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Table 3 Summary table of key issues by therapeutic area

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

Therapeutic area indication Medicines Key issues within therapeutic class
Cardiovascular
 Hypertension Aliskiren/amlodipine Aliskiren is recommended within clinical guidelines both as monotherapy and in combination with other antihypertensives. However, the fixed combination of aliskiren and amlodipine that was appraised by the G-BA is not covered within the guidelines
Ophthalmic
 Postoperative management of cataract surgery Bromfenac Guidelines suggest the therapeutic class (NSAID) in the perioperative period in cataract surgery, but do not specify any medicine
 Glaucoma Tafluprost/timolol Guidelines strongly support the use of preservative-free medicines if there is evidence that patients are allergic to the preservative, but do not specify any medicine
Metabolic
 Diabetes Canagliflozin
Canagliflozin/metformin
Linagliptine
Lixisenatide
Vildagliptine
Vildagliptine/metformin
Guidelines evolved over time. While metformin remains the gold standard for initial drug therapy, guidelines support other classes and products such as canagliflozin and its class (SGLT-2 inhibitors), linagliptin and vildagliptin (DPP-4 inhibitors), and lixisenatide and its class (GLP-1 agonists) i) as monotherapy (SGLT-2 and DPP-4 inhibitors) in patients who are not eligible for initial metformin treatment and ii) as combination therapy (SGLT-2 and DPP-4 inhibitors and GLP-1 agonists)
Insulin degludec Basal insulin analogues are recommended within guidelines. Within that class, insulin degludec is one option
 Hypercholesterolemia Lomitapide Lomitapide and other new therapeutic options are part of the suggested treatment algorithm in patients with homozygous familiar hypercholesterolemia
Digestive
 Irritable bowel syndrome Linaclotide Only one updated guideline is available [28]. This guideline recommends linaclotide as second-line treatment if previous laxatives did not help and patients had constipations for at least 12 months
Psychiatric
 Schizophrenia Lurasidone Guidelines generally recommend second generation antipsychotic drugs, but the evidence base for appropriate comparisons is considered limited
Musculoskeletal
 Dupuytren’s contracture Microbial collagenase Lack of relevant guidelines for the treatment of Dupuytren’s contracture
Genitourinary
 Overactive bladder Mirabegron Guidelines evolved over time and included mirabegron as second-line treatment [31]
CNS
 Epilepsy Perampanel Guidelines are heterogeneous [44] and partially not updated, e.g. the American Epilepsy Society is still presenting a 2004 publication on their homepage as guidance for refractory epilepsy.
Retigabine Retigabine is recommended as adjunctive second line treatment [32]
Oncology
 Colorectal carcinoma Regorafenib Regorafenib is recommended both in US and EU clinical guidelines [33] as second/third line of therapy.
 Gastrointestinal stromal tumor Regorafenib Regorafenib is recommended as second/third line of therapy [34]
 Prostate cancer Sipuleucel-T Sipuleucel-T is recommended by various guidelines in patients with metastatic prostate cancer and asymptomatic or minimally symptomatic disease
Other
 Hyperphosphatemia Colestilan Guidelines generally recommend phosphate binding agents but do not specify any medicine
 Hypolactasiaa Gaxilose No relevant guidelines were identified for hypolactasia.
 Wound healing Living larvae from Lucilia sericata Only one guideline from 2012 is available [35]. Living larvae considered superior versus hydrogel therapy in terms of wound cleansing
  1. aHypolactasia was classified as a metabolic disorder by the G-BA
  2. DPP-4 dipeptidyl peptidase 4, G-BA Federal Joint Committee, GLP-1 glucagon-like peptide-1 receptor, NSAID nonsteroidal anti-inflammatory drugs, SGLT-2 sodium-glucose co-transporter 2