title: From evidence assessments to coverage decisions?: the case example of glinides in Germany.
abstract: In Germany, coverage decisions in the statutory health insurance (SHI) system are based on the principles of evidence-based medicine. Recently, an evidence assessment by the Institute for Quality and Efficiency in Health Care (IQWiG) of the oral antidiabetics of the glinide class showed that their long-term benefit is not proven. Accordingly, the responsible Federal Joint Committee (G-BA) decided to exclude glinides from prescription in the SHI system. This was, however, objected to by the Ministry of Health, which is charged with legal supervision. We use this case to illustrate the path from evidence assessments to coverage decisions in Germany against the background of the latest health reform, which has changed the legal requirements for evidence assessments and the ensuing coverage decisions.
authors.affiliation: Department of Health Care Management, University of Technology, Berlin, Germany. j.kreis@iqwig.de
authors.forename: Julia
authors.initials: J
authors.lastname: Kreis
authors.forename: Reinhard
authors.initials: R
authors.lastname: Busse
mesh_terms: D002219:Carbamates / Q000191:economics*; D003363:Cost Control; D003362:Cost-Benefit Analysis; D003365:Costs and Cost Analysis; D003510:Cyclohexanes / Q000191:economics*; D003920:Diabetes Mellitus / Q000188:drug therapy*; D004608:Eligibility Determination; D019317:Evidence-Based Medicine; D005858:Germany; D018166:Health Care Reform / Q000331:legislation & jurisprudence; D006291:Health Policy / Q000331:legislation & jurisprudence; D006801:Humans; D007004:Hypoglycemic Agents / Q000191:economics*; D019458:Insurance Coverage; D000077715:Nateglinide; D009313:National Health Programs; D010649:Phenylalanine / Q000031:analogs & derivatives* / Q000191:economics; D010880:Piperidines / Q000191:economics*; D055553:Prescription Drugs / Q000191:economics*; D012051:Reimbursement Mechanisms; D013673:Technology Assessment, Biomedical
chemical_list: D002219:Carbamates; D003510:Cyclohexanes; D007004:Hypoglycemic Agents; D010880:Piperidines; D055553:Prescription Drugs; D000077715:Nateglinide; D010649:Phenylalanine; C072379:repaglinide