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IQWiG Reimbursement Decisions Database

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Records 1 to 9 of 9
Brand Name Generic Name Manufacturer Body System/ Condition Indication Benefit Assessment Summary Comparator Resolution Date
Aubagio  Teriflunomide  sanofi-aventis groupe / Genzyme GmbH  Nervous system   Multiple sclerosis  Additional benefits not proven  Beta-interferons (1a or 1b) or glatiramer acetate in compliance with each approved application area. (Glatiramer acetate is not approved for patients with primary or secondary progressive multiple sclerosis (MS))  2014-03-20 
Giotrif  Afatinib  Boehringer Ingelheim Pharma GmbH & Co. KG  Oncology   Non-small cell lung cancer  1) Not pretreated patients (i) ECOG PS 0-1 compared to Gefitinib or erlotinib or cisplatin + (Vinorelbine, Gemcitabine,docetaxel, paclitaxel or pemetrexed) (a) EGFR mutation Del19 - Indication of major added benefit (b) EGFR mutation L858R: Age <65 - Hint of minor added benefit; Age ≥ 65 no additional benefit (c) Other EGFR mutations - Indication of less benefit (ii) ECOG-PS 2 compared to Gefitinib or erlotinib or gemcitabine - Additional benefits not covered 2) With one or more Pretreated chemotherapy (n) patients compared to Erlotinib or gefitinib - Additional benefits not covered  1) Not yet naïve patients: (a) Gefitinib or erlotinib OR (b)Patients with ECOG performance status 0 or 1: cisplatin in combination with a Drittgenerationszytostatikum (vinorelbine, gemcitabine, docetaxel, paclitaxel, pemetrexed) in compliance with each approved application area (c) Patients with ECOG performance status 2: gemcitabine. 2) With one or more chemotherapy (n) treatment-experienced patients: Gefitinib or erlotinib.  2014-05-08 
Relvar/Ellipta   Fluticasone furoate / Vilanterol-Trifenatat  GlaxoSmithKline GmbH & Co. KG  Respiratory   Asthma, COPD  Dossier incomplete    0000-00-00 
Stivarga  Regorafenib  Bayer Vital GmbH  Oncology   Colorectal cancer  Hint of a minor added benefit  For patients who had previous fluoropyrimidine-based chemotherapy, an anti-VEGF-based therapy, and, if a kras wild type is present, have had an anti-EGFR-based therapy, or did not qualify for such treatment: Best Supportive Care.  2014-03-20 
Tafinlar  Dabrafenib  GlaxoSmithKline GmbH & Co. KG  Oncology   Melanoma  No additional benefits  Dacarbazine  2014-04-03 
Ultibro / Breezhaler / Xoterna / Breezhaler  Indacaterol / glycopyrronium  Novartis Pharma GmbH  Respiratory   Chronic obstructive pulmonary disease  1) Adult patients with COPD stage II compared to LABA (formoterol, salmeterol) and / or LAMA (Tiotropium bromide) - Hint of a minor added benefit 2) Patients with COPD and at most 2 exacerbations per year (COPD stage III) compared to LABA (formoterol, salmeterol) and / or LAMA (Tiotropium bromide) - Indication of minor added benefit 3) Patients with COPD and at most 2 exacerbations per year (COPD stage IV) compared to LABA (formoterol, salmeterol) and / or LAMA (Tiotropium bromide) - Additional benefit not proven 4) Adult patients with COPD stage III or IV and more than two exacerbations per year compared to LABA (formoterol, salmeterol) and / or LAMA (Tiotropium bromide) and additionally inhaled corticosteroids - Additional benefit not proven   The treatment of stable COPD of moderate (stage II) severity, severe (stage III) and very severe (stage IV) is carried out according to the recommendations of the National Disease Management Guideline for COPD. For the duration of drug therapy at level II long-acting beta 2-agonists (formoterol, salmeterol) and / or tiotropium are recommended. In COPD stage III / IV with more than two exacerbations per year in addition inhaled corticosteroids should be used.  2014-05-08 
Xtandi  Enzalutamid  Astellas   Oncology   Prostate cancer  1) Patients with visceral metastasis - Indication of major added benefit 2) Patients without visceral metastasis - Hint of significant additional benefits   1) Best Supportive Care 2) Best Supportive Care   2014-02-20 
Zelboraf  Vemurafenib  Roche Pharma AG  Oncology   Melanoma  Indication of a considerable additional benefit  Dacarbazine  2014-03-06 
Zytiga  Abiraterone acetate (new therapeutic indication)  Janssen-Cilag   Oncology   Prostate cancer  Hint of considerable added benefit  The appropriate comparator therapy is the wait and see approach while maintaining the existing conventional androgen deprivation or possibly the combined maximum androgen blockade with a non antiandrogen (flutamide, bicalutamide).  2013-07-04 

Records 1 to 9 of 9

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