Skip to main content

Table 2 Extent of additional benefit and recommendation status for all withdrawn medicines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