title: [Is autologous chondrocyte implantation a technology suitable for ambulatory health care?].
abstract: Statutory ambulatory health care services provided by physicians in Germany are specified by a joint committee of physicians and sickness funds, the Federal Committee of Physicians and Sickness Funds. To ensure that only effective interventions are covered, new medical technologies must demonstrate evidence of clinical effectiveness, cost-effectiveness and medical necessity. Due to increasing demands for reimbursement of autologous chondrocyte implantation, the Committee recently assessed this procedure. Autologous chondrocyte implantation (ACI) is a surgical procedure to reestablish the chondral layer in the knee following trauma. Such injuries may subsequently lead to osteoarthritis, and may eventually require joint replacement. Although the U.S. Food and Drug Administration (FDA) approval of ACI limits its usage to treatment of specific knee defects, other indications, such as for chondromalacia patellae, are promoted by proponents of the technology. The Committee conducted a thorough literature review and examined the status of ACI in other health care systems. Reimbursement of this technology was declined for the following reasons: the effectiveness of ACI has not yet been established in long term, comparative studies, and the procedure involves a type of operation not suitable for the ambulatory health care sector. Other public health insurance systems, such as in Switzerland and Canada, have not yet introduced funding for ACI, and an assessment is currently being conducted by the UK National Institute for Clinical Excellence (NICE). Autologous chondrocyte implantation is a technology that will compete with various other new interventions to correct chondral defects of the knee. It is essential that the treatment effect of ACI be demonstrated in clinically sound, comparative trials before this technology is introduced into the public health care system.
authors.affiliation: Kassenärztliche Bundesvereinigung, Köln.
authors.forename: B
authors.initials: B
authors.lastname: Gibis
authors.forename: C
authors.initials: C
authors.lastname: Gawlik
authors.forename: G
authors.initials: G
authors.lastname: Sander
authors.forename: P
authors.initials: P
authors.lastname: Rheinberger
mesh_terms: D000553:Ambulatory Care / Q000592:standards*; D000554:Ambulatory Care Facilities / Q000592:standards*; D017690:Cell Transplantation / Q000592:standards*; D019902:Chondrocytes / Q000166:cytology* / Q000637:transplantation; D005858:Germany; D006801:Humans; D007592:Joint Diseases / Q000628:therapy*; D011785:Quality Assurance, Health Care; D014182:Transplantation, Autologous; D014481:United States; D014486:United States Food and Drug Administration