatic (stage III-IV) renal cell carcinoma (patients ≥ 18 years or older; no restrictions according to performance status)
  • Author/Co-Author: AIFA (Italy), KCE (Belgium), GÖG (Austria), MHEC-DPA (Malta), HBV (Austria), RIZIV-INAMI (Belgium), AETSA (Spain), FIMEA (Finland), HAS (France), UCSC Gemelli (Italy), NIPHNO (Norway), CVZ (Netherland), Finohta/THL (Finland), NICE (UK)
  • Dedicated Reviewers: CAHIAQ (Spain), UCSC Gemelli (Italy), GYEMSZI (Hungary), CAST (Denmark), FOPH (Swizerland), NIPHNO (Norway), MoH Spain (Spain), UETS (Spain), AETSA (Spain), VEC (Latvia), RIZIV-INAMI (Belgium), IQWiG (Germany) , MoH Czech (Czech Republic), HAS (France)

G-BA assessment not available
Reason: First launch of Pazopanib was in 2010 (pre-AMNOG).

Subject:

  • Active Substance: Ramucirumab
  • Name: Cyramza®
  • Therapeutic area: Gastric or gastro-oesophageal junction adenocarcinoma
  • Pharmaceutical company: Lilly Deutschland GmbH

Time table:

  • Publication of final assessment: 20.03.2015

Assessment information:

  • Title: Ramucirumab in combination with Paclitaxel as second-line treatment for adult patients with advanced gastric or gastro-oesophageal junction adenocarcinoma
  • Author/Co-Author: NIPHNO (Norway), AAZ (Croatia)
  • Dedicated Reviewers: MoH Slovak Republic (Slovakia), FIMEA (Finland), GYMSZI (Hungary), UCSC Gemelli (Italy), HAS (France)

› G-BA assessment available (D-224)

Subject:

  • Active Substance: Regorafenib
  • Name: Stivarga©
  • Therapeutic area: Hepatocellular carcinoma (HCC)
  • Pharmaceutical company: Bayer Vital GmbH

Time table:

  • Publication of project plan: 10.07.2017
  • Publication of final assessment: 25.10.2017

Assessment information:

  • Title: Regorafenib (Stivarga©) indicated as monotherapy for the treatment of adult patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib
  • Author/Co-Author: HAS (France), INFARMED (Portugal)
  • Dedicated Reviewers: AAZ (Croatia), SNHTA (Swiss), FIMEA (Finland), LBI-HTA (Austria), NIPN (Hungary), AETSA (Spain),
  • Information retrieval: IQWiG (Germany)
  • Observer: EOF (Greece), EKAPTY (Greece)

G-BA assessment not available
Reason: Regorafenib has been withdrawn from the German maket prior to launch in the new indication (2016).

Subject:

  • Active Substance: Sorafenib
  • Name: Nexavar®
  • Therapeutic area: Thyroid carcinoma
  • Pharmaceutical company: Bayer Pharma AG

Time table:

  • Publication of final assessment: 17.03.2015

Assessment information:

  • Title: Sorafenib for the treatment of progressive, locally advanced or metastatic, differentiated (papillary/follicular/Hürthle cell) thyroid carcinoma refractory to radioactive iodine
  • Author/Co-Author: AIFA (Italy), INFARMED (Portugal)
  • Dedicated Reviewers: RIZIV-INAMI (Belgium), FIMEA (Finland), GYEMSZI (Hungary), NCPE (Ireland), MoH Slovak Republic (Slovakia)

G-BA assessment not available
Reason: First launch of Sorafenib was in 2010 (pre-AMNOG).

Subject:

  • Active Substance: Sotaglifozin
  • Name: Zynquista®
  • Therapeutic area: Type-1 diabetes mellitus
  • Pharmaceutical company: Sanofi S.A.

Time table:

  • Publication of project plan: 05.03.2019
  • Publication of final assessment: 07.06.2019

Assessment information:

  • Title: Sotagliflozin indicated as an adjunct to insulin therapy to improve glycaemic control in adults with type 1 diabetes mellitus with a Body Mass Index (BMI) ≥ 27 kg/m2, who have failed to achieve adequate glycaemic control despite optimal insulin therapy
  • Author/Co-Author: TLV (Sweden), ZIN (Netherlands), NCPE (Ireland)
  • Dedicated Reviewers: AEMPS (Spain), SNHTA (Switzerland), NVD (Latvia), INFARMED (Portugal), AOTMiT (Poland)
  • Information retrieval: N.N.
  • Observer: HIS (UK), EOF (Greece)

G-BA assessment not available
Reason: Sotaglifozin was not launched in Germany.

Subject:

  • Active Substance: Ustekinumab
  • Name: N.N.
  • Therapeutic area: Adult patients with moderately to severely active ulcerative colitis (UC)
  • Pharmaceutical company: Janssen-Cilag GmbH

Time table:

  • Publication of project plan: 29.07.2019
  • Publication of final assessment: 22.10.2019

Assessment information:

  • Title: Ustekinumab for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response with, lost response to or were intolerant to either conventional therapy or a biologic or have medical contraindications to such therapies.
  • Author/Co-Author: MIZ (Croatia), TLV (Sweden), AOTMiT (Poland)
  • Dedicated Reviewers: UCSC Gemelli (Italy), NIPN (Hungary), SNHTA (Switzerland), SESCS (Spain)/ Funcanis (Spain)
  • Observer: NCPHA (Bulgaria)

G-BA assessment not available:
Reason: First launch of Ustekinumab was in 2009 (pre-AMNOG).

Subject:

  • Active Substance: Vorapaxar
  • Name: ZONTIVITY
  • Therapeutic area: Reduction of thrombotic cardiovascular events
  • Pharmaceutical company: Merck & Company Inc.

Time table:

  • Publication of final assessment: 17.06.2015

Assessment information:

  • Title: Vorapaxar for the reduction of thrombotic cardiovascular events in patients with a history of myocardial infection (MI)
  • Author/Co-Author: HAS (France), MoH Slovak Republic (Slovakia)
  • Dedicated Reviewers: AOTMiT (Poland), SNHTA (Switzerland), AQUAS (Spain), HVB (Austria), SMC (Scotland), ZIN (Netherlands)

G-BA assessment not available
Reason: The marketing authorisation for Vorapaxar has been withdrawn at the request of the marketing authorisation holder.

Subject:

  • Active Substance: Preparation of live, attenuated varicella-zoster virus (Oka/Merck strain)
  • Name: Zostavax®
  • Therapeutic area: Treatment of Herpes Zoster
  • Pharmaceutical company: MSD SHARP & DOHME GMBH

Time table:

  • Publication of final assessment: 17.09.2013

Assessment information:

  • Title: Zostavax for the prevention herpes zoster and postherpetic nostalgia
  • Author/Co-Author: CVZ (Netherlands), UCSC Gemelli (Italy)
  • Dedicated Reviewers: HAS (France), DPA/MoH Malta (Malta), RIZIV-INAMI (Belgium), BIQG/GÖG (Austria), MoH Czech (Czech Republic), Veneto/ CRUF(Italy), DGFPS MSPSI (Spain)

G-BA assessment not available
Reason: First launch of Sorafenib was in 2006 (pre-AMNOG).

 

Ansprechpartner

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