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Table 1 Medications withdrawn from the German market since the introduction of AMNOG benefit assessments

From: “Market withdrawals” of medicines in Germany after AMNOG: a comparison of HTA ratings and clinical guideline recommendations

Active ingredient (brand name) Manufacturer Therapeutic area EMA approval Unlisteda Type of withdrawal Arbitration procedure
Aliskiren/amlodipine (Rasilamlo) Novartis Pharma Cardiovascular 14 Apr 2011 1 Sep 2011 Opt-out NAb
Bromfenac (Yellox) Bausch & Lomb/Dr. Mann Pharma Ophthalmic 18 May 2011 1 May 2014 Supply termination Yes
Canagliflozin (Invokana) Janssen-Cilag Metabolic 15 Nov 2013 15 Oct 2014 Opt-out NAb
Canagliflozin/metformin (Vokanamet) Janssen-Cilag Metabolic 23 Apr 2014 1 Mar 2015 Opt-out NAb
Colestilan (BindRen) Mitsubishi Pharma Other 21 Jan 2013 1 Apr 2015 Supply termination Noc
Gaxilose (LacTest) Venter Pharma S.L. Metabolic NAd 1 Mar 2016 Opt-out NAb
Insulin degludec (Tresiba) Novo Nordisk Pharma Metabolic 21 Jan 2013 15 Jan 2016 Supply termination Yes
Living larvae from Lucilia sericata (BioBag) BioMonde GmbH Other NAd 15 Jun 2015 Supply terminationi Yes
Linaclotide (Constella) Almirall Hermal Digestive 26 Nov 2012 15 Jul 2014 Supply termination Yes
Linagliptin (Trajenta) Boehringer Ingelheim Pharma Metabolic 24 Aug 2011 1 Jan 2012 Opt-out NAb
Lixisenatide (Lyxumia) Sanofi-Aventis Deutschland Metabolic 1 Feb 2013 15 Jun 2014 Supply termination Yes
Lomitapide (Lojuxta) Aegerion Pharmaceuticals Metabolic 31 Jul 2013 1 Aug 2014 Opt-out NAb
Lurasidone (Latuda) Takeda GmbH Psychiatric 21 Mar 2014 15 Nov 2015 Supply termination No
Microbial collagenase (Xiapex) Pfizer Pharma Musculoskeletal 28 Feb 2011 15 Jun 2012 Opt-out NAb
Mirabegron (Betmiga) Astellas Pharma GmbH Genitourinary 20 Dec 2012 1 Jun 2015 Supply termination Yes
Perampanel (Fycompa) Eisai CNS 23 Jul 2012 1 Aug 2014 Supply termination Yes
Regorafenib (Stivarga) Bayer Vital Oncology 26 Aug 2013 15 May 2016 Opt-out NAb
Retigabine (Trobalt) GlaxoSmithKline CNS 28 Mar 2011 1 Jul 2012 Opt-out NAe
Sipuleucel-T (Provenge) Dendreon UK Limited Oncology 6 Sep 2013 15 Jul 2015 Supply termination No
Tafluprost/timolol (Taptiqom) Santen Ophthalmic NAd 1 Aug 2015 Opt-out NAb
Vildagliptinf (Galvus, Jalra, Xiliarx) Novartis Pharma Metabolic 26 Sep 2007 15 Sep 2014
1 Jul 2014g
Supply termination Yes
Vildagliptin/metforminf (Eucreas, Icandra, Zomarist) Novartis Pharma Metabolic 14 Nov 2007 15 Sep 2014
1 Jul 2014h
Supply termination Yes
  1. aDate the medication was removed from the German pharmaceutical catalogue (Lauer-Taxe), which is updated bi-monthly
  2. bNot applicable as opt-out medications do not enter price negotiations
  3. cAn arbitration procedure was initiated [42] but not completed [5]
  4. dNot applicable as decentralized approval
  5. eThe manufacturer opted out before the price negotiations; however, price negotiations and eventually an arbitration procedure were subsequently initiated by a parallel importer [5]
  6. fAssessment of the existing market
  7. gFor Galvus and Jalra, respectively (Xiliarx is marketed by foreign third parties)
  8. hFor Eucreas and Icandra, respectively (Zomarist is marketed by foreign third parties)
  9. iSupply termination only for outpatient services, medicine still available in hospital settings
  10. AMNOG: Act on the Reform of the Market for Medical Products; CNS: central nervous system; EMA: European Medicines Agency