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Table 2 Extent of additional benefit and recommendation status for all withdrawn medicines

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

Medicine Reason for ‘no additional benefit’ ratinga Number of guidelines with positive recommendation (total number of guidelines reviewed)
At time of benefit assessment Additional guidelines June 2016
Guidelines Recommendationb Guidelines Recommendationb
Aliskiren/ amlodipine No appropriate data 1 (4) Medicine (aliskiren) 1 (2) Medicine (aliskiren)
Bromfenac No dossier submitted 4 (7) Class (NSAID) 1 (2) Class (NSAID)
Canagliflozin Insufficient clinical superiority 1 (4) Class (SGLT-2 inhibitors) 3 (3) Medicine (canagliflozin)
Canagliflozin/ metformin Insufficient clinical superiority 1 (5) Class (SGLT-2 inhibitors/metformin) 3 (3) Class (SGLT-2 inhibitors/metformin)
Colestilan Insufficient clinical superiority 1 (1) Class (phosphate binding agents) 1 (1) Class (phosphate binding agents)
Gaxilose No dossier submitted n.a. n.a. n.a. n.a.
Insulin degludec Insufficient clinical superiority 7 (7) Class (basal insulin analogues) 3 (3) Medicine (insulin degludec)
Living larvae from Lucilia sericata No dossier submitted 1 (1) Medicine (living larvae) n.a. n.a.
Linaclotide Insufficient clinical superiority 0 (4) n.a. 1 (1) Medicine (linaclotide)
Linagliptin Insufficient clinical superiority 2 (3) Class (DPP-4 inhibitors) 3 (3) Medicine (linagliptin) and class (DPP-4 inhibitors)
Lixisenatide Insufficient clinical superiority 5 (5) Class (GLP-1 agonists) 3 (4) Medicine (lixisenatide) and class (GLP-1 agonists)
Lomitapide Insufficient clinical superiority 0 (2) n.a. 1 (1) Medicine (lomitapide)
Lurasidone Insufficient clinical superiority 4 (4) Medicine (lurasidone) 2 (2) Class (second generation antipsychotic drugs)
Microbial collagenase Insufficient clinical superiority n.a. n.a. n.a. n.a.
Mirabegron Insufficient clinical superiority 0 (6) n.a. 1 (1) Medicine (mirabegron)
Perampanel No appropriate data 0 (1) n.a. 0 (1) n.a.
Regorafenib Insufficient clinical superiority 0 (7) n.a. 3 (6) Medicine (regorafenib)
Retigabine No appropriate data 1 (1) Medicine (retigabine) 1 (1) Medicine (retigabine)
Sipuleucel-T n.a. 4 (11) Medicine (sipuleucel-T) 5 (9) Medicine (sipuleucel-T)
Tafluprost/timolol Insufficient clinical superiority 2 (2) Class (preservative- free medicines) n.a. n.a.
Vildagliptin Insufficient clinical superiority 5 (5) Medicine (vildagliptin) 4 (4) Medicine (vildagliptin) and class (DPP-4 inhibitor)
Vildagliptin/ metformin Insufficient clinical superiority 5 (5) Medicine (vildagliptin/metformin) 4 (4) Class (DPP-4 inhibitors/metformin)
  1. aAll medicines had a ‘no additional benefit’ rating except Sipuleucel-T (‘non quantifiable benefit’)
  2. bRecommendation of medicine or therapeutic class
  3. DPP-4: dipeptidyl peptidase 4; GLP-1: glucagon-like peptide-1 receptor; n.a.: not applicable; NSAID: nonsteroidal anti-inflammatory drugs; SGLT-2: sodium-glucose co-transporter 2
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Health Economics Review

ISSN: 2191-1991

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