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

Staab, Thomas R.; Walter, Miriam; Mariotti Nesurini, Sonja; Dintsios, Charalabos-Markos; Graf von der Schulenburg, J.-Matthias; Amelung, Volker E.; Ruof, Jörg

doi:10.1186/s13561-018-0209-3

Table 1 Medications withdrawn from the German market since the introduction of AMNOG benefit assessments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	Unlisted^a	Type of withdrawal	Arbitration procedure
Aliskiren/amlodipine (Rasilamlo)	Novartis Pharma	Cardiovascular	14 Apr 2011	1 Sep 2011	Opt-out	NA^b
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	NA^b
Canagliflozin/metformin (Vokanamet)	Janssen-Cilag	Metabolic	23 Apr 2014	1 Mar 2015	Opt-out	NA^b
Colestilan (BindRen)	Mitsubishi Pharma	Other	21 Jan 2013	1 Apr 2015	Supply termination	No^c
Gaxilose (LacTest)	Venter Pharma S.L.	Metabolic	NA^d	1 Mar 2016	Opt-out	NA^b
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	NA^d	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	NA^b
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	NA^b
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	NA^b
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	NA^b
Retigabine (Trobalt)	GlaxoSmithKline	CNS	28 Mar 2011	1 Jul 2012	Opt-out	NA^e
Sipuleucel-T (Provenge)	Dendreon UK Limited	Oncology	6 Sep 2013	15 Jul 2015	Supply termination	No
Tafluprost/timolol (Taptiqom)	Santen	Ophthalmic	NA^d	1 Aug 2015	Opt-out	NA^b
Vildagliptin^f (Galvus, Jalra, Xiliarx)	Novartis Pharma	Metabolic	26 Sep 2007	15 Sep 2014 1 Jul 2014^g	Supply termination	Yes
Vildagliptin/metformin^f (Eucreas, Icandra, Zomarist)	Novartis Pharma	Metabolic	14 Nov 2007	15 Sep 2014 1 Jul 2014^h	Supply termination	Yes

^aDate the medication was removed from the German pharmaceutical catalogue (Lauer-Taxe), which is updated bi-monthly
^bNot applicable as opt-out medications do not enter price negotiations
^cAn arbitration procedure was initiated [42] but not completed [5]
^dNot applicable as decentralized approval
^eThe manufacturer opted out before the price negotiations; however, price negotiations and eventually an arbitration procedure were subsequently initiated by a parallel importer [5]
^fAssessment of the existing market
^gFor Galvus and Jalra, respectively (Xiliarx is marketed by foreign third parties)
^hFor Eucreas and Icandra, respectively (Zomarist is marketed by foreign third parties)
ⁱSupply termination only for outpatient services, medicine still available in hospital settings
AMNOG: Act on the Reform of the Market for Medical Products; CNS: central nervous system; EMA: European Medicines Agency

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ISSN: 2191-1991

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